Engstrom Carestation Users Reference Manual Sw Ver 5.X

User Responsibility This Product will perform in conformity with the description thereof contained in this User’s Reference manual and accompanying labels and/or inserts, when assembled, operated, maintained, and repaired in accordance with the instructions provided. This Product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted, or contaminated should be replaced immediately. Should repair or replacement become necessary, Datex-Ohmeda recommends that a telephonic or written request for service advice be made to the nearest Datex-Ohmeda Customer Service Center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by Datex-Ohmeda and by Datex-Ohmeda trained personnel. The Product must not be altered without the prior written approval of Datex-Ohmeda. The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Datex-Ohmeda.

CAUTION

U.S. Federal law restricts this device to sale by or on the order of a licensed medical practitioner. Outside the U.S.A., check local laws for any restriction that can apply. Datex-Ohmeda products have unit serial numbers with coded logic which indicates a product group code, the year of manufacture, and a sequential unit number for identification. The serial number can be in one of two formats. AAAX11111

AAAXX111111AA

The X represents an alpha character indicating the year the product was manufactured; H = 2004, J = 2005, etc. I and O are not used.

The X X represents a number indicating the year the product was manufactured; 04 = 2004, 05 = 2005, etc.

Engström, Carestation, ComWheel, D-fend, SpiroDynamics, and INview are registered trademarks of Datex-Ohmeda, Inc. Other brand names or product names used in this manual are trademarks or registered trademarks of their respective holders.

Table of Contents 1 Introduction What is an Engström Carestation?... 1-2 Symbols used in the manual or on the equipment... 1-3 Abbreviations... 1-7 Conventions used... 1-10 Hard keys... 1-10

2 System Controls and Menus Ventilator overview... 2-2 Display controls and indicators... 2-6 Menu keys... 2-7 Ventilator display... 2-8 Screen configuration... 2-8 Using menus... 2-12 System menus... 2-13 Select Patient menu... 2-13 System Setup menu... 2-13 Patient Setup menus... 2-14 Vent Preferences... 2-17 Screen Setup... 2-18 Parameters Setup... 2-20 Spirometry menus... 2-24 Procedures menus... 2-25 Alarms Setup menu... 2-27 Trends menu... 2-27

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3 Setup and Connections General use... 3-2 Power connection... 3-3 Module bay connection... 3-4 Gas supply connections... 3-5 Communication port... 3-6 Port 4 Communication... 3-6 Nurse call... 3-7 Electronic micropump nebulizer... 3-8 Assembling the nebulizer... 3-8 Filling the nebulizer... 3-10 Disassembling the nebulizer... 3-10 Disposable nebulizer... 3-10 Auxiliary pressure... 3-11 Purging of tubing... 3-11 Zeroing... 3-12 Humidifier mount (optional)... 3-13 Support arm (optional)... 3-15 Isolated electrical outlets (optional)... 3-16 Electrical outlet panel ratings... 3-16 EVair 03 compressor (optional)... 3-17 Before each use... 3-19

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4 Operation Preparing the ventilator for a patient... 4-2 Turning on the system... 4-2 Select Patient... 4-2 Patient weight... 4-3 Pre-use checkout... 4-4 Testing alarms... 4-5 Patient ID... 4-7 Vent Setup... 4-7 Ventilation preferences... 4-10 Alarms setup... 4-14 Selecting a data source... 4-16 Starting ventilation... 4-17 Entering Standby... 4-18 Turning the system off... 4-18 Monitoring... 4-18 Park Circuit... 4-19 Changing settings while ventilating... 4-20 Ventilation settings... 4-20 Ventilation preferences... 4-20 Alarm limits... 4-20 Using snapshots... 4-21 Taking a snapshot... 4-21 Viewing a snapshot... 4-21 Viewing trends... 4-22 Trends split screen... 4-22 Viewing waveforms... 4-22 Viewing spirometry Loops... 4-23 Sensor type... 4-23 Spirometry menu... 4-24 Using the cursor... 4-24 Spirometry split screen... 4-24

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Engström Carestation Performing procedures... 4-25 ↑O2... 4-25 Nebulizer... 4-25 Manual Breath... 4-26 Suction... 4-26 P 0.1... 4-27 Negative Inspiratory Force (NIF)... 4-27 Vital Capacity (VC)... 4-28 Intrinsic PEEP... 4-29 PEEPi Volume... 4-29 Inspiratory Hold... 4-30 Expiratory Hold... 4-30 Spontaneous Breathing Trial (SBT)... 4-31 EVair 03 compressor operation... 4-32

5 Airway Modules Compact airway modules... 5-2 D-fend water trap... 5-4 Connection to a patient... 5-4 Gas exchange... 5-6 Measurement limitations... 5-6 Patient spirometry... 5-7 Measurement principles... 5-7 Static measurements... 5-7 Gas calibration... 5-8

6 Alarms and Troubleshooting Alarms... 6-2 Alarm priorities... 6-2 Display changes during alarms... 6-3 Internal failure... 6-3 Backup audio buzzer... 6-3 Battery indicator... 6-3 List of alarms... 6-4 Troubleshooting... 6-12

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7 Cleaning and Maintenance System status... 7-2 Repair policy... 7-2 Maintenance summary and schedule... 7-3 User maintenance... 7-3 Battery performance test... 7-3 Datex-Ohmeda approved service... 7-4 EVair 03 compressor maintenance... 7-4 Airway module preventive maintenance... 7-4 Cleaning and sterilization... 7-5 Cleaning... 7-5 Sterilization... 7-5 Other cleaning and sterilizing agents... 7-6 CIDEX PLUS disinfection method... 7-7 CIDEX OPA disinfection method... 7-7 Expiratory flow sensor... 7-8 Exhalation valve housing... 7-8 Fan filters... 7-9 Aeroneb Pro nebulizer... 7-11 Support arm... 7-12 Expiratory water trap... 7-13 EVair 03 compressor... 7-13 Airway module components... 7-14

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8 Theory of Operation Ventilation theory... 8-2 Ventilating in Backup mode... 8-2 Ventilation modes... 8-3 Setting families... 8-3 Volume controlled ventilation (VCV)... 8-4 Pressure controlled ventilation (PCV)... 8-6 Pressure controlled ventilation volume guaranteed (PCV-VG)... 8-8 Synchronized intermittent mandatory ventilation volume controlled (SIMV-VC)... 8-10 Synchronized intermittent mandatory ventilation pressure controlled (SIMV-PC)... 8-12 BiLevel airway pressure ventilation (BiLevel)... 8-14 Constant positive airway pressure/pressure support ventilation (CPAP/PSV)... 8-16 Synchronized intermittent mandatory ventilation pressure controlled volume guaranteed (SIMV-PCVG)... 8-18 BiLevel airway pressure ventilation volume guaranteed (BiLevel-VG)... 8-20 Electrical operation... 8-22 Display Unit (DU)... 8-23 Ventilator Control Board (VCB)... 8-24 Ventilation Monitoring Board (VMB)... 8-24 Power Management Board (PMB)... 8-24 Motherboard... 8-24 Monitoring Module Power Supply Board... 8-24 Pneumatic operation... 8-25 Inspiratory... 8-26 Expiratory... 8-27 Hazard protection... 8-27

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9 Parts Exhalation valve assembly... 9-2 AC power cords... 9-3 System accessories... 9-4 System parts... 9-5 Neonatal flow sensor... 9-5 Airway module parts and accessories... 9-6 EVair 03 compressor parts... 9-6

10 Installation Mode Install/Service menu... 10-2 Menus... 10-3 Default menus... 10-10 Calibration menus... 10-11

11 Specifications Physical specifications... 11-2 Environmental specifications... 11-2 Pneumatic specifications... 11-2 Electrical specifications... 11-3 Battery information... 11-3 Ventilation operating specifications... 11-5 Ventilation delivery specifications... 11-5 Ventilation settings... 11-5 Waveforms... 11-7 Nebulizer... 11-7 Tidal volume delivery... 11-7 Inspired pressure control... 11-8 PEEP control... 11-8 Oxygen - air mixing accuracy... 11-8 Inspiratory and expiratory resistance... 11-8 Ventilator monitoring specifications... 11-9 Measurements... 11-9 Alarm settings... 11-10

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Engström Carestation Airway module specifications... 11-10 Gas specifications... 11-10 Typical performance... 11-11 EVair 03 compressor... 11-12 Specifications... 11-12 Compressor pneumatic diagram... 11-13 Compressor electrical block diagram... 11-14 Electromagnetic compatibility (EMC)... 11-15 Guidance and manufacturer's declaration electromagnetic emissions... 11-15 Guidance and manufacturer's declaration electromagnetic immunity... 11-16 Recommended separation distances... 11-18 Electrical safety... 11-19 IEC-60601-1 Classification... 11-19

12 INview Ventilation Tools FRC... 12-2 FRC theory... 12-2 Performing FRC... 12-2 FRC INview scaling... 12-4 PEEP INview... 12-5 FRC Log... 12-7 SpiroDynamics... 12-8 SpiroDynamics theory... 12-8 Setting up SpiroDynamics... 12-10 Viewing SpiroDynamics... 12-11 Using the cursor... 12-12 Lung INview... 12-13 Using Lung INview... 12-13 Troubleshooting... 12-15 Alarms... 12-16

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13 Neonatal Option Neonatal ventilation... 13-2 Theory of operation... 13-2 Symbols... 13-3 Neonatal flow sensor... 13-3 Connecting the flow sensor... 13-4 Turning the flow sensor off... 13-4 Calibrating the flow sensor... 13-5 Cleaning the flow sensor... 13-6 Preparing the ventilator for a patient... 13-7 Select Patient menu... 13-7 Pre-use checkout... 13-7 Testing alarms... 13-8 Patient weight... 13-8 Ventilation preferences menu... 13-8 Performing procedures... 13-9 ↑O2 and suction... 13-9 Nebulizer... 13-9 INview ventilation tools... 13-9 Alarms... 13-10 Troubleshooting... 13-11 Trends... 13-11 Graphical trends... 13-11 Neonatal specifications... 13-12 Ventilation operating specifications... 13-12 Ventilation delivery specifications... 13-12 Ventilator monitoring specifications... 13-13

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14 Non-invasive Option Non-invasive ventilation (NIV)... 14-2 Symbols... 14-2 NIV mode theory of operation... 14-3 Preparing the ventilator for a patient in non-invasive mode... 14-4 Changing from non-invasive mode to invasive mode . 14-5 Changing from invasive mode to non-invasive mode . 14-5 Changing NIV mode settings... 14-6 Non-invasive specifications... 14-7 Non-invasive mode ventilation settings... 14-7 Non-invasive mode alarm settings... 14-7 Neonatal nasal CPAP mode - theory of operation... 14-8 Preparing the ventilator for a patient in nCPAP mode... 14-9 Changing from nCPAP mode to invasive mode... 14-10 Changing from invasive mode to nCPAP mode... 14-10 Changing nCPAP mode settings... 14-10 nCPAP specifications... 14-11 nCPAP mode ventilation settings... 14-11 nCPAP mode alarm settings... 14-11 nCPAP monitoring specifications... 14-11 Alarms... 14-12 Recommended non-invasive ventilation interfaces... 14-13 Troubleshooting... 14-13 NIV... 14-13 nCPAP... 14-13

Index Warranty

x

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1 Introduction

In this section

What is an Engström Carestation?... 1-2 Symbols used in the manual or on the equipment... 1-3 Abbreviations... 1-7 Conventions used... 1-10

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1-1

Engström Carestation

What is an Engström Carestation? The Engström Carestation (EC) is a critical care ventilator that is flexible and physically adaptable to a variety of work environments. It has an intuitive user interface that is common to many DatexOhmeda products. A wide selection of performance options gives the user full control of the system configuration. The Engström Carestation is a complete system featuring patient monitoring, patient ventilation, and the capability of interfacing with central monitoring. Note

Photos and drawings shown in this manual may not be identical to all variants of the product. Some photos and drawings show accessories and options that may not be present or available on all variants. This manual does not cover the operation of every accessory; refer to the accessory documentation for further information. The EC must only be operated by authorized medical personnel well trained in the use of this product, for patient ventilation in the intensive care environment. It must be operated according to the instructions in this User’s Reference manual.

AB.98.127

The ventilator is designed to be used with infant through adult patients with a body weight of 5 kg or greater. If the neonatal option is installed on the ventilator, patients weighing down to 0.5 kg may be ventilated with the EC. The EC is designed to maintain lung ventilation in the absence of spontaneous breathing effort as well as in support of the patient’s existing spontaneous breathing effort. The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.

Figure 1-1 • Engström Carestation (EC)

1-2

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1 Introduction The Carestation consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows the user to interface with the system and control settings. The ventilator unit controls electrical power, nebulization, and pneumatic gas flow to and from the patient. The module bay allows the integration of various patient monitoring modules with the ventilator. Optional accessories include an air compressor, airway modules, module bay, support arm, humidifier and water trap mounting brackets, auxiliary electrical outlets, and a neonatal flow sensor.

Symbols used in the manual or on the equipment Symbols replace words on the equipment, on the display, or in Datex-Ohmeda manuals. Warnings and Cautions tell about the dangerous conditions that can occur if the instructions in the manual are not followed. Warnings tell about a condition that can cause injury to the operator or the patient. Cautions tell about a condition that can cause damage to the equipment. Read and follow all warnings and cautions.

REF

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On (power)

Off (power)

On for part of the equipment

Off for part of the equipment

Standby

Caution: federal law prohibits dispensing without prescription.

Type BF equipment

Type B protection against electrical shock

Attention, refer to product instructions IEC 60601-1

Caution, ISO 7000-0434

Stock number

SN

Serial number

Direct current

Alternating current

Earth ground

Protective earth ground

Equipotential connector

Fuse

1-3

Engström Carestation

+

1-4

Lock

Unlock

Variability

Variability in steps

Plus, positive polarity

-

Minus, negative polarity

Movement in one direction

Movement in both directions

This way up

Warning, dangerous voltage

Pneumatic inlet

Pneumatic outlet

Electrical input

Electrical output

Inspiratory port

Expiratory port

Electrical testing certification

Inspiratory breath identifier

Serial port

Module data indicator

Module bay port

Electronic micropump nebulizer

Auxiliary pressure port

Display signal input/output

No battery/battery failure

Battery in use. Bar indicates amount of battery power remaining.

Silence alarms

Submenu

Hour meter

Drain outlet

Air

Pump

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134°C

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Heavy object

USB port

Ethernet connection

Network ID connection (Datex-Ohmeda proprietary port)

Autoclavable

Not autoclavable

Authorized representative in the European Community

Systems with this mark agree with the European Council Directive (93/42/ EEC) for Medical Devices when they are used as specified in their User’s Reference Manuals. The xxxx is the certification number of the Notified Body used by Datex-Ohmeda’s Quality Systems.

Date of Manufacture

Neonatal option is installed

SpiroDynamics option is installed

Functional Residual Capacity option is installed

Maximum

Neonatal patient type

Pediatric patient type

Adult patient type

Indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of equipment.

GOST R Russian certification

Manufacturer

Non-invasive mode is in use

1-5

Engström Carestation This product consists of devices that may contain mercury, which must be recycled or disposed of in accordance with local, state, or country laws. (Within this system, the backlight lamps in the monitor display contain mercury.) Writing data into storage device

1-6

SD

Secure Digital

Non-invasive option is installed

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1 Introduction

Abbreviations Abbreviation

Definition

A ATPD

Ambient temperature pressure dry

B BiLevel

BiLevel airway pressure ventilation

BiLevel-VG

BiLevel airway pressure, volume guaranteed

BSA

Body surface area

BTPS

Body temperature pressure saturated

C Compl

Compliance

CPAP/PSV

Continuous positive airway pressure/pressure support ventilation

E EC

Engström Carestation

EE

Energy expenditure

ET

End-tidal concentration

EtCO2

End-tidal carbon dioxide

EtO2

End-tidal oxygen

F F-V

Flow-Volume loop

FI

Fraction of inspired gas

FI-ET

Difference between inspiratory and expiratory concentrations

FiO2

Fraction of inspired oxygen

FRC

Functional residual capacity

I I:E

Inspiratory-expiratory ratio

Insp Pause

Inspiratory pause time

K kg

kilogram

M ml

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milliliters

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Abbreviation

Definition

MVexp

Expired minute volume

MVexp/wt

Expired minute volume per patient weight

MVinsp

Inspired minute volume

N nCPAP

Nasal continuous positive airway pressure

Neo

Neonatal

NIF

Negative inspiratory force

NIV

Non-invasive ventilation

O O2

Oxygen

P

1-8

P 0.1

Airway occlusion pressure

P Vol

PEEPi volume

P-F

Pressure-Flow loop

P-V

Pressure-Volume loop

Pair

Air supply pressure

Paux

Auxiliary pressure

Paw

Airway pressure

Pbaro

Barometric pressure

PCV

Pressure controlled ventilation

PCV-VG

Pressure controlled ventilation - volume guaranteed

Ped

Pediatric patient

Pedi

Pedi-lite sensor

PEEP

Positive end expiratory pressure

PEEPe

Extrinsic positive end expiratory pressure

PEEPe+i

Total positive end expiratory pressure

PEEPi

Intrinsic positive end expiratory pressure

Pexp

Expiratory pressure

Phigh

High-pressure setting for BiLevel

Pinsp

Inspiratory pressure

Plimit

High pressure limit

Plow

Low-pressure setting for BiLevel

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