600 Series (A1) Users Reference Manual Sw Rev 01 Rev R July 2020

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 instruction 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, the manufacturer recommends that a telephonic or written request for service advice be made to the nearest manufacturer Customer Service Center. This product or any of its parts should not be repaired other than in accordance with written instructions provided by the manufacturer and by the manufacturer trained personnel. The product must not be altered without the prior written approval of the manufacturer. 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 the manufacturer.

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 the local laws for any restriction that may apply.

Table of Contents 1 Introduction Intended use... 1-2 Indications for use... 1-2 General information... 1-2 Serial numbers...1-4 Trademarks... 1-5 Feature overview... 1-5 Symbols used in the manual or on the equipment... 1-8 Symbols used on the equipment...1-8 Symbols used on the user interface... 1-11 Typeface conventions used...1-12 Abbreviations... 1-13 System information... 1-16 System classification... 1-16 Device standards IEC 60601-1:2005... 1-16 Device standards IEC 60601-1:1988... 1-16 Integral system components... 1-17 Not integral system components...1-17 System safety... 1-18 Preparing for use... 1-18 Inspecting the system... 1-19 Electrical safety... 1-20

2 System controls and menus System overview... 2-2 Using the brake... 2-6 Using flow controls... 2-7 Using the O2 flush button... 2-7 Positioning the display...2-8 Connecting the breathing system bag hose... 2-8

2076152-001

i

Carestation™ 620/650/650c (A1) Using the bag support arm... 2-10 Vaporizer controls... 2-11 Display controls... 2-12 Touch points...2-13 Measured value touch points... 2-13 Active alarm touch points... 2-14 Anesthesia system display... 2-15 Digit fields... 2-16 Waveform fields... 2-16 Split screen field... 2-17 ACGO display... 2-18 Aux O2+Air display... 2-20 Display navigation... 2-21 Using menus... 2-21 Using the ComWheel... 2-22 Using quick keys... 2-22

3 Operation System operation safety... 3-2 Turning on the system... 3-4 Starting manual ventilation... 3-6 Starting mechanical ventilation... 3-7 Start a case... 3-8 Minimum Alveolar Concentration... 3-8 Starting a case using default settings... 3-9 Starting a case using custom settings... 3-9 End a case... 3-11 Standby... 3-12 Turning off the system... 3-13 Ventilator setup... 3-14 Changing ventilator mode... 3-14 Changing ventilator settings... 3-14 Optional ventilator procedures... 3-14

ii

2076152-001

Table of Contents Auto limits... 3-15 Setting auto limits... 3-15 System setup... 3-16 Patient demographics... 3-16 Screen setup menu... 3-16 Fresh gas usage... 3-19 Alarm setup... 3-20 Setting alarms for manual ventilation... 3-20 Setting CO2 alarms... 3-21 Setting volume apnea alarm... 3-21 Setting MV/TV alarms... 3-22 Setting alarm limits... 3-22 Viewing alarm history... 3-22 Setting alarm volume...3-23 Setting apnea delay...3-23 Silencing leak audio alarms... 3-23 Setting auto MV limits... 3-24 Setting to default limits... 3-24 Next page... 3-25 Trends... 3-26 Setting trends... 3-26 Spirometry... 3-27 Setting loop type... 3-27 Setting loop graph scaling... 3-28 Setting patient and sensor type...3-28 Setting the data source... 3-28 Setting spirometry volume type...3-29 Saving, viewing, and deleting spirometry loops... 3-29 Procedures... 3-30 Pause gas flow... 3-30 Cardiac bypass... 3-30 Vital capacity... 3-31 Cycling... 3-32 Timer function... 3-34

2076152-001

iii

Carestation™ 620/650/650c (A1) Using the timer... 3-34 ecoFLOW...3-35 Using ecoFLOW... 3-36 Auxiliary Common Gas Outlet...3-37 Using the ACGO... 3-37 Auxiliary O2+Air...3-39 Using the Aux O2+Air... 3-39

4 Preoperative checkout Every day before your first patient... 4-2 Before every patient... 4-3

5 Preoperative tests Vaporizer installation... 5-2 Checking vaporizer installation... 5-2 Flow and pressure calibration... 5-4 Circuit compliance compensation... 5-5 Checkout menu... 5-6 Full test... 5-7 Ventilator leak... 5-8 Vaporizer leak... 5-8 Gas controls...5-8 Circuit leak... 5-8 Individual tests...5-10 Ventilator leak... 5-10 Vaporizer leak... 5-10 Gas controls...5-10 Circuit leak... 5-10 Vaporizer back pressure test...5-12 Low pressure leak test (with ACGO)...5-13

iv

2076152-001

Table of Contents

6 Airway modules Airway modules... 6-2 Safety information... 6-3 Airway Gas Option module... 6-4 CARESCAPE airway modules... 6-5 Connecting the airway module... 6-6 Connecting the Pedi-lite and D-lite sensors... 6-7 Parameters setup... 6-8 Data source... 6-8 Automatic agent identification... 6-9 Calibrating the airway module...6-10

7 Alarms and troubleshooting Alarms... 7-2 Alarm priorities...7-2 Pausing alarms... 7-2 Cancelling audio pause... 7-3 Display changes during alarms... 7-3 De-escalating alarms...7-3 Battery indicator...7-3 Internal failure... 7-4 Informational tones... 7-4 Alarm history... 7-4 List of alarms... 7-5 Sustained pressure threshold... 7-12 Alarm ranges... 7-13 Alarm tests...7-15 Breathing system problems...7-17 Electrical problems... 7-18 Pneumatic problems... 7-20 Reporting of serious incidents...7-21

2076152-001

v

Carestation™ 620/650/650c (A1)

8 Setup and connections Setup safety...8-2 Moving and transporting the system... 8-4 Connecting the breathing system... 8-5 Setting up the absorber canister... 8-6 When to change the absorbent... 8-7 Removing absorber canister... 8-7 Filling the reusable absorber canister... 8-8 Circuit O2 cell installation... 8-11 Electrical connections... 8-14 Mains inlet... 8-14 Equipotential stud... 8-14 Outlets... 8-14 Serial port... 8-15 Pneumatic connections... 8-16 Pipeline inlets... 8-16 Scavenging... 8-16 Scavenging a gas monitor sample flow... 8-17 Sample gas return port... 8-17 Suction control panel...8-18 Vacuum suction regulator (optional)... 8-18 Venturi suction regulator (optional)... 8-19 Auxiliary O2 flowmeter (optional)... 8-20 Auxiliary O2+Air (optional)... 8-20 Third cylinder supply (optional)... 8-21 Installing gas cylinders... 8-22 Cylinder cover... 8-22 Installing cylinders with pin indexed yokes... 8-22 Installing cylinders with DIN connections... 8-23 Installing large cylinders... 8-23 Performing a high-pressure leak test... 8-23 Passive AGSS... 8-24

vi

2076152-001

Table of Contents Connecting passive AGSS... 8-24 Active AGSS... 8-25 Attaching equipment to the top of the machine... 8-27 Cable management arm (optional)... 8-29 Cable routing groove... 8-30 Cable cover... 8-31

9 User maintenance Maintenance safety... 9-2 Repair policy... 9-3 Maintenance summary and schedule... 9-4 Authorized service personnel... 9-5 Circuit O2 cell replacement... 9-6 Flow control test... 9-9 Calibration menu... 9-11 Flow and pressure calibration... 9-11 Circuit O2 cell...9-11 Airway gas calibration... 9-12 Water buildup...9-13 How to help prevent water buildup... 9-13

10 Parts Top breathing system assembly... 10-2 Bottom breathing system assembly... 10-3 Absorber canister... 10-4 Test tools and system parts...10-5 Anesthesia system accessories... 10-6

11 Specifications and theory of operation System pneumatic circuits...11-2 Gas supplies... 11-3 O2 flow... 11-4

2076152-001

vii

Carestation™ 620/650/650c (A1) N2O flow... 11-4 Air flow... 11-4 Mixed gas...11-5 Pneumatic specifications... 11-6 Gas supplies... 11-6 ACGO port relief... 11-6 Electrical block diagram...11-7 Electrical power... 11-9 Power cord...11-9 Battery information...11-10 Flow specifications...11-11 Breathing system specifications... 11-12 Gas scavening... 11-13 Physical specifications...11-15 System loading... 11-16 Environmental requirements... 11-19 Airway module specifications... 11-20 Gas specifications for airway modules... 11-20 Suction regulators (optional)... 11-22 Ventilator theory...11-23 O2 monitoring theory of operation...11-23 ecoFLOW theory of operation... 11-24 Ventilation modes... 11-24 Ventilation modes factory default settings...11-35 Ventilation mode transition... 11-36 Ventilator operating specifications...11-37 Pneumatics... 11-37 Fresh gas compensation... 11-37 Pressure...11-37 Volume... 11-37 Oxygen...11-38 Ventilator accuracy data... 11-39 Electromagnetic compatibility (EMC)... 11-40 Essential performance...11-40

viii

2076152-001

Table of Contents Cables... 11-40 Guidance and manufacturer's declaration electromagnetic emissions... 11-41 Guidance and manufacturer's declaration electromagnetic immunity... 11-42

12 Super user mode Super user mode... 12-2 Gas usage... 12-3 Resetting cumulative gas usage... 12-3 Setting ecoFLOW... 12-3 Setting agent costs... 12-3 System configuration... 12-5 Display settings... 12-5 Ventilator settings... 12-5 Alarm settings... 12-6 Parameter settings... 12-6 Trends setup... 12-7 Page setup...12-8 Case defaults...12-10 Configuring case defaults... 12-10 Setting case name...12-10 Setting volume apnea defaults... 12-10 Default case type settings... 12-11 Copy logs...12-15 Using copy logs... 12-15 Procedures setup... 12-16 Setting vital capacity defaults... 12-16 Setting cycling controls and settings...12-16

Index

2076152-001

ix

Carestation™ 620/650/650c (A1)

x

2076152-001

1 Introduction

Introduction

In this section

Intended use... 1-2 Symbols used in the manual or on the equipment...1-8 Typeface conventions used... 1-12 Abbreviations... 1-13 System information... 1-16 System safety... 1-18

2076152-001

1-1

Carestation™ 620/650/650c (A1)

Intended use The Carestation™ 620/650/650c anesthesia systems combine advanced anesthesia delivery, patient monitoring, and care information management. The contemporary, compact design allows for easy mobility and addresses many ergonomic considerations including an effective cable management solution, aesthetic covers, and an expandable work surface area. Optional integrated features include auxiliary common gas outlet, auxiliary O2 outlet, auxiliary O2+Air outlet, suction control and respiratory gas monitoring. The system provides integration of ventilation and gas delivery, on a 15inch color touchscreen interface. This anesthesia system is designed for mixing and delivering inhalation anesthetics, Air, O2, and N2O. This anesthesia system uses electronic flow valve ventilation technology offering Volume Control Ventilation with tidal volume compensation and electronic PEEP. This technology also features optional Pressure Control Ventilation, Pressure Support Ventilation with an Apnea Backup (PSVPro™) that is used for spontaneously breathing patients, Synchronized Intermittent Mandatory Ventilation (SIMV) modes, Pressure Control Ventilation-Volume Guarantee (PCV-VG), Continuous Positive Airway Pressure + Pressure Support Ventilation (CPAP + PSV), and VCV Cardiac Bypass. In Volume Control Ventilation, a patient can be ventilated using a minimal tidal volume of 20 ml. In Pressure Control Ventilation, volumes as low as 5 ml can be measured. These advanced features allow for the ventilation of a broad patient range.

WARNING

MR unsafe. This system is not suitable for use in a magnetic resonance imaging (MRI) environment.

Indications for use The Carestation 620/650/650c anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonate, pediatric, and adult). The anesthesia systems are suitable for use in a patient environment, such as hospitals, surgical centers, or clinics. The systems are intended to be operated by a clinician qualified in the administration of general anesthesia.

General information This anesthesia system uses the Compact Breathing System (CBS). This compact breathing system is removable and autoclavable. Note

1-2

The O2 cell is not autoclavable.

2076152-001

1 Introduction This anesthesia system is designed for expansion and upgrades, so it is easy to add new technologies and ventilation capabilities without investing in a new system. The User’s Reference manual is intended to provide training on the operation of the system. Operate the system from the front with a clear view of the display. It must be operated according to the instructions in this User’s Reference manual. Make sure that all user documents are obtained from the manufacturer. Refer to the Technical Reference manual for service information including: special installation instructions, installation checklist, means of isolating the supply mains, and replacement of fuses, supply power cord, and other parts.

2076152-001

WARNING

Explosion Hazard. Do not use this system with flammable anesthetic agents.

Note

Configurations available for this product depend on local market and standards requirements. Illustrations and photographs in this manual are just for reference and may not represent all configurations of the product. This manual does not cover the operation of every accessory, and not all accessories and options are included with every system. Refer to the accessory documentation for further information.

1-3

AC.24.000

Carestation™ 620/650/650c (A1)

Figure 1-1 • Front view

Serial numbers Products have unit serial numbers with coded logic which indicates a product group code, the year of manufacture, the week of manufacture, a sequential unit number for identification, manufacture location, and product type.

1-4

2076152-001

1 Introduction

XXX YY FW 0000 S M The XXX represents product codes: SM6 = Carestation 620, SM7 = Carestation 650, and SM8 = Carestation 650c. The YY represents a number indicating the year the product was manufactured: 10 = 2010, 11 = 2011, and so on. The FW represents a number indicating the week the product was manufactured. The 0000 represents the serial number assigned to the machine. The S represents the production location: W = Wuxi, China; M = Madison, USA. The M represents the product type: A = Mass production A1.

Trademarks Carestation, CARESCAPE, D-fend, D-lite, PSVPro, Tec, and Selectatec are trademarks of General Electric Company or one of its subsidiaries. All other brand names or product names used in this manual are trademarks or registered trademarks of their respective holders.

Feature overview .

Hardware feature

Carestation 620 A1

Carestation 650 A1

Carestation 650c A1

Frame

Trolley

Trolley

Pendant or Wall mount

Anesthesia display arm

1 - pivot, no tilt 2 - pivots, with tilt

2 - pivots, with tilt

2 - pivots, with tilt

Flip shelf

Optional

Optional

Pendant: Optional Wall mount: Not available

Front handle

Not available

Included

Pendant: Included Wall mount: Not available

Drawers

Optional (0, 3)

Included (3)

Included (2)

Central brake

Not available

Included

Not available

Wheels

~5 in / 125 mm

~5 in / 125 mm

Pendant: ~3 in / 80 mm Wall mount: Not available

Caster guards

Not available

Included

Not available

Worksurface metallic insert

Not available

Included

Included

Bag arm

Optional

Optional

Optional

2076152-001

1-5

Carestation™ 620/650/650c (A1) Hardware feature

Carestation 620 A1

Carestation 650 A1

Carestation 650c A1

Top shelf color

White

Black

Black

.

Integrated monitoring

Carestation 620 A1

Carestation 650 A1

Carestation 650c A1

Integrated Airway module slot

Optional

Optional

Optional

O2 cell, breathing system

Optional

Optional

Optional

.

Patient monitor mounting

Carestation 620 A1

Carestation 650 A1

Carestation 650c A1

Top shelf post mount

Optional

Optional

Optional

Vertical mount, configured monitor (above anesthesia display)

Optional

Optional

Optional

Display (above anesthesia display)

Not available

Optional

Optional

F5 Frame (top shelf post mount)

Not available

Optional

Optional

CPU (lower right)

Not available

Optional

Not available (mount separately to Medi-rail or Wall)

Long cable management arm

Optional

Optional

Optional

Short cable management arm

Optional

Optional

Optional

CARESCAPE B850 mounting

.

Cylinders

Carestation 620 A1

Carestation 650 A1

Carestation 650c A1

In-board, cylinder yokes

Optional (0 - 2)

Optional (0 - 2)

Not available

In-board, cylinder yoke cover

Optional

Optional

Not available

Out-board, 3rd cylinder

Optional

Optional

Not available

Large cylinders (O2/N2O)

Optional (0 - 2)

Optional (0 - 2)

Not available

.

AC outlets

Carestation 620 A1

Carestation 650 A1

Carestation 650c A1

3 AC outlets

Optional

Optional

Not available

AC isolation transformer

Optional

Optional

Not available

.

Pneumatic Options

Carestation 620 A1

Carestation 650 A1

Carestation 650c A1

Drive gas

Air or O2

Air or O2

Air or O2

Fresh gas options (O2, Air, N2O)

2 or 3

2 or 3

2 or 3

1-6

2076152-001

1 Introduction Pneumatic Options

Carestation 620 A1

Carestation 650 A1

Carestation 650c A1

Pipeline inlets

2 or 3 (2nd O2 optional)

2 or 3 (2nd O2 optional) 2 or 3 (2nd O2 optional)

User guidance lighting

Included

Included

Included

Fresh gas flow, LED display (above control knobs)

Not available

Included

Included

Aux Common Gas Outlet (ACGO)

Optional

Optional

Optional

Integrated Aux O2 (independent flow meter)

Optional

Optional

Optional

Integrated Aux O2+Air (system fresh gas controls)

Not available

Optional

Optional

Integrated suction

Optional

Optional

Optional

.

Software features

Carestation 620 A1

Carestation 650 A1

Carestation 650c A1

VCV

Included

Included

Included

Additional vent modes

Some optional

All optional

All optional

Spirometry

Optional

Included

Included

VCV cardiac bypass

Optional

Optional

Optional

Auto alarm limits

Not available

Included

Included

EcoFlow

Not available

Optional

Optional

Pause gas

Not available

Optional

Optional

Cycling

Not available

Optional

Optional

Vital capacity

Not available

Optional

Optional

2076152-001

1-7

Carestation™ 620/650/650c (A1)

Symbols used in the manual or on the equipment Symbols replace words on the equipment, on the display, or in product manuals. Warnings and Cautions tell you about dangerous conditions that can occur if you do not follow all instructions in this manual. 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.

Symbols used on the equipment .

1-8

O2 Flush button

O2 concentration

Air

Air

APL settings are approximate

Anesthetic Gas Scavenging System

Maximum

Vacuum

Serial number

Stock number

Exhaust

Bellows volumes are approximate

Plus, positive polarity

Minus, negative polarity

Nominal mass weight

Caution: federal law prohibits dispensing without prescription.

Autoclavable

Selectatec™ Series Vaporizers Tec™ 6 Plus or greater

On (power)

Off (power)

Standby

Non-ionizing electromagnetic radiation

Type BF equipment

Type B equipment

Dangerous voltage

Frame or chassis ground

Protective earth ground

Earth ground

Direct current

Alternating current

2076152-001