Carestation 30 Users Reference Manual Sw Rev 2.x Rev P Sept 2018

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

Main Machine SN Information

GE Healthcare 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 is in the format below. MFYYMMXXXX The YY represents a number indicating the year the product was manufactured; 11 = 2011, 12 = 2012, and so on. The MM represents a number indicating the month the product was manufactured; 01 = Jan, 02 = Feb, and so on. The XXXX represents the serial number the machine was manufactured.

1 Introduction Intended use... 1-2 Symbols used in the manual or on the equipment... 1-3 Typeface conventions used... 1-6 Abbreviations... 1-6

2 System Controls and Menus Anesthetic System Controls... 2-2 Front view... 2-2 Rear view... 2-4 Breathing system components... 2-5 Vaporizer controls... 2-6 ACGO (optional)... 2-7 Ventilator controls... 2-8 Ventilator screen... 2-9 Using menus... 2-10

3 Setup and Connections Gas supplies... 3-5 Pipeline gas supplies... 3-5 How to install pin indexed cylinder yokes... 3-5 Vaporizer installation... 3-7 How to install vaporizer... 3-7 Vaporizer safety interlock... 3-9 Flow sensor connection... 3-10 Passive AGSS connection(optional)... 3-12 Passive AGSS... 3-12 How to install Passive AGSS... 3-12 Installing Passive AGSS... 3-13 Connecting Passive AGSS... 3-15 Canister setup... 3-16 When to change the absorbent... 3-17 Removing a canister... 3-17

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Carestation 30 Filling Absorber canister... 3-18 Installing the Absorber canister... 3-19 Electrical connections... 3-20 Mains inlet... 3-20 Equipotential stud... 3-20 USB and SpO2 port... 3-21 How to attach equipment to the top of the machine... 3-23 Installation notes... 3-23

4 Operation Turning on the system... 4-2 Starting manual ventilation... 4-3 Starting mechanical ventilation... 4-3 Enter standby mode... 4-3 Shutting down the system... 4-3 Ventilator setup... 4-4 Alarm limits setup... 4-5

5 Preoperative Tests Inspecting the system... 5-2 Power failure test... 5-3 Pipeline and cylinder tests... 5-4 Flow control tests... 5-5 O2 supply alarm test... 5-7 O2 flush... 5-7 Vaporizer back pressure test... 5-8 Low-pressure leak test... 5-9 Negative low-pressure leak test... 5-9 Positive low-pressure leak test... 5-12 Alarm tests... 5-15 Breathing system tests... 5-17 Monitor and ventilator tests... 5-19 Circuit compliance compensation... 5-21

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6 Preoperative Checkout Every day before the first patient... 6-2 Before every patient... 6-4

7 Alarms and Troubleshooting Alarms... 7-2 Alarm priority... 7-2 List of alarms... 7-3 Minimum system shutdown alarms... 7-5 Breathing system problems... 7-6 Electrical problems... 7-6 Pneumatic problems... 7-7 Self Help mode... 7-7

8 User Maintenance Repair policy... 8-3 Maintenance summary and schedule... 8-4 User maintenance... 8-4 GE Healthcare authorized maintenance... 8-5 Breathing system maintenance... 8-6 O2 cell replacement... 8-6 O2 cell calibration... 8-8 Installing cleaned, disinfected components... 8-9 Inspiratory and expiratory check valves... 8-9 Bellows... 8-9 Vaporizer... 8-10 Battery... 8-10 Prevent water buildup... 8-10

9 Cleaning and Disinfection Autoclave breathing system... 9-4 Removing APL valve... 9-4 Removing breathing system... 9-4

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Carestation 30 Autoclave breathing system... 9-4 How to disassemble the breathing system... 9-5 Installing the breathing system... 9-7 System cleanable parts... 9-8 Special requirements... 9-8 Surface cleaning... 9-8 Cleaning Flow sensor (optional)... 9-9 Cleaning and disinfection of inspiratory/expiratory valves . 9-10 Cleaning and disinfection of bellows parts... 9-11 Disassembling the bellows assembly... 9-11 Cleaning the Bellows... 9-13 Assembling the Bellows Assembly... 9-13 Bellows assembly tests... 9-13 Cleaning and disinfection of AGSS... 9-17 Removing the AGSS assembly... 9-17 Disassembling the AGSS assembly... 9-17 Absorber canister... 9-19 Mechanical cleaning in washer or washer-disinfector

9-19

Manual cleaning... 9-19 High level disinfection... 9-19

10 Parts Bellows assembly... 10-2 Breathing system inspiration and expiration valve assembly 103 Passive AGSS... 10-4 Breathing system protection... 10-5 Flow sensor... 10-5 Absorber canister... 10-6 O2 Sensor... 10-7 Vaporizer (Optional)... 10-8 System accessories (optional)... 10-9 Field upgrade kit... 10-10

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Test tools and system parts... 10-10

11 Specifications and Theory of Operation System pneumatic circuits... 11-3 Gas supplies... 11-9 O2 flow... 11-9 N2O... 11-9 Mixed gas... 11-9 Pneumatic specifications... 11-10 Gas supplies... 11-10 O2 controls... 11-10 Ventilator... 11-10 Flow specifications... 11-11 Breathing system specifications... 11-11 Gas scavenging... 11-12 Ventilator theory... 11-13 Ventilation mode... 11-13 O2 monitor theory of operation... 11-13 Ventilator and monitoring specifications... 11-14 Pneumatics... 11-14 Pressure... 11-14 Alarm settings... 11-14 Volume... 11-14 O2% monitoring... 11-14 Ventilator and monitoring accuracy data... 11-14 SpO2 and monitoring specifications... 11-16 Electrical functional block diagram... 11-17 Electrical power... 11-18 Power cord... 11-18 Battery information... 11-19 Electrical safety... 11-20 Electromagnetic compatibility (EMC)... 11-21 ESD safety precautions... 11-21 Guidance and manufacturer’s declaration - electromagnetic

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Carestation 30 emissions... 11-22 Guidance and manufacturer’s declaration - electromagnetic immunity... 11-23 Radiated immunity... 11-24 Recommended separation distances... 11-25 Physical specifications... 11-26 Environmental requirements... 11-26 IEC 60601-1 Classification... 11-27 Standards... 11-27 System Components... 11-28 Integral Components... 11-28 Not Integral components... 11-28

Index Warranty

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1 Introduction

In this section

Intended use... 1-2 Product description... 1-2 Symbols used in the manual or on the equipment... 1-3 Typeface conventions used... 1-6 Abbreviations... 1-7

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Carestation 30

Intended use The Carestation 30 anesthesia machine is a compact, integrated, and intuitive anesthesia delivery system. The Carestation 30 anesthesia machine provides general inhalation anesthesia and ventilatory support for patients during surgery as well as monitoring and displaying various patient parameters. In Volume Control Ventilation, a patient can be ventilated by using a minimal tidal volume of 50 ml.

WARNING

This anesthesia system is not suitable for use in an MRI environment. This system must only be operated by medical personnel authorized and trained to use this product. It must be operated according to the instructions in this User’s Reference Manual.

Product description

The Carestation 30 anesthesia machine is composed of the anesthetic breathing system, anesthetic gas transfer and receiving systems, anesthetic vapor delivery devices, anesthetic ventilator, and accessories.

Note

Configurations available for this product depend on local market and standards requirements. Illustrations in this manual may not represent all configurations of the product. This manual does not cover the operation of every accessory. Refer to the accessory documentation for further information.

WARNING

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

Figure 1-1: Front view

1-2

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1 Introduction

Symbols used in the manual or on the equipment Symbols replace words on the equipment, on the display, or in GE Healthcare manuals. Warnings and Cautions tell 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.

O2+

+

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On (system on)

Off (system standby)

Battery Indicator

Defibrillation-proof Type CF Applied Part

O2 flush button

Direct current

AC on and battery charging

On battery

Pneumatic inlet

Type B equipment

Caution, consult accompanying documents

Frame or chassis ground

Refer to instruction manual or booklet (blue background)

Attention, refer to product instructions, IEC 60601-1

Serial number

Stock number

Protective earth ground

Earth ground

Variability

Maximum

Plus, positive polarity

-

Minus, negative polarity

1-3

Carestation 30

134°C

Bag position/manual ventilation

Mechanical ventilation

Inspiratory flow

Expiratory flow

Lock

Unlock

ACGO switch set to BC

ACGO switch set to ACGO Mode

Autoclavable

Not autoclavable

Bellows volumes are approximate

OC

1-4

O2 %

O2 cell connection

APL settings are approximate

Anesthetic Gas Scavenging System

Equipotential

Read to top of float

End case key

Audio pause/Unpause key

USB port

Cylinder

Occlude Cone

Authorized representative in the European Community

Manufacturer name and address

Date of manufacture

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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.

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 xxx is the certification number of the Notified Body used by GE Healthcare’s Quality Systems. First CE marked in 2012.

GOST R Russian certification

Authorized representative in the European Community

ESD sensitive device. Connections should not be made to this device unless ESD precautionary procedures are followed.

Interference

ACGO display

Device contains phthalates XXXX indicates phthalate Possible phthalates include: DBP: Di-n-butyl phthalate DNPP: 1,2-Benzenedicarboxylic acid, dipentylester, branched and linear; Npentylisopentylphthalate; Di-n-pentyl phthalate; Diisopentylphthalate BBP: Benzyl butyl phthalate DEHP: Bis(2-ethylhexyl) phthalate; Di(2-ethylhexyl) phthalate DMEP: Bis(2-methoxyethyl) phthalate DIBP: Dissobutyl phthalate

No pushing

Eurasian Conformity

1-5

Carestation 30

Typeface conventions used Menu items are written in bold italic typeface; for example, Normal. Messages that are displayed on the screen are enclosed in single quotes; for example, ‘On Battery, Power OK?’ When referring to different sections and other documents, the names are written in italic typeface and enclosed in double quotes; for example, “System Controls and Menus.”

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Abbreviations The abbreviations that appear in the manual or on the screen are listed as below: Abbreviation

Definition

A ACGO AGSS APL A/D

Auxiliary Common Gas Outlet Anesthetic Gas Scavenging System Adjustable Pressure Limiting valve Analog/Digital

B BS BPM BTV BTPS

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Breathing System Breaths per minute Bag/Vent switch Body temperature, ambient pressure, saturated humidity conditions

C CPLD

Complex Programmable Logic Device

F F.G.F

Fresh Gas Flow

I I:E I/O

Inspiratory-expiratory ratio Input/Output

M MOPV MV

Mechanical Over Pressure relief Valve Minute volume

N N2 O

Nitrous oxide

O O2 OC

Oxygen Occluder Cone

P Paw Pleth Peak Pmean

Airway pressure Plethysmographic waveform Peak pressure Mean airway pressure

R RATE

Respiration rate

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Carestation 30

1-8

Abbreviation

Definition

S SpO2

Saturation of peripheral oxygen

T TV

Tidal volume

V VC VCV

Volume compensation Volume controlled ventilation

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WARNING

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

In this section

Anesthetic System Controls... 2-2 Front view... 2-2 Rear view... 2-4 Breathing system components... 2-5 Vaporizer controls... 2-6 ACGO (optional)... 2-7 Ventilator controls... 2-8 Ventilator screen... 2-9 Using menus... 2-10

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Anesthetic System Controls Front view

1

17

2 16

3

15 14

4 5 6 7

13

8 9

12

10

18

19

11

Figure 2-1: Front View Table 2-1: System controls --- Front view Item in Figure 2-1

Description

1

Ventilator display

Refer to "Ventilator controls" on page 2-8.

2

Cylinder pressure gauge(s) (upper row)

For indicating the cylinder gas pressure.

3

Pipeline pressure gauge(s) (lower row)

For indicating the pipeline gas pressure.

4

Task light

By default, task light is turned on when the system switch is switched on.

5

Handle

For moving the machine.

6

Vaporizer Manifold

For vaporizer mounting. Refer to "Ventilator controls" on page 2-8 for the vaporizer controls.

2-2

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2 System Controls and Menus Table 2-1: System controls --- Front view Item in Figure 2-1 7

System switch

Description Set the switch to the On (

) position to turn on the system.

Set the switch to the Off (

) position to turn off the system.

8

O2 flush button

Push the O2 flush button to supply a high flow of O2 to the breathing system.

9

ACGO switch

ACGO (Auxiliary Common Gas Outlet). When set to ACGO, fresh gas flows to the open breathing system through the ACGO, and there is no mechanical ventilation mode. Breathing system Mode:

ACGO Mode:

10

ACGO

Refer to "ACGO (optional)" on page 2-7.

11

Caster with brake (4 brakes on all casters)

Push down to lock. Lift to release.

12

AGSS (Optional)

Anesthesia Gas Scavenging System for scavenging the waste gas.

13

Breathing system

Refer to "Breathing system components" on page 2-5.

14

USB port and SpO2 port (Optional)

Insert the USB drive into the USB port to upgrade software or download logs; Connect the SpO2 sensor cable to the SpO2 port to monitor the arterial oxygen and pulse rate of the patient.

15

Paw pressure gauge

Measures patient airway pressure.

16

Flow controls

Turn the control counterclockwise to increase the flow and clockwise to decrease the flow. There is a hypoxic guard system in the flow controls. It maintains an approximate minimum 1 to 3 ratio of flow between O2 and N2O.

17

Flow meter module

Adjust and indicate the flow of O2, or N2O, or Air (optional).

18

Hook

For holding the patient circuit tubings.

19

Patient circuit

Connect to patient.

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Rear view

9 1

10

2 3 4 5

12

11 6 7 8

Figure 2-2: Rear View Table 2-2: System Controls --- Rear view Item in Figure 2-2 1

Auxiliary O2 pipeline inlet

7

Battery fuse

2

O2 pipeline inlet

8

Mains supply inlet (with two fuses)

3

N2O/Air pipeline inlet

9

Nameplate

4

O2 cylinder inlet

10

Hook

5

N2O/Air cylinder inlet

11

Suction device mounting bracket (Optional)

6

Equipotential stud

12

Yoke handle (T-handle or Hand-wheel)

2-4

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