Nanjing Superstar s6100 Service Manual

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S6100 Anesthesia System

Service Manual

Nanjing Superstar Medical Equipment Co., Ltd.

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Contents

Foreword

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Warnings，Cautions and notes ....................................................................................... 1

1.................

Warnings ..........................................................................................................................1

Cautions Notes

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...................................

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3........................

3.............................

1.0Theory of operation .....................................................................................................4

1 1 Introduction 1 2 Electrical and Pneumatic Connections

1.2.1 Electrical Connections .....................................................................

1.2.2 Pneumatic Connections ...................................................................

1 3 Gas flow

1.3.1Pneumatic Circuit Diagram .............................................................................................. 7

. .................................

1 3 2 Part list

1.3.3 Key to symbols ................................................................................................................ 8

1.3.4 Description .......................................................................................................................9

1.3.4.1 Anesthetic Gas Delivery System ..................................................................................9

1.3.4.2 Gas supplies .................................................................................................................9

1.3.4.3 Flow control system -EFCS ....................................................................................... 10

1.3.4.4 Vaporizer Manifold ......................................................................................................10

1.3.4.5 ACGO Assembly .........................................................................................................11

1.3.4.6 O2 flush button Assembly .......................................................................................... 12

1.3.4.7 Auxiliary Gas Supply Assembly ....................................................

1.3.4.8 High pressure O2 Output Assembly .......................................................................... 12

1.3.4.9 Pneumatically-Controlled Module of Anesthetic ........................................................12

1.3.4.10 Breathing System ..................................................................................................... 13

1.3.4.11 Anesthetic Gas Scavenging System ........................................................................ 14

1.4 The Breathing System ............................................................................................................. 16

1 4 1 Brif Introduction

1.4.2 Automatic Mode, Inspiration ..........................................................................................16

1.4.3 Automatic Mode, Expiration .......................................................................................... 16

1.4.4 Manual Mode, Inspiration ..............................................................................................17

1.4.5 Manual Mode, Expiration .............................................................................................. 18

1 4 6 Pneumatic PEEP

1.4.7 Ventilator in Standby ..................................................................................................... 18

1.4.8 Breathing System Components .................................................................................... 18

1 5 Ventilator UI 1 6 Ventilator control and Drive

1.6.1 Monitor Board ...................................................................................

1.6.2 High Pressure Sensor Board ...........................................................

1.6.3 Low Pressure Sensor Board ............................................................

1.6.4 DC Board ..........................................................................................

1.6.5 Power Supply ...................................................................................

1.6.6 Electrical Flow Control Board ..........................................................

Ventilator Pneum atic- O

1 7

1 7 1 Ventilator Pneumatic Drive

1.7.2 Drive Pressure-High Pressure Regulator (200 kPa, 29 psi) ........................................ 22

1.7.3 Drive Gas Assembly ...................................................................................................... 22

................................

2 0 Installation Guide

2.1 Preparation - Additional Material Required ............................................................................. 22

2.2 Assembly ..................................................................................................................................23

................................

..................................

................................

Drive Gas

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4. ..............................

5. ................................

7. ......

16. . .............................................................................................................

18. . ...........................................................................................................

19. .............................................................................................................................

21. .....................................................................................................

22. ........................................................................................

22. . ............................................................................................

22. .....................................................................................................

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2.2.1 Installation of the Breathing Circuit ..................................................

2.2.2 Installation of the bellow ...................................................................

2.2.3 Installation of the flow sensor ..........................................................

2.2.3 Installation of breathing tube and Y connector ................................

2.2.4 Installation of O

sensor ...................................................................

2.2.5 Installation of Soda lime tank ...........................................................

2.2.6Installation of reservoir bag ...............................................................

2.27 Installation of vaporizer .................................................................................................. 23

2 28 Installation of module

2 3 Functional Tests

.......................

2.3.1 Check system ................................................................................................................ 24

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................................

..................................

23.....

.................................

2.3.2 Pipe gas supply test ...................................................................................................... 24

2 3 3 O2 Flush Verification 2 3 4 Flow control device test

..............................

................................

25.........

...................................

25..

2.3.5 Vaporizer Leak Test ....................................................................................................... 25

2 3 6 Power Failure Test

..........

................................

.................................

................................

2.3.7 Evaporator Pressure test .............................................................................................. 26

2.4 Respiratory circuit test ............................................................................................................. 26

2 4 1 Bellows test

2.4.2 Mechanical ventilation respiratory loop leakage test ....................................................27

2.4.3Manual ventilation respiratory circuit leakage test ...........................

2 4 4 APL Valve Test

2. 5 Di splay Se tup Ch eck ..........................................................................................................28

2. 6 Ga s mo duel ve rific ation .......................................................................

2 7 Anesthesia ventilator test

...............................

................................

...................................

26...................

27.................................................................................................................

29..........................................................................................................

2.8 Check AGSS transmission and collection system .................................................................. 29

2 9 Alarm Test

2.9.1 Preparation before system operation ............................................................................30

2.9.3 Setting before alarm test ............................................................................................... 30

2.9.4 Test the Line Voltage Alarm ...........................................................................................32

30.................................................................................................................................

2.9.5 Vaporizer Interlock Test ................................................................................................. 33

2 10 Electrical Tests

33........................................................................................................................

2.1 0 .1 Auxilia ry Elec trical Outle t Test .................................................

2.1 0 .2 Ele ctrical Safety Insp ection Tes t ..................................................................... 33

3.0 Maintenance ............................................................................................................ 34

3 1 Maintenance intervals

34...............................................................................................................

3.2 Maintenance principle .................................................................................

3.3 Maintenance schedule ...............................................................................

3.4 Breathing system maintenance ..................................................................

3.5 Replace the fuse ...................................................................................................................... 36

3 6 O2 calibration

36............................................................................................................................

3.6.1 21%O2 calibration ............................................................................

3.6.2 100%O2 calibration ..........................................................................

3.7 Airway pressure meter zeroing ................................................................................................38

4.0 Alarm response measures ....................................................................................... 39

4.1 Alarm information table ...............................................................................

4.2 Physiological alarm ..................................................................................................................40

4.2.1Physiological alarm information ..................................................................................... 40

4 2 2 Technical alarm

43................................................................................................................

5.0 Cleaning and disinfection .........................................................................................47

5.1Cleaning methods .....................................................................................................................48

5.2 Disinfection methods ............................................................................................................... 48

5.3 Cleaning and disinfecting for the machine enclosure .............................................................48

5.4 Disassemble and install the components of the anesthesia ventilation system which could be

cleaned and disinfected .................................................................................................................49

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III

5.4.1 Disassemble the bellows components ......................................................................... 49

5.4.2 Disassembling the breathing air check valve components ..........................................50

5.4.3 Disassembling the inspiratory hose and connectors of type Y .................................... 51

5.4.4 Disassembling the manual breathing bag .................................................................... 51

5.4.5 Disassembling the flow sensor ..................................................................................... 52

5.4.6 Airway Pressure Gauge ................................................................................................ 52

5.4.7 Disassembling the soda lime canister .......................................................................... 53

5.4.8 Disassembling the water cup ........................................................................................53

5.4.9 Disassembling the oxygen sensor ................................................................................54

5.4.10 Disassembling the breathing circuit ............................................................................54

5.5 AGSS delivery and collection system ......................................................................................54

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Foreword

This Service is intended as a guide for technically qualified personnel performing repair and calibration procedures.

Warnings，Cautions and notes

Please read and adhere to all warnings, cautions and notes listed here and in the appropriate



areas throughout this manual.

 A WARNING is provided to alert the user to potential serious outcomes (death,injury or serious

adverse events) to the patient or the user.

 A CAUTION is provided to alert the user to use special care necessary for the safe and effective

use of the device. They may include actions to be taken go avoid effects in patients or user or users that may not be potentially life threatening or result in serious injury, but about which the user should be aware.

Cautions are also provided to alert the user to adverse effects on this device of use or misuse and



the care necessary to avoid such effects.

 A NOTE is provided when additional general information is applicable.

Warnings

 Whenever using anesthetic ages, nitrous oxide, oxygen or any hospital gas always follow the

appropriate agent evacuation/collection procedures.Use the hospital gas evacuation system.

 Use only an approved lubricant on any o-ring in contact with oxygen Krytox is the recommended

oxygen service lubricant.

 For continued protection against fire hazard, replace all fuses with the specified type and rating.

 In order to prevent an electric shock, the machine (protection ClassⅠ) may only be connected

to a correctly grounded mains connection (socket outlet with grounding contact).

 Remove all accessory equipment from the shelf before moving the anesthesia system over

bumps or on any inclined surface. Heavy top loading can cause the machine to tip over causing injury.

 Possible explosion hazard. Do not operate machine near flammable anesthetic agents or other

flammable substances. Do not use flammable anesthetic (e.g., ether or cyclopropane).

The use of anti-static or electrically conductive respiration tubes, when utilizing high frequency



electric surgery equipment, may cause burns and is therefore not recommended in any application of this machine.

 Possible electric shock hazard. The machine may only be opened by authorized service

personnel.

Avoid exposure to respiratory gases by always directing the fresh gas flow from the fresh gas



outlet to the waste gas scavenger.

When using the AG module to perform AG measurements on the patients who are receiving or



have recently received anesthetic agents, connect the outlet to the waster gas disposal system to prevent the medical staff from breathing in the anesthetic agents.

Remove the airway sampling line from the patient’s airway and seal the sample port while



nebulized medications are being delivered. Nebulized medications interfere with accuracy gas reading.

Before connecting the exhaust line to the sample gas outlet on the compact airway module,



ensure the other end is connected to the sample gas return port on the anesthesia machine. Incorrect connections may cause patient injury.

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Perform factory calibration in the working environment after completion of anesthesia machine



assembling .Contact us if factory calibration is required during system use.

Items can be contaminated due to infectious patients. Wear sterile rubber gloves. Contamination



can spread to you and other.

 Obey infection control and safety procedures. Using equipment may contain blood and body

fluids.

 Performance of safety for the equipment shall be checked before the equipment is started each

time so as to ensure that the equipment is in sound operation condition in service. Please refer to “Pre-use check” section in this operation manual.

 The equipment is to be operated by trained and authorized medical personnel only.

Parts which are damaged, missing, wearing, deformed or polluted, should be replaced



immediately. If need to repair or replace, we recommend that you call or write to the recent company's customer service center for help.

Don’t make any change for the equipment unless authorized by our company. If any trouble



occurred with the equipment, service shall be made by special technical personnel authorized by our Company or by trained and qualified technical personnel.

 If improper use, wrong maintenance and repairing, damage or changes made by any person not

in our company lead to product faults, the responsibility will be taken by users.

If necessary, please contact our company for further information.



Keep the machine stable and balance during operation, transportation or move. The maximum tilt



angle is not more than 10°.

Never use inflammable or explosive drugs with this equipment!

  The vaporizer only shall be filled with specified drugs. Never mix them up！

Only vaporizers provided or designated by Anesthesia system manufacturer that are in match



with the Anesthesia system shall be used. Otherwise, their performance will be degraded.

Don’t use antistatic breathing tube (threaded pipe) and mask with this equipment. If this kind of



breathing tube (threaded pipe) and mask are used adjacent to HF electrical surgical equipment, it will lead to fire.

The equipment shall not be used in a hazardous environment containing inflammable and



explosive gases.

 The equipment shall not be used in the Nuclear Magnetic Resonance environment.

When any alarm conditions occurred during operation, the equipment shall be checked and



trouble be removed immediately.

If alarm occurs in use, please ensure patient’s safety at first, then carry out fault diagnosis or



necessary maintenance.

 If power supply is interrupted, manual vent should be immediately carried out.

Although full consideration is given to clinic safety in the design of this equipment, its operator still



shall not neglect the observation of operation conditions of the equipment and monitoring of patient. Only by so doing, any mistakes or functional abnormal may get corrected right away once occurred.

 Breathing tube (threaded tube) shall be placed carefully so as not to enwind or asphyxiate the

patient during operation.

Moving or covering the equipment is not allowed during operation; nor is servicing of the



equipment allowed. Do not maintain the machine during operation.

 When N2O is used, its O2concentration shall not be less than 25%.

 To avoid risk of electric shock, this equipment must only be connected to a supply mains with

protective earth.

All parts of the ventilator must not be serviced or maintained while in use with the patient.



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No modification of this machine is allowed.



 Do regular check (Refer to the chapter of maintenance) and replacement (Refer to of replacing of

the back-up battery) of the battery.

Cautions

This device uses high pressure compressed gas. When attaching or disconnecting backup gas



cylinders, always turn the cylinder valves slowly. Use the flow meters to bleed down the pressure, watching the cylinder gauge indicate the depleting cylinder, before disconnecting the cylinder from the yoke. Always open and close cylinder valves fully.

 This device uses high pressure compressed gas at high pressures from the hospital center

supply. When connecting gas supply lines attach the hose connection to the machine before connecting the quick disconnect fitting to the hospital source. Disconnect the supply hose from the hospital source connection prior disconnecting it from the gas connection fittings.

 Refer to section periodical maintenance schedule for assistance when performing scheduled

periodic maintenance.

 Do not leave gas cylinder valves open if the pipeline supply is in use and the system master

switch is turned to ‘ON’. If used simultaneously, cylinder supplies could be depleted, leaving an in sufficient reserve supply in the event of pipeline failure.

 Use cleaning agent sparingly. Excess fluid could enter the machine, causing damage.  This machine must only be operated by trained, skilled medical staff.

Perform the electrical safety inspection as the last step after completing a repair of after routine



maintenance. Perform this inspection with all covers, panels, and screws installed.

 After changing the CO2absorbent, carry out a vaporizer and system leak test.

Only Selectatec compatible Vaporizers with Interlock-system may be used with the S6100 unit.

  After each exchange of a Vaporizer, carry out a system leak test.  Do not clean the machine while it is on and/or plugged in.

Pressing”cancel” at any time during the procedure will cancel the session’s settings and reload



the previously-stored calibration coefficients.

 Depleted sodalime changes color.Replace the sodalime if approximately 2/3 of the absorber

content is discolored. CO2absorbent can be safely changed without stopping mechanical ventilation.

 This equipment contains parts sensitive to damage by electrostatic discharge. Use ESD

precautionary procedures when touching, removing, or inserting parts or assemblies.

 The watertrap collects water drops condensed in the sampling tube and therefore prevents them

from entering the AG module. If the collected water reaches a certain amount, you should drain it to avoid airway blockage.

 The watertrap has a filter preventing bacterium, Vapor and patient secretions from entering the

module. After a long-term use, dust or other substances may compromise the performance of the filter or even watertrap once a month is recommended.

 Strong scavenging suction on the AG monitor exhaust port nay change the operating pressure of

the operating pressure of the monitor and cause inaccurate readings or internal damage.

Notes

 Unauthorized servicing may void the remainder of the warranty. Check with the factory or with a

local authorized distributor to determine the warranty status of a particular instrument.

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1.0Theory of operation

1.1 Introduction

The S6100 Anesthesia system is a simple and convenient anesthetic gas delivery system that

produces anesthesia gas and controls delivery of anesthesia gas by using a configured vaporizer. It

supports automatic and manual ventilation. It can also monitor various parameters of patents, such as

the airway pressure, inspired tidal volume and expired tidal volume.

The S6100 Anesthesia system provides the following ventilation modes:

 Intermittent positive pressure ventilation (IPPV), which includes pressure limit ventilation (PLV)

function.

Volume-Assistant/control ventilation(A/C).



 Pressure-Assistant/control ventilation(A/C).

 Pressure control ventilation(PCV-PC).

Pressure Control Ventilation with the Volume Guarantee Ventilation (PCV-VG).



 Volume-Synchronized Intermittent Mandatory Ventilation (V-SIMV).

 Pressure-Synchronized Intermittent Mandatory Ventilation (P-SIMV).

 Pressure Support Ventilation (PSV).

 Spontaneous ventilation in manual mode with the Airway pressure limit (APL) full open

 Manual Ventilation through the use of a breathing bag.

 Electronic positive and expiratory Pressure (PEEP) is available in all ventilation modes. Control

over inspiratory flow (Tslope) is possible in P-CMV, SIMV, and PSV modes. Automatic fresh gas

compensation helps patients suffer less from manual changes in fresh gas flow rate. The

traditional bellows system is driven by gas and makes patient ventilation clearly visible.

The S6100 fresh gas electronic flow metering system inherits the features of a traditional

anesthesia system and moreover is enhanced in ease of use.The dual-tube electronic flow meter

displays more precise readouts. Gas supply gauges indicate the pipeline and cylinder gas supply

pressures in real time. An auxiliary O2flow meters is placed on the upper left to make it convenient to

read the O2flush buttons in the traditional position near the front left corner of the table top.

Safety system within the S6100 works to prevent hypoxic mixtures from being delivered to the

patient. Nitrous Oxide will not be delivered unless oxygen pressure is present.

 Spontaneous ventilation in manual mode with the Airway pressure limit (APL) full open

 Manual Ventilation through the use of a breathing bag.

 Electronic positive and expiratory Pressure (PEEP) is available in all ventilation modes. Control

over inspiratory flow (Tslope) is possible in P-CMV, SIMV, and PSV modes. Automatic fresh gas

compensation helps patients suffer less from manual changes in fresh gas flow rate. The

traditional bellows system is driven by gas and makes patient ventilation clearly visible.

The S6100 fresh gas electronic flow metering system inherits the features of a traditional

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anesthesia system and moreover is enhanced in ease of use.The dual-tube electronic flow meter

displays more precise readouts. Gas supply gauges indicate the pipeline and cylinder gas supply

pressures in real time. An auxiliary O2flow meters is placed on the upper left to make it convenient to

read the O2flush buttons in the traditional position near the front left corner of the table top.

Safety system within the S6100 works to prevent hypoxic mixtures from being delivered to the

patient. Nitrous Oxide will not be delivered unless oxygen pressure is present.

The heating system of the S6100 patient breathing circuit minimizes condensed water and sends

warm and humidified gas back to the patient. The pressure gauge, APL valve and manual breathing

bag of the patient breathing circuit support fast plug and unplug to facilitate their installation and

maintenance. The APL valve has a rotary knob that provides a clear view of the manual breathing

pressure setting. The soda lime absorber canister can be opened and closed quickly through a handle.

It can absorb soda lime in standard pre-paks or loose-fill soda lime.

Two flow sensors are configured on the patient breathing circuit to monitor the flow of inspired and

expired gases and monitor the airway pressure. The operator can rotate and fix the patient breath

breathing circuit as required. In addition, the patient breathing circuit is equipped with a side plug for

gas leakage detection.The anesthesia Gas Scavening system (AGSS) connectors are at the left of the

S6100.

When the S6100 user AC power supply, the S6100 power management system supplies power for

its main system while charging its internal battery. In case of an AC power failure, the S6100 operates

on battery power, two new batteries supporting normal running in a minimum of 90 minutes.The main

system switch can power on and off the system.The four auxiliary AC sockets on the S6100 at the rear

of the machine operate independent of the main system switch.

Note: The warmer for the patient breathing circuit system does not operate when the S6100 is

working on battery power.

Note: If the main switch is set to off, the O2supply is turned off.

1.2 Electrical Connections

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FIGURE 1-1

power cord

Power input socket

Fuse 1

Fuse 2

Power management PCB

Battery

Main control board

monitor board

Shuttle board

Switch mask

Display

Touch screen

horn

Fan

Alarm board

ETCO2

Oxygen sensor

Oxygen Pressure monitoring board

N2O Pressure monitoring board

Air Pressure monitoring board

ACGO

Man/mechanical control

Tidal volume valve

PEEP valve

123

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1.3 Gas flow

1.3.1Pneumatic Circuit Diagram

FIGURE 1-2

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1.3.2 Part list

O2centre Gas

reserve O2centre Gas Supply

N2O centre Pipeline Gas Supply

Air centre Pipeline gas supply

5-1

Filter（O2supply）

5-2

Filter（N2O supply）

5-3

Filter（Air supply）

6-1

Pressure Gauge/O2supply

6-2

Pressure Gauge/N2O supply

6-3

Pressure Gauge/Air supply

7-1

Pressure Relief Valve（750kPa)/O

7-2

Pressure Relief Valve（750kPa)/N2O

7-3

Pressure Relief Valve（750kPa)/Air

8-1

Check Valve/O

8-2

Check Valve/ N2O

8-3

Check Valve/Air

9-1

Pressure Sensor//O2supply

9-2

Pressure Sensor/N2O supply

9-3

Pressure Sensor//Air supply

10-1

Pressure Regulator/O2Supply

10-2

Pressure Regulator/N2O Supply

10-3

Pressure Regulator/Driven Gas

10-4

Pressure Regulator/PEEP

Proportional Valve/Driven Gas

Proportional Valve/PEEP

Pressure Regulator/PEEP

Breathing valve

Safety valve(11kPa)

Atmosphere

cut-off valve

Flowmeter

Total Flowmeter

20-1

evaporator

21-1

evaporator

Check Valve

Oxygen flush

Pressure Relief Valve（40kPa)

ACGO selection switch

ACGO Interface

Oxygen sensor

Suction valve

Exhalation valve

Sodium lime absorption tank

31-1

Inspiration flow sensor

31-2

Expiration flow sensor

Pressure Gauge/Inspiratory port

Bellows

POP-OFF Pressure Relief Valve

Mechanical/Manual switch

Manual airbag

APL Valve

Monitor

Patient

AGSS

Filter

Regulator

Pressure Gauge

Check Valve

Gas Supply Connector

Pressure Relief Valve

Flowmeter

Flow Control Valve

Pressure Switch

Flow Restrictor

1.3.3 Key to symbols

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1.3.4 Description

1.3.4.1 Anesthetic Gas Delivery System

The anesthetic gas delivery system is connected to the gas supply,anesthetic gas delivery device （Vaporizer）and breathing system. The system inputs N2O,O2and Air from the gas supply assembly and outputs gas mixture of the three gases and anesthetic agent (fresh gas), pure O2(high-pressure O2output ,auxiliary O2supply and flushing O2), or Air-O2mixture. The following figure shows the pneumatic of the anesthetic gas delivery system.

FIGURE 1-3

1.3.4.2 Gas supplies

The S6100 anesthesia machine supports three supplies: O2, N2O and AIR. All the gas supply

interfaces are designed on IEC 60601-2-13, which prevents misconnection between different gases.

The S6100 gas supply inlet assemblies comprise the pipeline gas supply inlet assembly and cylinder

gas supply inlet assembly.

The following describes the O2gas flow. The difference between the O2and the AIR/N2O limbs lies in

that the drive gas output and high-pressure O2output are available at the upstream and of the

regulator on the O2limb.The configuration of other components are the same.The O2pipeline supply

inlet assembly includes filter, pressure gauge, pressure relief valve, check valve and regulator. The

cylinder gas supply inlet assembly includes the filter pressure gauge, pressure reducing valve,

pressure relief valve, check valve and regulator. Where, the pressure switch and regulator are shared

by the pipeline and cylinder gas supply limbs.

The following figure shows the physical pipeline gas supply inlet assembly of the system, including the

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gas supply inlet assembly and regulators. The gas supply inlet assembly integrates the filter, pressure

relief valve, pressure switch and check valve.

1.3.4.3 Flowmeter

The flow meter has a flow control valve that controls and directs the flow of fresh gas to the patient.

The flow meter is also equipped with O2, N2O proportional control device and N2O shut-off valve.

When the oxygen pressure falls below 180kPa, the N2O will be cut off.

The flowmeter (2 in Figure 1) can simultaneously display the flow of O2, N2O and AIR.

The flow is controlled by the corresponding flow control valve respectively:

——Turn counterclockwise to increase flow;；

——Turn clockwise to reduce flow。

The O2 and N2O flow control valves are also equipped with O2 and N2O proportional control devices

to ensure that the output O2 concentration is not less than 25% and not more than 40%. When the

O2 oxygen pressure drops below 180kPa, the N2O is automatically turned off at the same time.

1.3.4.4 Vaporizer Manifold

The vaporizer manifold is used to bear the vaporizers and provide an airtight chamber.In the chamber,

the gas mixture and anesthetic gas converge into the fresh gas and output to the downstream ACGO

assembly. Each column on the manifold is two-position three-way valve. When no vaporizer is

installed, the columns are at the original positions and the gas mixture is delivered to the downstream

through the bypass inside the manifold. When vaporizer are installed, the columns are bent and the

gas mixture is delivered to the manifold and output to the downstream.The following figure shows the

position of the vaporizer manifold in the system.

FIGURE 1-4

The following figure shows the structure model and the corresponding interface information.

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1.3.4.5 ACGO Assembly

FIGURE 1-5

The ACGO assembly is used to connect the fresh gas output from the vaporizer manifold and the O

output from the O2flush device to the breathing circuit of the anesthesia machine or to an independent

outlet. Mechanical ACGO configuration available.

FIGURE 1-6

When the ACGO assembly is switched to the ACGO state, the fresh gas will be output from the

independent outlet. Traditionally, the fresh gas is output from the ACGO limb integrated on the patient

circuit.By contrast, the independent ACGO outlet is independent from the patient circuit.The following

figure shows the position of the independent ACGO outlet in the system. The gas input is from the

ACGO outlet on the ACGO assembly.

FIGURE 1-7

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1.3.4.6 O2 flush button Assembly

The O2flush assembly is located on the work surface. When O2flush button is depressed, O2rushes

into the pneumatic circuit, and will be cut off when this button is released.The O2supply gas is at

0.25MPa, after being regulated, goes through the O2flush valve and into the O2flush inlet of the

ACGO assembly. The O2flush assembly is not affected by the system switch.Flushing O2can be

performed as long as O2supply is normal.The O2flush valve has slide valve structure inside that

ensures automatic reset each time the valve is depressed and released via the spring. The following

figure shows the position of the O2flush valve in the system.

FIGURE 1-8

The following figure shows the structure model the corresponding interface information.

FIGURE 1-9

1.3.4.7 High pressure O2 Output Assembly

The high pressure O2input comes from the gas supply (280-600kPa) directly and provides high

pressure O2for the external ventilation device (jet ventilation devices).

1.3.4.8 Pneumatically-Controlled Module of Anesthetic

The pneumatically-controlled module of the anesthetic ventilator provides drive gas fro the patient to

breathe. O2(or Air) from the gas supply inlet assembly enters the anesthetic ventilator and is output in

three pathway: drive gas entering the breathing system, drive gas discharged through the AGSS

outlet, and drive gas discharged through the PEEP outlet. The ventilator controls drive gas flow to

implement various ventilation modes and prevent excessively high pressure inside the pneumatic

circuit from injuring the patient.The following figure shows the pneumatic circuit diagram of the

anesthetic ventilator.

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FIGURE 1-10

The regulator (10-3) regulates pressure (about 0.27Mpa) inside the pneumatic circuit.The proportional

solenoid valve (11) controls the inlet gas flow. The mechanical over pressure valve (15) ensures that

the pressure in the drive gas circuit does not exceed the safety pressure. It releases excess gas when

gas pressure exceeds 11 kPa (110 cmH2O). Component EV is the expiratory valve.

The PEEP function is performed through the expiratory Valve. Component (12) is a low-flow

proportional solenoid valve. When it opens, gas is bled from the pneumatic resistor (13), forming

relatively stable pressure in the pneumatic circuit from component 12 to 13. Such pressure is exerted

on the membrane of the expiratory valve (34) to from PEEP.

TO prevent excessively high pressure inside the pneumatic circuit from injuring the patient and

damaging the equipment, the pressure relief valve (15), which is a solenoid on-off valve, is placed

before the gas pathway of the expiratory valve. The mechanical pressure relief valve (15) ensures

that the tube pressure after the expiratory valve is less than 10 cmH2O.

1.3.4.9 Breathing System

The breathing system provides a closed loop for the anesthetic gas. The expired gas from the

patient can be inspired in the inspiration phase to maintain the temperature and humidity

conditions of the patient's expired gas. During inspiration, the drive gas depresses the bag inside

the bellows to force the inside gas to enter the patient's lung. During expiration, the patient's

Page 19

expired gas goes into the bag inside the bellows. The soda lime absorber canister absorbs CO

that the patient expires. The following figure shows the pneumatic circuit of the breathing system.

FIGURE 1-11

1.3.4.10 Anesthetic Gas Scavenging System

The Anesthetic Gas Scavenging System (AGSS) is composed of the AGSS transfer system, the

AGSS receiving system, and the AGSS disposal system. Waste gas goes from the exhaust port

of the anesthesia machine through the AGSS transfer system and the AGSS receiving system

to the hospital's waste gas disposal system (AGSS disposal system), as shown below.

FIGURE 1-12

The following figure shows the operational theory of the AGSS. The throttling holes reduce the

Page 20

effect of negative pressure at the AGSS outlet onto the flow at the entrance. The float helps the

user determine if the disposal system meets the requirement for the minimum pump rate. The

filter provides for filtering of foreign substances to prevent the disposal system from being

occluded. The gas reservoir is connected to the air through pressure compensation openings.

When positive or negative pressure occurs inside the gas reservoir, gas is inputted or outputted to

ensure pressure balance inside the system.

The AGSS transfer system is a clear tube with 30 mm conical connectors at both ends. The inlet of the transfer system is a female 30 mm conical connector and the outlet a male 30 mm conical connector. The transfer system is connected to the receiving system through the male 30 mm conical connector. The receiving system is connected to the receiving hose through the 30 mm connector. The following picture shows the AGSS structure and the connections between the AGSS transfer system, receiving system, and disposal system.

Page 21

1.4 The Breathing System

1.4.1 Brif Introduction

The S6100 breathing system supports three operating modes: mechanical, manual ventilation,

and standby. These modes allow the operator to apply proper ventilation strategies based on the

patient’s needs.

The types of flow paths through the breathing system very with operating mode status.

1.4.2 Automatic Mode, Inspiration

When the Auto/Manual switch is positioned at Auto, the system closes the manual ventilation

path.Drive gas pushes down on the bellows.Gas flows from the bellows, through the co2 absorber

canister, and through the inspiratory check valve to the patient.

During inspiration, fresh gas into the inspiratory limb, upstream of the inspiratory check valve. In

volume mode, tidal volume is compensated for variations in fresh gas flow to ensure that the volume

delivered to the patient meet the set value.

In volume mode, tidal volume is compensated for variations in fresh gas flow to ensure that the

volume delivered to the patient meets the set value.

In pressure mode, the inspiratory pressure is regulated both in gas flow and airway pressure to

ensure the airway pressure is held at the set inspiratory pressure during the patient inspiration.

FIGURE 1-13 Automatic Mode, Inspiration Diagram

1.4.3 Automatic Mode, Expiration

When the Auto/Manual switch is to Auto, the system close the manual ventilation path. Drive-gas flow

stops and the exhaust valve opens.exhaled gas flows from the patient, through the expiratory check

valve, and into the bellows.

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Residual drive gas flows out of the bellows dome through the exhaust valve to the Scavenging

system (AGSS).

If PEEP is selected, static pressure on the pilot port of the exhaust valve set the PEEP level.

During exhalation, fresh gas flows backwards through the CO2absorber into the the expiratory limb,

downstream of the expiratory check valve.

FIGURE 1-14 Automatic Mode, Expiration Diagram

1.4.4 Manual Mode, Inspiration

When the Auto/Manual switch is set to Manual, the System close the Auto Ventilation path. Gas flows

from the breathing bag when compressed, through the CO2 absorber canister, into the breathing

circuit, and through the inspiratory check valve to the patient.

During inspiration, fresh gas flows from the machine into the inspiratory limb, upstream of the

inspiratory check valve.

If airway pressure exceeds the set value of the APL valve, the residual gas will pass through the APL

Valve to the scavenging system (AGSS).

FIGURE 1-15 Manual mode, inspiration Diagram

Page 23

1.4.5 Manual Mode, Expiration

When the Auto/Manual switch is set to Manual, the system close the Auto ventilation path. Gas flows

from the patient, through the expiratory check valve, and into the breathing bag. During exhalation,

fresh gas enters the breathing System. Residual fresh gas passes through the APL valve to the

AGSS.

FIGURE 1-16 Manual Model,Expiration Diagram

1.4.6 Pneumatic PEEP

The PEEP valve regulates the pressure at which the exhaust valve opens. Therefore, if PEEP is

selected, static pressure on the pilot port of the exhalation valve set the PEEP level during the

automatic ventilation.

1.4.7 Ventilator in Standby

When the anesthesia system is in standby mode, monitoring will be inactive, and automatic

ventilation will be unavailable.The patient should not be ventilated when the system is in standby

mode.

1.4.8 Breathing System Components

1.4.8.1 Ventilation Bellows system

The ventilator’s driving system is a flow generator.Driving gas fills the bellows dome to compress the

bellows. The breathing gas is pressed out of the bellows into the patient breathing circuit.The bellows

is refilled with fresh gas and the expired gas from the patient.

1.4.8.2 Manual Breathing Bag

In manual mode, this device acts as a normal breathing bag, enabling the user to ventilate the patient

manually.

1.4.8.3 CO2 Absorber Canister

The soda lime inside the CO2absorber canister absorbs the carbon dioxide from the exhaled gas.

The CO2absorber canister accommodates standard size pre-paks or loose-fill CO2absorbent.

Page 24

1.4.8.4 Inspiratory and Expiratory Valves

To ensure correct gas flow direction to and from the patient, check-valves are integrated in the

inspiratory and expiratory limb of the breathing system.

1.4.8.5 APL (Airway Pressure limiting) Valve

In manual mode, the APL Valve acts as normal spring-loaded pressure relief valve, limiting the

maximum pressure in the breathing system.

1.5 Ventilator UI

1.5.1 Display Interface Borad

FIGURE 1-17 Display Interface Board, Top View

FIGURE 1-18 Display Interface Board, Bottom View

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1.5.2 Warning light Board

FIGURE 1-19 Warning Light Board, Top View

FIGURE 1-20 Warning Light Board, Bottom View

1.5.3 Display and Touchscreen

The anesthesia machine is fitted up with a 15-inch 24-bit 1024x768 LVDS display as the main

output component, and a 15-inch touchscreen as the main input component (another touchpad

is available on the S6100 anesthesia machine).

1.5.4 Other Components

The display system also includes the backlight inverter board, warning Light board, touchscreen

control board and encoder board. The backlight inverter board provides backlight for the display;

the warning light board is used for reporting visual alarms on the anesthesia machine; the

touchscreen control board controls the inputs through the touchscreen and sends processed

touchscreen operation information through a serial port.

1.5.6 Indicator Light Board

FIGURE 1-21 Indicator Light Board, Top View

FIGURE 1-22 Indicator Light Board, Bottom View

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1.6 Ventilator control and Drive

FIGURE 1-23 Monitor Board, Top View

FIGURE 1-24 Monitor Board, Bottom View

Page 27

Ventilator Pneumatic- O2Drive Gas

1.7

1.7.1 Ventilator Pneumatic Drive

Oxygen is the driving gas for the ventilator. In addition to the flow meter block, a high pressure

regulator reduces the supply pressure to 200 kPa (29 psi). This pressure represents the drive

gas for the ventilator.

The drive pressure regulator is placed ahead of the proportional valve that generates the

driving gas flow during the inspiratory phase. This flow fills the bellows dome that surrounds the

bellows.

1.7.2 Drive Pressure-High Pressure Regulator (200 kPa, 29 psi)

The drive pressure regulator stabilizes the supply pressure provided to the proportional valve.

The flow generated by the proportional valve is therefore independent of pressure variations at

the supply.

Setting the drive pressure regulator at 200 kPa (29 psi) allows for a maximum inspiratory flow of

110 L/min at the ventilator.

1.7.3 Drive Gas Assembly

The manifold assembly module mainly consists of the inspiratory circuit and PEEP circuit. The

inspiratory circuit goes through the normally closed proportional solenoid valve, which generates a

gas flow of 0 to 110 L/min by the valve drive board. The gas flow of the PEEP circuit goes through the

normally closed proportional solenoid valve, which also generates a gas pressure of 0 to 30 cm H2O

by the valve drive board.

2.0 Installation Guide

2.1 Preparation - Additional Material Required

The following additional material are required before installation. The customer is responsible for

supplying this material. Missing items may result in delays, incomplete installations, and/or

additional service visits.

 Compatible emergency O2, N2O, and AIR cylinders

Agent vaporizers and key fillers (if not purchased with the anesthesia system)



 Liquid agent medication

CO2 absorbent Pre-Paks or loose fill



Active O2, N2O, and AIR lines (280 to 600 kPa (40 to 87 psi))



 Drop down hoses for ceiling-mounted medical gas utilities that are compatible with quick-

disconnect hoses (if not purchased with the anesthesia system)

 Negative pressure source, negative pressure source connection related hoses (if not purchased

with the anesthesia system)

Page 28

2.2 Assembly

When the S6100 is delivered, IMMEDIATELY inspect the box for any damage.

a. If there is NO damage and ALL tip indicators on the box exterior are intact, then sign and

date the bill of lading or airway bill to indicate safe receipt of the anesthesia system.

b. If there is DAMAGE or ANY of the tip indicators on the box exterior have activated, then

conditionally accept the delivery and clearly describe the damages on the bill of lading or

airway bill. BOTH the carrier and recipient must sign and date the bill of lading or airway bill.

Save all damaged factory packaging until further instructed.

2.21 Installation of vaporizer

Verify that each manifold port valve O-ring is intact. If necessary, remove the existing



O-rings and fit one new O-ring to each port valve, as described in the relevant anesthesia system User manual. Replacement O-rings are supplied with each vaporizer.

After confirmation, hold the main body of the vaporizer in an upright position with both hands.



Lower the vaporizer onto the manifold, ensuring that the vaporizer interlock ports engage correctly with the manifold port valves.

Turn the interlocking lever clockwise to lock the vaporizer onto the manifold.



The equipment may select enflurane or isoflurane or sevoflurane or halothane or desflurane



vaporizer with temperature and flow rate compensation function; and can be equipped with one or two Anaesthetic vaporizers. The vaporizer mating with the Anesthesia System nominated by our company shall be used. Otherwise, the performance of them will be decreased.

 There is the self-lock device on this vaporizer.

 Turn the concentration-regulating-knob to adjust the required concentrations of anesthetics.

2.2.2 Installation of module

2.2.2.1 Installation of AG module

 The mainstream type of anesthetic gas monitor installation, in accordance with

the chapter "gas monitoring module" instructions.

The side stream type of anesthetic gas monitor installation, in accordance with the



chapter "gas monitoring module" instructions.

2.2.2.2Installation of CO2Module

 The mainstream type CO2monitor installation, in accordance with the chapter "gas

monitoring module" instructions.

The side stream type CO2monitor installation, in accordance with the chapter "gas



monitoring module" instructions.

2.3 Functional Tests

Before the use of anesthesia system for each patient, the anesthesia system needs to do basic



operation test or maintenance to ensure equipment safety and effective.

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2.3.1 Check system

The initial examination of the anesthesia system, ensure that comply with the following requirements before use:

Equipment in good condition;



 Casters has been locked, and no loosening, can prevent the anesthesia system movement;

 System components is connected properly;

Supply system is connected properly, the screen showed a normal pressure monitoring;



 Cylinders gas supply, gas is enough, to ensure that cylinder valve is closed;

 Safety oxygen control switch is intact and function of flowmeter is normal;

The function of electronic flowmeter is normal;



 ACGO switch is intact;

 Breathing circuit is connected properly, respiratory tube is intact, Soda Lime enough;

Anesthesia ventilation system has been fixed on the seat, and the nut is screwed up;



 Adjustable pressure limiting valve, its calibration points to the minimum (MIN);

 The evaporator is installed and have adequate locking, anesthetics is enough, evaporator have

been closed;

 For airway maintenance and equipment for tracheal incubation was ready, in good condition;

 Required emergency equipment and medicines have been ready, in good condition;

Power line is connected to the AC power supply, AC power indicator light;



 Spare battery installed nondestructive;

 To ensure that all switch of anesthesia system work normally;

To ensure that the anesthesia ventilator associated parameter and alarm limit set for the



clinical level;

 To ensure that the system is in standby state.

2.3.2 Pipe gas supply test

The center gas source pressure hose of O2is screwed to oxygen port on the back of the



machine;

 The other end of pipeline connected to the wall type air connection;

To ensure that the central gas supply pressure in the range of 0.28 ~ 0.6kPa;



 Press system switch key, start the system, the main interface displayed normal O2pipeline

pressure;

Disconnect oxygen pipeline gas source;



 Should be observed in the main interface of monitoring O2pipeline pressure 0.0MPa, system

send out 【!! No O2Pressure】 alarm prompt;

If the current O2is selected as the system drive gas, O2gas pressure is lower than



0.2MPa, 【Low Driven Gas Press】 trigger alarm;

 If the current machine driven gas Air is selected as the driving gas, disconnect the

Air pipeline gas is lower than 0.2MPa, 【!!!Low Driven Gas Press】 trigger alarm.

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2.3.3 O2 Flush Verification

Touch the screen to start the manual ventilation mode and set the ACGO button to on.



 Set the flow to minimum (0.20 L/min). Connect a flow meter to the ACGO port.

 Verify that the O2flush flow is between 35 to 50 L/min when pressing the O2flush button.

2.3.4 Flow control device test

Equipped with an electron lowest oxygen transport system to avoid hypoxia mixed gas, can be detected according to the following function:

 When nitrous oxide as the carrier gas, the lowest oxygen transfer capacity for the

200mL/min. Fresh gas flow rate is greater than 0.8 L/min, the lowest oxygen concentration limit was 25%. Fresh gas flow settings below 0.8 L/min, the oxygen concentration automatically elevated to oxygen flow is equivalent value to 200 mL/min.

 When choosing the air as carrier gas, do not start SORC function, and range of 100% air can be

detected in the entire flow regulation.

FIGURE 2-1

2.3.5 Vaporizer Leak Test

Set the ventilation Auto/Manual ventilation switch to Manual.



 Set the APL valve to the SP position.

Connect one end of the breathing circuit to the bag arm, one end to the inspiratory port and the



Y-piece to the test port.

 Mount and lock the vaporizer onto the vaporizer mount. (Certain vaporizers need to be set to at

least 1% for correct testing. See the vaporizer manufacturer's manual for details.)

Set the fresh gas flow to 200 mL/min.



Set the APL valve to 75 and verify that the pressure on the airway pressure gauge increases



above 30 cmH2O within 2 minutes.

Turn off the vaporizer. Set APL valve to SP.



Repeat Steps 4, 5, 6, and 7 for the other vaporizer.



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2.3.6 Power Failure Test

Insert the plug into the socket on the wall;

 Press the system on / off key, starting system, unplug the power line;

Should be observed in AC indicator lights off of AC power, battery powered lights



flashing, alarm information display area prompt 【!AC Disconnect】 alarm;

 Put the power line connect to the AC power supply socket;

Should be observed in AC indicator lights on of AC power, the battery power indicator



light, from the original 【!AC Disconnect】 prompt alarm automatically canceled;

Long press again system On / off key, pop-up box to select 【 OK 】 button, enter the



5S countdown, after count down shut down system automatically; If you

choose “ ” button, quit interface, return to the current state, the shut down cancel.

2.3.7 Evaporator Pressure test

The following test of anesthesia system evaporator, to ensure its normal function:

 To ensure that the evaporator has been in accordance with the fourth chapter "installation of

vaporizer " installed;

 Press the system on / off key, starting system;

 Access pipeline gas supply or cylinders gas supply;

 Set the oxygen concentration is 100%, set the fresh gas flow rate of 6L/min, and

keep the stability of flow;

 Conditioning evaporator concentration from 0 ~ 1%;

 Should be observed, in the whole process flow of oxygen reduction shall not exceed 1L/min;

 If the observed flow decreased more than 1L/min should be replaced with an evaporator,

and then refer to the step 1) to step 5), re-testing, if the flow reduction is still more than 1L/min, it means the system failure, do not use the anesthesia system.

2.4 Respiratory circuit test

Ensure that the single direction valve on breathing circuit work on normal:

When Inspiration, inspiration direction valve open, the expiration direction valve closed



instantly, indicates that the inspiration direction valve work on normal.

When expiration, expiration direction valve open, the inspiration direction valve closed



instantly, indicates that the expiration direction valve work on normal.

2.4.1 Bellows test

Press system on / off key, boot device, and keep the device is in the standby state.



Manual / machine control switch is arranged in the machine control position.



Set the fresh gas flow to a minimum.



Blocked the patient end export, closed respiratory loop.



Press the fast O2+ button, fill in bellows, make the bellows folding bag rises to the top.



Ensure that the pressure of airway pressure table can not rise to more than 15 cmH2O.



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 The bellows folding bag shall not fall, if falling means the bellows leak. Please re-install the

bellows.

2.4.2 Power-on Self-test

According to the follow method to do the leak test:

 Make sure that the supply gas pressure is normal;

Set the bag/vent switch to vent position;



Plug the Y piece into the leak test plug to close the breathing system;



Push the O2flush button to fill the bellows, folding bag rising to the top;



 Press【Self test】,System starts respiring system self-test, meanwhile display fill loading. If the

check passed, will display information【Check Passed】. Otherwise display information【Check Failure】,at this time need to check whether the respire loop connection is right, pipe whether the pipe is intact,ensure if there are no problem, re-check the leak.

FIGURE 2-2 self-test

2.4.3 APL Valve Test

Manual / machine control switch to manual position;



 Ensure system on STANDBY mode, if not, press 【 Standby 】 button,select 【 ok 】 to enter

STANDBY mode;

 Connect the manual breathing bladder to the manual gas-save bag connector of breathing

circuit;

 Put “Y” shape of bellows into leakage test plug of circuit to block the gas outlet of “Y“shape.

 Adjust the APL valve, keep the valve in the fully closed （75 cmH2O position);

 Set oxygen concentration as 100%,set fresh gas flow as 3 L/min;

Press quick O2+or press【O2+】on the screen,keep the manual ventilation bagfull;



Page 33

Ensure the APL gauge no more than 85 cmH2O. Pressure fluctuation is permitted;



 Adjust APL Valve control the rotation,make APL valve pressure to 30 cmH2O;

 Ensure the APL gauge as 30 cmH2O;

 Adjust APL Valve control the rotation,make APL valve pressure to minimum（MIN position）;

 Ensure the AP gauge less than 5 cmH2O;

 set fresh gas flow as MIN;

Press quick O2+or press 【 O2+ 】 on the screen,Ensure the AP gauge as 0 and no less than



0cmH2O,APL Valve Exhaust no abnormal.

2.5 Display Setup Check

 Touch Continue to advance to the Standby screen display. For the S6100, check that the

screen displays the main screen, check that all ventilation modes are there, as shown in the figure below.

FIGURE 2-3 Display Setup Check

Page 34

2.6Anesthesia ventilator test

According to the following steps and methods to do the anesthesia system and ventilator test:

 Press the start button, start the system;

 Put manual / machine control switch to control position;

 Put the test lung connected to the Y tube connector;

 Set fresh gas flow as 100mL/min, ensure the minimum flow or close;

 Set the system to the standby mode;

 Through the operation interface, in accordance with the following parameters set options:

——Mechanical ventilation mode: select 【IPPV】

——Tidal volume TVe: 500mL

——Respiratory frequency Rate: 12bpm

——Breath Ratio I:E:1:2

——Pressure limit level Plimit: 30cmH2O

——Positive end expiratory pressure PEEP: OFF

 Oxygen meter on the screen, touch control in 0.5 ~ 1L/min;

 Press the rapid oxygenation button, the bellows folding bag completely supports;

 Click on the【Start Ventilation】 screen hotkey, into the ventilation condition;

 Observably, has launched the mechanical ventilation, bellows folding bag regular rising and the

basic function of anesthesia ventilator after test, according to the following steps and methods of anesthesia respirator leakage test:

 The system is set to the standby mode;

 Set the fresh gas flow about 0.3L/min

 The bellows on the Y shape is inserted into the test plug leakage circuit, blocking the outlet Y

shape;

 Press the rapid oxygenation button, the bellows folding was propped up, loosen the rapid

oxygen filling button;

 Should be observed, folding bag doesn't fall down, otherwise the system has a leak, should

investigate the cause and find solution then test again according to the above method.

2.8 Check AGSS transmission and collection system

Invent the AGSS, check float can freely move up and down. If the float motion any blocking adhesion phenomenon or appears damaged, it must be reset or replace the float before use.

If the float does not float, there may be several reasons:

Float adhesion. Please check the free movement of the float on the above way.



Float slowly rising. The filter may be blocked, please press removing filter in the manner



described check if the filter in the upper cap is blocked.

Exhaust gas treatment system does not work or pumping gas flow rate is lower than the normal



Page 35

work of AGSS flow 50L/min. Please check the waste gas treatment system test are described by way of waste gas treatment system.

2.9 Alarm Test

Anesthesia system automatically performs self-checking once it is turned on. The alarm lamp

blinks once as per yellow -red sequence, and a beep is given out. Boot-strap menu is displayed in the screen. When“ Selftest results”、“Automatic circuit leak test/compliance test” and “Manual circuit leak test” is finished, the equipment accesses its standby interface directly. This indicates that the audible and visual alarm indicator works normally.

2.9.1 Preparation before system operation

 Ensure that relevant parameters of ventilator and alarm limits set for clinical application, the

specific settings can refer to the relevant sections of the eighth chapter of operation and parameter setting.

To ensure that the system is in standby state.



Requires the following equipment: airway maintenance, manual ventilation and tracheal



incubation device, and the application of anesthesia and emergency medicine.

Manual / machine control switch is set to manual position.



Manual breathing bag port connects to manual breathing bag.



Close all evaporator.



Regulating the rotation control APL valve, the valve in the fully open state of APL (MIN).



Fresh gas flow is set to minimum.



To ensure that the breathing circuit is properly connected and undamaged.



2.9.2 Alarm function check

Setting before alarm test please refer to chapter“ Anesthesia ventilator test” steps.

Rotate “bag/vent” selection knob to“ ”;



Patient connector (“Y” connector) is connected with test lung;



 Adjust gross flow rate of fresh gas to 0.5L/min;

Press oxygen flush button to fully fill breathing bellow;



Open Anaesthesia System power supply;



 Basic ventilation parameters set as:

——tidal volume: 500 mL

—— frequency: 12 /min;

——inspiratory to expiratory time ratio(I:E):1:2

Check the “MV high !!” alarm:



—— set upper alarm limit value of MV as 8.0 L/min;

——adjust tidal volume and frequency to ensure that the MV is slightly greater than or equal to

the set upper alarm limit value of MV;

——S6100 displays the following medium priority alarm message “MV high !!”.

 Check the “MV low !! ”alarm:

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—— set the lower alarm limit value of MV as 6.0 L/min;

——adjust tidal volume and frequency to ensure that the MV is slightly less than or equal to the

set lower alarm limit value of MV;

——S6100 displays the following medium priority alarm message “ MV low !!” .

 Check the “PAW high !!! ”alarm:

—— set the upper limit value of airway pressure as 20 cmH2O;

——adjust tidal volume and airway resistance to ensure that airway pressure is slightly greater

than or equal to the set upper limit value of airway pressure;

——S6100 displays the following high priority alarm message “PAW high !!!”;

——After the “PAW high !!!” alarm, inhalation state shall be switched to exhalation state and

airway pressure shall be no more than 100 cmH2O.

Check the” PAW low !!!”alarm;



—— set the lower limit value of airway pressure as 0 cmH2O:

——adjust tidal volume and airway resistance to ensure that the airway pressure is slightly less

than or equal to the set lower limit value of airway pressure;

——S6100 displays the following high priority alarm message “PAW low !!!”.

 Check “NO VT !!” alarm;

——When beginning to expire, disconnect the breathing pipe and the flow sensor. ——Delay time is less than 6s, S6100 displays the following medium priority alarm message “NO

VT!!”.

 Check “Apnea !!” alarm

—— When beginning to expire, disconnect the breathing tube and the flow sensor, ——S6100 displays the following medium priority alarm message “Apnea !!”, delay time is

about 30s, after 2 minutes, there will be a message “Apnea＞2 minutes”.

 Check the continuous pressure alarm:

——Set PEEP as 0 cmH2O;

——Observe airway pressure gauge, pinch flow sample tube to ensure airway pressure is more

than 15 cmH2O and delay16s;

——S6100 displays the following high priority alarm message ” Pcon high !!!” .

Check the “ FiO2 high !!!” alarm:



——Put O2sensor in air;

—— set upper limit value of O2concentration as 20%;

——S6100 displays the following high priority alarm message “FiO2high !!! ” .

 Check “FiO2 low !!!” alarm:

——Put O2sensor in air;

——set lower limit value of O2concentration as 22%;

——S6100 displays the following high priority alarm message “FiO2low !!!” .

 Check “O2 supply low !!” alarm:

——Oxygen pressure regulation is lower than 180kPa;

——S6100 displays the following medium priority alarm message “O2supply low !!” .

Page 37

 Check “Vte high!!” alarm:

——Set upper alarm limit value of Vte as 500 mL;

——Reset Vte to make the Vte greater than or equal to the upper limit of Vte;

——S6100 displays the following medium priority alarm message “Vte high!!”.

 Check “Vte low!!” alarm:

——Set lower alarm limit value of Vte as 300 mL;

——Reset Vte to make the Vte less than or equal to the lower limit of Vte;

——S6100 displays the following medium priority alarm message “Vte low!!”.

Check “Freq high!!” alarm:



——Set upper alarm limit value of frequency as 20/min;

——Reset frequency to make the frequency greater than or equal to the upper limit of frequency;

——S6100 displays the following medium priority alarm message “Freq high!!”.

 Check “Freq low!!” alarm:

——Set lower alarm limit value of frequency as 10/min;

——Reset frequency to make the frequency less than or equal to the lower limit of frequency;

——S6100 displays the following medium priority alarm message “Freq low!!”.

 Check “etCO2 high!!” alarm:

——Set upper alarm limit value of etCO2as 100mmHg;

——Reset etCO2to make the etCO2greater than or equal to the upper limit of etCO2;

——S6100 displays the following medium priority alarm message “etCO2high!!”.

Check “etCO2 low!!” alarm:



——Set lower alarm limit value of etCO2as 50mmHg;

——Reset etCO2to make the etCO2less than or equal to the lower limit of etCO2;

——S6100 displays the following medium priority alarm message “etCO2low!!”.

 Alarm shall be sound alarm and alarm hint;

 Check mute:

——When an alarm occurs, the alarm will resume within 2 minutes by pressing audio paused key

“ ” (Item 2 in Fig. 4);

——If the alarm fault is not get rid of, then about 2 minutes later, this sound alarm continues;

—— When the sound alarm pause, alarm hint still exist unless fault is eliminated.

2.9.3 Test the Line Voltage Alarm

Interrupt AC line voltage.



 Verify that the following alarms activate:

An alarm tone sounds.



Battery in use message appears on the screen.



Plug the anesthesia system into AC line voltage.



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Verify that the alarm signals cease.



 Verify the presence of the battery charging icon in the upper right corner of the screen.

2.9.4 Vaporizer Interlock Test

 Attach two vaporizers to the Vaporizer Mounting Manifold and lock them in place.

Rotate either of the vaporizer dial to 3% agent.



 Verify that the other vaporizer dial cannot be rotated to a setting.

 Set both vaporizer dials to 0.

 Rotate the other vaporizer dial to 3%.

 Verify that the first vaporizer dial cannot be rotated.

 Rotate both vaporizer dials to T and remove both vaporizers.

 Verify that the locking spring is intact.

 Reconnect both vaporizers to the Vaporizer Mounting Manifold.

2.10 Electrical Tests

El e c t r i cal Safety Inspection Tes t

Perform protective earth resistance test:



1) Plug the probes of the analyzer into the protective earth terminal and equipotential terminal of the AC power cord.

Test the earth resistance with a current of 40 A.

Verify the resistance is less than 0.1ohms (100 mohms).

4) Plug the probes of the analyzer into the protective earth terminal of the AC power cord and the protective earth terminal of any auxiliary outlet. Repeat steps b and c.

5) If the resistance is larger than 0.1ohms (100 mohms) but less than 0.2 ohms (200 mohms), disconnect the AC power cord and plug the probe that is previously plugged in the protective earth terminal of the AC power cord into the protective earth contact of the power outlet. Repeat steps a to d.

 Perform the following earth leakage current tests:

1) Normal polarity;

2) Reverse polarity;

3) Normal polarity with open neutral; and

4) Reverse polarity with open neutral.

 Verify the maximum leakage current does not exceed 300 μA (0.3 mA) in the first two tests.

While for the last two tests, verify that the maximum leakage current does not exceed 1000

μA (1 mA).

Page 39

3.0 Maintenance

Warning:

1. Do not use the equipment with fault.

2. If fault occurs in equipment, then it shall be serviced by authorized professional technicians of our Company. If users need to service by themselves, the service shall be carried out by trained, qualified and competent technicians. If necessary, our company may provide necessary information.

3. Calibration of components of equipment shall be carried out by authorized professional technicians of our Company, or by trained, qualified and competent technicians.

4. Do not throw away the replaced battery into fire in maintenance and servicing so as to avoid blasting; do not open or destroy battery, since it contain hazard substance and may damage skin and eyes; nor throw away freely so as to avoid polluting the environment. It shall be sent to manufacturer to recover or disposed according to the requirements of local environmental laws and regulations.

5. Do not throw away the replaced electric and plastic parts freely in maintenance and servicing so as to avoid polluting the environment. It shall be handled according to the requirements of local environmental laws and regulations.

6. Our company will provide circuit diagrams, component part lists, descriptions, calibration instructions to assist service personnel, to repair those parts of the equipment that are designated by our company as repairable by SERVICE PERSONNEL.

Note:

After maintenance and servicing, the equipment check shall be carried out according to the steps of “check before use".

3.1 Before everyday operation

Before first operation, clean the surface of the machine everyday.



Pour out the water in the water trap of the machine.



3.2 After operation of every patient

Do disinfection after operation of every patient.



3.3 When needed

Calibrate the O2sensor.



CO2sensor zero calibration.



Check the equipotential terminal.



Charge the backup battery.



3.4 When Assembling after washing and disinfection

Check the folding bag, gasket of exhalation valve and “O” ring and other part when doing assemble after disinfection. If any part is broken, replace it immediately.

3.5 Operation over 1200 hours or 6 months

Every 6 months or over 1200 hours, take out the filter. Assemble it after removing the dust and other things.

3.6 Every year or operation over 2500 hours

 Maintain, and check the machine completely;

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 Replace the gasket, O type circle, silicone tube and PU tube;

NO.

Frequency

Content

Personnel

Method

Before the using of the first patient

Check before use

Operator

See clause 9

Before the using of the every patient

Check before use

Operator

See clause 9

After maintenance, servicing , cleaning disinfection

Check before use

Operator

See clause 9

folding bag, gasket and “O” ring

See clause 14.4

After repairing

Check before use

Operator

See clause 9

Used for the first time

Cleaning and disinfection for high pressure O2, N2O and Air hose

Operator

See subclause

13.1

Before the using of the first patient and after the using of the every patient

Equipment enclosure

Operator

See subclause

13.1

External anesthesia respiratory system surface

O2sensor and CO2sensor

Before everyday operation

Cleaning for equipment surface

Operator

See subclause

13.1

After each use

Cleaning and disinfection for equipment surface, “Y” connector, inhalation connector, exhalation connector, high pressure tube, reservoir bag, Inhalation, exhalation flap, CO2absorber, pressure relief valve,exhalation valve (except gasket and "O" ring), exhalation tidal volume sampling tube and water trap.

Operator

See subclause

13.3

When needed

The backup battery should be charged

Operator

See subclause

8.2.5

Calibrate the O2sensor

Operator

See subclause

10.7

CO2sensor zero calibration

Operator

See subclause

10.7

Check connection reliability of the

Service

See subclause

 Check and calibrate:

——Vaporizer;

—— Flow meter;

—— Pressure gauge;

—— Exhalation gas volume(tidal volume , minute MV) monitor;

—— Pressure monitor.

 To ensure continued safe use of this equipment, open the top cover by tools, then touch the

protective earth by a screwdriver to check its connection reliability every year. Pull out the appliance plug from the mains supply socket-outlet firstly.

3.7 Every two years or operation over 5000 hours

Every two years or operation over 5000 hours, check and calibrate every pressure limit valves

3.8 Maintenance intervals table

The following table provides an overview of the maintenance intervals for S6100.

Page 41

equipotential terminal

personnel

14.3

Every 6 months or over 1200 hours

Remove the dust and other things of the filter

Service

personnel

See subclause

14.5

Every year

Check connection of protective earth reliability

Service

personnel

See subclause

14.6

Every year or operation over 2500 hours

Maintain, and check the machine completely

Service

personnel

See subclause

14.6

Replace the gasket, O type circle, silicone tube and PU tube

Service

personnel

See subclause

14.6

Check and calibrate vaporizer, flow meter, pressure gauge, exhalation gas volume(tidal volume , minute MV)monitor and pressure monitor

Service

personnel

See subclause

14.6

Every two years or operation over 5000 hours

Check and calibrate every pressure limit valves

Service

personnel

See subclause

14.7

Every 3 ~ 6 years

Replace Li-ion battery

Service

personnel

See subclause

8.2.7

Use time of the battery in fully charged is less than 1 hour or when it fails

Replace Li-ion battery

Service

personnel

See subclause

8.2.7

No using for a long time

It should be discharged in regular time

Service

personnel

See subclause

8.2.6

Note:

warning：

1) Do not perform calibration while the unit is connected to a patient

2) To calibrate the O2sensor, the environment pressure should be the same as the oxygen deliver pressure in the circuit. Otherwise the monitoring value may be inaccurate.

3) Follow the biohazard regulation when dispose the O2sensor. To discard the sensor should follow the local medical waste disposable regulations.

Operator is a trained and qualified medical professional who operates this equipment.



 Service personnel is an individual or entity who is trained by manufacturer and obtain

corresponding written authorization.

3.9 Replace the fuse

To replace the fuse:

 Pull out the AC power plug；

 Open the fuse box with the screwdriver；

 Install the fuse, the fuse shall be the same as the original one；

 Installation procedure is adverse to the above steps.

3.10 O2 calibration

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Note：

1) The O2needs 21% calibration when the Oxygen concentration value is of big error or replace the sensor.

2) No need to calibrate the O2sensor when do not operate the O2sensor.

3) To calibrate the O2concentration, the system should be at standby.

Calibration procedure：

 Enter system setting surface, see Fig.3-1;

FIGURE 3-1

Turn the knob (Item 9 in Fig.4) to FiO2cal. button and press the knob (Item 9 in Fig.4) to enter O



concentration calibration surface, see Fig. 25;

FIGURE 3-2

Put the O2sensor in air;



 Turn the knob (Item 9 in Fig.4) to 21% button and press the knob (Item 9 in Fig.4) to calibrate O2,

until the screen displays "Complete ";

Take out the reservoir bag and install the O2sensor;



 The “bag/vent” selection knob is revolved to “ ”position;

Remove breathing tube (Item 6 in Fig.9) ;



Adjust O2flow valve to 10 L/min;



 Push oxygen flush valve about 10s;

Turn the knob (Item 9 in Fig.4) to 100% button and press the knob (Item 9 in Fig.4) to calibrate O2,



until the screen displays "Complete”;

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 After calibration, turn the knob (Item 9 in Fig.4) to Exit button and press the knob (Item 9 in Fig.4)

Note：

1) In case of calibration failure, please check related technical alarms. Repeat the calibration then.

2) In case of repeated calibration failures, replace the O2sensor and repeat the calibration. If calibration still fails, contact our company technical support.

Note：

When clean or disinfect the parts, the part shall be replaced if it is cracked, broken,

deformed or abrased.

to exit the oxygen concentration calibration surface.

3.8 Airway pressure meter zeroing

If the airway pressure meter does not return to zero, the pressure indicator will be not correct. By

stoping the manual or mechanical ventilation to make the airway pressure close to zero, and then

observe the indicator position at zero or not. To zero the airway pressure meter if the indicator does

not return to zero. The procedure is as follows:

Stop the manual or mechanical ventilation, and make sure the ventilation pipe is connected to



the anethesia breathing system. The patient connector of the respiratory pipeline is open to the atmosphere and the folding bag is fully fell in the below.

Use a small screw driver or the finger to open the lens cover of the airway pressure meter and



remove the lens.

Use the small slotted screw driver to adjust the zeroing screw until the pressure meter indicator



needle to zero position.

 To turn the “manual/mechanical switch” to mechanical ventilation, and start the mechanical

ventilation.

 Seal the patient connector of the Y-tube to close the breathing circuit.

Press the “O2flush” button repeatedly to make the pressure meter indicator needle swing back



and forth.

 Reopen the patient connector of the Y-tube and loose the “O2flush” button, then check the

indicator return to zero or not. If the pressure indicator has returned to zero, assemble the pressure meter lens.

 Please contact our company after-sales service department if the pressure indicator still unable

to return to zero.

Maintenance of AGSS transmission system tube

Check the tube, please change it if it’s damaged.



Method for clearing stagnant water

Connect the inspiratory port and expiratory port with a tube.



 Press the “Start” key, the machine starts work.

 Enter the system and choose【Start Ventilation】.

Turn the “manual/mechanical switch” to “ ” mechanical ventilation.



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Ensure Sufficient gas supply.



 Open O2 supply, adjust flow to no less than 10L/min.

Keep ventilation state, the machine works for 1~2 hours until the water is removed from the



respiratory system.

4.0 Alarm response measures

When the anesthesia system alarm occurs, see the following steps and take the appropriate



measures:

Page 45

—— Check the alarm parameter or alarm type.

Alarm

Priority

Setting range

Default

value

Alarming way

High Ppeak alarm

High

2 cmH2O～ 100 cmH2O

50 cmH2O

When the monitoring value is greater than or equal to the upper limit of Ppeak, there will be a sound alarm and display “PAW high!!!”.

Low Ppeak alarm

High

0cmH2O～ 98 cmH2O

10 cmH2O

When the monitoring value is less than or equal to low limit of Ppeak, there will be a sound alarm and display “ PAW low!!!”.

High MV alarm

Medium

0.2 L/min,

0.5 L/min ～ 100

L/min

20 L/min

When the monitoring value is greater than or equal to upper limit of MV, there will be a sound alarm and display “MV high!!”.

Low MV alarm

Medium

0 L/min ～ 99 L/min

0 L/min

When the monitoring value is less than or equal to low limit of MV, there will sound alarm and display “MV low!!”.

No tidal volume alarm

Medium

If there is no tidal volume (≤5 mL) in 6 seconds, there will be a sound alarm and display “No Vt!!”.

High O2alarm

High

OFF, 19%～100%

100%

When the monitoring value of O2concentration is greater than or equal to the upper limit of O2, there will be a sound alarm and display “FiO

high!!!”.

—— Check the patient's condition.

—— Identify the Cause of the alarm and the reasons for troubleshooting.

——After remove the alarm, check the alarm is eliminated or not.

System alarm information and processing methods refer to the chapter "alarm information table"



4.1 Physiological alarm

4.1.1Physiological alarm information

Page 46

Alarm

Priority

Setting range

Default

value

Alarming way

Low O2alarm

High

18%～99%

18%

When the monitoring value of O2 concentration is less than or equal to low limit of O

concentration, there will be a sound alarm and display “FiO

low!!!”.

High Vte alarm

Medium

5 mL～1600 mL

1000mL

When the monitoring value of Vte is greater than or equal to the upper limit of Vte, there will be a sound alarm and display “Vte high!!”.

Low Vte alarm

Medium

0 mL～1595 mL

50mL

When the monitoring value of Vte is less than or equal to low limit of Vte, there will be a sound alarm and display “Vte low!!”.

High etCO2alarm

Medium

OFF, 22 mmHg～99 mmHg

60 mmHg

When the monitoring value of etCO2is greater than or equal to the upper limit of etCO2, there will be a sound alarm and display “etCO2high!!”.

Low etCO2alarm

Medium

OFF, 1 mmHg ～ 60 mmHg

OFF

When the monitoring value of etCO2is less than or equal to low limit of etCO2, there will be a sound alarm and display “etCO2low!!”.

High Freq alarm

Medium

4 /min～100 /min

40 /min

When the monitoring value is greater than or equal to upper limit of Freq, there will be a sound alarm and display “Freq High !!!”.

Low Freq alarm

Medium

2 /min～98 /min

2 /min

When the monitoring value is less than or equal to low limit of Freq, there will sound alarm and display “Freq Low !!!”.

Continuous pressure alarm

High

If the airway pressure (PEEP+1.5kPa) over or under the set upper or low limit of continuous pressure alarm in 16 seconds, there will be a sound alarm and display “Pcon high!!!”.

Page 47

Alarm

Priority

Setting range

Default

value

Alarming way

Apnea alarm

Medium

5s～60s

OFF

If there is no spontaneous or assisted ventilation during Apnea time, the mode will change to AC, and there is alarm indication “ Apnea !!!” (Red color).

If there are 3 times of Spontaneous ventilation after change mode to A/C, the mode will change to the former ventilation mode, and there is alarm indication “ Apnea !!!

Page 48

4.2.2 Technical alarm

Alarm

Priority

Setting range

Default

value

Alarming way

Power failure alarm

Low

When Main power is not connected or fails, the back-up battery is working, there will be a sound alarm and display the signal of “ ”.

The battery is running out alarm

High

When the voltage of back-up battery is lower than 10.2V, the display shows "The battery is running out!!!. At the same time, there is a " " prompt in the lower right corner.

Low voltage alarm

High

When the voltage of back-up battery is low (10.2V ± 0.3V), the power state indication place will display the signal of “ ” ， and there will be a sound alarm.

Fan failure

Medium----

When the fan doesn't work, the

screen will display the signal of "Fan failure", and there will be a sound alarm.

Oxygen deficiency ncy

alarm

Medium

180 kPa

When the input pressure of the gas supply is less than 180kpa, the screen will display the signal of "O2supply low !!", and there will be a sound alarm.

No absorber

canister alarm

High

When the absorber is not connected or the absorber is not locked, the screen will display the signal of "No absorber canister!!!", and there will be a sound alarm.

Page 49

4.2.3 Cause of alarm and solution of the alarm:

Alarm

Cause

Solution of alarm

High Ppeak alarm

1 Block of breathing circuit pipe

2 Block of patient airway.

3 Upper limit of alarm is too low.

4 Ventilation parameters are set

improperly.

1 Check the breathing circuit pipe

2 Check the patient status

3 Re-set the upper limit of alarm.

4 Reset ventilation parameters.

Low Ppeak alarm

1 Leakage or disconnection of

breathing circuit pipe

2 Low limit of alarm is too high.

3 The compliance of patient

changes.

1 Check and reconnect the pipe.

2 Reset the low limit of alarm

3 Check the patient status.

High MV alarm

1 Upper limit of MV alarm is too

low.

2 High frequency or High tidal

volume

1 Reset the upper limit of MV alarm.

2 Reset frequency or tidal volume

Low MV alarm

1 Low limit of MV is too high.

2 Leakage or disconnection of

breathing circuit pipe

3 Low frequency or Low tidal

volume

4 No input gas

5 Problem with flow sensor

1 Reset the low limit of MV.

2 Check and reconnect the pipe.

3 Reset frequency or tidal volume

4 Check the input gas supply

5 Check the flow sensor

High O

concentration alarm

1 Upper limit of alarm is too low.

2 Problem with O2sensor

1 Reset the upper limit of O2.

2 Re-adjust the O2sensor.

Low O

concentration alarm

1 Low limit of alarm is too high.

2 problem with O2sensor.

1 Reset the low limit of O2alarm.

2 Calibrate the O2sensor.

High etCO

alarm

1 Upper limit of alarm is too low.

2 problem with CO2sensor.

1 Reset the upper limit of etCO2.

2 Check the CO2sensor.

Low etCO

alarm

1 Low limit of alarm is too high.

2 problem with CO2sensor.

1 Reset the low limit of etCO2alarm.

2 Check the CO2sensor.

High Vte alarm

1 Upper limit of alarm is too low.

2 Flow sensor sampling tube failure

1 Reset the upper limit of Vte

2 Check the flow sensor sampling tube

Page 50

Alarm

Cause

Solution of alarm

Low Vte alarm

1 Low limit of alarm is too high.

2 Problem with breathing tube

3 Block of patient airway

4 Flow sensor sampling tube failure

1 Reset the low limit of Vte.

2 Check the breathing tube

3 Check the patient status

4 Check the flow sensor sampling tube

High Freq alarm

1 Upper limit of alarm is too low.

2 Change of patient's condition

1 Reset the upper limit of Freq

2 Check the patient status

Low Freq alarm

1 Low limit of alarm is too high.

2 Change of patient's condition

1 Reset the low limit of Freq.

2 Check the patient status

Oxygen deficiency alarm

1 gas supply pressure is too low

2 The output pressure of the pressure reducing valve of the gas cylinder is too low

1 Adjust gas supply pressure within

440 kPa± 160 kPa

2 Adjust pressure regulator to make sure

that the output pressure is 440 kPa

Continuous pressure alarm

1 Problem with breathing circuit

pipe

2 Block of patient airway

3 Alarm limit of is too low

4 Ventilation parameters are set

improperly.

1 Check and reconnect the pipe

2 Check the patient status

3 Reset the alarm limit

4 Reset the ventilation parameters

Power

failure alarm

1 Main power disconnection or

problem

2 Problem with fuse

1Check the main power supply

2 Replace the fuse

The battery is running out alarm

1 The battery is running out

1 The system shall be switched to AC in

time and the battery shall be charged.

Alarm of low voltage of battery

1 Low voltage of battery

1 Change the power supply to main power. If you cannot switch to AC power, please turn off the anesthesia system and turn on the manual mode for the patient.

Fan failure

1 Fan doesn’t work.

1 Change the fan.

No absorber

canister alarm

1 Absorber canister is unlocked 2 Absorber canister is

disconnected

1 Check the absorber canister

2 Install the absorber canister

Page 51

4.2.4 Troubleshooting

Fault

Cause

Solution way

There is no display on screen and Anaesthesia System do not work.

1 The main power is off

2 Power line disconnection

3 The switch of Anaesthesia System

is off.

4 Fuse is broken

1 Check the power supply in the working place

2 Connect the power line

3 Switch on the Anaesthesia System

4 Change the fuse

Abnormal display of tidal volume

1 Leakage of breathing circuit pipe

2 Leakage of exhalation valve

1 Re-connect or change pipe

2 Check exhalation valve

Air leakage of anaesthetic breathing system

1 “APL” valve is not closed

2 CO2 absorber is not tightly installed

3 Breathing tube damage or

connector is loosened

4 Damage of breathing reservoir bag

5 Inhalation, exhalation flap cover is

damaged or unpressed

1 Close “APL” valve

2 Reinstall and clean out foreign matter of seal washer of CO2 absorber

3 Replace new tube or reinstall

4 Replace air bag

5 Replace new flap cover or repressed

At the end of exhalation， breathing buffer pocket of bellow can not expand to top or gradually drop

1 Over fast selected breathing rate

at the bigger tidal volume

2 Flow rate control valve is not

opened or flow rate is too small

3 Air leakage of breathing circuit

4 Buffer pocket of bellow is

damaged or detached

1 Reset proper breathing rate

2 Open flow rate control valve switch or adjust proper flow rate

3 According to the method of “air leakage of anaesthetic breathing system” to check and treat

4 Check and replace buffer pocket of bellow

During inhalation, buffer pocket of breathing bellow is not compressed or compress range is not enough

1 “bag/vent” selection knob is still

at position “bag”

2 Airway blocking

1 Switch the selection knob to “ventilator”

2 Check and get rid of

Difficult drench of vaporizer

1 Evaporation concentration

adjustment knob did not revolve to“0”, or drenching is carried out at once after the knob revolved to “0”.

2 The perfusion port’s screw is not loosened

1 Evaporation concentration adjustment knob revolves to 0 or drenching is carried out 2 minute after drenching

2 The perfusion port’s screw is not loosened

Page 52

Fault

Cause

Solution way

Without concentration output of vaporizer

1 Flow rate control valve is not

opened, without flow rate output

2 No liquid medicine

1 Adjust flow rate control valve

2 Dosing

5.0 Cleaning and disinfection

Warning:

1) Please comply with applicable security regulations.

2) The company provides the clean machine and accessories in the factory, but without disinfection and sterilization. If it offers the products and their components with disinfection and sterilization, in the prominent position on its packaging will indicate "sterile" and other information.

3) Before first time to use it, follow the recommended method in this chapter, take the necessary cleaning, disinfection and sterilization for the machine and accessories. Prohibition of the cleaning, disinfection and sterilization to the disposable use accessories.

4) Reusable Accessories of anesthesia system or anesthesia ventilation system, it should be cleaned and disinfected before re-use as necessary in accordance with the method recommended in this chapter, without disinfection will result in the risk of cross infection.

5) Carefully read all operating and maintenance instructions of the disinfection equipment.

6) Read the material safety data description of each detergent.

7) Wear protective gloves and safety glasses.

8) The components can only be removed and installed by the instructions of this chapter , if the components are removed and installed improperly, it will lead to the leak risk of the anesthesia ventilation systems.

9) The components can only be leaned and disinfected by the instructions of this chapter , if the components are leaned and disinfected improperly, it will lead to the damage risk of the anesthesia ventilation systems.

10) Do not use calcium carbonate, calcium stearate, maize starch, talc or similar material to prevent adhesions. These materials may enter the patient's airway or lungs, causing irritation or damage.

11) Checking if the parts are damage during operation, the damaged parts should be replaced.

12) After the cleaning and the disinfection are completed and re-installed, be sure to pass the test examination of the instructions of "preoperative test" , the anesthesia system will be allowed to use ; otherwise, you should discontinue use it and contact our after-service personnel.

13) Do not inhale the smoke dust during operation;If the oxygen sensor is damaged, it could lead to leak and cause burns.

14) After cleaning or disinfecting The machine,the accessories, ensure the related components are completely dry, after that, install and connect the AC power.

Notice:

1) High temperature steam sterilize only the components which are marked with parts 134 ℃.

2) To prevent the abrasion of device, do not use abrasive cleaning agents (such as the silver polish or cleaning agents, the steel wool).

Page 53

3) Do not use halogenated organic or petroleum-based solvents, acetone, glass cleaner or other harsh cleaning agents.

4) If there is any doubt about the cleaning agent, please check the reference data and instructions which are provided by the manufacturer.

5) Cleaning solution pH must be within the range of 7.0 to 10.5.

6) Do not soak the synthetic rubber parts over than 15min, otherwise it will lead to accelerated aging or swelling.

7) Do not allow the liquid to flow into the anesthesia system housing case.

8) Ensure that all liquids away from the electronic components.

5.1Cleaning methods

Warning:

Ensure that no liquids penetrate inside the control module in the cleaning process, in order to avoid causing personal injury or damage of internal components.

Note:

1) The disinfection method by spreading or spraying the disinfectant to the housing case, due to the short reaction time, it can only reduce the number of bacteria in the surface of the machine, so do not adopt it!

2) Display screen can not touch the liquid, it can only be cleaned by the dry lint-free soft cloth.

There are two manual cleaning methods: general cleaning and rinsing soak.



——General cleaning is that using the damp cloth which are soaked in the flexible detergent

solution (as 70% of medical alcohol) to wipe the shell surface, then wipe it dry with a dry cloth.

——Refers to the rinsing soak, rinsing with water, then add warm water with weakly alkaline

detergent solution soak for 3 ~ 5min, then use the water to rinse, and finally wipe it clean with the solution of 70% medical alcohol .

5.2 Disinfection methods

 The autoclavable Disinfection is achieved by the stream with 134 ℃ at most. Before disinfecting

the components, they should be cleaned, and then at 121 ℃ temperature and under the 1.05kg / cm2 steam pressure, sterilizing during 15 ~ 20min. All the components have 134 ℃ 's high temperature sterilization mark which are applicable with this disinfection methods.

 Take the combined action of hydrogen peroxide and ozone disinfection manner. The disinfection

is according to the disinfection procedures (atomization 15min, disinfection 60min, 10min drying procedures).

5.3 Cleaning and disinfecting for the machine enclosure

Make sure the AC input plug has been pulled out, and the device is turned off;



 In accordance with the first methods of this chapter "Cleaning Methods", cleaning the whole

enclosure.

Page 54

5.4 Disassemble and install the components of the anesthesia

 Cleaning and disinfection：

ventilation system which could be cleaned and disinfected

If you want to make the cleaning and the disinfection to the system of anesthesia ventilation, you should firstly disassemble all the components of respiratory system which could be rinsed and disinfected

5.4.1 Disassemble the bellows components

 Disassembly：

—— Holding the shell of the bellows cover with two hands, counterclockwise unscrewing；

—— Lifting the bellows cover;

——Remove the folding bag from the base seat of the bellows.

——According to the second article of chapter "cleaning methods", and also the first article and

second article of "Disinfection Methods", clean the bellows components by the method of

Page 55

completely rinsing soak cleaning and disinfect by autoclaving or disinfect the components by

Note:

1) If you need disinfect the bellows components by autoclaving, firstly you should assemble the bellows components well before effecting the autoclavable disinfection. On being disinfected by autoclaving, make the bellows components towards up.

2) On cleaning, please disassemble the bellows assembly apart to clean, otherwise it will take a long time to dry them.

3) After drying folding bag, it should be suspended and fully developed. Otherwise, it may make the folding bag adhesive.

the method of hydrogen peroxide and ozone combined action.

Installation:



——According to the reversed operational process, install the bellows components.

5.4.2 Disassembling the breathing air check valve components

 Disassembly

——Holding the cover of the check valve, unscrew it counterclockwise, take the cover of the

check valve out.

——Pull out the inspiratory check valve from the circuit

Cleaning and disinfection



——According to the second article of chapter "cleaning methods" , and also the first article and

second article of "Disinfection Methods", Clean the components of the expiratory and inspiratory check valve by the method of completely rinsing soak cleaning and disinfect them by autoclaving or disinfect the components by the method of hydrogen peroxide and ozone combined action .

Installation



——According to the reversed operational process, install the expiratory and inspiratory air

check valve components.

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5.4.3 Disassembling the inspiratory hose and connectors of type Y



Cleaning and disinfection

Note:

1) Do not reuse disposable filters, expiratory and inspiratory hoses and masks, thet should be disposed of in accordance with local medical waste disposal regulations.

2) To prevent damage to the expiratory and inspiratory tubes, please hold on joints of both ends of the expiratory and inspiratory tube for disassembling.

Disassembly



——Take down the inspiratory hose and expiratory hose from the inspiratory port and expiratory

port.

——Take down the filter from the patient connecting port of the Y-shaped tube.

——According to the second article of chapter "cleaning methods" , and also the first article and

second article of "Disinfection Methods", Clean the silica gel hoses and the Silica gel masks by the method of completely rinsing soak cleaning and disinfect them by autoclaving or disinfect the components by the method of hydrogen peroxide and ozone combined action .

 Installation

——According to the reversed operational process, install the expiratory and inspiratory tube and

the Y-type connector.

5.4.4 Disassembling the manual breathing bag

 Disassembly

——Hold the port parts of the bag, push down with the appropriate force, take down the bag from

the connection port.

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 Cleaning and disinfection：

Note：

1) Do not reuse the disposable bladder,it should be disposed of in accordance with local medical waste disposal regulations.

warning

1) Do not disinfect the flow sensors by the autoclave;

2) Do not clean the flow sensors with a brush or by the high pressure gas ;

3) Do not use unapproved cleaning agents containing polycarbonate.

4) Do not clean the inner surface of the flow sensor, you can only wipe the outer surface with a damp cloth.

——According to the second article of chapter "cleaning methods" , and also the first article and

second article of "Disinfection Methods", Clean the silica gel bladder by the method of completely rinsing soak cleaning and disinfect it by autoclaving or disinfect the bladder by the method of hydrogen peroxide and ozone combined action .

 Installation

——According to the reversed operational process, install the manual expiratory and inspiratory bladder.

5.4.5 Disassembling the flow sensor

Disassembly



——Unscrew counterclockwise the lock nut which is on the inspiratory port.

——Pull out both the lock nut and the inspiratory port.

——Pull out the inspiratory flow sensor.

Cleaning and disinfection：



——According to the second article of chapter "cleaning methods", Clean the inspiratory flow

sensor and the expiratory flow sensor by the method of rinsing soak cleaning. That is, first rinse with water, then added weakly alkaline detergent solution of warm water and soak for 3 ~ 5min, then use the water to rinse, and finally wipe clean the surface of the inspiratory flow sensor with 70% of medical alcohol.

 Installation

—— According to the reverse operation Process, install the expiratory flow sensor and the

inspiratory flow sensor separately.

5.4.6 Airway Pressure Gauge

Disassembly



——Hold the airway pressure gauge and press buckle spring, remove the airway pressure

gauge from the circuit.

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Cleaning and disinfection

warning:

Do not rinse soak the airway pressure gauge, or disinfect it by autoclave;

warning:

Soda lime has a strong corrosive, such as a strong irritant to the eyes, respiratory system and skin. If you accidentally stick to soda lime, wash immediately with water, if there is still discomfort after washing, please seek for medical help immediately.



——According to the first article of chapter "cleaning methods", wipe clean the outer surface of

the airway pressure gauge.

Installation



——Press the buckle spring does not move, Loosen it after installed the upper airway pressure

gauge, and install the airway pressure gauge with a appropriate force.

5.4.7 Disassembling the soda lime canister

Disassembly



——Grab handle canisters, slightly with the point force will press the handle down to unlock the

canister;

——Guide groove disengage and remove the canister.

 Cleaning and disinfection

——According to the second article of chapter "cleaning methods" , and also the first article or

second article of "Disinfection Methods", Clean the absorption canister by the method of rinsing soak cleaning, disinfect it by autoclave or by the method of hydrogen peroxide and ozone combined action.

Installation



——Please see the chapter the process of the installation of soda lime canister.

5.4.8 Disassembling the water cup

 Disassembly

——Rotate counterclockwise and remove the water cup.

 Cleaning and disinfection

——According to the first article of chapter "cleaning methods" , and the second article of

"Disinfection Methods", Clean the water cup by the method of hydrogen peroxide and zone

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combined action.

Warning:

1) Do not put the oxygen sensor soaked in the liquid alone or with anesthesia ventilation system;

2) Do not disinfect the oxygen sensors by autoclave;

3) The condensation water vapor that on the oxygen sensor surface would cause inaccurate measurement of the oxygen concentration, the moisture on the surface should be promptly removed.



Installation

——According to the reverse operation process, install the oxygen sensor.

Warning:

When removing the circuit, first make sure the demolition absorb CO2 canister is removed, then the following steps disassembly operations. Otherwise lead to the demolition fail.

Note:

1) Do not put the whole circuit case soaking in liquid or disinfect it by autoclave.

2) Be careful, make sure that the circuit electrical connections must be correct.

5.4.9 Disassembling the oxygen sensor

 Disassembly

——Pull out the electric cable plug of the oxygen sensor

——Counterclockwise unscrew the oxygen sensor, remove the oxygen sensor.

Cleaning and disinfection



——According to the first article of chapter "cleaning methods" , clean the the oxygen sensor by

the method of the general cleaning, General cleaning is that using the damp cloth which are soaked in the flexible detergent solution to wipe clean the oxygen sensor , then wipe it dry with a dry cloth.

5.4.10 Disassembling the breathing circuit

 Disassembly

——Ensure that the components has been disassembled, hold the circuit by one hand and press

the lock key on the circuit.

——Take down the circuit on the base seat of the circuit.

 Cleaning and disinfection：

——According to the first article of chapter "cleaning methods", and second article of

"Disinfection Methods", disinfect it by the method of hydrogen peroxide and ozone combined action.

5.5 AGSS delivery and collection system

 Disassembly

——Counterclockwise unscrew the nut which is for fixing the AGSS,remove the waste gas

treatment system which is connected with the cover of the AGSS;

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——Counterclockwise unscrew the cover till it is released from the observation window.

——Remove the filter which is installed on the inside of the cover;

——Remove the observation window；

——Remove the float；

Cleaning and disinfection



——Blow away the dust which is attached to the filter of the AGSS components with the

compressed air.

——In accordance with the instruction of this chapter "cleaning method", clean the float of the

AGSS components by the method of the general cleaning. That is, wipe clean the choke plate and the float with a damp cloth which are soaked in the flexible detergent solution, then wipe it dry with a dry cloth.

Installation



——After completed drying the AGSS components, reference to the above disassembly step, according to the opposite operation of the process, finish the installation of the AGSS system components.

Nanjing Superstar s6100 Service Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Foreword

Warnings，Cautions and notes

Warnings

Cautions

Notes

1.0Theory of operation

1.1 Introduction

1.2 Electrical Connections

1.3 Gas flow

1.3.1Pneumatic Circuit Diagram

1.3.2 Part list

1.3.3 Key to symbols

1.3.4 Description

1.3.4.1 Anesthetic Gas Delivery System

1.3.4.2 Gas supplies

1.3.4.3 Flowmeter

1.3.4.4 Vaporizer Manifold

1.3.4.5 ACGO Assembly

1.3.4.6 O2 flush button Assembly

1.3.4.9 Breathing System

1.3.4.10 Anesthetic Gas Scavenging System

1.4 The Breathing System

1.4.1 Brif Introduction

1.4.2 Automatic Mode, Inspiration

1.4.3 Automatic Mode, Expiration

1.4.4 Manual Mode, Inspiration

1.4.5 Manual Mode, Expiration

1.4.6 Pneumatic PEEP

1.4.7 Ventilator in Standby

1.4.8 Breathing System Components

1.4.8.1 Ventilation Bellows system

1.4.8.2 Manual Breathing Bag

1.4.8.3 CO2 Absorber Canister

1.4.8.4 Inspiratory and Expiratory Valves

1.4.8.5 APL (Airway Pressure limiting) Valve

1.5 Ventilator UI

1.5.1 Display Interface Borad

1.5.2 Warning light Board

1.5.3 Display and Touchscreen

1.5.4 Other Components

1.5.6 Indicator Light Board

1.6 Ventilator control and Drive

Ventilator Pneumatic- O2Drive Gas

1.7.1 Ventilator Pneumatic Drive

1.7.3 Drive Gas Assembly

2.0 Installation Guide

2.1 Preparation - Additional Material Required

2.2 Assembly

2.21 Installation of vaporizer

2.2.2 Installation of module

2.2.2.1 Installation of AG module

2.2.2.2Installation of CO2Module

2.3 Functional Tests

2.3.1 Check system

2.3.2 Pipe gas supply test

2.3.3 O2 Flush Verification

2.3.4 Flow control device test

2.3.5 Vaporizer Leak Test

2.3.6 Power Failure Test

2.3.7 Evaporator Pressure test

2.4 Respiratory circuit test

2.4.1 Bellows test

2.4.2 Power-on Self-test

2.4.3 APL Valve Test

2.5 Display Setup Check

2.8 Check AGSS transmission and collection system

2.9 Alarm Test

2.9.1 Preparation before system operation

2.9.2 Alarm function check

2.9.3 Test the Line Voltage Alarm

2.9.4 Vaporizer Interlock Test

2.10 Electrical Tests

El e c t r i cal Safety Inspection Tes t

3.0 Maintenance

3.1 Before everyday operation

3.2 After operation of every patient