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Statement

Beijing Aeonmed Co, Ltd. (Aeonmed for short) holds the copyrights to this manual,
which is non-public published, and reserves the rights to keep it as a secure
document. Refer to this manual when operating, maintaining and repairing
Aeonmed products only. Anyone other than Aeonmed may not make it known to
others.

Proprietary materials protected by the copyright law are included in this manual. Any
section of it cannot be reproduced, copied, or translated into other languages
without any prior written approval from Aeonmed who reserves the copyright.

Everything written in this manual is considered to be correct. Aeonmed is not legally


responsible for any mistakes printed within and any damages caused by incorrect
installation and operation. Aeonmed does not supply privileges endowed by the
patent law to any other parties. Aeonmed is not legally responsible for the results
caused by patent law breaking and any rights of the third party violating.

Refer to this manual before any Aeonmed product is used. The manual includes
operating procedures which must be performed with cautiously, operations that may
result in non-normal working conditions and the dangers which may damage
equipment or cause bodily harm. Aeonmed is not responsible for the security,
reliability and function of the equipments in case that the dangers, damages and
non-normal phenomenon mentioned in this manual happen. Free repairs for these
malfunctions will not be provided by Aeonmed.

Aeonmed have the rights to replace any content in this manual without notice.

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Shangrila590 Ventilator User Manual

Manufacturer Responsibility
Aeonmed is responsible for the security; reliability and function of the equipments
when to following conditions are adhered to:

 Installation, adjustments, mending and repairs must be performed by


individuals authorized by Aeonmed;
 Necessary electrical equipment and the working environment must be in
accordance with the national standards, professional standards and the
requirements listed in this manual;
 Equipment must be used as instructed in the operating instructions.

CAUTION: This equipment is not for family use.

CAUTION: Malfunctioning equipment may become invalid and


cause bodily injury if a set of effective and approving
repairing proposals cannot be submitted by the
institution which is responsible for using this
equipment.
The paid theoretical framework diagram will be supplied according to customer
requirements by Aeonmed, plus calibrating method and other information to help the
customer, under the assistance of qualified technicians, repair the equipment parts
where can be done by customer himself based on the stipulation by Aeonmed.

Warranty
Manufacturing techniques and materials:

For a period of one year from the date of original delivery, the components and
assemblies of this product is warranted to be free from defects manufacturing
techniques and materials, provided that the same is properly operated under the
conditions of normal use and regular maintenance. The warranty period for other
parts is three months. Expendable parts are not included. Aeonmed‟s obligation
under the above warranties is limited to repairing free of charge.

ii
Statement

Free Obligations:

 Aeonmed‟s obligation under the above warranties does not include the
freight and other fees;
 Aeonmed is not responsible for any direct, indirect or final product broken
and delay which result from improper use, alteration by using the
assemblies unratified and maintenance by anyone other than Aeonmed;

 This warranty does not apply to the followings:

Improper use;
Machines without maintenance or machines broken;

The label of Aeonmed original serial number or mark is removed or


replaced;
Other manufacturers‟ products.

Security, reliability and operating condition:

Aeonmed is not responsible for the security; reliability and operating condition of this
product in case that:

 The assemblies are disassembled, extended and readjusted


 This product is not operated correctly in accordance with the manual
instruction. The power supply used or operating environment does not
follow the requirements in this manual.

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Shangrila590 Ventilator User Manual

Return
Follow the steps in case that the product needs to be returned to Aeonmed:
1. Obtain the rights of return
Contact with the customer service of Aeonmed by informing them the number and
type of the product. The number is marked on the surface of the product. Return is
unacceptable if the number cannot be identified. Enclose a statement of the number,
type and the reason of return as well.

2. Transportation charges
Transportation and insurance charges must be prepaid by the user for transporting
the product to Aeonmed for repairing. (Customers charges is added with regard to
the products sold to non-Chinese mainland users)

Manufacture: Beijing Aeonmed Co., Ltd.


Address: 11B2,Fengtai Science Park, Beijing, China
European Shanghai International Holding Corp.GmbH
Representative: (Europe)
Address: Eiffestrasse 80, 20537 Hamburg Germany.
P.C.: 100070
Tel.: +8610-83681616
Fax: +8610-63718989
Web site: www.aeonmed.com
E-mail: service@aeonmed.com

iv
Contents
1 Introduction ......................................................................................................... 1–1
1.1 What‟s Shangrila590? ................................................................................... 1–1
1.1.1 Intended use .......................................................................................... 1–1
1.1.2 Contraindication ..................................................................................... 1–1
1.2 Symbols ......................................................................................................... 1–2
1.3 Definitions, Acronyms, and Abbreviations ..................................................... 1–3
1.4 System composition ...................................................................................... 1–4
2 Structure .............................................................................................................. 2–1
2.1 Frontview ....................................................................................................... 2–1
2.1.1 Front panel ............................................................................................. 2–1
2.1.2 LCD screen ............................................................................................ 2–3
2.1.3 Front cover-board and base plate ......................................................... 2–4
2.2 Rear panel ..................................................................................................... 2–7
2.2.1 RS232 interface ..................................................................................... 2–8
2.2.2 VGA interface ......................................................................................... 2–8
3 Operating Guide .................................................................................................. 3–1
3.1 Starting System ............................................................................................. 3–1
3.2 Setup ventilation mode .................................................................................. 3–2
3.3 Ventilation mode introduction ........................................................................ 3–3
3.3.1 A/C ......................................................................................................... 3–3
3.3.2 VCV (optional) ....................................................................................... 3–4
3.3.3 PCV (optional) ....................................................................................... 3–4
3.3.4 SIGH ...................................................................................................... 3–4
3.3.5 SIMV ...................................................................................................... 3–5
3.3.6 SPONT................................................................................................... 3–6
3.3.7 PSV ........................................................................................................ 3–6
3.4 Alarm Settings menu ..................................................................................... 3–6
3.4.1 Setting alarm parameters ...................................................................... 3–7
3.4.2 Alarm log submenu ................................................................................ 3–8
3.5 Lung mechanics menu .................................................................................. 3–9
3.6 Patient data menu ....................................................................................... 3–11
3.7 Configuration menu ..................................................................................... 3–11
3.8 Emergency start menu ................................................................................ 3–15
3.9 Nebulizer on ................................................................................................ 3–15
3.10 Ventilating parameter settings ..................................................................... 3–16
4 Preoperative Checkout ....................................................................................... 4–1
4.1 Preoperative Checkout procedures ............................................................... 4–1
4.2 System Checkout .......................................................................................... 4–2
4.3 Mains failure alarm test ................................................................................. 4–3
4.4 Test humidifier performance .......................................................................... 4–3
4.5 Alarm test ...................................................................................................... 4–3
4.6 Breathing system test .................................................................................... 4–4
5 Installation and Connection ............................................................................... 5–1
5.1 Installation tools ............................................................................................. 5–2
5.2 Installing compressor .................................................................................... 5–3
5.2.1 Install column assembly......................................................................... 5–3
5.2.2 Install elliptical board ............................................................................. 5–5
5.2.3 Install lines carrier .................................................................................. 5–7

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Shangrila590 Ventilator User Manual

5.2.4 Install humidifier carrier ..........................................................................5–7


5.3 Installing ventilator .........................................................................................5–9
5.3.1 Connect display to main unit ..................................................................5–9
5.3.2 Connect ventilator to compressor ........................................................5–10
5.4 Connect accessories ...................................................................................5–12
5.4.1 Connect pipelines ................................................................................5–14
5.4.2 Install support arm ...............................................................................5–15
5.4.3 Install humidifier ...................................................................................5–16
5.4.4 Connect tubes ......................................................................................5–18
5.5 Connecting Gas and Electricity ...................................................................5–22
6 Cleaning and disinfecting ..................................................................................6–1
6.1 Cleaning and sterilizing .................................................................................6–2
6.1.1 Cleaning: general guidelines .................................................................6–3
6.1.2 Disinfection and sterilization ..................................................................6–3
7 User Maintenance ...............................................................................................7–1
7.1 Repair Policy .................................................................................................7–1
7.2 Maintaining Outline and Schedule .................................................................7–2
7.2.1 User maintenance ..................................................................................7–2
7.2.2 Useful life estimation ..............................................................................7–2
7.2.3 Calibrating ..............................................................................................7–3
7.2.4 Calibrate flow valve ................................................................................7–5
7.2.5 Calibrate expiratory valve ......................................................................7–6
7.3 Replacing fuses .............................................................................................7–7
7.4 Transport .......................................................................................................7–7
7.5 Maintaining battery ........................................................................................7–8
8 Alarm and Troubleshooting ...............................................................................8–1
8.1 About alarm ...................................................................................................8–1
8.2 Alarm message list ........................................................................................8–2
8.3 Troubleshooting .............................................................................................8–4
9 Specifications ......................................................................................................9–1
9.1 Physical specification ....................................................................................9–1
9.2 Environment requirements ............................................................................9–1
9.3 System technical specification ......................................................................9–2
9.4 Operation principle ........................................................................................9–3
9.5 Performance parameters ...............................................................................9–4
9.5.1 Ventilation mode ....................................................................................9–4
9.5.2 Setting ventilating parameters ...............................................................9–5
9.5.3 Monitoring performance .........................................................................9–6
9.5.4 Assistant performance ...........................................................................9–7
9.5.5 Setting alarm parameters.......................................................................9–7
9.6 Electromagnetic Compatibility .......................................................................9–8

vi
1 Introduction
1.1 What‟s Shangrila590?
The Shangrila590 Ventilator System is designed to manage work of breathing, offer
different modes of breath delivery, and help a practitioner select the most
appropriate ventilator settings. The user interface is intended to be intuitive to
anyone who knows how to operate a ventilator, and can be learned with minimal
training. The user interface includes 10.4‟ TFT screens that display monitored data
separately from ventilator settings for easy assessment of your patient‟s condition.

WARNING: The user of Shangrila590 must be professional and


trained.
WARNING: Shangrila590 is unsuitable for use in a magnetic
resonance imaging (MRI) environment.

1.1.1 Intended use

The Shangrila590 Ventilator System is a high-capability ventilator intended for acute


and subacute care of pediatric and adult patients. The user interface, breath delivery,
and patient monitoring capabilities are designed for easy future enhancement. It can
be used in ICU, respiration and emergency room.

WARNING: Shangrila590 is not to be used with infant.

1.1.2 Contraindication
The machine is not suitable for the below circumstances:
1. Pneumothorax and mediastinal emphysema is not good drainage.
2. A large number of pleural effusion.
3. Giant lung bulla.
4. Low blood volume shock is not corrected.
5. Acute myocardial infarction with heart failure.
However, when necessary, high frequency ventilation can be used in pneumothorax,
bronchial fistula, acute myocardial infarction and heart failure.

1–1
Shangrila590 Ventilator User Manual

1.2 Symbols

WARNING and CAUTION indicate all the possible dangers in case of


violation of the stipulations in this manual. Refer to and follow them.

WARNING: indicates potential hazards to operators or patients


CAUTION: indicates potential damage to equipment

Instead of illustrations, other symbols may also be utilized. Not all of them may
necessarily appear in the equipment and manual. The symbols include:

ON (Power) Type B equipment

OFF (Power)
Warning or Caution, ISO
7000-0434
Standby NOTE: refer to the manual

Alternating Current Dangerous Voltage

Direct Current Battery

Protectively earth Buzzer

Equipotential Address of manufacture

SN Serial Number Date of manufacture

The system, with this label


under the stipulations in the
operating manual, complies
with the requirements
CE Representative
related from 93/42/EEC.
0123 is the certificate
number to certify
authorizations

1–2
1. Introduction

1.3 Definitions, Acronyms, and Abbreviations

CPAP Continuous Positive Airway Pressure (setting)

f Respiratory rate, i.e. breaths per minute (setting)

fspont Respiratory rate of spontaneous breathing by the patient


(monitored)

ftotal Total respiratory rate, i.e. sum of f and fspont (monitored)

FiO2 Delivered oxygen percentage (monitored data)

FiO2 Oxygen percentage (setting)

I:E Inspiration to expiration time, I to E ratio, (monitored)

MV Exhaled minute volume (monitored)

MVspont Minute volume of spontaneous expiration by the patient (monitored)

Paw Patient airway pressure

PEEP Positive end expiratory pressure (monitored data)

PEEP Positive end expiratory pressure, it may be used to improve


oxygenation of the patient (setting)

PINSP Inspiratory airway pressure in PCV (setting)

Pmean Mean airway pressure is updated every at the end of last breath
cycle, i.e. a running mean (monitored)

Ppeak Maximum patient airway pressure during a patient breath


(monitored)

Pplat Patient airway pressure measured at the end of inspiratory pause


time (monitored)

Psens Pressure sensitivity (setting)

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Shangrila590 Ventilator User Manual

PSUPP Pressure support (setting)

TI Inspiration time (setting)

TP Inspiratory pause time; increase inspiration time to facilitate increased


patient oxygenation (setting)

Vsens Flow sensitivity (setting)

VT Tidal volume of mechanically delivered breaths (setting)

VTE Exhaled tidal volume (monitored)

VTI Inhaled tidal volume (monitored)

1.4 System composition


Name Specifications Stock number
Main unit standard configuration 122001285
O2 pipeline 5m 122000048
Air pipeline 1m 122001279
Medical air compressor Optional 121000024
Reservoir bag Expendable, 1L 230000188
Face mask Expendable, adult 230000132
Respiratory circuit Expendable 240000117
Fuse Spare 210000173
Nebulizer Optional 230000359
Humidifier Optional 210000180
Valve diaphragm Mounted 130000231
Valve plate Mounted 130001348
Cover Attachment 230000047

1–4
2 Structure
2.1 Frontview

CAUTION: Monitoring conditions of this system: inspiratory module:


ATPD;

Expiratory module: BTPS.

WARNING: Independent means of ventilation (e.g. a self-inflating


manually powered resuscitator with mask) should be
available whenever the Shangrila590 Ventilator System
is in use.

WARNING: Do not use antistatic or electrically-conductive breathing


tubes and mask.

2.1.1 Front panel

Figure 2-1 Frontview of Shangrila590

1. Display screen

In the figure 2-1, display screen has been marked with rectangle frame; it displays
the most information including alarm message, patient data, waveform monitored
etc. More details refer to section 2.1.2.

2–1
Shangrila590 Ventilator User Manual

2. controls and indicators

Press this key, you can select ventilation mode


Mode select required.
More details refer to section 3.2 and 3.3.
Press this key, you can setup alarm parameters
Alarm settings such as lower limit of Paw etc.
More details refer to section 3.4.

Lung mechanics More details refer to section 3.5.

Monitor some data for patient such as fspont, Pplat


Patient data
etc.

Configuration The operator can customize some parameters such


key as language, date and time, unit of pressure etc.

Alarm silence key. Turns off alarm sound for 2


minutes except low-priority alarm. The yellow light
Alarm silence on the alarm silence key lights during the silence
key period, and turns off if you press the alarm reset
key or the 2-minute interval times out. A new
high-urgency alarm cancels the silence.

Clears inactive alarms and cancels an active alarm


Alarm reset key
silence.

When the yellow light on the screen lock key is lit,


pressing other keys (including the knob) has no
effect until you press the screen lock key again.
Screen lock key
The screen lock key allows you to clean the LCD
screen and prevents inadvertent changes to
settings and displays.

Return Return to main interface directly.

System turned ON first is in a state of standby, and


Standby the indicator light is ON. Push standby key to start
ventilation, the indicator light is OFF.

Ventilate patient according to preset parameters to


Emergency start save time for emergency.
More details refer to section 3.8.

2–2
2. Structure

Press this key to startup nebulizer function.


Nebulizer on
More details refer to section 3.9.
AC power When the ventilator connected ac power, the lamp
indicator lamp lights.

Internal battery When charging, red lamp lights.


indicator lamp When supplying power, green lamp lights.
Adjusts the value of a setting. A button that is
highlighted means that the knob is linked to that
knob setting. Where applicable, turning the knob
clockwise increases the value, and turning the knob
counterclockwise decreases the value.

2.1.2 LCD screen

Figure 2-2 Main interface

1. Parameters monitored area

Parameters monitored on the main interface are: MV, VTE, Ppeak, PEEP, FiO2. the
upper and lower limit can be set on the alarm settings menu.

2. Waveforms

Setting about waveforms display refers to section 3.7.

3. Foot bar

Ventilating parameters are on the bottom of screen, you can use the knob to setup.

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Shangrila590 Ventilator User Manual

4. Head bar

In the head bar, the left is ventilation mode; alarm message at the middle; the right is
additional information such as power, time, triggering icon or locking icon.

 When silencing, the icon appears behind the alarm message and
2-minute counts down.

 When triggering, the icon appears above the time and flashes.

2.1.3 Front cover-board and base plate

WARNING: The inspiratory and expiratory connectors are marked


with flow-direction arrow to connect tubes rightly and
conveniently.

2–4
2. Structure

1 Expiratory module 2 Spout for atomization


3 Expiratory port 4 Emergency respiratory port
5 Inspiratory connector 6 Battery cover board
7 Handrail

2–5
Shangrila590 Ventilator User Manual

1. Emergency respiratory port

WARNING: The emergency respiratory port is non-conical. It’s


designed to make sure air can be inspired by patient
when the ventilator failed suddenly.
2. Spout for atomization

Used for connecting nebulizer with pipe.

3. Expiratory module

Dial the locking switch to (unlocking) and take off expiratory module, and then
disinfect it. When disinfecting finished, insert the expiratory module to the original
position rightly and then the locking switch returns to (locking) automatically.
Make sure the installation must be right, or else leakage may occur. And test the
ventilator before putting into operation.

2–6
2. Structure

2.2 Rear panel

Figure 2-3 Rear panel of Shangrila590

1 Cooling fan 2 Nameplate


3 RS232 interface 4 VGA interface
5 Power switch 6 Power socket
7 Equipotential terminal 8 Exhaust port
9 Oxygen inlet 10 Air inlet

CAUTION: Do not block cooling fan port.


Do not block the exhaust port.

Be careful of static electricity, take proper handling


before use and grounding precautions required.

2–7
Shangrila590 Ventilator User Manual

WARNING: Pay attention to the protection of flammable or breakable


parts. Power supply must be switched off before
opening fuse box cover to replace the fuse which must
be in accordance with the requirements of fuse type and
rated current, if necessary, please turn to professional.

2.2.1 RS232 interface


RS-232 port on the rear of display can permit serial inlet and outlet of command and
data.
Signal Standard: RS232C (EIA-574)
Signal Definition: DTE configuration
Interface: DB9/M

DB-9 Connector Pin Out


Pin # Signal Name Signal Description
2 RXD Receive Data
3 TXD Transmit Data
5 GND Signal Ground / Common

2.2.2 VGA interface


Shangrila590 can be connected with external commercial display by VGA interface,
and the display mode can be supported as 640×480.
The VGA interface is 15-pin, D-model and female.

2–8
3 Operating Guide
3.1 Starting System
Step 1 Connect power supply
Plug the power cord into AC power
outlet. The power indicator light will be
bright when power is connected.
Step 2 Power On

Set power switch to ON (“ ”).


The ventilator startup, the display
screen lights and shows startup
interface, see figure 3-1. After a while,
Standby interface appears on the
screen. See figure 3-2.

Figure 3-1 Startup interface

Press the Standby key, the display


screen switches to main interface.
Switch to standby interface from main
interface by pressing the Standby key
for 3 to 5 seconds.

Figure 3-2 Standby interface

3–1
Shangrila590 Ventilator User Manual

3.2 Setup ventilation mode

Step 1

Press the Mode Select key, the


ventilation mode menu appears on
the screen as showed right figure.

Step 2

Turn the knob to select 【Sigh】, the


background color of selected item
changed.

Step 3

Push the knob, there is a dialogue


popped on the menu as shown in
right figure.

3–2
3. Operating Guide

Step 4

Turn the knob to select Yes and push it, then ventilation mode turn to SIGH mode.

Setting method about other ventilation mode is similar to the above.

3.3 Ventilation mode introduction

3.3.1 A/C

In A/C mode, the ventilator delivers only mandatory breaths. When the ventilator
detects patient inspiratory effort, it delivers a patient-initiated mandatory (PIM)
breathe (also called an assisted breath). If the ventilator does not detect inspiratory
effort, it delivers a ventilator-initiated mandatory (VIM) breath (also called a control
breath) at an interval based on the set respiratory rate. Breaths can be pressure- or
flow-triggered in A/C mode.
Figure 3-3 shows A/C breath delivery when no patient inspiratory effort is detected
and all inspirations are VIMs. And Tb is the breath period in seconds.

Figure 3-3 A/C mode, no patient effort detected

Figure 3-4 shows A/C breathe delivery when patient inspiratory effort is detected.
The ventilator delivers PIM breathes at a rate more than the set respiratory rate. And
Tb is the breath period in seconds.

Figure 3-4 A/C mode, patient effort detected

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Shangrila590 Ventilator User Manual

Figure 3-5 shows A/C breath delivery when there is a combination of VIM and PIM
breaths. And Tb is the breath period in seconds.

Figure 3-5 A/C mode VIM and PIM breaths

CAUTION:
Setting of trigger pressure’ false or ability for breath of patient intensify may
lead to A/C mode delivers too much.

3.3.2 VCV (optional)

VCV (Volume Control Ventilation) is mandatory ventilation with preset respiratory


frequency and tidal volume. When ventilator detects patient‟s spontaneous breath, it
will work according to the above settings.

3.3.3 PCV (optional)

PCV (Pressure Control Ventilation) is mandatory ventilation with preset respiratory


frequency and pressure limit. Trigger operation refers to VCV mode.

3.3.4 SIGH

SIGH is base on A/C mode. The difference is a high tidal volume (1.5 times as set)
delivers every 100 breath.

3–4
3. Operating Guide

3.3.5 SIMV

SIMV (Synchronized Intermittent Mandatory Ventilation)is a mixed ventilator mode


that allows both mandatory and spontaneous breaths. The mandatory breaths can
be volume or pressure-based, and the spontaneous breaths can be
pressure-assisted (for example, when pressure support is in effect.) You can select
pressure- or flow-triggering in SIMV.

The SIMV algorithm is designed to guarantee one mandatory breath each SIMV
breath cycle. This mandatory breath is either a patient-initiated mandatory (PIM)
breath (also called an assisted breath) or a ventilator-initiated mandatory (VIM)
breath (in case the patient‟s inspiratory effort is not sensed within the breath cycle).

As Figure 3-6 shown, each SIMV breath cycle (Tb) has two parts: the first part of the
cycle is the mandatory interval (Tm) and is reserved for a PIM. If a PIM is delivered,
the Tm interval ends and the ventilator switches to the second part of the cycle, the
spontaneous interval (Ts), which is reserved for spontaneous breathing throughout
the remainder of the breath cycle. At the end of an SIMV breath cycle, the cycle
repeats. If a PIM is not delivered, the ventilator delivers a VIM at the mandatory
interval, then switch to the spontaneous interval.

Figure 3-6 SIMV breath cycle (mandatory and spontaneous intervals)

WARNING: This mode may cause insufficient ventilation or apnea if


patient ‘state becomes depravation.

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Shangrila590 Ventilator User Manual

3.3.6 SPONT

In SPONT (spontaneous) mode, inspiration is usually initiated by patient effort.


Breaths are initiated via pressure or flow triggering, whichever is currently active. An
operator can also initiate a manual inspiration during SPONT. An operator can also
initiate a manual inspiration during SPONT. VIM breaths are not possible in SPONT
mode.

3.3.7 PSV

PSV (Pressure Support Ventilation) is pressure-assisted spontaneous breathing


mode. Patient controls respiratory rates and when trigger ventilator, it‟ll immediately
deliver gas under the preset pressure to overcome the airway resistance.

3.4 Alarm Settings menu


Press the Alarm Settings key, the following menu appears on the screen.

Figure 3-7 Alarm settings menu

3–6
3. Operating Guide

3.4.1 Setting alarm parameters

There are the following parameters can be set:

MV: upper limit and lower limit, unit: L;


Paw: upper limit and lower limit, unit: 1cmH2O;
VTE: upper limit, unit: L
fspont: upper limit, unit: bpm
Tapnea: upper limit, unit: second;
FiO2: upper limit and lower limit
Alarm volume: 5 rating: 20%, 40%, 60%, 80%, 100%.

Setting method as shown in the following, taking alarm volume for example.

Step 1

Turn the knob to select Alarm


sound button and push it, as shown
in the right figure.

Step 2

Turn the knob to select appropriate


alarm volume and push it. You
cannot turn off alarm volume.

3–7
Shangrila590 Ventilator User Manual

3.4.2 Alarm log submenu

To view the alarm log, turn the knob to select the Alarm Log button and press it, the
Alarm Log submenu appears. See the following figure.

Figure 3-8 Alarm log submenu

The alarm log shows alarm events in order of occurrence, with the most recent
event at the top of the list. There are 3 buttons: Clear Log, Browse and Exit.

View alarm log:

Turn the knob to select Browse button and push it, the rectangle frame outside
alarm event activated. Then rotate the knob to check details up and down.

Clear alarm log:


Operating method is similar to the above.

NOTE:

The alarm log can store up to 100 of the most recent entries.

3–8
3. Operating Guide

3.5 Lung mechanics menu


Press the Lung mechanics key, the Lung mechanics menu appears on the screen
like the following figure.

Figure 3-9 Lung mechanics menu

3–9
Shangrila590 Ventilator User Manual

Static Compliance
measurement:

Turn the knob to select Start


button and push it, then
measuring procedure begins.

Resistance measurement:

Operating method is similar to


the compliance measurement.

AutoPEEP measurement:

Operating method is similar to


the compliance measurement.

3–10
3. Operating Guide

3.6 Patient data menu


Press the Patient data key, the Patient data menu appears on the screen like the
following figure.

Figure 3-10 Patient data menu

3.7 Configuration menu


Press Config key, the Configuration menu appears on the screen like the following
figure.

Figure 3-11 Configuration menu

3–11
Shangrila590 Ventilator User Manual

Language:

Chinese and English.

Pressure Unit:
cmH2O、0.1KPa、mBar
When pressure unit changed, the
Y-axis unit of waveforms changed
in-phase and keep identical.

Date/Time

Setting method is similar to the


above.

3–12
3. Operating Guide

Waveform style:

Line and block.

Set proper waveform style according


to the operator custom.

Trigger Type:

P-TRIG: pressure trigger


V-TRIG: flow trigger

If trigger typed changed, the relative


parameter on the foot bar changed
in-phase and keep identical.

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Shangrila590 Ventilator User Manual

Waveforms: 5 types:

Paw-t waveform
Flow-t waveform
V-t waveform
Paw-V waveform
V-Flow waveform

Barometric pressure:
Mass sensor was used to measure flow in the Shangrila590 Ventilator System. It
was affected by atmospheric pressure. So, compensation has been taken for
measure accuracy at atmospheric pressure of 50kPa to 106kPa.

Operating time:

You can maintain ventilator periodically according to operating time. It‟s very
convenient.

3–14
3. Operating Guide

3.8 Emergency start menu


Press the Emergency Start key, the Emergency start menu appears on the screen
as shown in the following figure. Make sure preset tidal volume match with the
patient condition such as body weight before starting emergency ventilation. Does
this can avoid ventilating overmuch and preventing patient airway barotraumas. In
addition, set proper alarm limit will be better.

Figure 3-12 Emergency start menu

Setting method about parameters refers to section 3.4.1.

3.9 Nebulizer on

Press key, the Nebulizer on alarm occurs; it reminds that the nebulizer
function would be ended automatically after 30 minutes. Check whether medicine
has been added before the nebulizer startup.

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Shangrila590 Ventilator User Manual

3.10 Ventilating parameter settings

Turn the knob in main interface to


select VT button as shown in right
figure.

Press the knob and rotate it to


adjust Vt value until the wanted,
and then press it again to confirm.

CAUTION

If you don’t press the knob to


confirm at last, the setting is
invalid. After a while, it returns to
original.

Setting procedure about other parameters is similar to one above.

3–16
4 Preoperative Checkout
4.1 Preoperative Checkout procedures
Test interval Preoperative Checkout should be done in the following situation:

Before use of the first patient each day.


Before use of each patient.
After repair or maintenance.

Test schedule is given in the table below:

Before use of the first patient each day Before use of each patient
System check: Breathing system test:
Mains failure alarm test:
Alarm test:
Breathing system test:

WARNING: Do not use this system before the operation and


maintenance manual are read and understood.

 Whole system connection

 All warning and cautions

 Using guide of each system module

 Testing method of each system module

Before using this system:

 Complete all tests of this section

 Test all the rest of system modules


If test failure, do not use this system. Please contact service representative.

4–1
Shangrila590 Ventilator User Manual

CAUTION: The following measures are adopted for evasion of


software risks:
 The breathing control mechanism cannot function
before the normal operation of the ventilator so that the
high Paw pressure or excessive ventilation could be
avoided;

 The hardware watchdog monitor and control system


operates. If the system fails to reset the watchdog within
1.6 seconds, the system shall be forced to reset so that
the system is under the control.

4.2 System Checkout

WARNING: Make sure the breathing circuit is connected correctly


and in good condition.

Make sure:
1 Equipment is in good condition.
2 All the components are correctly connected.
3 The connection and pressure of pipeline gas supply system are correct.
4. The required emergency device is ready and in good condition.
5. Connect the power cord to the AC power outlet. The power indicator light
will light up when power is connected.
If failure, that means no electric power supplying. Exchange other sockets,
close breaker, or replace power cord.

4–2
4. Preoperative Checkout

4.3 Mains failure alarm test

1. Turn power switch to “ ”, stand-by interface appears after a while.


2. After operating 5 minutes, pull out power cord.
3. Make sure that power off failure alarm occurs, it has the following
characteristics:

Alarm sound;

“Mains Failure!!” message displays on the top screen;

4. Connect power cord again.


5. Make sure the alarm eliminate.

4.4 Test humidifier performance


Test about humidifier refer to relative instructions for use.

4.5 Alarm test


1. High pressure alarm test

Set Vt to 500, upper limit of Paw to 20cmH2O. Press standby key to ventilate,
and then press the reservoir bag to make the pressure increasing in the patient
circuit, when Paw more than 20cmH2O, the high pressure alarm generated, and
the ventilator switches to expiration phase immediately.

2. Continuous high pressure alarm test

After high pressure alarm occurs, continue to press the reservoir bag, when
high pressure alarm lasting more than 15 seconds, the continuous high
pressure alarm occurs.

3. low tidal minute volume test

Set the upper limit of VTE to 0.6, and adjust Vt to 500ml, low tidal minute volume
alarm occurs.

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Shangrila590 Ventilator User Manual

4. low oxygen concentration alarm test


Setup the lower limit of oxygen concentration to 50%, then use air only for
ventilation, the low FiO2 alarm appears later.
5. circuit disconnect alarm test
Take out the reservoir bag in ventilating process, the circuit disconnect alarm
occurs after 3 cycles.
6. Apnea alarm test
Set ventilation mode to SPONT, the apnea alarm occurs after a while, and the
ventilator turns to A/C mode from SPONT mode.

4.6 Breathing system test

WARNING:
 Failure to make sure of correct setup and operation before use can result in
patient injury.

Please follow these steps to do before you begin Ventilator Settings (described in
part 3):

1. Gas supply and external power supply

Check the gas supply and external power can supply enough resource for the
ventilator. Check the patient circuit for leak, disconnect or connecting mistakes. And
make sure all cables, plugs, sockets and screw pipe are accord to safe requirement.

2. Check Apnea Alarm

Set the ventilator to SPONT mode, meanwhile start to time until the alarm is
triggered. This period should be about 12 to 18 seconds.

4–4
4. Preoperative Checkout

3. Check the work state of the ventilator

This is a standard work state of the ventilator settings:


Ventilation mode A/C
Rates of breath: 20bmp
TI 1.0s
TP 0s
VT 400mL
Airway pressure upper limit (×0.1kPa) 40
Airway pressure lower limit (×0.1kPa) 5
Psens -0.3kPa
PEEP 0kPa
FiO2 21%
Gas supply rated pressure 0.4MPa

4. Check tidal volume:

Cut off the gas supply, turn to the A/C ventilation mode, it should be 0 of the tidal
volume monitor. Recover the gas supply and adjust Vt to 400mL, check the tidal
volume monitor is at a range of 400mL±15%.

5. Test high airway pressure alarm:

Adjust the tidal volume to set the airway pressure peak is about 2.5kPa, Then set
the Airway Pressure Upper Limit to a numerical value lower than 2.5kPa slightly.
The Airway Pressure Upper Limit alarm has been triggered meanwhile the ventilator
turn to expiration, the airway pressure decreases.

6. Test low airway pressure alarm:

Set the airway pressure upper limit to 0.1kPa, then disconnect patient pipe, the
airway pressure lower limit alarm takes place after 4-15 sec.
7. Test trigger pressure sensitivity:

Set the trigger pressure at -0.1kPa, wear the mask and do a inspiration, the
inspiration step of the ventilator begins after airway pressure lower than the setting,
meanwhile the “trigger” indicator light on the front panel flashes.

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Shangrila590 Ventilator User Manual

8. SIMV

Set ventilation mode to SIMV, change the breathing rates, see the display of “ftotal” in
1 minute, it should accordant as setting you just made.

9. Sigh

Let the ventilator work at a standard work state, record the tidal volume. Then
change ventilation mode to Sigh, adjust the airway upper limit pressure to maximum,
see the display of the tidal volume data, it should 1.5 time as normal the second time
respiration takes place. This happens every 100 times, during this ventilation mode.

10. SPONT

Set the ventilation mode to SPONT, adjust the trigger pressure with -0.2kPa, wear
mask. The ventilator begins a ventilation when the airway pressure lower than
-0.2kPa. when the patient spontaneous inspiration finishes or the ventilation time get
to the certain time determined by breathing rates and I : E, or the airway pressure up
to 6cmH2O, the ventilator will turn to expiration and waiting for next patient
spontaneous inspiration.

4–6
5 Installation and Connection

WARNING: To prevent generating wrong data and malfunction,


please use the cables, hoses, and tubes from Aeonmed.

WARNING: The operator will have to ensure that the inspiratory and
expiratory resistances as shown in section9.3 are not
exceeded when adding attachments or other
components or sub-assemblies to the breathing system.

CAUTION: To avoid equipment false alarm caused by high strength


electric field:

 Put the electricity surgical conducting wire far from


the breathing system.

 Do not put the electricity surgical conducting wire


on any parts of the anesthetic system.
CAUTION: To protect the patient, as the electricity surgical
equipment is being used:

 Monitor and ensure that all the life supporting and


monitoring equipment are operated correctly.

 Never use electrical conduction masks or hoses.

5–1
Shangrila590 Ventilator User Manual

5.1 Installation tools


 Cross-screwdriver
 Internal hexagonal wrench: M3, M4, M5
 Paper knife

WARNING: Do not use excessive force to fix bolts.

CAUTION: Installation personals must be professional and


experienced.
Abbreviation:

Ventilator: Shangrila590 ventilator


Compressor: Hummera medical air compressor (optional)
Humidifier: SH330 humidifier (optional)
Certificate: Product Qualified Certificate

5–2
5. Installation and Connection

5.2 Installing compressor

5.2.1 Install column assembly

(1) Take out column and six sets bolts,


nuts, washers, spring washers.

(2) Fix bolts with M5 hexagonal wrench.

5–3
Shangrila590 Ventilator User Manual

Take out the column, set it to cover the


framework.

5–4
5. Installation and Connection

5.2.2 Install elliptical board

(1) Take out elliptical board and four sets


bolts.

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Shangrila590 Ventilator User Manual

(2) Fix the elliptical board with


cross-screwdriver.

5–6
5. Installation and Connection

5.2.3 Install lines carrier

(1) Take out lines carrier and bolts.

(2) Fix it on the back of column with M3


hexagonal wrench.

5.2.4 Install humidifier carrier

(1) Take out humidifier carrier and bolts.

5–7
Shangrila590 Ventilator User Manual

(2) Fix it on the face of column with M4


hexagonal wrench.

5–8
5. Installation and Connection

5.3 Installing ventilator

5.3.1 Connect display to main unit

Twist the cable of display to the baffle,


and make the T block on the rear of
display insert the trough of baffle.

5–9
Shangrila590 Ventilator User Manual

5.3.2 Connect ventilator to compressor

Set ventilator on the elliptical panel, one


hold it to stop falling, another take out
four bolts, washers, and spring-washers
from accompanying file packet. Then fix
them with M4 hexagonal wrench.

5–10
5. Installation and Connection

See right picture, it is well after finishing


installation.

CAUTION: Make sure each joint


secure and firmly.

5–11
Shangrila590 Ventilator User Manual

5.4 Connect accessories

Figure 5-1 connection for patient tubing

5–12
5. Installation and Connection

1 Oxygen pipeline 2 Tubes 3 Cover 4 Support arm 5 Air pipeline


6 Hanger 7 Handwheel 8 Arm carrier

Humidifier

5–13
Shangrila590 Ventilator User Manual

5.4.1 Connect pipelines

(1) Connect air pipeline


Plug in „Air‟ jack with one end of air
pipeline, and plug in air output
interface with the other end of air
pipeline.

(2) Connect oxygen pipeline


Plug in „O2‟ jack with one end of
oxygen pipeline, and connect the
other end to oxygen reducer.

5–14
5. Installation and Connection

5.4.2 Install support arm

(1) Fix arm carrier on the handle of


ventilator with handwheel.

(2) Insert arm to the carrier and screw


it hard.

(3) Fix arm to the position required by


adjusting handle of the joint.

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Shangrila590 Ventilator User Manual

5.4.3 Install humidifier

(1) Set the bulge on the back of


humidifier to slide the trough of
humidifier carrier.

(2) Install adapters.

1 inlet 2 outlet(indicated by arrow)

5–16
5. Installation and Connection

CAUTION:
Outlet adapter has a port for
thermometer.

5–17
Shangrila590 Ventilator User Manual

5.4.4 Connect tubes

(1) Pull out sealed cover.

(2) Connect one end of tube to


inspiratory port, the other end to
humidifier inlet.

5–18
5. Installation and Connection

(3) Connect one end of tube 2 to


humidifier outlet, the other end
to water trap.

Connect one end of tube 3 to


the water trap, the other end to
Y piece.

(4) Similarly, connect tube 4


from expiratory port to water
trap 2, tube 5 from water trap 2
to Y piece.

5–19
Shangrila590 Ventilator User Manual

Then connect right-angle


connector.

5–20
5. Installation and Connection

Connect reservoir bag.

Connecting accessories
finished.

More details refer to user


manual.

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Shangrila590 Ventilator User Manual

5.5 Connecting Gas and Electricity

WARNING:
 Put the power cord and screwed tube in a certain place, to avoid apnea the
patient.
 Only connect external power adapter with ISO-standard socket. And pay
attention to polarity if necessary.

 For two-phase alternating current circuit user, do not attempt to switch earth line
and zero line. Shangrila590 ventilator belongs to Class I equipment specified in
EN60601-1 Medical Electrical equipment: Part one: General requirement for
safety.

 Low battery alarm may be occur, if you power on the ventilator with it do not
have external power supply for a long time. If this happens, connect the
ventilator with the external power supply (use the exclusive power adapter) to
charge for 10 hours at least. If the alarm still existed, the internal battery must
be replaced. (Please connect qualified technician).

1. Connecting power supply

Plug the power cord to the socket on the rear panel of ventilator, connect the other
end of power cord to wall power, and make sure the power supply voltage complying
with this manual.

WARNING: If voltage fluctuation exceeds 10%, Aeonmed


recommends using an AC stabilizer.

2. Connecting gas supply


The gas connectors designed for non-interchange to avoid man-made mistake.

The rated working pressure of gas supply is 0.4MPa.

WARNING: Use only dry, compressed medical gases.

5–22
6 Cleaning and disinfecting
WARNING: Use a cleaning and sterilizing schedule that conforms to
your institution’s sterilization and risk-management
policies.
 Refer to the material safety data policy of each
agent.
 Refer to the operating and maintaining manual of all
the sterilizing equipments.
 Wear safety gloves and safety goggles.

CAUTION: To prevent damage:


 Refer to the data supplied by the manufacturer if
there are any questions about the agent.
 Never use any organic, halogenate or oil base
solvent, anesthetic, glass agent, acestone or other
irritant agents.
 Never use any abrasive agent to clean any of the
components (i.e. Steel wool, silver polish or agent).
 Keep liquids far from the electrical components.
 Prevent liquid from entering the equipment.
 Do not immerse the synthetic rubber components
more than 15 minutes: any longer will cause inflation,
or accelerating aging.
 The PH value of the cleaning solution must be from
7.0 to 10.5.

WARNING: Talc, zinc stearate, calcium carbonate, or corn starch


that has been used to prevent tackiness could
contaminate a patient’s lung or esophagus, causing
injury.

WARNING: Check if there is damage in the components. Replace if


necessary.

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Shangrila590 Ventilator User Manual

6.1 Cleaning and sterilizing

CAUTION:
 This manual can only give general guidelines for cleaning, disinfecting, and
sterilizing. It is the user‟s responsibility to ensure the validity and effectiveness
of the methods used.
Table 6-1 Cleaning, disinfecting, sterilizing
Part Procedure Comments
Do not allow liquid or
Wipe clean with a damp cloth and
sprays to penetrate the
mild soap solution or with one of
ventilator or cable
these chemicals or their
connections. Do not use
equivalents. Use water to rinse off
pressurized air to clean
Ventilator exterior chemical residue as necessary.
or dry the ventilator,.
(including LCD
screen) WARNING:
 Do not use organic impregnate to clean the ventilator
surface.
 If use ultraviolet radiation to disinfect, do not let the time
over 1 hour.
Disassemble and clean, then If submerged in liquid, use
autoclave, pasteurize, or pressurized air to blow
chemically disinfect. Disinfect the moisture from inside the
Breath Valve when patient tubing before use. Inspect
changing. for nicks and cuts, and
Single-patient use: Discard. replace if damaged.
Patient circuit
tubing CAUTION:
 Steam sterilization is a viable sterilizing method of
Shangrila510 patient circuits supplied by Aeonmed, but it
may shorten the tubing‟s life span. Discoloration
(yellowing) and decreased tubing flexibility are expected
side effects of steam sterilizing this tubing. These effects
are cumulative and irreversible.
Take off expiratory module, After disinfecting and
dismantle it and disinfect them airing, install the
Expiratory module respectively to use steaming. expiratory module and
Disinfect expiratory module when pay attention to
patient changing. airtightness.

6–2
6. Cleaning and Sterilizing

WARNING:
 Sterilizing after special infection or infectious patient use: use 2% soda water to
clean the surface of the ventilator. After that clean it with water.
 After using ventilator on a tuberculosis patient, a special sterilizing is needed.
Immerse components in certain disinfection solution over 2 hours. And then put
it in a formalin fume box 12 hours for more disinfection.

6.1.1 Cleaning: general guidelines

Do not clean or reuse single-patient use or disposable products. On cleaning parts,


do not use hard brushes or other instruments that could damage surfaces.
1. Wash parts in warm water and mild soap solution.

2. Rinse parts thoroughly in clean, warm water (tap water is fine).


3. Aeonmed recommends that you inspect all parts at every cleaning. Replace
any damaged parts.

4. Whenever you replace parts on the ventilator, make sure it can work in a good
condition before connect it to patient.

CAUTION:
 Follow the soap manufacturer‟s instructions. Exposure to soap solution that is
more highly concentrated than necessary can shorten the useful life of the
products. Soap residue can cause blemishes or fine cracks, especially on parts
exposed to elevated temperatures during sterilization.

6.1.2 Disinfection and sterilization

Do not disinfect, sterilize, or reuse single-patient use or disposable products. When


sterilizing tubing, coil it in a large loop, avoiding kinks or crossing tubing. The tubing
lumen should be free of any visible droplets prior to wrapping.

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6–4
7 User Maintenance
WARNING: Movable components and detachable parts can cause
injury. Use caution when system components and parts
are being moved or replaced.
WARNING: Disposal of waste or invalidated apparatus must be in
accordance with the relevant policies in local
government.

7.1 Repair Policy


Do not use malfunctioning equipment. Make all necessary repairs, or ask an
authorized Aeonmed Service Representative for servicing. After repair, test the
equipment to ensure that it is functioning properly, in accordance with the
manufacturer‟s published specifications.
To ensure full reliability, have all repairs and service done by an authorized
Aeonmed Representative. If this is not possible, replacement and maintenance of
parts in this manual should be performed by a competent, trained individual with
experience in Anesthesia Systems repair, and appropriate testing and calibration
equipment.

CAUTION: No repair should ever be undertaken or attempted by


anyone without proper qualifications and equipment.

It is recommended that you replace damaged parts with components manufactured


or sold by Aeonmed. After any repair work, test the unit to ensure it complies with
the manufacturer‟s published specifications.

Contact the nearest Aeonmed Service Center for service assistance. In all cases,
other than where Aeonmed‟s warranty is applicable, repairs will be made at
Aeonmed‟s current list price for the replacement part(s) plus a reasonable labor
charge.

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Shangrila590 Ventilator User Manual

7.2 Maintaining Outline and Schedule


The following schedule is a recommended minimum standard based upon normal
usage and environmental conditions. Frequency of maintenance for the equipment
should be higher if your actual schedule is more than the minimum standard.

7.2.1 User maintenance

Frequency Maintenance
Daily Clean the outer surface.
weekly Perform pressure sensor calibration.
monthly Perform flow sensor calibration.
When cleaning and Check if any components are broken, and replace or
installing repair them if necessary.
As required Replace invalid fuse with new one.

7.2.2 Useful life estimation

CAUTION: The useful life of the following parts should be


considered in normal environment and operating
requirements.
Face mask, Patient circuit Single use
Power cord, gas pipe 8 years
Main unit 8 years
Battery 1 year

7–2
7. User Maintenance

7.2.3 Calibrating

Set the ventilator standby, then press the Config key, the Configuration submenu
appears on the screen, compared with figure3-12, you may find the added Calibrat
button.

Figure 7-1 Configuration menu in the standby mode

Figure 7-2 Calibration submenu

7–3
Shangrila590 Ventilator User Manual

1. Calibrate flow sensor

Turn the knob to select Flow


sensor button and press it, see
right figure.

Pay attention to on-screen


prompt.

Select Start button and push the


knob, the flow sensor is
calibrating.

If succeed, the word Calibration


completed will be on the screen
as shown in right figure.

If failed, contact Aeonmed.

7–4
7. User Maintenance

2. Calibrate pressure sensor

Turn the knob to select Pressure


sensor and press it, see right figure.

Calibrating procedure refer to


Calibrating Flow sensor.

Pay attention to prompt on-screen.

7.2.4 Calibrate flow valve

This item must be performed by authorized personnel by Aeonmed. Follow the


below processes.
Connect inspiratory port and
expiratory port with tube according to
the right picture.

Turn the knob to select Flow valve


button and press it, input the
password 7294, and press Start to
perform calibration.

Refer to Calibrate flow sensor for


other processes.

Pay attention to on-screen prompt.

7–5
Shangrila590 Ventilator User Manual

7.2.5 Calibrate expiratory valve

Connect inspiratory port and


expiratory port with tube according to
the right picture.

Turn the knob to select Flow valve


button and press it, input the
password 3108, and press Start to
perform calibration.

Refer to Calibrate flow sensor for


other processes.

Pay attention to on-screen prompt.

After all calibrations completed, press “Standby” key to normal operating state.
When the difference between the value of tidal volume monitored and the setting is
more than 30%, calibrations from 7.2.3 to 7.2.5 should be repeated until the value in
the specified range.

7–6
7. User Maintenance

7.3 Replacing fuses

WARNING: Disconnect from power supply before replacing fuses,


otherwise that can injure operator even death.

WARNING: Replace fuses with only those of the specified type and
current rating, otherwise that can damage the
equipment.

CAUTION: The fuse is fragile, so replacement should be carefully.


Do not use excessive force.
Replacing steps:
1 Plug the screwdriver to groove on the end of fuse box.
2 Turn counterclockwise 3 to 5 circles then pull out fuse tubes
lightly.
3 Take off fuse tubes.
4 Enclose the new ones.
5 Push fuse tubes to original place gently.
6 Turn clockwise 3 to 5 circles with screwdriver to tighten.
7 Connect mains supply.

7.4 Transport
The machine must be put in proper place for the clinic personnel‟s convenience
during operation. During the up and down-stairs movement one must take care of
the ventilation loop and power cables. It‟s better to take the ventilation loop off
prevent damage. Avoid fierce shock and vibration while transport the ventilator.

The transportation environment should be at temperature of -20°C ~+50°C and


relative humidity above 93%.

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Shangrila590 Ventilator User Manual

7.5 Maintaining battery


1 Specification
DC 24V 2.3 AH; 12V lead-acid battery, two in serial
Charge: 6 hours typically
2 Cautions
Charge: The battery will be charged automatically if AC power connected. It is
recommended that charging time is better than 6 hours.
Discharge: It will last 40 minutes generally to use the battery supply.
The alarm “Battery Low!!” should be displayed on the screen when the capacity of
battery is not enough until the system shut-off. The user/operator should connect
mains supply to charge battery in time and avoid the system shut-off abnormally.
Do not disassemble battery device without valid authorization.
Do not short-circuit between positive plate and negative plate of battery.
3 Storage

The maintenance of charging should be carried out with interval of 3 months at least
if storage of battery exceeds 3 months.
Stored environment should avoid dampness, high temperature.

If improper maintenance makes battery damage, replace it in time to avoid liquid of


battery corrading the apparatus. Replace the battery, please contact Aeonmed
service representatives.
4 Replacement
Aeonmed recommends the battery with CE mark and same technical specification.

CAUTION: An authorized Aeonmed services representative can


replace battery. If not to use the battery for long-time,
please contact Aeonmed service representatives to
disconnect battery. The waste battery should be
disposed in accordance with the local policies.

CAUTION: When ‘battery low’ alarm occurs, charging should be


done immediately. Or else, the Shangrila590 Ventilator
System will shut off in several minutes automatically.

7–8
8 Alarm and Troubleshooting
WARNING: No repair should ever be undertaken or attempted by
anyone without proper qualifications and equipment.

8.1 About alarm

CAUTION: If alarm occurs, protect patient safe firstly, and then go


to diagnose fault or service it necessarily.

WARNING: Never leave patient unattended when alarm silence is


activated.
Alarm messages (1) displays on the top area of display screen, see figure8-1.

Figure 8-1 Alarm message area

The high priority alarms must be disposed immediately.

Priority Sound Silence Prompt Alarm lamps


High 5 tones, 2 hurry; 120 Red background, “!!!” Red,
Periods: 10 seconds seconds blinking
Medium 3 tones 120 Yellow background, Yellow,
Periods: 25 seconds seconds “!!” blinking
Low 1 tone --- Yellow background, Yellow
Once only. “!”

NOTE: If a high-priority alarm goes away spontaneously (autoresets),


its message remains lit with blue background (not flashing)
until you press the alarm reset key.

NOTE: When alarm silencing, the alarm bell has dashed


“X” in itself and the countdown of 120 seconds
present underside. At the same time, alarm sound
disappears. After 120 seconds, alarm bell turns to
original shape and alarm sound reappears.

8–1
Shangrila590 Ventilator User Manual

8.2 Alarm message list

Message Priority Alarm definition Operator action


Nebulizer Low Press atomization key in ---
on! ventilating state, then
nebulizer and alarm are
activated, in 30 minutes later,
the nebulizer stopped and
alarm canceled.
Air supply Low Standby, or Air supply Check patient and air
down! pressure less than 0.16MPa source. Obtain
alternative ventilation if
necessary.
O2 supply Low Standby, or O2 supply Check patient and
down! pressure less than 0.16MPa oxygen source. Obtain
alternative ventilation if
necessary.
Air & O2 Low Standby, or Air & O2 supply Check patient, air and
supply pressure both less than oxygen source. Obtain
down! 0.16MPa alternative ventilation if
necessary.
Expiratory Low VTE greater than high limit. Check patient and
tidal volume settings. Consider
high! whether the patient‟s
compliance or resistance
has changed.
MV low!! Medium MV less than low limit. Check patient and
settings.
MV high!! Medium MV greater than high limit. Check patient and
settings.
FiO2 low!! Medium FiO2 less than low limit. Check patient, air and
oxygen supplies, oxygen
analyzer, and ventilator.
FiO2 high!! Medium FiO2 greater than high limit. Check patient, air and
oxygen supplies, oxygen
analyzer, and ventilator.
Mains Medium No AC power detected after Prepare for power loss.
Failure!! startup. Check integrity of ac
power source
fspont high!! Medium fspont greater than high limit. Check patient and
settings.

8–2
8. Alarm and Troubleshooting

Battery Medium Battery capability detected Charge the battery


Low!! less than 23.7V after startup. quickly.
Obtain alternative
ventilation if necessary.
Air supply High Air supply pressure less than Check patient and air
down!!! 0.16MPa in ventilating source. Obtain
process. alternative ventilation if
necessary.
O2 supply High O2 supply pressure less than Check patient and
down!!! 0.16MPa in ventilating oxygen source. Obtain
process. alternative ventilation if
necessary.
Airway High Paw monitored less than low Check patient and
pressure limit, and last more than 7 settings.
low!!! seconds.
Circuit High There is a disconnection in Check patient.
disconnect!! the patient circuit. Reconnect patient
! circuit. Press the alarm
reset key.
Apnea!!! High The set apnea interval has Check patient and
elapsed without the ventilator, settings.
patient, or operator triggering
a breath. The ventilator has
entered apnea ventilation.
Airway High The measured airway Check patient, patient
pressure pressure is equal to or circuit, and endotracheal
high!!! greater than the set limit. tube.
Reduced tidal volume likely.
Airway High Paw monitored more than
pressure high limit last for 15 seconds
continue in ventilating process.
high!!!
Air & O2 High O2 and air supplies pressure Check patient, air and
supply both less than 0.16MPa in oxygen source. Obtain
down!!! ventilating process alternative ventilation if
necessary.
Battery High Battery capability detected Charge the battery
Exhausted! less than 23V after startup. immediately.
!! Obtain alternative
ventilation if necessary.

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Shangrila590 Ventilator User Manual

8.3 Troubleshooting

Malfunctions Possible cause Recommended action


AC indicator is not Power cord is unplugged. Plug it firmly.
bright Power cord is damaged. Replace power cord.
Power socket failure. Turn to other socket.
Fuse is burned. Replace fuse.
Maximum pressure Patient circuit is occluded; Check the pipeline leak part;
alarm sounds Patient‟s respiratory tract Reset the alarm settings;
continuously is occluded; Check the patient
Maximum pressure setting
is too low;
Ventilator parameters
changed.
Minimum pressure Patient circuit leaks; Check the pipeline leak part;
alarm sounds Alarm settings is too high; Reset the alarm settings;
continuously Patient‟s compliance Check the patient
changed;
Trigger icon blinking The trigger value may be Reset trigger value.
smaller.

8–4
9 Specifications
9.1 Physical specification
All specifications are approximately, maybe changed at any moment without notice.

CAUTION: Do not put Shangrila590 into the shock environment.

CAUTION: Do not lay the heavy on the top.

Size 400mm(H)×303mm(W)×250mm(D)
Weight 15kg
Power cord Rating voltage: 90 to 264VAC;
Capacity of current: 220 to 240VAC 10A;
Type: Three-core cable (Medical level)
Gas pipe Compression resistance: 1MPa
Patient circuit Single use
Face mask Single use
Screen 10.4‟ TFT LCD

9.2 Environment requirements

Temperature Operation: 5℃~40℃


Storage: -20℃~55℃
Relative humidity Operation: ≤90%
Storage: ≤93%
Atmospheric Operation: 50 ~ 106kPa
Pressure
Storage: 50 ~ 106kPa

CAUTION: The device should be stored at the room that is drafty


and no corrosion gas exists.

CAUTION: When the storage conditions are beyond the


requirements of operational environment, and the
storage state is transferred into operation state, the
product only can be used after being stored in
environment for over 24 hours.

9–1
Shangrila590 Ventilator User Manual

9.3 System technical specification


Gas supply Composition: O2 ,Air (All gas must be medical level)
Pressure: 0.28MPa~0.6MPa
Velocity of flow: >60L/Min
Connector: DISS-male, DISS-female, NIST (ISO
5359)
Power supply Voltage & 110~240VAC, 50Hz/60Hz
Frequency
Power:  65VA
Fuse: 250V/0.5A, Ф5X20 (T)
Earth resistance: <0.1Ω
Inspiratory and Conical connectors (ISO5356)
expiratory port
Inspiratory and At flow of 60ml/min for adult use, inspiratory resistance
expiratory ≤0.6kPa; expiratory resistance ≤0.6kPa
resistance At flow of 30ml/min for pediatric, inspiratory resistance
≤0.6kPa; expiratory resistance ≤0.6kPa
Maximum security  8kPa
pressure
Compliance  4mL/100Pa
Electrical safety Meet requirements for Class I, type B equipment specified in
EN60601-1 Medical Electrical equipment: Part one:
General requirement for safety.
Classification According to EN 60601-1, Shangrila590 belongs to the
following classifications:
Class I, Type B, General, transportable equipment.
Noise:  65dB(A)

9–2
9. Specifications

9.4 Operation principle

Figure 9-1 Shangrila590 System operation principle schematic diagram

9–3
Shangrila590 Ventilator User Manual

9.5 Performance parameters

9.5.1 Ventilation mode

Ventilation mode
A/C mode
VCV mode
PCV mode
PSV mode
SIGH mode
SIMV mode
SPONT mode

9–4
9. Specifications

9.5.2 Setting ventilating parameters

Item Range Resolution Accuracy Remark


VT 50~1500ml 10ml ±20 ml Peak flow =
(≤1000ml) (50<VT≤100mL); VT * f / T I
100ml (other) ±15% (other)
f 4 ~ 100bpm 1bpm ±1bpm (≤10bpm); -----
±10% (other)
1 ~ 40bpm 1bpm ±1bpm (≤10bpm); SIMV mode
±10% (other)
TI 0.1s~12s ---- ±0.1s (0~0.5s); ----
±20% (other)
TP 0~4s ---- ±0.1s (0~0.5s); Limited by TI, the
±20% (other) maximum of Tp
is 50%Ti.
FiO2 21%~100% 1% ±15% Invalid when
single gas
supply operated.
Psens -2~0kPa 0.1kPa ±50Pa (-0.5~0kPa); ----
±10% (other)
Vsens 0.5~20LPM 0.5LPM ±1L/Min(0.5~5L/Min); ----
±20% (other)
PEEP 0 ~ 4kPa ---- ±0.2kPa (1kPa) ----
(adjustable); ±20% (other)
0 ~ 2kPa
(useable)
PSV 0 ~ 6kPa ---- ---- Based on PEEP
(adjustable);
0 ~ 3kPa
(useable)
PCV 0.5 ~ 6kPa ---- ±0.3kPa (≤1kPa); Based on PEEP
±20% (other)
MVmax More than ---- ---- ----
18L

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Shangrila590 Ventilator User Manual

9.5.3 Monitoring performance

Item Range Resolution Accuracy


VTI 0~2000mL 1mL ±20mL (0ml<VTI≤100ml);
±15% (other)
VTE 0~2000mL 1mL ±20mL (0ml<VTI≤100ml);
±15% (other)
fspont 0~100bpm 1bpm 2bpm (≤20bpm); ±10% (other)
0~40bpm(useable)
ftotal 0~100bpm 1bpm 2bpm (≤20bpm); ±10% (other)
I:E 1:9~4:1 ---- ±15% (calculating value designed
for user understanding
conveniently)
MVspont 0~99L 1L 0.5L(≤3L); ±15% (other)
0~30 L (useable)
MV 0~99L 1L 0.5L(≤3L); ±15% (other)
0~30 L (useable)
FiO2 15%~100% ---- ±3% of the full scale
Waveform Supply Paw-t curve, ---- ----
monitor Flow-t curve, V-t
curve, P-V loop and
F-V loop.

9–6
9. Specifications

9.5.4 Assistant performance

Item Description
Lung mechanics Includes static compliance measuring, AutoPEEP measuring
and Resistance measuring in the airway.
Emergency Start Default ventilation mode: VCV
Nebulizer The function will be finished in 30 minutes.

9.5.5 Setting alarm parameters

Item Range Accuracy


MV-upper limit 0~30L ±1L(1~3L); ±15%(other)
MV-lower limit 0~30L ±1L(1~3L); ±15%(other)
Paw-upper limit 2~8kPa ±10%
Paw-lower limit 0~2kPa 100Pa (0~0.5kPa);
20% (0.5~2kPa)
VTE-upper limit 0.05~2.00L, OFF ±30ml(50~200ml); ±15%(other)
fspont 0~60bpm 2bpm (0~20bpm);
10% (other)
Tapnea 10s~20s ±20%
FiO2-lower limit 20%~99% ±10%
FiO2-upper limit 21%~100%, OFF ±10%

CAUTION: All low limits of parameters in above table may not be set
up the high limits, nor may the high limits be set below
the low limits.

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Shangrila590 Ventilator User Manual

9.6 Electromagnetic Compatibility


Changing or reassembling this equipment without Aeonmed‟s authorization may
cause electromagnetic compatibility problems. Contact with Aeonmed for assistance.
Designing and testing this equipment is in accordance with the following
stipulations.

WARNING: Using cell phone or other radio radiant equipment near


this product may cause malfunction. Closely monitor the
working condition of this equipment if there is any radio
radiant supply nearby.

Using other electrical equipment in this system or nearby may cause interference.
Check if the equipment works normally in these conditions before using on a patient.

Be careful of the following when Shangrila590 is connected:

Do not put any object which is not in accordance with EN 60601-1 in the 1.5M range
of patients.

An isolated transformer must be used for alternating current supply (in accordance
with IEC60989), or additional protective ground wires are equipped if all the devices
(for medical or non-medical use) are connected to Shangrila590 by using signal
input/signal output cable.

If a portable all-purpose outlet is used as the alternating current supply, it must be in


accordance with EN 60601-1-1 and cannot be put on the floor. Using another
portable all-purpose outlet is not recommended.

Do not connect the non-medical equipment directly to the alternating current outlet
on the wall. Only the alternating current supply of the isolated transformer can be
used. Otherwise, the surface leaking current may exceed the range permitted by EN
60601-1 under the normal conditions, and misoperation may cause injury to patients
or operators.

A complete system current leaking test (according to EN 60601-1) must be


performed after any equipment is connected to these outlets.

WARNING: Medical electrical equipment operators contact


non-medical electrical equipment and patients at same
time. It is dangerous of patients or operators.

9–8
9. Specifications

Guidance and manufacture’s declaration – electromagnetic emissions-


for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration – electromagnetic


emission
The Shangrila590 Ventilator is intended for use in the electromagnetic environment
specified below. The customer of the user of the Shangrila590 Ventilator should
assure that it is used in such and environment.

Emission test Compliance Electromagnetic environment –


guidance

RF emissions The Shangrila590 Ventilator uses RF


CISPR 11 energy only for its internal function.
Therefore, its RF emissions are very
Group 1
low and are not likely to cause any
interference in nearby electronic
equipment.

RF emission The Shangrila590 Ventilator is suitable


Class B
CISPR 11 for use in all establishments, including
domestic and those directly connected
Harmonic
to the public low-voltage power supply
emissions Class A
network that supplies buildings used
IEC 61000-3-2
for domestic purposes.
Voltage
fluctuations/ flicker
Complies
emissions
IEC 61000-3-3

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Shangrila590 Ventilator User Manual

Guidance and manufacture’s declaration – electromagnetic immunity –


for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration – electromagnetic immunity


The Shangrila590 Ventilator is intended for use in the electromagnetic environment specified
below. The customer or the user of Shangrila590 Ventilator should assure that it is used in such an
environment.
Electromagnetic
Immunity test IEC 60601 test level Compliance level environment -
guidance
Electrostatic 6 kV contact 6 kV contact Floors should be wood,
discharge (ESD) 8 kV air 8 kV air concrete or ceramic tile.
IEC 61000-4-2 If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast 2 kV for power 2kV for power Mains power quality
transient/burst supply lines supply lines should be that of a
IEC 61000-4-4 1 kV for input/output typical commercial or
lines hospital environment.

Surge 1 kV differential 1 kV differential Mains power quality


IEC 61000-4-5 mode mode should be that of a
2 kV common mode 2 kV common mode typical commercial or
hospital environment.
Voltage dips, short <5% UT <5% UT Mains power quality
interruptions and (>95% dip in UT) (>95% dip in UT) should be that of a
voltage variations on for 0.5 cycle for 0.5 cycle typical commercial or
power supply input hospital environment. If
lines 40% UT 40% UT the user of the
IEC 61000-4-11 (60% dip in UT) (60% dip in UT) Shangrila590 Ventilator
for 5 cycles for 5 cycles requires continued
operation during power
70% UT 70% UT mains interruptions, it is
(30% dip in UT) (30% dip in UT) recommended that the
for 25 cycles for 25 cycles Shangrila590 Ventilator
be powered from an
<5% UT <5% UT uninterruptible power
(>95% dip in UT) (>95% dip in UT) supply or a battery.
for 5 sec for 5 sec
Power frequency 3A/m 3A/m Power frequency
(50Hz) magnetic magnetic fields should
field be at levels
IEC 61000-4-8 characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

9–10
9. Specifications

Guidance and manufacture’s declaration – electromagnetic immunity –


for LIFE-SUPPORTING EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity
The Shangrila590 Ventilator is intended for use in the electromagnetic environment specified
below. The customer or the user of Shangrila590 Ventilator should assure that it is used in such an
environment.
Immunity IEC 60601 Compliance
Electromagnetic environment - guidance
test test level level
Portable and mobile RF communications equipment
should be used no closer to any part of the
Shangrila590 Ventilator, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended separation distance
Conducted 3 Vrms 3V  3.5  12 
RF 150 kHz to d   P d   P
 V1  V2 
IEC 80 MHz
61000-4-6 outside ISM  12  80 MHz to 800 MHz
a d   P
bands 10V  1
E
 23  800 MHz to 2.5 GHz
10 Vrms d   P
150 kHz to  E1 
80MHz Where P is the maximum output power rating of the
in ISM band 10 V/m transmitter in watts (W) according to the transmitter
a manufacturer and d is the recommended separation
b
Radiated distance in metres (m).
RF Field strengths from fixed RF transmitters, as
c
IEC 10 V/m determined by an electromagnetic site survey,
61000-4-3 80 MHz to should be less than the compliance level in each
d
2.5 GHz frequency range.
Interference may occur in the vicinity of equipment

marked with the following symbol:


NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a
The ISM (industrial, scientific and medical) bands between 150kHz and 80MHz are 6.765
MHz to 6.795 MHz; 13.553MHz to 13.567MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz
to 40.70.
b
The compliance levels in the ISM frequency bands between 150 kHz and 80MHz and in the
frequency range 80MHz to 2.5GHz are intended to decrease the likelihood that
mobile/portable communications equipment could cause interference if it is inadvertently
brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating
the recommended separation distance for transmitters in these frequency ranges.
c
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the Shangrila590 Ventilator
is used exceeds the applicable RF compliance level above, the Shangrila590 Ventilator
should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the Shangrila590
Ventilator.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Shangrila590 Ventilator User Manual

Recommended separation distances between portable and mobile


RF communications equipment and the EQUIPMENT or SYSTEM –
for LIFE-SUPPORTING EQUIPMENT and SYSTEMS

Recommended separation distances between


portable and mobile RF communications equipment and the Shangrila590 Ventilator
The Shangrila590 Ventilator is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Shangrila590 Ventilator
can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the Shangrila590 Ventilator
as recommended below, according to the maximum output power of the communications
equipment.
Separation distance according to frequency of transmitter
Rated maximum (m)
output power of 150 kHz to 80 M 80 MHz to 800 MHz 800 MHz to 2.5 GHz
transmitter Hz
 3.5  7
(W)
 3.5  d   P d   P
d   P  E1   E1 
 V1 
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.

NOTE 2 The ISM (industrial, scientific and medical) bands between 150 kHz and 80MHz are
6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66MHz
to 40.70MHz.

NOTE 3 An additional factor of 10/3 is used in calculating the recommended separation distance
for transmitters in the ISM frequency bands between 150kHz and 80MHz and in the frequency
range 80MHz to 2.5GHz to decrease the likelihood that mobile/portable communications
equipment could cause interference if it is inadvertently brought into patient areas.

NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

9–12
9. Specifications

Shangrila590 Ventilator User Manual

Edition 03.20

Jan 2010

Beijing Aeonmed Co., Ltd.

9–13

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