Rev. 2.

3 – 07/16

Pasithec - Upgraded Version

INNOVATION IN DESIGN AND TECHNOLOGY

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Contents

Contents .................................................................................................................................................... 3
Statement .................................................................................................................................................. 7
1. Product Description ............................................................................................................................... 9
1.1. General Information ........................................................................................................................... 9
1.2. Symbols........................................................................................................................................... 9
1.3. Abbreviations ............................................................................................................................... 12
1.4. Warnings and Cautions ................................................................................................................ 15
2. Components ........................................................................................................................................ 21
2.1. Configuration ................................................................................................................................... 21
2.5. Breathing System.......................................................................................................................... 27
2.5.1. APL Valve ............................................................................................................................... 29
2.7. Anesthetic Gas Scavenging System-AP1000 (Optional) ............................................................... 31
2.8. SUCTION（Optional） ................................................................................................................. 32
2.9. Accessories ................................................................................................................................... 33
3. User interface ...................................................................................................................................... 34
3.1. Main interface display layout ....................................................................................................... 36
3.1.3. The Interface layout with CO2 and anesthesia gas monitoring ............................................. 39
3.2.1. Ventilation mode set and display area .................................................................................. 39
3.2.2. Parameter set and display area............................................................................................. 40
3.2.4. Machine information area..................................................................................................... 43
3.2.5. Waveform display area ......................................................................................................... 44
3.2.9. Flowmeter area ..................................................................................................................... 47
3.2.11. Shortcut key area ................................................................................................................ 48
Name description and Diagram....................................................................................................... 50
4. Pre-operative Preparation ................................................................................................................... 51
4.1. Installation and Connection ......................................................................................................... 51
4.1.1. Connection of Tubes and Cables ........................................................................................... 51
4.1.2. Installation of Breathing Bag ................................................................................................. 53
4.1.3. Connection of test plug ......................................................................................................... 54
4.1.4. Connection of O2 sensor ........................................................................................................ 55

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4.1.5. Connection of the anesthetic gas/CO2 monitoring module (optional) ................................. 56

4.1.6. AGSS Installation and Connection ......................................................................................... 59
4.2. Pre-operative Test ........................................................................................................................ 61
4.2.1. Test before Operation ........................................................................................................... 62
4.2.2. Pipeline Gas Supply Test........................................................................................................ 63
4.2.3. Vaporizer Test........................................................................................................................ 63
4.2.4. Alarm Test ............................................................................................................................. 64
5. Operating guide ................................................................................................................................... 66
5.1. Opening ........................................................................................................................................ 66
5.2. System Self–test ........................................................................................................................... 67
5.3. Automatic Leak Test ..................................................................................................................... 68
5.4. Manual Test .................................................................................................................................. 73
5.5. Patient type setting ...................................................................................................................... 76
5.6. Ventilation mode setting .............................................................................................................. 78
5.6.1. Ventilation mode introduction .............................................................................................. 78
5.6.1.6. Pressure control ventilation with Volume Guaranteed (PCV-VG) ----Optional .................. 83
5.6.2. Ventilation mode setting ....................................................................................................... 85
5.6.3. Mode parameter setting ....................................................................................................... 86
5.7. Menu screens ............................................................................................................................... 88
5.7.1. Menu operating logic ............................................................................................................ 90
5.7.2. Alarm setting ......................................................................................................................... 90
5.7.3. System setting ....................................................................................................................... 92
5.7.4. Calibration ............................................................................................................................. 93
5.7.5. Trend ..................................................................................................................................... 95
5.7.6. Check ..................................................................................................................................... 96
5.7.7. Configuration ......................................................................................................................... 99
5.8. Shutdown ................................................................................................................................... 101
6. Alarm and troubleshooting ............................................................................................................... 102
6.1. Brief introduction of alarm message .......................................................................................... 102
6.2. Alarm message ........................................................................................................................... 103
6.2.1. Alarm default value and setting range ................................................................................ 103
6.2.2. Technical alarm message table ........................................................................................... 104
6.2.3. Functional alarm message ................................................................................................... 108

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6.2.4. Self-test alarm ..................................................................................................................... 112

6.3. Failure diagnosis ......................................................................................................................... 114
7.1. Guideline .................................................................................................................................... 123
7.2. User maintenance ...................................................................................................................... 124
7.3. Breathing system disassembly ................................................................................................... 125
7.4. Methods for cleaning and disinfecting ....................................................................................... 130
7.4.1. Cleaning and disinfecting for breathing system .................................................................. 131
7.4.2. Cleaning and disinfecting for bellows ................................................................................. 131
7.4.3. Cleaning and disinfecting for AGSS ..................................................................................... 132
8. Term maintenance ............................................................................................................................ 132
8.1. General principle of maintenance .............................................................................................. 133
8.2. Maintenance schedule ............................................................................................................... 134
8.2.1. Appearance checklist........................................................................................................... 134
8.3. Replacement of replaceable parts ............................................................................................. 135
8.4. Maintenance of O2 sensor .......................................................................................................... 136
8.4.1. Replacement of O2 sensor ................................................................................................... 136
8.4.2. Main technical parameter of O2 sensor............................................................................... 136
8.5. Maintenance of fuse .................................................................................................................. 138
8.6. Battery Maintenance .................................................................................................................. 139
8.7. Consumptive components replacement .................................................................................... 140
9. Technical Data ................................................................................................................................... 140
9.1. Pneumatic Diagram .................................................................................................................... 140
9.2. System technical data................................................................................................................. 142
9.3. Electrical diagraph ...................................................................................................................... 143
9.4. Physical data ............................................................................................................................... 145
9.5. Environmental requirement ....................................................................................................... 145
9.5.1. IEC60601-1:2005 classification ............................................................................................ 146
9.6. Input and output ........................................................................................................................ 147
9.6.1. Electrical .............................................................................................................................. 147
9.6.3. Electromagnetic compatibility ............................................................................................ 148
9.6.4. Guidance and manufacture’s declaration ........................................................................... 150
9.6.5. Recommended separation distances .................................................................................. 155
9.7. Breathing system technical data ................................................................................................ 157

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9.7.1. Compliance correction ........................................................................................................ 158

9.8. Anesthetic ventilator technical specifications ........................................................................... 159
9.8.1. Anesthetic ventilator performance ..................................................................................... 159
9.8.2. Ventilation parameter ......................................................................................................... 160
9.8.3. Gas dynamics ....................................................................................................................... 161
9.8.4. Monitor performance .......................................................................................................... 161
9.9. O2 sensor specification ............................................................................................................... 163
9.10. Gas monitoring module technical specifications ..................................................................... 163
9.10.1. Mainstream gas monitoring module ......................................................................... 164
9.10.2. Sidetream gas monitoring module ............................................................................ 171
10.Warranty .......................................................................................................................................... 178

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Statement

HEYER Medical AG holds the copy rights 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 products only. Anyone other than HEYER 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 HEYER who reserves the copyright.

Everything written in this manual is considered to be correct. HEYER is not legally responsible for any
mistakes printed within and any damages caused by incorrect installation and operation. HEYER does
not supply privileges endowed by the patent law to any other parties. HEYER 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 the 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. HEYER 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 HEYER.

HEYER has the rights to replace any content in this manual without notice.

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 HEYER,
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 HEYER.

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Use Notice

Welcome to use our products.

To use this product correctly and effectively, the user must read this user manual carefully before using

this product. When the user is using this product, this user manual must be understood totally and

observe strictly.

This product is only applied to the use this user manual described.
Only trained and professional service persons are allowed to repair and examine this product. If there

is any case happened in the process of use, please call us and intense service will be provided.

If there is any change in product specification, another informs will not be given.

Manufacture: HEYER Medical AG

Address: Carl-Heyer-Str. 1/3, Bad Ems, Germany
Tel： +49 2603 7910
Fax： +49 2603 79122
Website： http://www.heyermedical.de

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1. Product Description

1.1. General Information

HEYER Pasithec Anesthesia Machine is a continuous flow anesthesia system which offers manual or
automatic ventilation, easily adjustable fresh gas delivery, anesthetic agent delivery, ventilation
monitoring, convenient ergonomics, and state-of-the-art safety systems.

In terms of theory of operation, HEYER Pasithec Anesthesia Machine, driven by pneumatics and
controlled by electricity, is a device used to administer to a patient continuously or intermittently, a
general inhalation anesthetic and to maintain a patient’s ventilation. The integrated breathing system
delivers the mixture of O2, N2O, AIR and anesthetic agents for patient breathing control, while electrical
control system functions as monitoring patient parameters.

HEYER Pasithec Anesthesia Machine is intended for use by licensed clinicians, for patients requiring
anesthesia within a hospital. This product is suitable for infants, children and adults.

1.2. Symbols

The following table provides descriptions of symbols that are used on the device and/or within this
manual.

Symbol Description Symbol

CAUTION！ Attention, consult accompanying documents./ Refer to

user manual.

Turn on power switch ON

Turn off power switch OFF

"ON" for a part of equipment

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"OFF" for a part of equipment

alternating current (AC)

direct current (DC)

dangerous voltage

Earth (ground)

protective earth (ground)

equipotentiality

date of manufacture

manufacturer

Catalogue number

serial number

rotation in two directions

Rotate to adjust(increase counter-clockwise)

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lock

unlock

Insp. flow

Exp. flow

O2 flush O2+

breathing bag/manual ventilation

fuse

Read the reading of the top floating-point

draining valve operation guide

Outer power supply has been connected

Recycle

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This mark means that pneumatic and electric device rubbish is not
allowed to be dealt as unclassified city rubbish and should be
collected separately.

battery charging condition

alarm mute icon

alarm icon

interference many occur in the vicinity of equipment marked with

this symbol

Refer to product instructions

Authorized representative in the European community

This device complies with the requirements of Medical Device

Directive, 93/42/EEC.

1.3. Abbreviations

Abbreviation Definition
A
AGSS anesthetic gas scavenging system
APL adjustable pressure limiting
B
BDU basic data unit
C
C compliance
CGO common gas outlet

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cmH2O Centimeters of Water

CO2 carbon oxide
D
Des. Desflurane
E
EEPROM electrically erasable programmable read only memory
Enf. Enflurane
ETCO2 End-expiratory CO2 concentration
ETO2 End-expiratory O2 concentration
F
FiO2 Fraction of Inspired Oxygen
Flow-t flow-time wave
Flow flow
Freq Frequency
FreqMIN Minimum Frequency in PS mode
G
GUI Graphic user interface
H
Hal. Halothane
I
I:E Inspiratory to Expiratory Ratio
INSCO2 Inspiratory CO2 concentration
Iso. Isoflurane
IPPV Intermittent positive pressure ventilation
L
L/min liter per minute
L liter

M
MAC Minimum Alveolar Concentration
Manual manual ventilation
PMEAN mean pressure

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mL Mill Liter
MRI Magnetic resonance imaging
MV minute volume
N
N2O nitro oxide
O
O2 oxygen
P
Paw airway pressure
Paw-t pressure-time wave
Pb plumbum
PIP Peak Inspiratory Pressure
PLAT plat pressure
PCV Pressure Control Ventilation
PEEP Positive End Expiratory Pressure
PLIMIT limit pressure
PMEAN mean pressure
PPEAK Peak pressure
PS Pressure Support Ventilation
PTARGET Target Pressure
S
SIMV Synchronized Intermittent Mandatory Ventilation
Sev. Sevoflurane
T
TINSP Inspiratory Time
TP Inspiratory Pause Time
Trigger flow trigger
TSLOPE Inspiratory Slope Time
V
VT tidal volume
W
WDT watch dog timer

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ΔP Differential Pressure

1.4. Warnings and Cautions

Please read and adhere to all warnings, CAUTIONs and NOTICEs listed here and in the appropriate areas
throughout this manual.

A WARNING statement gives important information that, if ignored, could lead directly to personal
injury.

A CAUTION statement gives important information that, if ignored, could lead directly to equipment
damage and indirectly to personal injury.

WARNING：HEYER Pasithec must only be operated by trained, skilled medical staff.

WARNING ： HEYER Pasithec Anesthesia Machine must and can only be serviced by HEYER’s

authorized service representatives.

WARNING：For a full understanding of the performance characteristics of this equipment, the user

should carefully read this manual before operating：

• All system connections.

• All WARNINGs and CAUTIONs.

• How to use the machine.

• How to test the machine.

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WARNING：Do the following things before operating HEYER Pasithec：

• Finish all the tests listed in Pre-use Preparation.

• Test other systematic parts.

WARNING ：Do not use the machine if any test failures. Contact HEYER’s authorized service

representative for maintaining the machine.

HEYER Pasithec is not suitable for use in a magnetic resonance imaging （MRI）environment.

WARNING：To avoid the risk of electric shock, this equipment must only be connected to a supply

mains with protective earth.

WARNING：The highest attitude of HEYER Pasithec anesthesia machine is 3000m.

WARNING ：The pipeline inlet pressure of HEYER Pasithec anesthesia machine must be 280-
600kPa.

WARNING：Breathing tube, mask, SUCTION filter and so on, adapter of mainstream CO2 module,
water trap of sidestream CO2 module etc. are disposable accessories. Before using check the pipeline
to ensure the disposal subassembly is out of using .Check the tube which will be used before use and
avoid reusing.

WARNING：When the suction flow is insufficient, the suction port filter should be checked or

replaced.

WARNING：Do not use anti-static and/or electric breathing tubes or masks; otherwise, they will be

flammable near high frequent surgery equipment.

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WARNING：Do not incline the machine at the angle of more than 10 degree.

WARNING：Perform the pre-use checkout before operating HEYER Pasithec.

WARNING：Remove all equipments on the top cover before moving the machine. Use the handle

on the machine to move the machine.

WARNING：Ensure that the machine does not incline when it is upgrading, downgrading, turning

around or getting across a threshold. Do not push the machine across pipelines, lines or any barrier on

the ground.

Remove all the equipments attached at the flank of the machine before

transportation, otherwise, incline of the machine will lead to personnel damage.

WARNING：Apply the castor brakes when the anesthesia machine is in use.

WARNING: Do not put the item over 25 kg on the top board of HEYER Pasithec anesthesia machine.

WARNING: Do not put the item over 12 kg on the work table of HEYER Pasithec anesthesia machine.

WARNING: The whole width of machine should be less than 0.8m when hanging some stuff.

WARNING：In order to protect patients and users from electrical hazards, it is imperative that all

systems consisting of electrical medical devices and other electrical devices, such as but not limited to

PCs, priters, etc., be mounted exclusively by trained personnel.

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WARNING: The medical gas pipeline system malfunction could cause one or more devices

connected to the system stopping their operation; this is not applicable to the anesthetic machine

that only uses cylinders for gas supply.

WARNING: The parts of machime in contact with gas to be inhaled by patients don’t contain

phthalates, which are known to be carcinogenic, mutagenic or toxic to reproduction.

WARNING：Possible explosion hazard. Do not operate machine near flammable anesthetic agents

or other flammable substances. Do not use flammable anesthetic agents (i.e. either or cyclopropane).

WARNING ： Only non-flammable anesthetics such as desflurane, sevoflurane, enflurane and

isoflurane, which are compatible to other gas are allowed to use in anesthetic system.

WARNING：Possible fire hazard. Fuses (i.e., additional sockets) must only be replaced by fuses of

the same type and with the same rating.

Possible electric shock hazard. The machine may only be opened by HEYER

qualified or HEYER authorized service engineer.

WARNING：Electric shock and fire hazard. Do not clean the machine while it is on and /or plugged

in.

WARNING：Disconnect the power plug from the mains supply before removing the rear panels or

servicing the machine.

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

with mask) must be available whenever the machine is in use.

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WARNING：Malfunction of the central gas supply system may cause more than one or even all

devices connected to it to stop their operation simultaneously.

WARNING：Use a cleaning and sterilizing schedule that confirms to your institution’s sterilization

and risk-management policies.

• Refer to the material safety data as applicable.

• Refer to the operation and maintenance manuals of all sterilizing equipment.

• A damaged oxygen sensor may lead to leakage of its highly caustic contents that contain
potassium chloride. Wear safety gloves and safety googles per manufacturer’s
recommendations.

• Do not inhale fumes that may result from any sterilization process.

WARNING：Use extreme care while handling the absorbent as it is a caustic irritant.

WARNING：Use care in lifting and manipulating vaporizers during the mounting process as their

weight may be greater than expected, based on their size and shape.

WARNING：All gas supplies should be of medical grade. To avoid endangering a patient, do not
perform testing or maintenance when the machine is in use.
WARNING：All gas volume, flow and leakage specifications have been tested under STPD, except

those associated with the Anaesthetic Breathing System, which be tested under BTPS.

WARNING：After the device replacement is finished, all calibrations must be done again and only

the service engineer is allowed to do this.

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WARNING: If the anesthetic machine is equipped with Anesthetic Gas Delivery System,

Monitoring Equipment, Alarm System and Production Device, no matter the machine is supplied by
separate device or system assembly, the anesthetic machine checklist must be provided.

WARNING: The medical device connected to the anesthesia system must conform to IEC

60601-1:2005 and IEC 60601-1-2:2007

CAUTION：For your safety and that of your patients, strictly follow this user manual.

CAUTION：Perform the tests specified on the Pre-use Preparation and in case of a fault, do not

operate the machine until the fault has been corrected.

CAUTION：Before starting the machine, users must be familiar with the information contained in

the User Manual.

CAUTION：If the machine does not function as described, it must be examined and repaired as

necessary by authorized service representative before being returned to use.

CAUTION：Handle the machine with care to prevent damage or functional faults.

CAUTION ： Ensure that the gas supply of the machine always complies with the technical

specifications.

CAUTION：Before clinical use, the machine must be correctly calibrated and the respective tests

must be performed, as described in the User Manual.

CAUTION: After servicing, all calibrations must be performed again and only the professional service

engineer can do this.

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CAUTION: The anesthesia system conforms to ISO 80601-2-13:2011.

CAUTION: The anesthesia ventilator used together with anesthesia system conforms to ISO 80601-

2-13:2011.

CAUTION: The anesthesia system is used together with the following monitoring device, alarm

system and protection device:

• Conform to the pressure measurement of ISO 80601-2-13:2011;

• Pressure limit device in conformity with ISO 80601-2-13:2011;

• Conform to the exhale output monitor of ISO 80601-2-13:2011;

• Conform to the respiratory system with alarm system of ISO 80601-2-13:2011;

• Conform to the O2、CO2、anesthetic gas monitor of ISO 80601-2-55:2011.

2. Components

2.1. Configuration

Touch screen

E-Flowmeter

Auxiliary network power

Standard
configuration Auxiliary flowmeter

Breathing system (supporting high-temperature sterilization)

2 drawers

Auxiliary drive gas output

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Heater function

Battery

SUCTION (Negative pressure suction device)

Liquid collecting bottle

Vaporizer

Optional
External lamp
configuration

YOKE

AGSS (Anesthetic Gas Scavenging System)

CO2/anesthesia gas monitoring module(mainstream or sidestream)

Ventilation mode : SIMV-PC、PCV-VG

Functional description of components is as follows.

NO. Item Description Figure

Under any ventilation mode,

STANDBY mode or power off
Aux.
3 status, it can provide pure
Flowmeter
oxygen at the maximum of
15L/min.

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Counterclockwise rotation of
flowmeter rotary knob increases the
flow; clockwise rotation of
flowmeter rotary knob decreases the
flow.
When flow meter is connected
Electrical with gas supply, rotate O2 or Air
4
flowmeter
knob, the digital screen displays
data; there is O2 or Air flowing
out.

When O2 flow≥0.25L/min，turn N2O

knob, there is N2O flowing
out ； when O2 ≥ 0.5L/min ，

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increase of N 2O flow is
controlled by O 2 flow, the
increase ratio of O 2 and N 2O is
approximate to 1:3.
It locates on the front of the
machine. It can provide oxygen
from 35L/min to 75 L/min to
6 O2 flush breathing system and breathing
bag.
CAUTION：When central gas supply or
backup cylinder is connected, pressing
O2 flush will deliver oxygen to breathing
system and breathing bag, even if the
machine is powered off.

Castor Push down to lock

7
(with brake) Lift to release

WARNING：When adjusting

External the external lamp, don’t touch the

8
Lamp lamp surface for 1s.

Measure gauge gas supply pressure

of N2O, AIR, O2 flowing by airway.
Gas supply
10
gauge

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Set power switch to “ON” to let gas flow in and open

anesthetic system.
Set power switch to “OFF” and close anesthetic
11 Power Switch
system to prevent gas flowing in.

Cylinder gauges can measure the

pressure from N2O, AIR and O2
12 Cylinder
Gauges respectively.

Functional description of components is as follows.

NO. Item Description Figure

When the range of inlet gas pressure is 280—

600kpa, the flow of drive gas output is more
than 90L/min.

Auxiliary O2 output
3
port WARNING: The requirement flow of the
device connected to the auxiliary drive gas
outlet interface cannot exceed 90L/min

Common Gas It functions as the linkage between

5 mainframe and breathing system and
Outlet（C•G•O） delivers fresh gas to breathing system.

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There are 3 interfaces: O2 sensor cable

7 interface, heating gas cable interface and
Outlet module drive gas interface respectively. By
8 connection of 3 interfaces, the breathing
system can connect with the main machine.

Functional description of components is as follows.

Auxiliary mains
outlet socket
WARNING: The
connection of
electrical equipment to

8. the auxiliary mains outlet

socket may reduce the system
safety level; therefore the
electrical
equipment connected to the auxiliary mains outlet socket must conform
to the IEC 60601-1.
9 Fuse The HEYER Pasithec anesthesia machine has two
types fuse:

F2AL 250VAC，

F10AL 250VAC.

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10 RS-232 The RS-232 interface can be used to transmit patient’s data to other
interface device.

WARNING: The medical

device connected to the

anesthesia system through

RS-232 interface must

conform to IEC
60601-1:2005 and IEC
60601-1-2:2007

2.5. Breathing System

CAUTION：Breathing system used with HEYER Pasithec complies with ISO 80601-2-13:2011：

2011.

Breathing system is mainly used to store fresh gas including anesthetic gas, oxygen, and absorb waste
gas. It directly connects to airway to support patient’s respiration.

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Fig.2-4 Breathing System

Number Name Number Name
1 Expiration Valve 8 CO2 Absorber Canisters
2 Bag Arm 9 CO2 Absorber Canisters Release
Handle
3 APL 10 PAW Gauge

4 Expiratory Limb 11 Inspiratory Valve

5 Y-Piece Seal 12 O2 Sensor Seal
6 Hook equipment 13 Bellows Assembly （
including bellow）
7 Inspiratory Limb 14 bellows dome

Functional description of components is as follows.

NO. Item Description Figure

It guarantees the single direction of gas flow in

1 Exp. valve
breathing system.

8 CO2
Absorber
It is used to absorb CO2 patient having exhaled.
Canisters

PAW It can measure airway pressure through breathing

10
gauge system.

It guarantees the single direction of gas flow in

11 Insp. valve
breathing system.

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CAUTION：If the temperature of O2 sensor is

lower than the dew temperature of respiratory gas,
12 O2 sensor steam will congeal to its surface, so the display
value of O2 concentration would be below the
practical value.

The bellow is made of latex，more attention should

be given when use.

Remark 1: The value monitored by the ventilator is the

13
Bellow exact value, the scale marked on the bellows is just a

trend observation value. When the electrical

machine is in severe malfunction or loses control,
the tidal value marked by bellows can be read as a
reference value.

NOTE:

1. Description of inspiratory/expiratory valve:

Inspiratory and expiratory valve guarantee the single direction of gas flow in the breathing system.
When the anesthesia machine is working normally:

In the inspiratory phase, the inspiratory valve is acting and the expiratory valve is at rest; In the
expiratory phase, expiratory valve is acting and the inspiratory valve is at rest.

2. Applied Part of HEYER Pasithec anesthesia machine is the part between mask and Y-piece.

2.5.1. APL Valve

WARNING：Keep all inlets/cables away from the APL valve, and do not put lines/ cables underneath

the APL valve in order to adjust the APL valve smoothly.

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CAUTION ： The APL valve is automatically excluded from the breathing system whenever an

automatic ventilation mode is selected.

APL valve has two functions; one is that it limits the maximum pressure during manual ventilation; the
other is that the airway pressure can be exhausted quickly by lifting the APL valve.

The APL valve has a labeled knob for selecting between 0cmH2O to 70cmH2O and for indicating
approximate pressure settings. Click sound will be heard when adjusting the APL valve. In manual
mode, the APL valve knob can be rotated to change the pressure threshold at which gas will flow
through the pressure threshold at which gas will flow through the valve and into AGSS. Clockwise
rotation of the APL valve knob increases the pressure threshold, and counterclockwise rotation of the
APL valve knob decreases the pressure threshold. Lifting the top of the APL valve knob will temporarily
relieve pressure. The leakage from the anesthetic breathing in all operational modes when tested at
pressure of 3.0kPa (30cmH2O) is 40ml.

Fig. 2-5 APL Valve

2.6. Vaporizer

The vaporizer delivers anesthetic agent of accurate concentration to breathing system. Anesthetic
agent of accurate concentration will be acquired by adjusting control knob on the vaporizer. It has
temperature compensation, flow compensation and pressure compensation. The vaporizer cannot be
used for patient with respiration because of the strong interior resistance. The vaporizer can only use
one specific anesthetic agent which can be identified by the label.

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WARNING：Only dry gas of medical degree can be used on the vaporizer. Any improper operation

of the vaporizer will bring damage to patient.

WARNING：The vaporizer should be placed vertically at the vaporizer mounting manifold.

Turn the vaporizer to OFF when it is not used.

CAUTION：The vaporizer used with HEYER Pasithec Anesthesia Machine complies with ISO 80601-

2-13:2011.

CAUTION：For more operating and maintaining information of the vaporizer, refer to User Manual.

2.7. Anesthetic Gas Scavenging System-AP1000 (Optional)

Anesthetic gas scavenging system absorbs waste gas exhausted from breathing system and delivers it
to processing system.

Fig.2-7 Anesthetic Gas Scavenging System-AP1000

Number Name Number Name
1 window 5 floater
2 U-bracket 6 Patient inlet
3 canister 7 Pressure release port
4 Flow control knob

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WARNING： Do not block the pressure relieve hole on top of the gas tank when using AGSS.

CAUTION：The anesthetic gas scavenging system used with HEYER Pasithec Anesthetic Machine

complies with ISO 80601-2-13:2011.

CAUTION: If the AGSS used together with anesthesia system is produced by other manufacturer,

make sure that the AGSS conforms to ISO 80601-2-13:2011.

CAUTION：For more operating and maintaining information of AGSS, refer to AP1000 User Manual.

2.8. SUCTION（Optional）

An optional suction device is available to remove secretions, blood or other semi-liquid fluid from the
patient’s respiratory tract.

Before performing suction, adjust the negative pressure on the Suction device to an appropriate value.
When using the Suction device, connect the gas inlet to the HEYER Pasithec auxiliary gas supply port.
If the Suction device is connected with other gas supplies, the pressure of gas supply should be less
than 0.4MPa.

If suction flow is insufficient, check the suction port filter.

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Figure 4-8 Negative pressure suction device

No. Name No. Name

1 Negative pressure control switch 4 Overfill protection device

2 Negative pressure indicator 5 Negative pressure connector

3 Negative pressure control 6 Positive pressure input port

CAUTION: The negative pressure suction device used together with anesthesia system conforms to

EN ISO 10079-3.

CAUTION: For more information about operation and maintenance of the negative pressure

suction device, please refer to the Instruction for Use provided with the negative pressure suction

device.

2.9. Accessories

For a detailed accessories list refer to Appendix A.

CAUTION: Use only the referred accessories to ensure patient safety and equipment
functionality.
CAUTION: when wanting to use different accessories than listed, contact manufacturer
beforehand.

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3. User interface

WARNING: The anesthesia breathing machine used together with anesthesia system conforms to

ISO 80601-2-13:2011.

The panel of the anesthetic machine is composed of user interface, alternating current indicator light,
and function button and knob. See figure 3-1

Figure 3-1 User interface

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No Name Description
1 Touch screen Touch screen.
The user interface can display real-time pressure and flow waveforms,
respiratory loop, monitoring data, Electronic Flowmeter settings and
anesthesia System and provides both sound and visual alarms to assist
the user.

2 MANUAL/ In Standby mode, first press MANUAL/AUTO knob, the system switch to
AUTO Manual mode, then secondly switch to IPPV mode.
In automatic mode, first press MANUAL/AUTO knob, the system switch
to Manual mode, then secondly switch to the original mode. When
entering or exiting the Manual mode, the user information area displays
according to the original model.

3 MUTE If there is an alarm, press MUTE and the silence will keep for 110
seconds; press the key again, and the silence is cancelled. If the alarm
has a change but the silence less than 120s, the silence will be cancelled.

4 Knob The user can set the parameter values by rotating the knob and confirm
set values by pressing the knob. Rotating the knob clockwise increases
values and rotating the knob counter-clockwise decreases values.

CAUTION: The required circumstance of the monitoring of the breathing system as follows:

Circumstance temperature: 25 ℃;

Gas temperature: 25 ℃;

Gas tidal: 30%; Gas:

O2.

CAUTION: The anesthesia ventilator which is used with the anesthetic system complies with ISO

80601-2-13:2011.

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3.1. Main interface display layout

The user interface is divided into eleven areas, see Figure 3-2.

Figure 3-2 User interface areas

NO Name NO. Name

1 Anesthetic gas monitoring area 7 Shortcut key area

2 Flowmeter area 8 Machine information area

3 Ventilation mode set area 9 Patient message area

4 Parameter set and display area 10 Waveform display area

5 Prompt message area 11 Alarm indication area

6 Patient parameter monitoring area 12 Ventilation mode display area

Because of the gas module configuration and the system setting, there are 3 layouts of the main
interface.

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3.1.1. The Interface layout without CO2 or anesthesia gas monitoring

Figure 3-3 Main interface display layout 1

3.1.2. The Interface layout with only CO2 monitoring

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Figure 3-4 Main interface display layout 2

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3.1.3. The Interface layout with CO2 and anesthesia gas monitoring

Figure 3-5 Main interface display layout 3

3.2. Information of the main interface
3.2.1. Ventilation mode set and display area

3.2.1.1 Ventilation mode display

Name description

Ventilation mode display: ventilation mode area shows current ventilation mode. The mode setup menu
will be open by clicking the ventilation mode area via touch screen.

3.2.1.2 During mode setting process, there are five states for mode button as shown below:
Name description Diagram

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The normal mode - without any operation to the mode button.

Focusing state - when rotating the knob to the purpose mode, the corresponding
button will display this state.

White state - means the current mode that is selected.

Pending state- this state is displayed when switching modes.

White focus state - this state has been selected and then rotate knob through
the button.

3.2.2. Parameter set and display area

3.2.2.1. Parameter display

Name description and Diagram

Parameter setting area is located at the bottom of the screen, with green/blue background and round
white buttons, which are applied for real-time respiratory parameter adjustment, including six setting
buttons.

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The ventilation parameters of all models are arranged from left to right, as shown in the chart below:
Model Parameter Parameter Parameter Parameter Parameter Parameter 6

1 2 3 4 5

Standby Patient type Blank Blank Blank Blank Blank

IPPV VT Freq. I:E TP PEEP PMAX

PCV PTARGET Freq. I:E PEEP TSLOPE Blank

VT Freq. TINSP PEEP Trigger More

SIMV
TP △P TSLOPE PMAX Blank Back

PS △P FreqMIN TSLOPE PEEP Trigger TSLOPE

Ptarget Freq. TINSP Tslope PEEP More

SIMV-PC
(Optional)
ΔP Trigger Blank Blank Blank Back

PCV-VG
VT Freq. I:E Tslope PEEP Pmax
(Optional)

ALARM
Manual on/off Blank Blank Blank Blank Blank

3.2.2.2. The button status when setting parameter

Name description Diagram

There are three display statuses in the process of parameter setting:

1. The first status displays when no operation has been performed

to the button;

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2. The second status displays when the button has been selected by the
rotation of the knob;

3. The third status displays when the button has been pressed.

3.2.3. Alarm indication area

Name description and Diagram

Alarm indication: when an alarm appears, an alarm bell icon shows in the warning area. For a senior-
level alarm, the alarm bell is red with white lettering. An intermediate-level alarm is yellow with black
lettering. A low-level alarm is blue-green with black lettering. At most, four alarms can display on the
screen at one time

By pressing MUTE button, an “X” shows on the alarm icon. Below the alarm bell a countdown timer
appears. The “X” and countdown second display the same color as the alarm bell.

The flickering frequency of higher priority alarm among all alarms indicates all alarms, alarm bell and
countdown seconds (if any). The alarm information text keeps own color respectively (if any).

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3.2.4. Machine information area

Name description Diagram

Machine information area is at the top right-hand corner of the screen.

There are four icons in this area: Battery and AC Power Indicator, USB
Indicator, Time Indicator and Date Indicator.

The description of these icons is as follows.

Name description Diagram

Power status includes AC power and backup battery state, which will be always
shown. When AC power is normal, the white plug icon shows consistently
without flashing. When net power is disconnected or fails, the white plug icon
disappears.

Battery power 100%

Battery power 75%

Battery power 50%

Battery power 25%

Battery power low (≤10%)

Battery not connected

Anesthesia machine should be able to automatically detect a USB device. When

the machine detects USB access, this icon shows. When the device is unplugged
or fails to detect USB, this icon does not show.

Current date indicates at date display area, with format “YYYY/MM/DD,

MM/DD/YYYY or DD/MM/YYYY”.

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Name description Diagram

CAUTION: Date format and value can be set in system setup menu.

Current time indicates at the time display area, either 12 hour or 24 hour format.

WARNING: Time format and value can be set in system setup menu.

3.2.5. Waveform display area

Waveform display area is located in the center of the screen, including waveform and breathing loop.
Waveform name Diagram

Pressure-time waveform (Paw-t)

Velocity-time waveform (Flow-t)

Tidal volume - time waveform（VT-t）

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Carbon dioxide-time waveform

(CO 2-t)

Breathing Loops

3.2.6. Patient message area

Name description Diagram

The patient message area is to the right of the alarm zone, and to
the left of the information area. In this area, there are two icons:
patient type and trigger type.

The description of these icons is as follows.

Name description Diagram

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Patient type shows adult or child.

CAUTION: Patient type setting is conducted under standby mode.

When patient triggers, the trigger logo will show in the patient
information area, and disappear after 250ms. The background color will
restore the original color.

3.2.7. Patient parameter monitoring area

Name description Diagram

The patient parameter monitoring area is on the right side of the

screen. There are at most four groups of parameters:
pressure group, capacity group, oxygen concentration group and
carbon dioxide concentration group.

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3.2.8. Anesthesia gas monitoring area

Name description Diagram

Gas monitoring parameter displays on the left side of the

screen, including three parameters: primary agent, nitrous oxide
(N 2O) concentration, and exhale MAC value.

3.2.9. Flowmeter area

Name description Diagram

The electronic flow meter displays real-time N2O, air and O2 flow values.
Every flowmeter has 2 virtual flow tubes that display flow. Each flow tube
has the same icon, scale, structure and color (grey). The units and
numerical readings are displayed in white. The fill color of virtual flow
tubes is the same with gas icon color.

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3.2.10. Message prompts area

Name description and Diagram

Message prompt area is in the upper left corner of the parameter settings area. Message prompt area is
used to display critical information or to provide real-time help to the user.

3.2.11. Shortcut key area

The shortcut key area includes shortcuts to alarm settings, system settings, calibration, trend, breathing
loop, self test, configuration and main interface.

CAUTION: Shortcut keys are disabled during power up self test.

Name description Diagram

Alarm settings: when user presses alarm setting key, alarm menu appears. If
this button is pressed in open state, alarm setting menu closes, and returns
to main interface.

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System settings: by pressing system setup key, the system setup menu
appears. If this menu is pressed in open state, system settings menu
disappears, and returns to main interface.

Calibration: by pressing calibration key, the calibration menu appears. If

this button is pressed in open state, calibration button disappears and
returns to main interface.

Trend: by pressing trend key, the trend menu appears. If this button is pressed
in open state, trend menu disappears and returns to main interface.

Loops: by pressing Loops key, the loops menu appears. If this button is
pressed in open state, the functional menu disappears and returns to
main interface.

Check: user will repeat start-up self-check process, including leak

detection and system test. User only repeats self test in standby mode.
At this time the message will display "execution only in Standby mode
".

Configuration: by pressing configuration key, the user opens or closes

a menu that will cover the entire monitoring area. The shortcut key
exists only in standby mode. There is no configuration shortcut key in
other mode.

Interface: when normal key is pressed, all menus will be closed to

return to main interface.

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3.3. General menu layout

Name description and Diagram

The background of the overall menu is gray with the menu title shown centered, at the top of the
window. Below the menu title there are a number of tabs containing a variety of content within the
menu. In the top, right corner of the window is an "x" button which closes the menu when pressed.
The menu elements include option key, button, label, indicative text and pictures, etc.

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4. Pre-operative Preparation

4.1. Installation and Connection

4.1.1. Connection of Tubes and Cables

First step:
Connect CGO connection cable of the
breathing system with CGO interface in the left
of anesthetic machine.

Fig.4-1
Second step:
Connect one end of heating cable with the
interface below the breathing system; the other
end connected with interface marked “Heater”
in the outlet module.

Fig.4-2
Third step:
Connect one end of drive gas tube with the
interface below the breathing system.

Fig.4-3

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Fourth step:
Connect the other end of drive gas tube with
interface marked “Ventilator” in the outlet
module.

Fig.4-4

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4.1.2. Installation of Breathing Bag

Step 1:
Hold breathing bag to bag arm directly.

Fig.4-5
Second step:
Connect manual bag to manual bag arm with an
upper force.

Fig.4-6

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4.1.3. Connection of test plug

First step:
Test plug is between inspiratory port and
expiratory port of the breathing system,”T” is
marked above the plug.

Fig.4-7
Second step:
Connect Y-piece to the Y-Piece seal.

Fig.4-8

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4.1.4. Connection of O2 sensor

First step:
Pull out O 2 cell plug from inspiratory valve
cover.

Fig.4-9

Fig.4-10
Second step:
Connect the transparent joint which connects
O 2 sensor by cable to the top port of O 2 sensor.

Fig.4-11

Fig.4-12

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Third step:
Connect O 2 sensor with inspiratory valve cover.

Fig.4-13
Fourth step:
Connect the other end of O 2 sensor connecting
cable to the port marked “Oxygen” of the outlet
module.

Fig.4-14

4.1.5. Connection of the anesthetic gas/CO2 monitoring module (optional)

CAUTION：The anesthetic gas/CO2 monitoring module has mainstream and sidestream. The two

types can’t be used at the same time.

CAUTION：The anesthetic gas/CO2 monitoring module conforms to ISO 80601-2-55:2011.

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4.1.5.1. Connection of the mainstream monitoring module

Step 1 ：
Snap the probe on top of the airway adapter. It
will click into place when properly seated.

Fig.4-15

Fig.4-16
Step 2 ：
Connect the RS232 interface of the adapter to
the RS232 interface on the back of the
machine.

Fig.4-17

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Step 3：

CAUTION：After powering on the system,

a green LED indicates that the probe is ready

for use. Fig.4-18

Connect the smaller end of the adapter to the

Y-piece connector.

Fig.4-19
Step 4：
Connect the other end of the adapter to the
face mask or breathing bag.

Fig.4-20

4.1.5.2. Connection of the sidestream monitoring module

Step 1 ：

Take out the sampling tube and elbow.

Sampling tube Elbow

Fig.4-21

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Step 2:
Connect one end of the elbow to the Y-piece

Fig.4-22
Step 3:
Connect the other end of the elbow to the
breathing bag, or to patients through tube.

Fig.4-23
Step 4:
Connect the other end of the elbow to the
sampling tube, and make a connection between
the sampling tube and the CO 2 or anesthesia
gas water trap.

Fig.4-24

4.1.6. AGSS Installation and Connection

CAUTION： AGSS cannot at an angle exceeding 5 degrees during normal operation.

CAUTION： Make sure AGSS installs at a place where operator can get a clear view of it.

CAUTION： Connect AGSS according to the practical situation if no GCX rail is available on the

anesthesia machine.

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CAUTION： Make sure good connection in case of anesthesia gas leaks to operating room.

Step 1 ：
A wide slot at the left side of anesthesia
machine specially designed for putting AGSS;
put AGSS to U-bracket.

Fig.4-25
Step 2 ：
Hold AGSS with both hands ensuring the fixity
faces the wide slot. Slide AGSS horizontally to
rail till its limiting position.

Fig.4-26

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Step 3 ：
Connect the two ends of screw thread to
port beneath breathing system and
AGSS respectively.

Fig.4-27
Step 4 ：
Connect exhaust pipeline to exhaust port of
AGSS, screw it clockwise tightly.

Fig.4-28

4.2. Pre-operative Test

WARNING：For a full understanding of the performance characteristics of this equipment, the user

should carefully read this manual before operating：

• All system connections.

• All WARNINGs and CAUTIONs.

• How to use the machine. • How to test the machine.

WARNING：Do the following things before operating HEYER Pasithec:

• Finish all the tests listed in Pre-use Preparation.

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• Test other systematic parts.

WARNING：Do not use the machine if any test failures. Contacts authorized service representative

for maintaining the machine.

4.2.1. Test before Operation

Pre-use test should be performed under the following circumstances:

• Every day before used on the first patient.

• Before used on every patient.

• After maintenance or service.

4.2.1.1. System Check

WARNING：Make sure that the breathing system is in good connection and with no damage.

Make sure the anesthesia machine has no damage.

1. Make sure all parts are correctly connected.

2. Make sure the breathing system is correctly connected and has no damage; the absorber canister
is fully filled with soda lime.

3. Make sure the vaporizer is well locked and is filled with adequate anesthetic agent.

4. Make sure the pipeline gas supply system is correctly connected and is at proper pressure.

5. Make sure backup equipments are available and functioning.

6. Make sure anesthetic agent and emergent medicine are available.

7. Make sure the castors are not loose and the forefront two castors are locked.

8. Make sure the anesthesia machine is connected to power socket and power indicator is light.
There is no power supply if power indicator does not light.

4.2.1.2. Power Failure Alarm Test

1. Turn on power switch; user interface is light, STANDBY interface displays after self-test is finished.

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2. After the anesthesia machine operates under STANDBY mode for five minutes, pull out power cord

3. Make sure power failure alarm occurs (alarm bell sounds or user interface displays POWER
FAILUREURE message).

4. Reconnect power cord.

5. Make sure alarm is eliminated.

4.2.2. Pipeline Gas Supply Test

CAUTION：Operator should make sure gas supplies are correctly connected during operation，

there is no leak，wrong connection and damage in breathing circuit。 If something abnormal occurs，

check the connection.

WARNING: The malfunction of the center gas supply system may cause one or even all connection

equipment connected with it stopping work.

1. Cut off pipeline gas supply. Perform the following steps if pipeline gauge does not read zero：

2. Connect O2 supply.
3. Set flow to the middle level.

4. Make sure N2O cylinder gauge reading restores to zero.

5. Cut off O2 supply.

6. Make sure O2 cylinder gauge reading restores to zero. Low gas source alarm occurs when O 2
pressure is decreasing.

4.2.3. Vaporizer Test

CAUTION：For information of vaporizer’s function test, refer to Vaporizer User Manual

• Make sure the vaporizer is steadily installed.

• Make sure the vaporizer is locked.

• Make sure only one vaporizer can be open at a time.

• Make sure the vaporizer is filled with adequate anesthetic agent.

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4.2.4. Alarm Test

1. Connect a test lung to Y-piece.

2. Turn on power switch.

3. Set the following items:

Ventilation Mode IPPV

Ventilator Vt：700mL
Freq.：20
I:E：1:2
PAW-High：40cmH2O
Anesthesia Machine All gas flow：OFF
Push O2 flush to inflate bellows.
4. Make sure：

• Initiate mechanical ventilation.

• No low gas source pressure alarm occurs.

• Ventilator displays correct values.

• Bellows moves up and down during mechanical ventilation.

5. Set O2 flow at 5L/min.

6. Make sure：

• End respiratory pressure is approximately between 2cmH2O to 3cmH2O.

• Ventilator displays correct values.

• Bellows moves up and down during mechanical ventilation.

7. Test O2 monitoring and alarm：

• Disassemble O2 sensor, make sure that O2 takes up 21% of room air according to the test result.

• Set low O2 alarm to 50%, make sure low O2 alarm occurs.

• Set low O2 alarm to 21%, make sure low O2 alarm is eliminated.

• Assemble O2 sensor in breathing system.

• Set high O2 alarm to 50%.

• Push O2 flush button to inflate bellows.

• Make sure high O2 alarm is initiated.

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• Set high O2 alarm to 100%, make sure high O2 alarm is eliminated.

• Put O2 sensor in pure oxygen; make sure that O2 takes up 100% according to the test result.

8. Test low minute volume alarm：

• Return to alarm menu.

• Set low minute volume alarm limit to 16.0L/min.

• Make sure low minute volume alarm occurs.

• Return to alarm menu.

• Set low minute volume alarm limit to 10.0L/min, make sure low minute volume alarm is
eliminated.

9. Test high PAW alarm：

• Set high PAW below peak PAW.

• Make sure high PAW alarm occurs.

• Set high PAW alarm to 40cmH2O.

10. Test low PAW alarm：

• Disconnect test lung form breathing system.

• Other alarms occur, such as low minute volume alarm.

• Make sure low PAW alarm occurs.

11. Test continuous PAW alarm：

• Set control items：

APL valve： Adjust to the maximum value

Ventilation Mode： Manual

• Mechanical ventilation stops when the machine operates at Manual ventilation mode.

• Block patient end and push O2 flush button.

• Make sure continuous PAW alarm occurs when continuous pressure is at 10cmH2O for 15
seconds.

12. Turn off power switch.

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5. Operating guide

5.1. Opening

WARNING: Make sure the assembly of patient breathing tube and controlling setting is correct

before ventilating.

1. Plug the power cord to an electrical outlet.

2. Connect the pipeline gas resource or cylinder gas resource (open the cylinder valve).
3. Close O2, N2O, Air flow meter and the auxiliary O2 flow meter.
4. Turn the switch to “ON”.

The user interface is lighted

entering into the system self-test
interface.

Fig.5-1

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5.2. System Self–test

Enter into the system self-test

interface after opening.

Fig.5-2
After the system self-test:
1) Select and confirm “Continue”, the
Automatic Test begins.

Fig.5-3
2) Select and confirm “Skip”, the
“Manual Test” interface appears.

Fig.5-4

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5.3. Automatic Leak Test

After System Self Test , the

automatic Test begins.
Follow instructions on the user
interface.
1) Select “Continue” to perform
Automatic Test.
2) Select “Skip” to proceed to
Manual Test.

Fig.5-5
Select “Continue”, the system
enter into the Automatic Test
interface.
“Automatic Test … ” appears in the
user interface.

Fig.5-6

These situations may appear during the automatic test,

If these situations appear, please:

1. Do according to the prompt message on the user interface.

2. Select “Continue” and press the knob ,the system begins to re-test,
The interface displays shown as above picture.

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1. If the E-flowmeter isn’t closed,

the message “Please close the
flowmeter” appears on the user
interface.

1) Select “Continue” to perform

Automatic Test again.
2) Select “Skip” to proceed to
Manual Test.

Fig.5-7
2. If the bellows is not full, the
message “Push “O 2+ ” flush to
completely fill the Bellows”
appears on the user interface.
1) Select “Continue” to perform
Manual Test again.
2) Select “Skip” to proceed to
Manual Test.

Fig.5-8

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Automatic Test results

1. Automatic Test failed

If the pressure sensor (Ambient

pressure sensor and Airway
pressure sensor) is disabled, the
automatic test will fail and the prompt
message will appear on the user
interface.

In the situation, only the manual

ventilation is available.

Select “Manual” to enter into Standby

screen. Fig.5-9
2. Automatic Test failed

If the safety valve in the gas module

is disabled the automatic test will
fail, and the interface as the picture
on the right appears.

Select “Continue” to perform Manual

Test, the automatic ventilation is
disabled.

Fig.5-10

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3. Automatic Test failed

If the pressure rises during automatic

test, the test will fail and the interface
as the picture on the right appears.

Select “Retry” to do the

Automatic Test again.
Select “Skip” to proceed to Manual
Test, the automatic ventilation is
disabled.
Fig.5-11

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4. If the leakage is more than

400 ml/min, the interface shows as
the picture on the right.

1) Select “Retry” to perform the

Automatic Test again.
2) Select “Skip” to proceed to the
Manual Test, the automatic
ventilation is disabled.

Fig.5-12
5. If the leakage is at the range of
100 — 400 ml/min, the interface
shows as the picture on the right.

1) Select “Retry” to perform the

Automatic Test again.
2) Select “Skip” to proceed to the
Manual Test, the automatic
ventilation is disabled.

Fig.5-13
6. If the safety valve is valid and
the leakage is less than
100 ml/min, the automatic test is
passed and then the system
proceeds to the Manual Test.

Fig.5-14

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5.4. Manual Test

1. If the automatic test is not done
before performing the manual test,
the user interface of manual test
will display as the picture on the
right.

Follow the instructions on the user

interface.

Select “Skip” , the system will enter

into normal interface.
Fig.5-15
2. If system enters into the Manual
Test when partial automatic test is
done, the user interface will display
as the picture on the right.

Press “ O 2+ ” button according to the

instructions on the user interface
during 60s.

Select “Skip”, the system will enter

into normal interface.
Fig.5-16

Manual test results

1. If the PAW gauge value is bellow 20
cmH2O, the interface will display as
the picture on the right.

During the 60s count time proceed the

procedure according to the instructions
on the user interface.

Select “Skip”, the system will enter into

Standby interface.

Fig.5-17

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2. If the manual test fails for three

times, the interface displays as the
picture on the right.

Select “Skip”, the system will enter into

Standby interface.

Fig.5-18
3. If the Y-piece port and manual bag
arm connector are not occluded, the
interface after test is shown as the
picture on the right.

During the 60s count time proceed the

procedures according to the
instructions on the user interface. Or
the system will enter into Standby
interface automatically after 60s.

Select “Skip”, the system will enter into

Standby interface. Fig.5-19

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4. There is no operation of pushing

“O 2+ ” to fulfill the bellows during the
first 60s count time after manual test
interface appears, the interface on
the right follows.

Select “ Skip ” , the system will enter

into Standby interface.

Fig.5-20
5. If no operation is done during the
first two 60s count down after the
Manual test interface appears, the
interface displays shown as the
picture on the right.

Select “ Skip ” , the system will enter

into Standby interface.

Fig.5-21
6.Manual test success
If the manual test succeeds , the
interface displays as shown on the
right.
The system will enter into Standby
mode automatically after 5s count
time.

Fig.5-22

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5.5. Patient type setting

The patient type of the HEYER Pasithec anesthesia system has 2 type options: Child and Adult. The user
can select the needed.

CAUTION : Adult is the default patient type after starting system.

CAUTION : The changing of the patient type is only allowed in STANDBY mode

Adult is the default patient type after

starting system.

Fig.5-23
Press the knob to select the patient
type button in the bottom, left corner
of the screen. This button will show
yellow when selected.

Fig.5-24

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Turn the knob to change the patient

type to “Child”.

Fig.5-25

Press the knob to confirm the setting.

Fig.5-26

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5.6. Ventilation mode setting

5.6.1. Ventilation mode introduction

The system has five mechanical ventilation modes:

 Manual: Manual ventilation

 IPPV: Intermittent Positive Pressure Ventilation

 PCV: Pressure Controlled Ventilation

 SIMV: Synchronized Intermittent Mandatory Ventilation

 PS: Pressure Support Ventilation

In addition, Standby mode is available. In Standby mode, mechanical ventilation cannot be carried
out and there are no ventilation waveforms or monitoring values.

5.6.1.1. Manual Ventilation (Manual)

In Manual mode, ventilation can be carried out by manual operation; there are ventilation waveforms
and monitoring values at present.

5.6.1.2. Intermittent Positive Pressure Ventilation (IPPV)

All the breathings are provided by the anesthesia machine, the patient cannot switch them by self.
The ventilation is managed by the predetermined ventilation volume, breathing frequency and ratio
of inspiratory time to expiratory time to keep the tidal volume stable, thereby assure the stable MV.

Method: time switch and pressure switch.

IPPV mode setup parameters:

• Tidal volume (VT): 20-300mL (child), 20-1500mL(adult);

• Breathing frequency (Freq): 4-100bpm;

• Breathing ratio (I: E): 4:1-1:8;

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• Inspiratory pause time (TP): OFF, 5-60%;

• Maximum pressure (Pmax): 10-70cmH2O;

• Positive End-Expiratory Pressure (PEEP): OFF, 3-30cmH2O.

Fig.5-27 Waveform of IPPV

5.6.1.3. Pressure control ventilation (PCV)

Ventilation is managed according to a set goal pressure. Ventilation capacity (and velocity) is changed
accordingly, and related to respiratory system compliance and airway resistance. Tidal volume
changes with pulmonary compliance and airway resistance. Flow is slow-moving wave. Pulmonary
alveoli are full at the beginning of inspiratory which is helpful for the gas exchange in the lung.

PCV mode setup parameters: PTARGET, Freq, I: E, TSLOPE, PEEP.

• Pressure control level (PTARGET): 5-70cmH2O;

• Breathing frequency (Freq): 4-100bpm;

• Breathing ratio (I: E): 4:1-1:8;

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• Pressure rising slope time (TSLOPE): 0-2s;

• Positive End-Expiratory Pressure (PEEP): OFF, 3-30cmH2O.

Fig.5-28 Waveform of PCV

5.6.1.4. Synchronized Intermittent Mandatory Ventilation (SIMV)

SIMV is a ventilation mode which combines spontaneous breathing with control ventilation. Within
the trigger window, the patient can trigger the command positive pressure ventilation synchronizing
with the spontaneous breathing. Between the two command ventilation cycle, the patient is allowed
to breath spontaneously. The command breathing follows the presets volume. By setting frequency

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and tidal volume to assure the minimum MV, cooperating with the patient’s spontaneous breathing to
reduce the rivalry between patient and machine and negative effect of blood dynamics, and prevents
the potential syndrome, such as air pressure injury and so on.

By changing the presets frequency to change the breathing support level, in other words, from entire
support to partial support, the machine can be used for long-term patient to retreat from machine.

The Setup Parameters of SIMV Mode:

• Tidal volume (VT): 20-300mL(child), 20-1500mL(adult);

• Breathing frequency (Freq): 4-100bpm;

• Inspiratory Time (TINSP): 0.2-5s;

• Inspiratory pause time (TP): OFF, 5-60%;

• Positive End-Expiratory Pressure (PEEP): 3-30cmH2O.

• Flow Trigger (Trigger): 1-15L/min;

• Differential Pressure (△P): 3-50cmH2O;

• Inspiratory Slope Time (TSLOPE): 0-2s;

• Maximum pressure (PMAX): 10-70cmH2O.

Fig.5-29 Waveform of SIMV

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5.6.1.5. Pressure support ventilation (PS)

PS belongs to a partial ventilation support model, and is an auxiliary mechanical ventilation mode for
patient trigger, pressure goal and flow switch. Patient triggers ventilation and control respiratory
frequency and tidal volume. When airway pressure reaches default pressure support level and inhale
velocity reduces to the level lower than threshold, inhale phase switches to exhale phase. For
appropriate setup level, there will be few human-machine confrontation, it will effectively reduce
work of breathing and increase the effectiveness of effort to breathe. Some studies believe that 5-8
cmH2O PS can overcome the resistance of endotracheal tube and breathing machine circuit, so PS can
be used for machine withdrawal process. PS tidal volume is determined by breathing system
compliance and resistance.

PS ventilation mode setup parameters: △P, FreqMIN, Trigger, PEEP, TSLOPE.

• Differential Pressure (:△ 3-50cmHP) 2O;

• Minimum frequency (FreqMIN): 2-60cmH2O;

• Triggering sensitivity (Trigger): 1-15L/min;

• Positive End-Expiratory Pressure (PEEP): OFF, 3-30cmH2O; • Inspiratory Slope Time (TSLOPE): 0-2s.

Fig.5-30 Waveform of PS

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5.6.1.6. Pressure control ventilation with Volume Guaranteed (PCV-VG) ----Optional

In PCV-VG, breaths are controlled by the anesthesia machine (mandatory) and will be delivered at a
set rate and set volume (VT). Inspiratory pressure will be regulated to achieve the operator set volume
(Tidal Volume). The pressure range that the anesthesia machine will use is between the PEEP + 2
cmH2O level on the low end and 5 cmH2O below Pmax on the high end. The inspiratory pressure
change between breaths is a maximum of +/- 3 cmH2O. PCV-VG begins by first delivering a volume
breath at the set tidal volume. The patient’s compliance is determined from this volume breath and
the inspiratory pressure level is then established for the next PCV-VG breath. Inspiratory pressure
from the last 3 breaths will be averaged to determine the pressure needed to maintain the set tidal
volume. Breath to breath inspiratory pressure change will be in increments of 3 cmH2O up to PMAX - 5
cmH2O. When PMAX is reached the pressure is maintained at the PMAX value until the end of inhalation.
The inspiratory and expiratory valves will adjust to maintain the PMAX value. When PMAX is reached, the
next breath cycle will be normal PCV-VG control and should not maintain PMAX.

PCV-VG ventilation mode setup parameters:

• Tidal volume (VT): 20-300mL (child), 20-1500mL (adult);

• Breathing frequency (Freq): 4-100bpm;

• Breathing ratio (I: E): 4:1-1:8;

• Positive End-Expiratory Pressure (PEEP): OFF, 3-30cmH2O;

• Inspiratory Slope Time (TSLOPE): 0-2s;

• Maximum pressure (Pmax): 10-70cmH2O.

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Fig.5-31 Waveform of PCV-VG

5.6.1.7. Synchronous intermittent mandatory ventilation with Pressure Control (SIMV-PC) ----
Optional

In SIMV - PC breaths will be controlled by the anesthesia machine (mandatory) or triggered by the
patient (spontaneous). When controlled by the anesthesia machine, breaths will be pressure limited
and time cycled, resulting in an operator set pressure (PTARGET) being delivered for an operator set
period (TINSP). The anesthesia machine delivers the mandatory breath in synchrony with the patient’s
inspiratory effort. If no inspiratory effort is detected, the anesthesia machine will deliver a
mandatory breath at the scheduled time. Mandatory breaths will be PCV-type breaths with
decelerating flow waveform. Between mandatory breaths the patient will be able to breathe
spontaneously. These breaths can be pressure supported. When PMAX is reached the pressure is
maintained at the PMAX value until the end of inhalation. The inspiratory and expiratory valves should
adjust to maintain the PMAX value. SIMV-PC mode setup parameters:

• Target Pressure (PTARGET): 5-70cmH2O;

• Breathing frequency (Freq): 2-100bpm;

• Inspiratory Time (TINSP): 0.2-5s;

• Positive End-Expiratory Pressure (PEEP): OFF, 3-30cmH2O;

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• Flow Trigger (Trigger): 1-15L/min;

• Differential Pressure (△P): 3-50cmH2O; • Inspiratory Slope Time (TSLOPE): 0-2s.

Fig.5-32 Waveform of SIMV-PC

5.6.2. Ventilation mode setting

The user can select the ventilation mode according to the patient’s actual situation.
The ventilation mode menus locate on
the left corner of screen. Click on the
ventilation menu to select the
corresponding ventilation mode.

Fig.5-31

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If you wish to choose PS mode, click the PS mode

button. The button will display as highlighted yellow
when selected.

Fig.5-32
Click the PS button again to confirm
your selection.

Fig.5-33

5.6.3. Mode parameter setting

If the patient type and ventilation mode have been selected, the system will display default parameters
according to the ventilation mode. The user could set the needed breathing parameter.
ΔP of PS mode is used below as an example of how this is done. These instructions also apply for other modes
and parameters.

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Turn the knob to select the parameter setting you

wish to adjust. The selected parameter setting
button displays with a yellow glow around it.

Fig.5-34
Press the knob to enable the
adjustment of the parameter setting.
The button will be highlighted yellow
when adjustment is allowed.
.

Fig.5-35

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Turn the knob to adjust the parameter

setting.

Fig.5-36

Press the knob and to confirm the setting.

Fig.5-37

5.7. Menu screens

CAUTION: The menu window covers the second and third waveform.

CAUTION: When selected, a short cut key will display the selected menu. When Normal is
selected all menus will be removed.

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Menu screens are used to access most

functions in the anesthesia machine. All
menus, except for the Normal menu,
open in specific menu windows. Each
menu opens or closes by touching the
screen or rotating the knob. Value
selection in the menu is accomplished
by touching the screen, rotating the
navigator knob and pressing the
navigator knob to confirm selection.
Fig.5-38

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5.7.1. Menu operating logic

1. Open / close current menu by pressing the corresponding touch key.

2. An open menu can also be closed by clicking on the "X" key or “Normal" key.
3. Press the "Alarm" key to open / close the alarm setting menu. Press once to open, and press
again to close.
4. When the mode is in "pre-selection" status, closing or switching to another menu will close pre-
selection state.
5. If parameters are being set and not confirmed, the unconfirmed set values will be lost and the
original set values will be restored if the user closes the current menu or switches to another
menu.
5.7.2. Alarm setting

The alarm settings can be opened by touching the Alarm shortcut key. The alarm setting menu includes
four sub-options: Vent, Gas, Agent, and Log. The default alarm sub-option on start-up is
Vent Alarm limits.

Vent:

At the left side of the vent menu,

there is a patient type icon, which
can be either adult or child, and will
match the patient icon at the top of
the interface.

In the middle of the vent menu, the Fig.5-39 low and high alarm limits of MV, Pressure, and FreqMIN
can be set.

At the right side of the vent menu, the

alarm volume can be adjusted.

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Gas:

The low and high alarm limits

of FiO2, etCO2, and FiCO2
can be set.

Fig.5-40

Agent:

Alarm limits for Sevoflurane (SEV),

Desflurane (DES), Halothane (HAL),
Isoflurane (ISO), and Enflurane (ENF)
can be set.

Fig.5-41
Log:

There are two pages in the log

menu, one for alarm
messages and another for
alarm event messages.

Fig.5-42

Fig.5-43

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5.7.3. System setting

System setting menu includes three sub-menus: Display, Info and Setup. Display submenu is default

menu.

The display information on the

interface can be set in the display
menu.
Pressure: two options: Mean and Plat.
WAVE 2: three sections including
Flow, CO 2 and V T, which displays in
WAVE 2 area.

Fig.5-44
WAVE 3: three options: Flow, CO2 and VT, which displays in WAVE 3 area. Touch Sound: two options:
ON and OFF.
CO 2 UNIT: two options: % or mmHg.
The View Info. includes the follow
items.

Run Time: view machine power times,

total run time and last run time.

Gas Module: view the module type, the

software version, the hardware version
and S/N.
Fig.5-45
RT Sens Mon: the real-time monitoring value of the inspiratory valve flow sensor, the expiratory flow
sensor, the airway pressure sensor, the ambient pressure sensor, the oxygen sensor, the oxygen
supply pressure sensor, the air supply pressure sensor, the breathing system temperature sensor,
and the chassis temperature sensor.

EFM RT Sens Mon: view the real-time monitoring value of the oxygen flow meter sensor, the N2O flow
meter sensor, the air flow meter sensor, and the pressure sensor.

RT Vent Mon: view the real-time monitoring value of the inspiratory volume, the expiratory volume,
the system resistant, the system compliance, and the tube compliance.

SW Versions: the version of GUI, BDU, SBD, PSU, KBD, and EFM.

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HW Versions: the version of MCB, ADB, BCB, SBD, APB, GSPB_O2, GSPB_AIR, KBD, ISB, and EFMB.

The Setup sub-menu includes the

follow items.

Language: three sections, including,

English and Chinese.

Demo: two sections, including OFF

and ON.

Fig.5-46 Data: three sections, including MM/DD/YYYY, DD/MM/YYYY and YYYY/MM/DD.

Time: two sections, 12 hour or 24 hour format.

O2 Sensor: two sections, including Enabled and Disabled.

Gas Module: two sections, including Enabled and Disabled.

5.7.4. Calibration

The Calibration sub-menu includes a User viewable item and Service only items. The user calibratable
item is the oxygen sensor.

6.4.4.1 Oxygen sensor calibration

CAUTION: Remove the oxygen sensor from the breathing system and expose the sensor to room air

for at least three minutes before proceeding.

Note: A plug is provided on a chain attached to the side of the breathing system for plugging the O2

sensor port on the inspiratory valve during this operation.

CAUTION: The alarm “O2 Cal Due” will be displayed when the oxygen sensor has not been calibrated

for over 72 hours.

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The oxygen sensor calibration calibrates

the oxygen sensor at 21% oxygen
concentration.

If the oxygen sensor is not connected,

the interface will display “Oxygen
sensor is not connected”.

Select “Start” to calibrate. Fig.5-47

Remove the oxygen sensor from the
breathing system and expose the
sensor to room air for at least three
minutes before proceeding.

Select “Start” to proceed.

Fig.5-48
When the calibration is successful, the
interface will display “Calibration
Successful” and the running bar will be
completely green.

On the calibration interface, there is a

voltage value (300~360mV). After
calibration, if the voltage value is lower
than 300mV, then the sensor should be
replaced; if the voltage value is higher
than 360mV, repeat calibration a second
time.

Fig.5-49

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If the calibration fails, the interface will

display “Calibration Failed” and the bar
will be completely red.

To perform the calibration again, press

the “Repeat” button.

Fig.5-50

5.7.5. Trend

When the trend shortcut is selected, the trend data can be viewed. The machine will record the last 8
hours of trend data at intervals of 30 seconds.

The trend time will appear on the left side of the menu, and the trend data will appear on the right
side of the menu, including Ppeak, Pplat, Pmean, PEEP, Freq, Vt, MV, FiO2, etCO2, FiCO2, Agent1,
Agent2, N2O, MAC, FG-O2, FG-AIR and FG-N2O.

The first page includes data from 10

parameters, as shown in Figure.

Fig.5-51
The next page includes data from 7
parameters, as shown in Figure.

Fig.5-52

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5.7.6. Check

In standby mode, when the “Check” button is selected, the system test will be performed including Leak
test and Compliance Test.

CAUTION: Check can only be performed in standby mode. Leak Test

After the “Check” button is selected,

the interface is as shown in the
figure on the right.
Follow instructions on screen to
perform test

CAUTION : Leak Test can only

be performed in standby mode.

Fig.5-53

Select “Start” to perform Leak Test

after completing the procedures on
the screen.

Fig.5-54
If the Leak Test is success, the
interface is shown as the picture on
the right.
Select “Finish” to perform
Compliance Leak

Fig.5-55

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If the Leak Test fails, the interface is

shown as the picture on the right.
Select “Repeat” to perform the Leak
Test again.
Select “Return” to enter into normal
interface.

Fig.5-56

Compliance Test

Select “Compliance Test” sub-menu, if

the interface shown as the picture on
the right, select the “Leak Test” sub-
menu to perform leak test. Select
“Return” to enter into normal
interface.

NOTE: Perform the Leak Test prior to

the Compliance Test when starting the
system test.
Fig.5-57
If the Leak Test is performed first, the
interface as the picture shown on the
right appears after selecting
Compliance Test sub-menu.

Follow instructions on screen to

perform test

Fig.5-58

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Select “Start” to perform Compliance

Test after completing the procedures
on the screen.

Fig.5-59
If the Compliance Test is success,
the interface is shown as the picture
on the right.
Select “Return” to finish the test.

Fig.5-60

If the Compliance Test fails, the

interface is shown as the picture on
the right.
Select “Repeat” to perform the Leak
Test again.
Select “Return” to enter into normal
interface.

Fig.5-61

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5.7.7. Configuration

CAUTION: Configuration button is effective only in standby mode.

When the “Configuration” button is
selected, the interface is as shown in
the figure on the right, including Vent
Defaults, Alarm Defaults and Service
mode.

Vent Defaults and Alarm Defaults are for

super user.

Service Mode is for service represent.

Fig.5-62
Enter the right password and click on “
”, the interface shown as the
picture on the right.

If enter wrong password, click on “ ”

to clear the entered number.

There are four ventilation modes in the

“Vent Defaults” tab, including IPPV,
PCV, SIMV and PS.
Fig.5-63
Select one ventilation mode, the
interface shown as the picture on the
right appears.
There are two sections in the menu,
one for adult and one for child. The
user can configure the default
parameters for each ventilation mode.
Settings entered will be used as the
default settings after unit power up.
"Load Factory Settings" button when
pressed , will change the default settings Fig.5-64
to the factory defaults

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Select the Alarm Defaults sub-menu,

the interface shown as the picture on
the right appears.

Fig.5-65
Enter the right password and click on “
”, the interface shown as the picture
on the right appears

If enter wrong password, click on “ ”

to clear the entered number.

There are four alarm limits in the

“Alarm
Defaults” tab, including Adult Vent
Alarm Limits, Child Vent Alarm Limits,
Gas Alarm Limits and Agent Alarm Limits.

Settings entered will be used as the default

settings after unit power up. "Load Factory
Settings" button when pressed, will change
the default settings to the factory defaults.

Fig.5-66

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“Service mode” tab is reserved for

service only.

Fig.5-67

5.8. Shutdown

The shutdown of the anesthesia system is as follows:

 Set the vaporizers to OFF;

 Turn OFF the gas supplies, until the gas in the system has gone out completely;

 Set all E-flowmeter settings to OFF;

 Set the auxiliary flowmeter to OFF;

 Turn the power switch to OFF to shut down the anesthesia system.

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6. Alarm and troubleshooting

WARNING: Person without maintaining experience mustn’t mend the machine.

CAUTION: If alarm occurs, the patient’s safety must be protected firstly, then do troubleshooting

or necessary remedy.

CAUTION: Alarm presets will change with patient type automatically.

CAUTION: When several alarms occur at the same time, alarm message only displays the front two

in a sequence of “High” to “Low”.

CAUTION: When alarm silencing, the alarm bell has dashed “X” on itself. After 120s, the
alarm bell renews to the old state; If the alarm is not dealt in time, alarm continues.

CAUTION: If alarm occurs when the anesthetic machine works normally, visible and audible signals

will delay a certain time.

WARNING: Do not set alarm limit exceeding the extremes, otherwise, alarm system will failure.

WARNING: A potential hazard can exist if different alarm presets are used for the same or similar
equipment in any single area, such as ICU or cardio tic operating room.

WARNING: The operator should examine if the current alarm setting is suitable for every patient.

WARNING: When power supply is interrupted, system will still renew the last alarm settings when

opening again.

6.1. Brief introduction of alarm message

The alarm states have 3 priorities: high, medium, low. High alarm needs to be dealt in time.

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The sound pressure level of alarm signal is no less than 60dB.

The operator can judge if the alarm system is functional by visible and audible alarm message. The
distance that the operator can hear the alarm sound or distinguish the priority of alarm is 4 meters at
least. And the distance to see the alarm message is not less than 1 meter at the front of the machine.

The top area of the user interface displays alarm message, see figure 6-1.

Table 6-1 Alarm message

Table 6-1
Priority Definition Alarm Tone Mute Notice Message

High Death or 10 alarm tones 120s Red background,”!!!”flickering,

including 2 hurry, displaying frequency is 2Hz.
irreversible
alarm cycle is 8s.
injury.

Medium Reversible injury. 3 alarm tones, alarm 120s Yellow background,”!!” flickering,
cycle is 10s. displaying frequency is 0.5Hz.

Low Slight injury or 2 alarm tones, no --- Yellow background,”!” flickering,

uncomfortable. repeat. long-term display.

6.2. Alarm message

The alarm method includes technical alarm and functional alarm; technical alarm includes startup test
list and alarm occurring during normal operation.

6.2.1. Alarm default value and setting range

High Low Setting range of high limit Setting range of
low limit
MV（Adult） 12 1 1～25 0～20
MV（Child） 6 1
PAW（Adult） 50 10 10～80 0～70

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PAW（Child） 40 8
Freq（Adult） 18 --- 8～60 ---
Freq（Child） 30 ---
FiO2 100% 18% 21%～100% 18%～99%
Hal. 1.5 OFF 0.1%～8.4% OFF,0.1%～8.3%
Iso. 2.3 OFF 0.1%～8.4% OFF,
0.1%～8.3%
Enf. 3.4 OFF 0.1%～9.9% OFF,
0.1%～9.8%
Sev. 4.2 OFF 0.1%～9.9% OFF,
0.1%～9.8%
Des. 12.0 OFF 0.1%～21.9% OFF,
0.1%～21.8%
ETCO2 6.6% OFF 0.1%～9.9% OFF,
0.1%～9.8%
50mmHg OFF 1～75mmHg OFF,
1～74mmHg
INSCO2 0.7% --- ---
0.1～1.4%
5mmHg --- 1～10 ---
Other default items：

Manual Mode: Enabled

Alarm Volume: 2 tones

Patient type： Adult

Pressure：PLAT

6.2.2. Technical alarm message table

Table 6-2
Alarm Name Priority Cause Remedy

Low gas supply High Drive gas pressure is less Check pipeline gas supply and
pressure than 2.9psi±15% replace pipeline.

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AC power Low AC power failure alarm when Check connection, AC power

failure AC power supply supply and fuse;
failure
Replace fuse when it is melt.

Low Medium No AC power and the Connect AC power supply

battery battery voltage lower than
immediately;
capacity 22V.
When the alarm appears, the
battery capacity can last 10
minutes.

Switch to the manual mode,

backup battery begins to supply
power and assure battery
capacity is full.

O2 sensor High Monitor O2 concentration Use exterior measurement

system or replace O2 sensor.
failure ＜ 10%,the alarm occurs
immediately.

Monitor O2

concentration≥10%,
cancel the alarm
immediately.

When O2 sensor in the

system setting menu is
configured “Disable”, no
alarm occurs.

Alarm Name Priority Cause Remedy

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BDU communication High GUI receives and sends data Ventilator failure.
from BDU unit failure lasts
failure
for 2s Switch to manual mode and the
user interface is still available.
User interface switches to
STANDBY mode automatically.

Call service Rep.

EFM communication High GUI receives and sends data Switch to the manual mode
from EFM unit failure lasts
failure for 2s Call service Rep

Communication High Communication between Switch to manual mode and call

BDU and power supply board service Rep.
between BDU and
is abnormal.
power supply
board
failure

Gas module High When gas module

communication is
communication
abnormal, if the cable is
failure interrupted, this abnormal
state will last 5s.

Gas module High Pull out adapter probe in Call service Rep.
probe failure gas module for several
seconds.

CAUTION: If the gas

module communication
failures or interior error in
gas module, the alarm
message will not occur.

Alarm Name Priority Cause Remedy

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Interior error in gas High Any case of software, Call service Rep.
module hardware, electric
“rotational speed“ exceeds
limit, no factory calibration
or factory calibration failure
appears, the alarm will
occur.

CAUTION: If the gas

module
communication
failures, the alarm
message will not occur.
Gas module High When any parameter of the Call service Rep.
monitor detected CO2,N2O, O2 ，
concentration
anesthetic gas exceeds
exceed limit
limit, the alarm message
appears.

CAUTION: If the gas

module communication
failures or interior error in
gas module or gas module
probe is disabling, the alarm
message will not appear.

Keyboard High No communication Switch to manual mode, Call

service Rep.
communication between UI and keyboard
failure

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6.2.3. Functional alarm message

Table 6-3

Alarm Name
Priority Condition Solution Remedy

1. In MANUAL mode, airway

pressure>10cmH2O, and 1. Use manual
last more than 15s,this ventilation.
alarm occurs;
2. 2.Check patient’s
In other mode, airway
expiratory passage
Continuos high pressure>PEEPsetting After alarm
airway High values, and last more than occurs, if the
pressure alarm
15s,this alarm lasts at least for
8s
3. occurs; call service Rep
In STANDBY mode, this
4. alarm will not appear;
In MANUAL mode, this alarm
will not be closed.
1.Switch to 1.Reset airway high
expiratory phase, alarm limit;
1. Airway Ppeak≥Ppeak; 2.Detect if
the timer
2. In STANDBY mode, this expiratory passage
High airway 2. Alarm message is blocked or not;
High alarm will not appear;
pressure lasts for 8s after
3. In MANUAL mode, this 3. If Vt setting is
alarm condition too big;
alarm could be closed. disappears. 4.If the patient’
airway is blocked.
1. Airway pressure≤SW883 -
2cmH2O and lasts for
Do not block
Negative more than 4s.
High SUCTION exhaust
pressure In MANUAL mode, this
port
alarm, this alarm will not
be closed.

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1. Monitor tidal volume

<10ml,or
2. Monitor average
pressure<1cmH2O, in
MANUAL mode, it is not
APNEA High Alarm occurs.
determined, or
3. Monitor average pressure
equals to 1cmH2O, and
monitor PEEP≤0cmH2O, in
MANUAL mode, it is not
determined.
1. In MANUAL mode, airway
pressure is lower than
pressure alarm low
limit>30s;
2. In other mode,Freq≥4;
airway pressure is lower
Low airway 1. Ventilator
Medium than alarm low Reset airway low
pressure works normal.
limit>15s,Freq<4,airway alarm limit
pressure is lower than
pressure alarm low
limit>30s;
3. In STANDBY mode, this
alarm will not appear.
APNEA backup
ventilatio n SW425.2 in PS mode,
Medium Alarm occurs.
FreqMIN trigger ventilator.

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1.Reduce alarm
setting;
2.Reduce air or
N2O
compensation

1. Alarm occurs. ； value;

Low FiO2 High 1. FiO2≤Low FiO2 setting 2.Ventilator 3.Recalibrate O2
works as normal. sensor;
4.O2 battery is
exhausted;
5. Call service
Rep.

1. Measured FiO2 value ≥

setting 1.Alarm occurs.；
When O2 sensor 1.Increase FiO2
High
Medium configuration in the 2.Ventilator and alarm setting
FiO2 system menu is works normal.
“Disabled”, this alarm will
not appear.

1. MV≥upper setting limit In 1. Alarm occurs 1.Increase high

MANUAL mode, this alarm MV
High MV Medium could be closed. 2.Ventilator works alarm limit;
normal.

1.Reduce MV
1.Alarm occurs.； alarm setting
1. MV≤lower alarm limit In
Low MV Medium MANUAL mode, this alarm
2.Ventilator 2.Check if there is
could be closed.
works normal leak in patient end.

1. MV≥High Freq setting 1.Alarm occurs.；

2. The patient has 2.Ventilator works 1.Check patient’s
High state and if there is
Medium spontaneous breathing. normal.(effective
Freq spontaneous
3. This alarm only applied to PS in PS mode) breathing;
mode.
High
Expiratory CO2 concentration
ETCO2 concentr
High exceeds high limit and lasts at
ation
least 2 continual breathes

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Low
ETCO2 concentration is lower
ETCO2 concentr
High than low alarm limit and lasts
ation
at least 2 continual breaths.

High
INCO2 concentr Alarm according to detected real-
High
ation time data

Detected PEEP exceeds PEEP

this alarm does not
setting +5cmH2O for 2 breaths
High PEEP Medium High alarm occurs. occur in STANDBY
or 30s (choose the minimum and MANUAL mode.
one between the two).PEEP

Gas module
When gas module
communication Check connection
communication is abnormal, Alarm occurs.
failure or replace gas
High such as unconnected, and lasts Alarm occurs.
module
for 5s.

Several seconds after pulling up

Gas module adapter of gas module
Check or replace
probe High CAUTION: If the gas module Alarm occurs.
adapter
failure communication failures, this
message will not appear.

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6.2.4. Self-test alarm

Table 6-4

Alarm Name Probable Cause Remedy

BDU EEPROM data fail Incorrect calibration in EEPROM check Call service Rep.

EEPROM IC fail EEPROM cannot read/write Call service Rep.

PAW sensor fail The data of the pressure sensor is Call service Rep.
incorrect.

Ambient pressure sensor fail The data of the ambient pressure sensor Call service Rep.
is incorrect.

PEEP valve fail Incorrect PEEP valve data Call service Rep.

Inspiratory valve fail Incorrect monitor sensor ZERO state Call service Rep.

Vent/Manual fail Incorrect valve state Call service Rep.

Flow sensor fail Incorrect sensor data Call service Rep.

SW version fail BDU, GUI, KBD software version Call service Rep.
is not the same with the released one.

BDU Comm. fail If GUI cannot receive and send data from All breathing functions fail,
BDU unit for 0.5s. call service Rep.

KBD Comm. fail No communication between GUI and All breathing functions fail,
Keyboard. call service Rep.

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Inspiration valve fail Incorrect voltage value the The machine can continue
inspiratory valve feedbacks to work, but there is only
manual mode but
automatic mode, the
monitor function is
effective, call service Rep.

O2 supply fail The pressure of drive gas is lower Check if the pipeline
than 200kPa ± 15% . supply is normal, connect
the backup gas supply.

Alarm speaker fail Alarm speaker fails The ventilation machine

works as normal, the user
recedes or ignore, call
service Rep.

AC power fail AC power fails Check AC power supply,

check the fuse, replace it
when it is melt.

O2 sensor disconnect or fail O2 sensor fails or unconnected Replace O2 sensor or

connect O2 sensor; when
this alarm appears, the
setting of O2 sensor in the
system menu is disabled;
when there is no alarm, the
setting is Enabled.

EFM communication GUI receives and sends data from Switch to the manual mode
EFM unit failure lasts for 2s
fail Call service Rep

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6.3. Failure diagnosis

Table 6-5
No. Message Cause Remedy

1. O2 sensor The anesthetic gas 1. Use external gas measuring

failure measurement system has
system.
failed

2.Call service Rep.

2. APNEA 1. Breathing or ventilation has 1.Patient must immediately be

stopped
ventilated manually.

2.Check patient’s spontaneous

breathing ability.

3. Check ventilator settings.

4.Check fresh gas setting.

5. Check that everything is

connected.

6.Check hose system and tube.

3. Battery low The AC power failures and 1.Connect to main power.
the battery capacity of the
un-interruptible power 2.Check patient’s condition.
supply is almost exhausted(
﹤20%). 3.Prepare manual ventilation with
100% O2.

4. APL valve 1.The connection or setting 1.Check APL valve connection；

of APL valve is incorrect.
failures
2.Select STANDBY mode and
return to the old ventilation mode;

3. Check APL valve setting.

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5. High breathing 1. Breathing system is too 1.Check breathing system and

system high. breathing gas temperature;
temperature 2. Call service Rep.

No. Message Cause Remedy

6. Gas monitoring 1. Sample line is blocked or 1.Check sample line, water trap and
unconnected.
has no Y-piece filter.
sampling signal
2.Replace if necessary.

7. Breathing system 1.Incorrect connection of 1. Check tube, sample line and

leaks filter.
pipeline or line

8. Close AIR 1. Cylinder valve is open 1. Close cylinder valve to avoid

cylinder although central supply is unintentionally drawing gas from
available. the cylinder.

9. Close N2O 1. Cylinder valve is open 1. Close cylinder valve to avoid

cylinder although central supply is unintentionally drawing gas from
available. the cylinder.

10. Close O2 1. Cylinder valve is open 1. Close cylinder valve to avoid

cylinder although central supply is unintentionally drawing gas from
available. the cylinder.

11. CO2 sensor 1. CO2 gas measurement 1.Use external gas measuring
failure system has failed.
system.

2.Call service Rep.

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12. Continuous high 1. The breathing pressure 1.Check ventilation and/or

pressure exceeds the set limit for
spontaneous breathing of the
more than 15s.
patient.

2.Check breathing hoses, breathing

system, and gas scavenging system
for correct functionality.

3.Check alarm limit for correct

setting.

No. Message Cause Remedy

13. ET CO2 high 1. The end-expiratory CO2 1. Check ventilation.

concentration has exceeded
the high alarm limit for at
least two breaths.

14. EXP.flow sensor 1. Expiratory flow sensor has 1. Replace flow sensor.
failure failed.

15. Fresh gas flow too high 1.Total fresh gas flow is above 1. Reduce fresh gas flow;
19L/min.
2. Check vaporizer setting.

16. Fresh gas low or leak 1. Fresh gas setting too low; 1.Increase fresh gas flow;
2. Leak. 2. Repair leak.

17. Gas sensor 1.Complete gas measurement 1.Use external gas measuring
failure system fails.
system;
2. Call service Rep.

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18. High airway 1. Hifh alarm limit for the 1.Check hose system and tube;
pressure
airway pressure has been
2. Correct the ventilation settings.
exceeded;
2.Ventilation hose kinked;
3. Ventilation settings are not
correct.

19. Inaccurate fresh 1. Reduced accuracy of fresh 1.Reduce fresh gas flow for each
gas flow gas flow measurement.
gas to below 12L/min;

2. Check to take flow meter.

3. Call service Rep.

20. Inhaled CO2 1.Soda lime in circle system 1. Increase fresh gas flow;
high
exhausted;
2.Replace breathing system;
2.Leak or fault in breathing
system; 3.Adjust alarm limits if necessary;
4.Check ventilation settings;
3.High ventilation
5. Replace flow sensor.
frequencies;
4.Dead space ventilation.

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21. Inspiratory flow 1. Inspiratory flow sensor is 1. Replace flow sensor.

sensor failure faulty.

22. Inhaled N2O 1. Inhaled N2O concentration 1. Check N2O concentration in the
concentration exceeds the high alarm limit fresh gas flow.
high of 82%.

23. Inhaled O2 1. Inhaled O2 concentration 1. Check O2 concentration in the

concentration exceeds the high alarm limit.
fresh gas flow.
high

24. Inhaled O2 1. Inhaled O2 concentration is 1. Check O2 concentration and

concentration below the low alarm limit.
fresh gas setting.
low

2.Check O2 supply;

3.Check breathing system and

breathing bag.

25. No air supply 1.Comm pressed air supply 1.Open optional backup air
has failed; supply;

2. Pipeline supply hose not 2.Check connection to piped

connected or kinked. medical air supply;

3.Optional air cylinder is 3.Connect a full air cylinder or

empty or closed; open the cylinder valve;

4. Compressed air 4. Check compressor.

compressor has failed.

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26. No N2O supply 1.N2O supply has failed; 1. Open N2O backup cylinder;

2.Pipeline supply hose not 2.Check central gas supply and

connected or kinked; connection to central gas supply;

3. N2O cylinder empty or 3. Connect a full N2O cylinder or

closed. open the cylinder valve.

27. No O2 supply 1.O2 supply has failed; 1.Open O2 backup cylinder;

2.Pipeline supply hose not 2.Check central supply and

connected or kinked; connection to central supply;

3. O2 cylinder empty or closed. 3. Connect a full O2 cylinder or

open the cylinder valve.

28. O2 cylinder 1. Pressure has dropped 1. Use a new O2 backup cylinder

pressure low below the pressure limit set and the central gas supply.
for the O2 cylinder.

29. O2 flow 1. Fresh gas flow 1.Use only O2 as fresh gas and
measurement measurement for O2
observe total flow meter.
failure has failed.

2.Call service Rep.

30. PEEP high 1. Expiratory pressure 5cmH2O 1.In automatic ventilation modes
above PEEP for 2 breaths, or
check the ventilation parameters.
Expiratory pressure 5cmH2O
above PEEP in pressure
2.Check the anesthetic gas
support mode for more than
scavenging line.
30s.

31. Power failure 1.Power failure. 1.Restore central supply and

2.Short-circuit in one of the observe battery capacity; 2.

devices connected to an
Prepare manual ventilation.
auxiliary outlet.

3. Call service Rep.

32. Pressure 1. Pressure sensor faulty. 1.Perform self test;

sensor failure 2. Call service Rep.

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33. Reinstall 1.Breathing system has been 1.Check correct installation of

ventilator installed incorrectly or in breathing system;
completely.
2.Breathing system 2.Check that upper diaphragm has
defective. been installed correctly.

3.Use a different breathing

system.

34. Setting 1. The last setting has not 1.Repeat settings.

cancelled been accepted due to
temporary errors. 2.Alarm can be reset by pressing
“Mute” button.

35. Speaker failure 1. Speaker faulty. 1.No alarm tone;

2. Call service Rep.

36. Ventilator failure 1. Ventilator is no longer 1.Patient must immediately be

operational. ventilated manually.

2.Adequate substitute monitoring

must be ensured if pressure and
volume monitoring has failed.

3.Call service Rep.

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7. Cleaning and Disinfecting

WARNING：Turn off HEYER Pasithec power switch before 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.

 The O2 sensor may leak and burn (by Chlorine Potassium Oxide) if damaged.

 Do not inhale fumes.

WARNING：Do not inhale any agents generated during cleaning and disinfecting.

CAUTION：User cleaning agent sparingly. Excess fluid could enter the machine, causing damage.

CAUTION：Do not autoclave any parts of the machine unless specifically identified as autoclave

able in the User Manual. Clean the machine only as specified in the User Manual.

CAUTION：To prevent system damage:

 Refer to the literature supplied by the manufacturer of the cleaning agent.

 Never use organic, halogenated or petroleum-based solvents, anesthetics, glass

cleaning agents, acetone or other irritant agents.

 Never use abrasive agents (i.e. steel wool or silver pool ish) to clean components.

 Keep all liquid away from entering the equipment.

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 Prevent liquid from entering the equipment.

 Do not immerse the bellows for more than 15 minutes as this may cause expansion

or accelerated aging.

 Only the components marked 134℃ are heat-resistant and pressure-resistant parts

that are capable of withstanding autoclave sterilization.

 All cleaning solutions used must have a pH between 7.0 and 10.5.

CAUTION：Never use the oxygen sensor or its connector in any type of liquid.

CAUTION：Dispose of the oxygen sensor per the manufacturer’s specification.

CAUTION：Do not use acetic hydroperoxide or formaldehyde steaming.

CAUTION：Do not autoclave the APL valve.

CAUTION：The valve disc is fragile and must, therefore, be handled with care while removing the

valve cage from the valve assembly.

CAUTION：If moisture remains in the bellows after cleaning, it may become tacky.

CAUTION：Do not wash the inner surface of the connector.

CAUTION：Do not autoclave the oxygen sensor.

CAUTION：Prior to use after cleaning or disinfecting, power up the machine and follow the on-

screen prompts to perform the Leak Test and the Compliance Test.

CAUTION： The PAW gauge cannot withstand immersion or the heat and pressure of autoclaving.

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CAUTION：Peracetic acid and formaldehyde fumigation will damage external surfaces.

7.1. Guideline

Operator should have a better understanding of WARNINGS and CAUTIONS before cleaning and
disinfecting. Different methods will be used for different parts. Parts need to be completely dried after
cleaning and disinfecting.

After cleaning and disinfecting, the peruse calibration must be done before using after the
anesthesia machine is reinstalled, refer to “Preoperative preparation” in HEYER Pasithec User
Manual.

The recommended disinfection time of the machine is 100~300, according to the use condition and
sterilization time of anesthesia machine specificially.

ISO17664 conformity

Process of autoclave sterilization of the anesthetic breathing system conforms to ISO17664:2004. The
condition conforming to ISO17664:2004 is use bacteria or virus filter to filter the flow that exhaled by
the patient and enters into the system and the flow which returns to the patient, so the installation of
the filter must be correct.

Cleaning Information

Cleaning is supposed to do before using the breathing system for the first time after installation.

If there is potential infective object in the breathing system, such as blood or secretion, please clean
it with disposable cloth and authorized sterilant instantly.

Only the components marked 134℃ are heat-resistant and pressure-resistant parts that are capable
of withstanding autoclave sterilization, all parts expect O2 sensor and PAW gauge can be washed with
moderate sterilant in the automatic washing machine.
O2 sensor and PAW gauge can be only cleaned on surface, O2 sensor, cannot be autoclave sterilized
and cleaned with automatic washing machine.

WARNING：Disinfection by ultraviolet light must be performed on the whole machine.

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7.2. User maintenance

Foundational Action
maintenance
every day clean anesthetic machine’s surface
every week Ventilate for the system, open flow meter to make floating-point move in
order to flow meter pipe block or floating-point conglutination.
every month Leak test of bellow assembly; 100% O2 concentration calibration.
Cleanness and Check if assembly is damaged, replace or repair if necessary.
installation
According to actual Open drain valve to replace soda lime.
situation Pipeline replacement: User replaces breathing pipeline in time according to
actual situation to ensure normal running (no gas leak in breathing
pipeline”) after breathing pipeline is used for a certain time.

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7.3. Breathing system disassembly

WARNING：Wear latex gloves during disassembly in case that operator’s hands get damaged.

Take C•G•O assembly from C•G•O.

Fig.7-1,7-2
Take the heater cable from the outlet module.

Fig.7-3,7-4
Take the heater cable from the heater port in
the breathing system.

Fig.7-5,7-6

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Take the screwed pipe from the outlet module.

Fig.7-7,7-8
Take the screwed pipe from the breathing
system and store safely.

Fig.7-9,7-10
Take the integrated gas sampling pipe from the
outlet module.

Fig.7-11,7-12
One hand holds the bracket, the other hand
holds the other side of the breathing system ,
and lift the breathing system vertically, take the
breathing system from the anesthesia machine.

Fig.7-13

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Fig.7-14

Fig.7-15

Fig.7-16
Take PAW gauge from the breathing system
and store it safely.

Fig.7-17,7-18
Take O 2 sensor from the inspiratory valve.

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Fig.7-19,7-20,7-21
Turn the bellows counterclockwise and take it
from the breathing system.

Fig.7-22,7-23

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Take the bellows and store safely.

Fig.7-24,7-25
As shown in the right figure, autoclave sterilize
the disassembled breathing system.

Fig.7-26

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7.4. Methods for cleaning and disinfecting

A: Wiping(Glutaraldehyde-based formulation of 2%; isopropyl alcohol at 70%～90%)

B: Washing Machine (Wet pasteurization at 70℃, 158℉, for 30 minutes after detergent cleaning)
C: Immersion (Glutaraldehyde-based formulations of 2%)
D: Autoclaving (Including steam r hot air at 134℃, 273℉). Use your manufacturer’s or your facility’s
recommendations.
Table 7-1
Part Name Method

A B C D
Workstation(Outside) √√√
Vaporizer √
Connection Cables and Wires √
Breathing Bag, Y-Fitting, T-Fitting √
Reusable Screw Tube √ √ √ √
Breathing System(After √ √ √ √
Disassembly）
Insp./Exp. Valve Disc √ √ √ √
Insp./Exp. Valve Bracket √ √ √ √
Insp./Exp. Valve Dome √ √ √ √
O-Ring √ √ √ √
Apl Valve √ √ √ √
Paw Gauge √
O2 Sensor √
Flow Sensor Surface √
Flow Sampling Tube √
Flow Sampling Detector √ √ √
Absorber Canister √ √ √
Bellows Dome √ √ √
Bellows √ √ √
Bellows Gasket √ √ √ √
AGSS √ √ √ √
AGSS Transfer Tube √ √
√ √
√ √
√ √ √

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7.4.1. Cleaning and disinfecting for breathing system

1. Breathing Circuit

After using on every patient, clean breathing circuit with 70%～90% alcohol, wash with clean water
and dry, or place it in autoclave staircase for sterilization.

2. Silicon screw tube and breathing bag

After using on every patient, clean silicon screw tube and breathing bag with clean water, completely
dry and put them in autoclave staircase for sterilization.

CAUTION：Do not use ultra-violet wave to sterilize silicon tube or breathing bag in case of aging.

3. Absorber canister, breathing system tubes(not include single-use tube),bellows plate

Either vaporing or immersion disinfection can be used in practice, in case of immersion all sterilized
parts must be dried with the high pressure air or oxygen before reuse.

4. Insp./Exp. Valve

Dismount the cover of the inspiratory and expiratory valves by rotating it counter-clockwise, then
takes away the valve patch, clean valve seat and circle together. And clean cover of the inspiratory
and expiratory valves and valve patch with the gauze soaked with water soluble sterilizing agent,
after all parts cleaned and dried recover it in original integration. Then one must check the leakage
and the movement of the inspiration and expiration valves in accordance with the required
regulation and checking procedure. Please handle all parts with care preventing any damage.

WARNING：Take care and do not damage or crash valve disc during cleaning.

7.4.2. Cleaning and disinfecting for bellows

WARNING: Never separate the diaphragm and the valve seat in a pressure-relief valve.

CAUTION: Do not immerse them more than 15 minutes to prevent inflation or aging.

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CAUTION: Dry by hanging while fully spread. If moisture is left in the bellows, they may become

tacky.

1) Disassembling.

2) To prevent component damage, clean them lightly. Put the recommended non-enzyme mild agent

used for latex and plastic in hot water.

3) Rinse using clean hot water, and then dry.

4) Check the components if they are broken or damp, then perform the assembling and function test.

5) Connect the bellow assembly, ventilator and breathing system.

6) Perform the preoperative check.

7.4.3. Cleaning and disinfecting for AGSS

CAUTION：For more cleaning and disinfecting information of AGSS, refer to AGSS User Manual

(Material No.:130).

8. Term maintenance

WARNING: To prevent fire:

 Please use admitted lubricant for anesthetic or O2 device.

 Do not use lubricant containing oil or lipin, because when O2 concentration reaches a certain
degree, burning or explosion may happen.

WARNING；Please observe disinfection control and safety regulation because the devices having

been used may contain blood and sap.

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WARNING: Moving part and removable elements is in danger of jamming hands or crush.

More attention must be paid when moving or replacing system parts.

WARNING: In the process of removing product, strike and quiver must be avoided..

WARNING: Exhausted and old instruments (such as battery and LCD screen) harmful to

environment must be treated according to present local regulations.

8.1. General principle of maintenance

This chapter provides message needed by HEYER Pasithec anesthetic machine in term maintenance.
Replace or adjust some components before doing some calibration or adjustment. If user uses
improper components such as improper specification causes malfunction, our company will not take
responsibility. Do not use malfunction device. Replacement and maintenance should be finished by
authorized service engineer or qualified, trained persons with repairmen experience. After
maintenance, the device should be tested and ensure its normal function and comply with the
manufacture’s regulation. Use components manufactured or sold by our company if replacement is
needed, then test and ensure device comply with the manufacture’s specification. If service support
is needed, please call local service engineer. In any case, the repairmen cost will include the current
price and reasonable personnel cost, but except repairmen items within HEYER company’s warranty.

CAUTION: Person without repair experience about such device must not repair this device.

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8.2. Maintenance schedule

Table 8-1
Action After each repair Every 12 months Every 36 months
Check before use X X X
Check before operation √ X X
Check with eyes √ X X
Replace exhausted √ X X
component
Replace O2 sensor √ √ √
Replace/maintenance √ √ X
battery
Function test √ X X

CAUTION: According to this schedule to do maintenance timely and replace corresponding parts.

CAUTION: The recommended repair time interval is 5 years. Breathing system, vaporizer and parts

are recommended to have a comprehensive test and replacement every 5 year.

WARNING: The ineffective sodium lime has an obvious change in color when it’s ineffective.

8.2.1. Appearance checklist

1. Assure the appearance of HEYER Pasithec no damage, the anesthesia machine can run
normally.
2. Assure absorbent canister install correctly and fill enough soda lime. Assure enough
anesthetic in vaporizer.
3. Assure the exhaust gas absorber pipe connected with APL valve no damage and dry inside.
4. Assure O2, N2O, AIR, VAC and EVAC connection pipe no damage.
5. Assure O2, N2O, AIR, VAC and EVAC flexible pipe no damage (if they are be used).
6. Assure AC power cable no damage.

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8.3. Replacement of replaceable parts

No. Replaceable part Every 6 Every 12 Every 36 Part Number

month month month

1. Replace O2 sensor No Replace Replace 210001975

2. Replace O-ring in O2 No Replace Replace 304000101

sensor
3. Check /Replace No Check Replace 210002830
battery
4. Clean/Replace latex Clean Clean Replace 230000318
screwed pipe φ17
5. Check /Replace No Check Replace 122005548
bellows assembly
6. Check /Replace No Check Replace 130004091
U-type sealing ring
7. Check /Replace AGSS No Check Replace 122001806
transmitted
pipe
8. Check /Replace No Check Replace 130004147
valve sealing gasket
9. Check /Replace O-ring Check Replace Replace 304000096
φ 9×1.8
（Pressure gauge）
10. Check /Replace Check Replace Replace 304000044
O-ring 14×2.65 （ on
vaporizer mount）

CAUTION: The life-span of all components above is the result in normal circumstance and work

condition.

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8.4. Maintenance of O2 sensor

WARNING: Exhausted and old O2 sensor must be treated according to the present local regulation.

Not burn or dispose the O2 sensor casually.

CAUTION: Calibration of O2 sensor please refers to Chapter 5.11.3.1.

8.4.1. Replacement of O2 sensor

Replacement steps of O2 sensor:

1. Pull out O2 sensor from inspiratory valve of breathing system.

2. Pull out O2 sensor cable connection port from O2 sensor.

3. Connect new O2 sensor to cable connection port and install it on inspiratory valve of breathing
system.

8.4.2. Main technical parameter of O2 sensor

CAUTION: Specific parameters refer to the latest published technical data by manufacture.

O2 sensor can be used to detect partial O2 concentration of the anesthetic machine. O2 sensor
belongs to consumptive products, so attentions should be paid to its useful-life and use as the
characteristics and technical requirements provided by manufacture. Main technical
requirements of O2 sensor in HEYER Pasithec as follows:

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Performance parameters:

Maximum input range of interface: 0－500mV DC

Interface form and definition: FCC-68 4 core telephone pin (RJ11-4), see the following figure.

Output ：9-13mV（210mBar O2）

Range ：0-1500mBar O2

Signal ：100±1（100% O2）

Resolution ：1mBar O2

Expected use life-span：1.5x106% O2 hour(in 20℃ circumstance）；0.8x106% O2hour（in 40℃

circumstance）

Total response time：T90＜15s

ZERO signal（N2，+20℃）：＜200uV

Operation’s temperature range ：-20℃～+50℃

Temperature compensation：within 0～40℃ is ±2%

Pressure range：0.5～2.0Bar

Relative humidity range ：0～99%（no condensation）

Long-term output excursion：＜5%（in 100% O2 circumstance and use more than one year）
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Crust Material：White ABS

N2O resistance：100% N2O

Valid time：13 months

Complied standard：EN12598/ISO7767

Suggested type and main characteristic parameters

8.5. Maintenance of fuse

ALARM: Disconnect AC power before fuse replacement, otherwise, it may cause injury even death.

WARNING: When fuse replacement, fuse of the same type and size must be used, otherwise, it

can be harmful to the anesthetic machine.

CAUTION: Fuse belongs to damageable assembly, proper force must be used when replacement.

CAUTION；Use screwdriver to swirl fuse and not use force largely and suddenly, otherwise, it

may cause fuse box broken.

Replacement steps:

Insert screwdriver into groove of the fuse box.

1. Pull out fuse box after swirling 3-5 circles counter-clockwise.

2. Take the fuse.
3. Install new fuse.
4. Pull new fuse to the original position.
5. Reuse screwdriver to swirl 3-5 circles to fix.
6. Connect AC power.

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8.6. Battery Maintenance

CAUTION: Only service engineer authorized by our company can replace battery. If the anesthetic
machine is not used in a long time, please call service engineer to cut power supply connection.

CAUTION: The exhausted and old battery must be treated according to present local regulations.

 Battery configuration

DC24V，2.3AH，12V leadacid battery， 2 nodes in series.

Use time：8 hours and a half of an hour

 CAUTIONs when use

Charging: when the AC power is connected, the system will charge the battery automatically, the
recommended charging time is no less than 8 hours.

Discharging: when the device uses battery to supply power, normally the work time is 120
minutes.When the battery’s electric capacity is insufficient, the device will display “Low power”
alarm until power off. When the “Low power” alarm occurs, the user should connect AC power
immediately and avoid the system closes (considering safety, manual startup should be done to
renew operation after the device closes automatically.)

Do not disassembly the battery causally and short battery connection line to avoid danger.

 Battery’s Preservation

If the battery is not used for a long time, it should be preserved after the battery is charged fully.

When the preservation time exceeds 3 months, charge the battery at least every 3 months.

When preservation, humid and high temperature circumstances must be avoided.

Improper maintenance will cause battery broken, the battery should be replaced immediately to
avoid fluid leak erode device. Call manufacture when replace battery.

 Battery’ removal

Use screw driver to remove the screws of the back cover board, disconnect the battery module
with device to remove battery.

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8.7. Consumptive components replacement

Since installation, consumptive components names and code in every time dimension as the table in
below:

Consumptive components 6 months 12 months 48 months

Check /replace bellows assembly needless Check Replacement

Check /replace U sealed circuit needless Check Replacement
Check/replace AGSS transmission needless
tube(optional) Check Replacement

Replace O2 sensor Check Replacement Replacement

9. Technical Data

CAUTION： All technical specifications should be updated based on the real state of HEYER
Pasithec Anesthesia Machine; no notification will be made if any change happens.

CAUTION：All display values are measured under dry environment and proper pressure.

WARNING： Cylinder valve should be closed during pipeline gas supply, so that gas shortage can

be avoided due to exhausted gas supply or pipeline problems.

9.1. Pneumatic Diagram

Pneumatic system plays the role of supplying O2, N2O, AIR and anesthetic agent to breathing system,
ensuring their pressures are within normal range respectively, so that normal operation of
anesthesia machine and patient’s safety can be guaranteed.

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Fig.9-1 HEYER Pasithec Pneumatic Diagram（V1.0）

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1 Inlet filter 21. Safety valve

2 Pressure gauge 22 PEEP valve
3 Check valve 23 Ambient pressure
4 N2O Pressure regulator 24 Flow sensor
5 AIR Pressure regulator 25 Airway pressure
6 O2 Pressure regulator 26 Sensor board
7 Pressure sensor 27 AGSS
8 Pressure regulator 28 Exhaust valve
9 Pressure regulator 29 Pressure reversing valve
10 Auxiliary breathing O2 30 Bellows
11 Auxiliary supply O2 31 Reversing valve
12 O2，N2O ratio valve 32 APL valve
13 E-flowmeter 33 Breathing bag
14 O2 flush valve 34 Flow sampling
15 Suction 35 Absorber container
16 Check valve 36 O2 sensor
17 Vaporizer mount 37 Insp. Check valve
18 Proportional solenoid valve 38 Exp. Check valve
19 Solenoid valve 39 Breathing system
20 Throttle

9.2. System technical data

CAUTION：All system gas supplies should be of medical degree.

Gas Supply

Table 9-1
Pipeline Gas O2, N2O,AIR
Pipeline Connection DISS-male，DISS-female，NIST（ISO 5359）.
Connectors for each of the gas cannot be interchanged.
Pipeline Input Pressure 280-600kPa（2.8-6bar）

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Flow Speed Table 9-2

Gas Range Range

（thin flow tube） （thick flow tube）
O2 0.05-1L/min 1.1-10L/min
N2O 0.05-1L/min 1.1-10L/min
AIR 0.05-1L/min 1.1-12L/min
9.3. Electrical diagraph

HEYER Pasithec Anesthesia Machine can be divided into three parts: UI, drive control and circuit. UI

consists of computer system, auxiliary control circuit, power and etc. which mainly takes charge of

display, alarm, keyboard input and interface expansion. Drive control has BDU as its core. Exterior

sensor, signal processing, amplifier, power and battery are part of drive control which mainly used

for data acquisition and ventilation mode control. UI and drive control should be connected by

cables.

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Fig.9-2 Electrical Diagraph

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9.4. Physical data

CAUTION：All physical specifications are of approximate values, no CAUTION can be made if any

change happens.

CAUTION：Do not place HEYER Pasithec Anesthesia Machine in vibrant environment.

CAUTION：Do not put heavy stuff on the top panel or in the drawers.

Table 9-3
Dimensions： 1403mm(H)×681mm(W)×855mm(D)
Weight： 100kg （ not include vaporizer and
System
backup cylinder）
Top Panel Load： 25kg
Castor 125mm，each front castor with brake
Drawer 142mm(H)×376.5mm(W)×438mm(D)
Display 12.1’ TFT LCD
Cylinder Gauge（AIR,O2, Range：0-1MPa. Stepping：0.05MPa Accuracy：±2.5% of
N2O） full range
Range：-10 - 100cmH2O. Stepping：200Pa Accuracy：±2.5% of
PAW Gauge
full range

9.5. Environmental requirement

CAUTION：The anesthesia machine should be stored in draught room where there is no caustic

gas and storing magnetic field.

Table 9-4
Temperature Operation: 10~40℃

Storage: -20 ~ 55℃

Transport -20 ~ 55℃

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Relative Humidity Operation: Not more than 80%, non-condensing.

Storage: Not more than 93%, non-condensing.

Transport Not more than 93%, non-condensing.

Atmospheric pressure Operation: 70~106kPa

Storage: 70~106kPa

Transport 70~106kPa

Power AC100-240V,50Hz/60Hz

Highest Attitude 3000 m

9.5.1. IEC60601-1:2005 classification

HEYER Pasithec belongs to this class:

 Class I device

 B type applied part

 Common device/IP21

 Traveling device

 not use flammable anesthetic

 Continuous running

NOTE：

The applied Part of HEYER Pasithec anesthesia machine is the part between mask and Y-piece.

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9.6. Input and output

NOTE:

1. When the anesthesia system stops transferring, the pipeline supplying pressure should be 280 to

600KPa.

2. When main power fails, the system switches to battery power automatically, and all the anesthesia

machine components can work normally.

3. When main power and internal battery both fails, the gas output is not affected.

9.6.1. Electrical

WARNING: IEC60601-1 is applicable to the connections between medical devices, and to the
connections between at least one medical device and one or more non-electrical devices. Even if no
functional connections between the single device, when using one auxiliary power outlet, they
forms a medical electrical system. User must be aware of the risk of increased leakage current and
temperature and other increased risk may exist, when the device is connected to the auxiliary
socket-outlet.

WARNING：When earth wire has failure, if the device connects with auxiliary power supply, it may

cause patient current leakage exceeding the permitted range

WARNING：If the exterior protective grounded wire has questions during wiring, interior power

supply must be used for device running.

Table 9-5
Supply Voltage 100-240VAC，50/60Hz
Maximum Input Current 8A
AC power fuse F10AH 250VAC，φ5X20（F）

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Auxiliary AC power plug 4

Auxiliary AC power plug fuse T2AH 250VAC，φ5X20（F）
Maximum output valve of auxiliary AC 1.5A(single plug)；6A(in total)
power plug
Grounded resistance Small than 0.2Ω

9.6.2. Pneumatic

Table 9-6

Pipeline supply O2、AIR、N2O

Pipeline connection DISS-male, DISS-female, NIST (ISO 5359)
All fittings used to connect O2, N2O and Air pipeline gas
supply are all ready.
APL valve 250kPa
Vaporizer connection 2 Selected interfaces
Pressure display Color mark list
Pipeline inlet pressure 280-600kPa
9.6.3. Electromagnetic compatibility

Changing or reassembling this equipment without authorization may cause electromagnetic

compatibility problems. Contact with HEYER 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 HEYER Pasithec is connected:

Do not put any object which is not in accordance with EN60601-1 in the 1.5M range of patients.

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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 HEYER Pasithec 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 EN60601-1-1 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 EN60601-1 under the normal conditions, and
disoperation may cause injury to patients or operators.

HEYER Pasithec is equipped with all-purpose alternating current outlet for connecting other medical
equipments. Do not connect non-medical equipment to these outlets. Otherwise, the surface
leaking current may exceed the range permitted by EN60601-1 under normal conditions and
disoperation may be dangerous to patients or operators.

A complete system current leaking test (according to EN60601-1) must be performed after any
equipment is connected to these outlets.

WARNING: The medical electrical equipment operators contact non-medical electrica

equipment and patients at same time. It is dangerous of patients or

operators.

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9.6.4. Guidance and manufacture’s declaration

Guidance and manufacture’s declaration – electromagnetic emissions- for

all equipment and systems
Guidance and manufacture’s declaration – electromagnetic emission

The HEYER Pasithec Anesthetic machine is intended for use in the electromagnetic environment
specified below. The customer of the user of the HEYER Pasithec Anesthetic machine should assure
that it is used in such and environment.

Emission test Compliance Electromagnetic environment – guidance

RF emissions Group 1 The HEYER Pasithec Anesthetic machine uses RF

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

RF emission Class A The HEYER Pasithec Anesthetic machine is suitable

for use in all establishments, other than domestic
CISPR 11 establishments and those directly connected to the
public low-voltage power supply network that
Harmonic emissions Class A supplies buildings used for domestic purposes.

IEC 61000-3-2

Voltage Complies
fluctuations/
flicker emissions IEC
61000-3-3

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Guidance and manufacture’s declaration – electromagnetic immunity – for

all equipment and systems
Guidance and manufacture’s declaration – electromagnetic immunity

The HEYER Pasithec Anesthetic machine is intended for use in the electromagnetic environment
specified below. The customer or the user of HEYER Pasithec Anesthetic machine should assure that
it is used in such an environment.

Immunity test IEC 60601 test Compliance level Electromagnetic environment -

guidance
level

Electrostatic ±6 kV contact ±6 kV contact Floors should be wood,

discharge (ESD) IEC concrete or ceramic tile. If floor
61000-4-2 ±8 kV air ±8 kV air 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 should be
supply lines supply lines that of a typical commercial or
transient/burst
hospital environment.
IEC 61000-4-4

Surge ±1 kV differential ±1 kV differential Mains power quality should be

that of a typical commercial or
mode mode
IEC 61000-4-5 hospital environment.

±2 kV common ±2 kV common
mode mode

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Voltage dips, short <5% UT <5% UT Mains power quality should be

that of a typical commercial or
interruptions and
(>95% dip in UT) for (>95% dip in UT) for hospital environment. It should
voltage variations be that the HEYER Pasithec
on power supply 0.5 cycle 0.5 cycle Anesthetic machine be
powered from an
input lines uninterrupted power supply or
a battery.
IEC 61000-4-11
40% UT 40% UT

(60% dip in UT) for 5 (60% dip in UT) for 5

cycles cycles

70% UT 70% UT
(30% dip in UT) for 25
cycles (30% dip in UT) for
<5% UT
(>95% dip in UT) for 5
25 cycles
sec

<5% UT

(>95% dip in UT) for

5 sec
Power frequency 3A/m 3A/m Power frequency magnetic
fields
(50/60Hz)
magnetic field
Should be at levels
IEC61000-4-8
characteristic of a typical
location in a typical
commercial or hospital
environment.

CAUTION UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacture’s declaration – electromagnetic immunity – for

equipment and systems that are life-supporting
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Guidance and manufacture’s declaration – electromagnetic immunity

The HEYER Pasithec Anesthetic machine is intended for use in the electromagnetic environment
specified below. The customer or the user of HEYER Pasithec Anesthetic machine 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 HEYER
PasithecI Anesthetic machine, including cables, than
the recommended separation distance calculated
from the equation applicable to the frequency of the
transmitter.
Conducted 3Vrms 3 Vrms Recommended separation distance
150 kHz to 80
3.5
RF MHz outside 𝑑 = [ ] √𝑃
𝑉1
ISM bands a
IEC 10 Vrms 12
10 Vrms 𝑑 = [ ] √𝑃
61000-4-6 𝑉2
150 kHz to 80 12
𝑑 = [𝐸 ] √𝑃 80 MHz to 800 MHz
MHz in ISM 1

bands

10 V/m 23
10 V/m 80 MHz 𝑑 = [𝐸 ] √𝑃 800 MHz to 2.5 GHz
1
Radiated RF to 2.5 GHz
IEC
61000-4-3
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in metres (m). b

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey,c

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should be less than the compliance level in each

frequency range.d

Interference may occur in the vicinity of

equipment marked with the following symbol:

CAUTION 1 At 80 MHz and 800 MHz, the higher frequency range applies.

CAUTION 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 6.765MHz to

6.795MHz; 13.553 MHz to 14.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70

MHz.

b
The compliance levels in the ISM frequency bands between 150kHz and 80MHz and in the
frequency range 80 MHz 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 HEYER Pasithec Anesthetic machine is used exceeds
the applicable RF compliance level above, the HEYER Pasithec Anesthetic machine should be
observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the HEYER Pasithec Anesthetic machine.

d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

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9.6.5. Recommended separation distances

Recommended separation distances between portable and mobile

rf communications equipment and the equipment or system – for
equipment or system that are not life-supporting
Recommended separation distances between

portable and mobile RF communications equipment and the HEYER Pasithec Anesthetic machine

The HEYER Pasithec Anesthetic machine is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The customer or the user of the HEYER Pasithec
Anesthetic machine can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the
HEYER Pasithec Anesthetic machine as recommended below, according to the maximum output
power of the communications equipment.

Separation distance according to frequency of transmitter

Rated (m)
maximum
150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2.5
output power outside ISM bands
in ISM bands MHz GHz
of transmitter
3.5 12 23
𝑑 = [ ] √𝑃 12 𝑑 = [ ] √𝑃 𝑑=[ ] √𝑃
𝑉1 𝑑 = [ ] √𝑃 𝐸1 𝐸1
(W) 𝑉2

0.01 0.1167 0.1200 0.1200 0.2300

0.1 0.3689 0.3795 0.3795 0.7273

1 1.1667 1.2000 1.2000 2.3000

10 3.6893 3.7947 3.7947 7.2732

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100 11.6667 12.0000 12.0000 23.0000

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.

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

CAUTION 2 The ISM(industrial, scientific and medical) bands between 150kHz and 80MHz are
6.765MHz to 6.795MHz; 13.553 MHz to 14.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz
to 40.70 MHz.

CAUTION 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 80 MHz and in the
frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable
communications equipment could cause interference if it is inadvertently brought into patient
areas.

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

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9.7. Breathing system technical data

Table 9-7

Flow compensation range：1-20L/min Fresh

gas compensation
Gases：O2、N2O、AIR、anesthetic agent

Absorbent 1500mL(for each absorber canister)

Connection CGO ： ISO5356 connector （ standard 22mm exterior diameter or
15mm interior diameter）
Breathing system leak These data ensures the continuous pressure is higher than the

anticipated pressure during mechanical ventilation.

Pressure: 3kPa，leak volume≤150ml/min

Breathings system Use a two-way sine wave test breathing system: Freq:20/min,
resistance Vt=1L,expiration.resistence≤0.6kPa,inspiration resistence≤0.6kPa.
Breathing system with small patient resistance should be selected in
order to be accordance with standards.

APL valve resistance Flow speed:3L/min，flow resistance：0.05 - 3kPa

Flow speed:30L/min，flow resistance：0.1 - 0.5kPa
Connector leak （APL valve close）leak volume≤50ml/min
Check valve resistance In dry environment：≤0.15kPa
Pressure generated <0.14kPa
from moist check
valve
Pressure of opening <0.1kPa
moist check valve
System compliance 45ml/kpa，use standard pipeline
Interior capacity 7.6L±0.1L
O2 flush 25-75L/min
O2 supply failure alarm <200kPa
O2 concentration Not less than 19%
Safety valve Open pressure is 8.5kPa, the flow is 5L/min.

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9.7.1. Compliance correction

In all of software version, the anesthesia machine is able to carry out a compliance correction which
compensates for volume "lost" in hoses and in the breathing system.
The anesthesia machine determines the system compliance (hoses and breathing system) and
required later for compliance correction during the self test or standby leak test. The hose of
standard equipped compliance has a fixed value of 11mL/kPa.

The VT set is delivered during the first breath.

ΔP is calculated from end-expiratory pressure (P1) and end-inspiratory pressure(P2).

Csys: the system compliance.

Figure11-3 Pressure values

Having the system compliance (Csys) and ΔP, Anesthesia machine can calculate which volume (ΔV)
has been "consumed" by the system, or, in other words, which volume has not been delivered to
patient.

ΔV = Csys x ΔP

The anesthesia machine increases the volume to be delivered by the value ΔV.

VT corr = VT + ΔV

The anesthesia machine repeats this procedure during each breathing phase so that the VT
delivered to the patient gradually approaches the set VT. This procedure is completed as soon as
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the plateau value stops changing (±0.5 cmH2O).The displayed flow and the resulting values (for
example, MV) are updated accordingly.

9.8. Anesthetic ventilator technical specifications

9.8.1. Anesthetic ventilator performance

Table 9-8
Maximum Inspiratory 80cmH2O
Pressure
Noise of the whole Work normally(not including alarm)，no more than 60dB(A)
Machine
Warm-up Time ≥5min
MV Max 20L/min
Inspiratory Flow Max 75L/min
Pressure Transmission 5-80cmH2O
Range

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9.8.2. Ventilation parameter

Table 9-9
Item Range Stepping Default Value Remark

Vt 20-1500mL 10mL 120mL（Child）； 20-100mL，error is ±20mL；

500mL（Adult） 100-1500mL，error is ±20%

Freq. 4-100bpm， 1bpm 20bpm（Child）； error is ±1bpm or ±5% ，

2-60bpm （PS 12bpm（Adult） choose the maximum one
mode）
I:E 4:1-1:8 0.5 1:2 error is ±15%
TINSP 0.2-5.0s 0.1sec 1sec（Child）； Have this function in SIMV mode
2sec（Adult） ， error is ±10% or 0.1s ，
choose the maximum one
PEEP OFF，3-30cmH2O 1cmH2 OFF When it is OFF，PEEP value is
O 1-3cmH2O ；
when 3-30cmH2O，error is
±2cmH2O or ±15% ， choose
the maximum one.
FreqMIN 2-60bpm 1bpm 4bpm（Child）； Have this function in PS mode
2bpm（Adult）
TP OFF，5%-60% 5% 10% Have this function in IPPV 、
SIMV mode，error is ±30% of
the setting or ±0.05s，choose
the maximum one
Trigger 1-15L/min 1L/min 2L/min（Child）； Have this function in SIMV、
3L/min（Adult） PS mode ，error is ±20% or
±1.3L/min ， choose the
maximum one
PTARGET 5-70cmH2O 1cmH2 10cmH2O（ Child ） Have this function in PCV
O 20cmH2O（Adult） mode

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ΔP 3-50cmH2O 1cmH2O 5cmH2O Have this function in SIMV、 PS

mode ， setting
range :5-70 cmH2O。error is ±4
cmH2O or ±20%，choose the
maximum one

TSLOPE 0-2s 0.1sec 0.5sec error is ±1s

9.8.3. Gas dynamics

Table 9-10
Gas source Anesthetic system
Gas component O2
Rating supply pressure 400kPa
Inlet pressure range 280kPa ~ 600kPa
Flow valve range 5~75L/min
1
Output Pressure range: 0 ~ 8kPa；Flow range: 0 ~ 75L/min

Label 1：Within rated outlet pressure range and under double maximum rated inlet pressure
condition.

Table 9-11
According to ISO8835-2, test under peak flow 60L/min, fresh gas 10L/min.

Item Standard Requirment Test Result

Expiratory resistance under <0.6kPa 0.51
manual condition

Inpiratory resistance under <0.6kPa 0.39

manual condition

Expiratory resistance <0.6kPa 0.57

under automatic condition

Inpiratory resistance under <0.6kPa 0.22

automatic condition

9.8.4. Monitor performance

Table 9-12
Item Range Stepping Accuracy

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Vt 0 - 3000mL 1mL 20-100mL ， error is ±20mL ； 100-

3000mL，error is ±20%
Freq. 0 - 110bpm 1bpm ±1bpm

PEAK -20 - 99cmH2O 1cmH2O ±5%，at least1cmH2O

MEAN -20 - 99cmH2O 1cmH2O ±5%，at least1cmH2O

PLAT -20 - 99cmH2O 1cmH2O ±5%，at least1cmH2O

FiO2 18 - 100％ 1% Error is ±3 ％（ concentration

value）
C 0-100mL/cmH2O 1mL/cmH2O Error is ±20% or ±5mL/ cmH2O，
choose the maximum one
PEEP -20 - 99cmH2O 1cmH2O ±2cmH2O

PAW -20-99cmH2O 1cmH2O Error is±3cmH2O or ±10% ， choose

the maximum one

Battery 100%，75%，50%，25%，0%。
voltage When battery is used to supply power, this sign displays available remaining electric
state voltage. When the machine is connected with AC power, this sign means charging.
display
Pressure monitor range: 0 - 80cmH2O.According to different airway pressure, gain the
wave form displays is different.
Paw-t 0 ~ 10cmH2O，pressure axis gain： 5cmH2O
wave 0 ~30cmH2O，pressure axis gain： 10cmH2O
form 0 ~80cmH2O，pressure axis gain： 20cmH2O
Time axis is a fixed range.（the axises of Flow-t，Paw-t is same.）：
When gas module is opened，0 ~15s；Gas module is closed, 0 ~20s.
Display range of flow rate: -90 - 90L/min,gain :45L/min. On time axis, the positive axes
Flow-t stands for inspiratory direction; under the time axis, the negative axes stands for
wave expiratory direction. Flow rate is 0L/min, which means no gas flow rate in airway.
form

CO2 CO2 display range is 0 - 76mmHg,gain is 38mmHg。Time axis is a fixed range. When
time gas module is opened，0 ~15s；Gas module is closed, 0 ~20s.
wave
form
Horizontal abscissa displays Paw：fixed range :-20 ~ 80cmH2O，gain is 20cmH2O。
P/V Loop Vertical abscissa displays tidal Volume：fixed range is 0 ~ 1500ml，gain is 250ml.

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Horizontal abscissa displays tidal Volume： -1400 ~ 0mL，gain is 700mL. Vertical

abscissa stands for Flow：fixed range ：-90 - 90L/min，gain is 45L/min； The positive
F/V Loop axes stands for aspiratory flow rate, the negative axes stands for expiratory flow.

9.9. O2 sensor specification

Table 9-13
Response time No more than 15s.
Sensor type Chemical fuel battery
Antipated battery Normal operation period is 12 months.
life-span
O2 monitor monitors and displays O2 concentration in the patient loop.
O2 sensor accessory includes one O2 sensor. This sensor can produce a
voltage proportional with O2 partial pressure in its detected surface and
its metal electrode will exhaust gradually in the process of oxidation.

O2 sensor is an electrochemical appliance (chemical battery). O2 diffuses

into this device by penetrating a membrane to make the metallic
electrode oxidizing. In this process, electric current occurs, which
matches with partial pressure of oxygen displayed by electrode sensor.
Operating principle of O2
monitor The sensor’s voltage is influenced by the temperature of monitoring gas
blender. The thermostat outside of the sensor can compensate the
temperature change in sensor.

O2 monitor uses signal to deal and analyze circuit, transforming the

sensor signal to corresponding oxygen percentage value.
The system displays this value and compares it with the saved alarm
extremes. If this value exceeds the extremes, the monitor will send
alarm.

9.10. Gas monitoring module technical specifications

The gas monitoring module is used to connect other medical devices, provide monitor data, monitor
and display CO2, N2O and 5 anaesthetic gases (halothane, isoflurane, enflurane, sevoflurane,
desflurane).

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The gas monitoring module is connected to the patient’s breathing pipeline to monitor the inspiratory
and expiratory gas and can be applied to Adult/Child and Infant.

CAUTION: Gas monitoring module complies with ISO 80601-2-55:2011.

9.10.1. Mainstream gas monitoring module

Table 9-14
IRMA CO2 / AX+
Model

Interface type RS232,9600bps

Accessories Airway adapter, disposable.

Working principle of gas The gas module is a mainstream gas monitoring module, connecting to
module
patient to monitor gas concentration of breath.

The gas module can be used for adults, children and infants.

The gas module uses infrared technology, which determines gas

concentrations by measuring 10 different wavelengths according to
different absorption of gases to different ray.

Table 9-15
Basic Configuration

Description Extremely compact infrared mainstream multi-gas module.

Available in various parameter configurations.

Dimension(W×D×H) IRMA CO2/ AX+:

38×37×34mm(1.49″×1.45″× 1.34″)

Cable length 2.50m±0.02m

Weight <25g(except cable)

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Operating temprature IRMA CO2: 0-40℃, 32-104℉

IRMA AX+: 10-40℃, 50-104℉

Storage and transportation -20-50℃,-4-122℉

temperature
IRMA CO2: -40-75℃, -40-167℉

IRMA AX+: -20-75℃, -4-167℉

Operating humidity 10-95%RH, no condensation

Storage and transportation 5-100%RH, condensation1)

humidity

Operating atmospheric IRMA CO2:

pressure 525-1200hPa(525 hPa corresponding to an
altitude if 4572m/15000feet)

IRMA AX+:
700-1200hPa(700 hPa corresponding to an
altitude of 3048m/10000feet )

Storage and transportation 500-1200hPa

pressure

Mechanical strength Withstands Repeated 1.8m drops on a hard surface.

Complies with requirements for road ambulances according to prEN1789

(clause 6.4) and requirements for shock and vibration according to ISO
80601-2-55:2011 (clause 201.15.3.5.101, transport).

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Power supply IRMA CO2:

4.5-5.5VDC, Max 1.0W

(power on surge @ 5V less than 350mA during 200ms)

IRMA AX+:

4.5-5.5VDC, Max1.4W

(power on surge @ 5V less than 350mA during 200ms)

Surface temperature (at IRMA CO2:

ambient temperature
Max41℃/106℉ IRMA
23℃)
AX+:

Max 50℃/122℉

Interface Modified RS-232 serial interface operating at 9600bps

Airway adapter Disposable adult/child:

Adds less than 6mL deadspace;

Pressure drop less than 0.3cmH2O @ 30LPM.

Disposable infant:

Adds less than 1mL deadspace;

Pressure drop less than 1.3cmH2O @ 10LPM.

NOTE 1: After being in a condensing atmosphere, this module shall be stored for more than 24

hours in an environment equivalent to operating humidity.

The humidity range 50-100% is valid for the temperature range -40 - 40℃.

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Table 9-16
Data Output

Fi and ET The newest breathing value (Fi and ET) is continually displayed after one
breath.

Gas monitor module CO2：CO2

Automatic agent IRMA AX+: Primary and secondary agent.

identification

Table 9-17
Gas Analyzer

Probe 2-9 channel NDIR type gas analyzer measuring at 4-10 μm. Pressure,
temperature and full spectral interference correction.

Calibration When the detected value is offset;

When alarm occurs because “gas module monitor concentration exceeding

the limits”;

After replacing gas circuit adapter of gas monitor module.

Warm-up Time Record concentration and full-range accuracy identified automatically by

anesthetic gas in 10s;

IRMA CO2: within 10s;

IRMA AX+: within 1 minute.

Rise time (@10L/min) CO2≤90ms

N2O≤300ms

HAL, ISO, ENF, SEV, DES≤300ms

Agent identification <20s (Typically<10s)

time

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Total system <1s

response time
Table 9-18

Accuracy specifications - standard conditions

Range1)

Gas CO2 AX+ Accuracy

CO2 0-15 0-10 ± (0.2vol%+2% of reading) ±

10-15 (0.3vol%+2% of reading)

15-25 15-25 Unspecified

N2O -- 0-100 ± (2vol%+2% of reading)

HAL,ISO,ENF -- 0-8 ± (0.15vol%+5% of reading)

8-12

SEV -- 0-10 ± (0.15vol%+5% of reading)

10-15

DES -- 0-22 ± (0.15vol%+5% of reading)

22-25

NOTE 1: Gas concentration reported in units of volume percent.

Table 9-19
Accuracy specifications –all conditions1)

Gas Accuracy

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CO2 ± (0.3vol%+4% of reading)

N2O ± (2vol%+5% of reading)

Agents2) ± (0.2vol%+10% of reading)

NOTE 1: The accuracy specification is valid for the operating temperature and humidity

conditions specified, except for interference specified in the table “Interfering gas and vapor effects”

below.

NOTE 2: The accuracy specification for IRMA AX+ is not valid if more than two agents are present

in the gas mixture.

Table 9-20
Interference gas and vapor effects

Gas or vapor Gas CO2 Agents N2O

level
IRMA CO2 IRMA AX+

N2O3) 60 vol% --1) --1) --1) --1)

HAL3) 4vol% --1) --1) --1) --1)

ENF,ISO,SEV3) 5vol% +8% of reading2) --1) --1) --1)

DES3) 15vol% +12% of reading2) --1) --1) --1)

Xe(Xenon) 3) 80vol% -10% of reading2) --1) --1) --1)

Xe(Helium) 3) 50vol% -6% of reading2) --1) --1) --1)

Metered dose Not for use with metered dose inhaler propellants
inhaler propellants3)

C2H5OH(Ethanol) 3) 0.3vol% --1) --1) --1) --1)

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C3H7OH(Isopropan 0.5 vol% --1) --1) --1) --1)

ol) 3)

CH3COCH3(Aceton 1 vol% --1) --1) --1) --1)

e) 3)

CH4(Methane) 3) 3 vol% --1) --1) --1) --1)

CO(Carbon 1 vol% --1) --1) --1) --1)

monoxide) 3)

NO(Nitrogen 0.02 vol% --1) --1) --1) --1)

monoxide)3)

O23) 100 vol% --1) --1) --1) --1)

NOTE 1: Negligible interference, effect included in the specification “Accuracy, all conditions”

above.

NOTE 2: Interference at indicated gas level. For example, 50vol% helium typically decreases the

CO2 readings by 6%. This means that if measuring on a mixture containing 5.0vol% CO2 and 50vol%

helium, the measured CO2 concentration will typically be (1-0.06)*5.0vol%=4.7 vol% CO2.

NOTE 3: According to the ISO 80601-2-55:2011.

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9.10.2. Sidetream gas monitoring module

Table 9-21
ISA CO2 / AX+
Model

Interface type RS232, 9600bps

Accessories Sampling tube, CO2 or anesthetic gas Water trap, disposable.

Working principle of gas The gas module is a sidestream gas monitoring module, connecting to
module
patient to monitor gas concentration of breath by electrical machine
inhaling trace gas.

The gas module can be used for adults, children and infants.

The gas module uses infrared technology, which determines gas

concentrations by measuring 10 different wavelengths according to
different absorption of gases to different ray.

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Table 9-22
Basic Configuration

Description Ultra-compact, low-flow sidestream gas analyzers with integrated pump,

zeroing valve and flow controller.

Dimension(W×D×H) ISA CO2/ AX+:

23×64×39mm(0.9″×2.5″× 1.5″)

Weight 70g

Operating temprature ISA CO2: 0-50℃, 32-122℉

ISA AX+: 5-50℃, 41-122℉

Storage and -40-70℃,-40-158℉

transportation
temperature

Operating humidity ＜4kPa H2O(no condensation)

(95%RH at 30℃)

Storage and 5-100%RH(condensation)1)

transportation humidity
(100%RH at 40℃)

Operating 52.5-120kPa(corresponding to a max altitude of 4572m/15000feet)

atmospheric
pressure

Storage and 20-120 kPa(corresponding to a max altitude of 11760m/38700feet)

transportation pressure

Ambient CO2 ≤800ppm

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Mechanical strength ISA CO2:

Meets the shock and vibration requirements for transport of ISO

80601-2-55:2011 (clause 201.15.3.5.101) and EN
1789(clause6.3.4.2).

ISA AX+:

Meets the shock and vibration requirements for transport of ISO

80601-2-55:2011 (clause 201.15.3.5.101)

Power supply 4.5-5.5VDC,

ISA CO2: ＜1.4W(normal op.), ＜1.8W(peak @5VDC）

ISA AX+: ＜1.6W(normal op.), ＜2.0W(peak @5VDC）

Interface Modified RS-232 serial interface.

Software upgrade possible using the RS-232 serial interface.

Water handling Sampling line with proprietrary water removal tubing.

Sampling lines 2±0.1m and 2±0.1m versions

Sampling flow rate 50±10mL/min

NOTE 1: After condensation, the unit shall be stored for more than 24 hours in an environment

with relative moisture content below 95%RH (non-condensing).

Table 9-23
Data Output

Fi and ET ISA CO2: CO2

ISA AX+: CO2, N2O, primary and secondary agents(HAL, ENF, ISO, SEV, DES)

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Automatic agent ISA AX+: Primary and secondary agent.

identification

Table 9-24
Gas Analyzer

Sensor head 2-9 channel NDIR type gas analyzer measuring at 4-10 μm.

Calibration When the detected value is offset;

When alarm occurs because “gas module monitor concentration exceeding

the limits”;

After replacing gas circuit adapter of gas monitor module.

Warm-up Time ISA CO2: <10s(concentrations reported and full accuracy)

ISA AX+: <20s(concentrations reported, automatic agent identification

enabled and full accuracy)

Rise time (@10L/min) CO2≤200ms N2O≤350ms

HAL,ISO,ENF,SEV,DES≤350ms

Agent identification <20s (typically<10s)

time

Total system <3s(with 2m sampling line)

response time

Table 9-25

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The following accuracy specifications are valid for dry, single gases at 22±5℃ and 1013±40 hPa.
Accuracy specifications - standard conditions

Gas Range Accuracy

CO2 0-15% ± (0.2vol%+2% of reading)

15-25% Unspecified

N2O 0-100% ± (2vol%+2% of reading)

HAL,ISO,ENF 0-8 % ± (0.15vol%+5% of reading)

8-25% Unspecified

SEV 0-10% ± (0.15vol%+5% of reading) Unspecified

10-25%

DES 0-22% ± (0.15vol%+5% of reading) Unspecified

22-25%

Table 9-26

Accuracy specifications – all conditions

Gas Accuracy

CO2 ± (0.3vol%+4% of reading)

N2O ± (2vol%+5% of reading)

Agents1) ± (0.2vol%+10% of reading)

NOTE 1: The accuracy specification is not valid if more than two agents are present in the gas

mixture. If more than two agents are present, an alarm will be set.

Table 9-27

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Interference gas and vapor effects

Gas or vapor Gas CO2 Agents N2O

level
ISA CO2 ISA AX+

N2O4) 60 vol% --2) --1) --1) --1)

HAL4) 4vol% --1) --1) --1) --1)

ENF,ISO,SEV4) 5vol% +8% of reading3) --1) --1) --1)

DES4) 15vol% +12% of reading3) --1) --1) --1)

Xe(Xenon) 4) 80vol% -10% of reading3) --1) --1) --1)

Xe(Helium) 4) 50vol% -6% of reading3) --1) --1) --1)

Metered dose Not for use with metered dose inhaler propellants
inhaler propellants4)

C2H5OH(Ethanol) 4) 0.3vol% --1) --1) --1) --1)

C3H7OH(Isopropan 0.5 vol% --1) --1) --1) --1)

ol) 4)

CH3COCH3(Aceton 1 vol% --1) --1) --1) --1)

e) 4)

CH4(Methane) 4) 3 vol% --1) --1) --1) --1)

CO(Carbon 1 vol% --1) --1) --1) --1)

monoxide) 4)

NO(Nitrogen 0.02 vol% --1) --1) --1) --1)

monoxide)4)

O24) 100 vol% --1) --1) --1) --1)

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NOTE 1: Negligible interference, effect included in the specification “Accuracy, all conditions”

above.

NOTE 2: Negligible interference with N2O/O2 concentrations correctly set, effect included in the

specification “Accuracy specifications- all conditions” above.

NOTE 3: Interference at indicated gas level. For example, 50vol% helium typically decreases the

CO2 readings by 6%. This means that if measuring on a mixture containing 5.0vol% CO2 and 50vol%

helium, the measured CO2 concentration will typically be (1-0.06)*5.0vol%=4.7 vol % CO2.

NOTE 4: According to the ISO 80601-2-55:2011.

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10.Warranty

Warranty declaration by HEYER Medical AG

In addition to the legal warranty acc. to HBG §377, HEYER MEDICAL AG shall grant a warranty of 12
months for the purchase of a new apparatus from the HEYER product range. The warranty period
begins with the date of invoice and is subject to the following conditions:

1. Within the warranty period we will eliminate free of charge any defects or damages on the
device that are shown to be caused by a manufacturing or material error. The warranty does
not include easily breakable parts, e.g. glass or consumable parts.

2. Warranty services can only claimed upon submission of a delivery note (bill of delivery or
invoice); the type and method of damage remedy (repair or replacement) shall be at the
discretion of HEYER MEDICAL AG. Warranty services do not result in an extension of the
warranty period, nor do they entail a new warranty being granted. There is no independent
warranty period for installed spare parts.

3. Excluded from the warranty are: Damages caused by improper use, operating errors,
mechanical stress or non-observance of the operating instructions, as well as damages
caused by force majeure or by extraordinary environmental conditions.

4. Warranty services may only be claimed if proof is submitted to confirm that all service and
maintenance work has been carried out by authorized staff.

5. The warranty includes all faults that impair a faultless functioning of the device on the basis
of technical defects of individual components. The warranty obligation can only be
recognized by us if the device has been used properly and according to its intended use and
no repair attempts have been undertaken by the client himself or by third parties. The
warranty claim does not include faults caused by mechanical damages or if the device is being
operated with accessories originating from third parties.

6. The warranty is also void if changes, alterations or repairs are made to the device by persons
not authorized to do this.

7. The warranty claim only applies to customers of HEYER MEDICAL AG; it cannot be transferred
to third parties.

8. The rejected device is to be shipped back to our plant postage free. In case of a request by
our customer service department, the costs for shipping to the plant are to be initially
generally borne by the customer. After successful repair, we will send the device back freight
collect. If HEYER MEDICAL AG confirms the existence of a warranty claim, the customer will
receive reimbursement for the costs of delivery and/or transport of the apparatus. Repair
parts that do not fall under the warranty claim will be billed by us. The shipping of the device
to us always counts as a complete assignment to eliminate all faults and/or replace missing
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parts, unless the customer expressly excludes partial services. Additional claims to transfer
or reduce and replace damages of any kind in particular also of damages not incurred on the
object of delivery itself are excluded.

Our service address: HEYER Medical AG

Carl-Heyer-Straße 1-3
D-56130 Bad Ems
Tel.: (02603)791-3
Fax: (02603)70 424

Subject to technical changes!

Rev. No.: 2.3 – dated 11.07.2016

NOTES

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HEYER Pasithec User Manual

Edition 2.3
July 2016

HEYER MEDICAL AG

Directive 93/42/EEC concerning

Medical Devices

HEYER Medical AG
Carl-Heyer-Str. 1/3
D-56130 Bad Ems / Germany
Phone: +49 2603 791 3 ◦ Fax: +49 2603 70424
[email protected] ◦ www.heyermedical.de

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