1.4 Details of the Manufacturer....................................................................................................................................... 6
2.1.1 Range of Use.................................................................................................................................................. 7
3 System Components.........................................................................................................................................................11
3.2 Breathing System ................................................................................................................................................... 17
3.4.1 Front Panel.................................................................................................................................................... 20
3.5 Menu ...................................................................................................................................................................... 25
3.5.2 Menu Diagram............................................................................................................................................... 28
4.1.1 System Self Test............................................................................................................................................ 34
4.1.2 Manual Leak Test .......................................................................................................................................... 36
5.1.2 Main Failure Alarm Test................................................................................................................................. 46
5.2 Test Gas Supply Pipeline........................................................................................................................................ 46
5.3.1 Monitoring without Oxygen............................................................................................................................ 46
5.3.2 Monitoring with Oxygen................................................................................................................................. 48
5.4 Installing and Testing Vaporizer............................................................................................................................... 49
5.6 Breathing System Test............................................................................................................................................ 51
6 Installation and Connection.............................................................................................................................................. 53
6.1 Install the Absorber Canister................................................................................................................................... 54
6.1.1 When to Replace Absorbent.......................................................................................................................... 54
6.2 Connecting Tubes and Lines................................................................................................................................... 55
6.2.1 Connect CO2 Monitor..................................................................................................................................... 56
6.3 Connecting Gas and Electricity............................................................................................................................... 57
6.3.1 AC Inlet......................................................................................................................................................... 58
6.3.3 Communication Port...................................................................................................................................... 59
6.3.4 Gas Inlet Module........................................................................................................................................... 59
7 Cleaning and Disinfecting................................................................................................................................................ 60
7.1 Cleaning and Disinfecting prior to first Use ............................................................................................................. 60
7.2 Cleanable Breathing System Components.............................................................................................................. 61
8 User Maintenance............................................................................................................................................................ 69
8.2 Maintaining Outline and Schedule........................................................................................................................... 69
8.2.1 User Maintenance......................................................................................................................................... 70
8.2.2 Useful Life Estimation.................................................................................................................................... 70
8.2.3 Replacement of Consumable Parts............................................................................................................... 70
8.3 Maintaining the Breathing System........................................................................................................................... 70
8.3.3 Calibrate CO2 Sensor.................................................................................................................................... 74
8.5 Replace the Fuses.................................................................................................................................................. 78
8.7 The IRMA Probe..................................................................................................................................................... 79
9 Alarm and Troubleshooting .............................................................................................................................................. 80
9.1 About Alarm............................................................................................................................................................ 80
9.2 Alarm Message List ................................................................................................................................................ 80
10.3.1 Gas Supply.................................................................................................................................................... 88
10.8.4 Gas Dynamics Performance.......................................................................................................................... 93
HEYER Medical AG (“HEYER”) holds the copyright to this manual, which is not publicly published, and
reserves the right to maintain it as a secure document. Refer to this manual when operating,
maintaining and repairing products only. Releasing information contained within the manual is
prohibited.
Proprietary materials protected by copyright law are included in this manual. No section of it can be
reproduced, copied, or translated into other languages without prior written approval from HEYER.
All instructions in this manual are considered to be correct. HEYER is not legally responsible for
damages caused by incorrect installation or operation. HEYER does not supply privileges endowed by
patent law to any other parties. HEYER is not legally responsible for the consequences of breaking the
patent law or of a third party violation.
Refer to this manual before using the product. The manual includes: Operating procedures which must
be performed with caution; information on actions and situations that may result in damage to the
equipment, and actions and situations that may cause bodily harm. HEYER is not responsible for the
security, reliability, and/or function of the equipment in the event that damage or other irregular actions
occur. Repairs for these malfunctions are not covered by the warranty.
HEYER has the rights to replace any content in this manual without notice.
1.1 Manufacturer Responsibility
HEYER is responsible for the security, reliability, and function of the equipment when the following
conditions are adhered to:
Installation, adjustments, and repairs must be performed by individuals authorized by HEYER;
Necessary electrical equipment and the working environment must be in accordance with national
and professional standards and the requirements listed in this manual;
Equipment must be used as stated in the operating instructions.
CAUTION: This equipment is not for family use.
CAUTION: Malfunctioning equipment may cause damage and/or bodily injury if repair
request are not submitted in a timely manner by the company or organization
using the equipment.
The paid theoretical framework diagram, calibrating method, and other instructions will be supplied to
the customer upon request. With the assistance of qualified technicians and when stipulated by
HEYER, specific equipment parts can be repaired by the customer.
1.2 Security, Reliability and Operating Conditions
HEYER is not responsible for the security, reliability and operating conditions of this product when:
The assemblies are disassembled, extended, or readjusted
The product is not operated correctly in accordance with the manual instructions; the power
supply that is used is incorrect, and/or the product is operated in an environment other than
optimal conditions per this manual.
In the event a product needs to be returned to HEYER, please follow these steps:
1. Obtain the right of return.
Contact our customer service department with the product number and type. The number is
marked on the surface of the product and is required for a return. Enclose a letter containing
the product number, type, and the reason for the return.
2. Transportation charges
Transportation and insurance charges must be prepaid by the user prior to shipping the
product to HEYER for repair.
1.4 Details of the Manufacturer
Apparatus: Anesthesia System HEYER Pasithec
Manufacturer: HEYER Medical AG
The HEYER Pasithec is a compact and integrated anesthesia transmitting system. The anesthetic
ventilator not only provides patients undergoing operations with auto ventilation, but also monitors and
displays the patient’s various parameters.
The anesthetic ventilator used in the system is controlled by a microprocessor, which internally
configures the monitor and the volume mode; other functions are optional.
Not all the optional functions available may be included in the manual. It is also possible to add other
equipment to the top or middle of this system for added functions. For more information with respect to
the existing product, please contact your local representatives.
WARNING: All Pasithec users must be trained.
WARNING: HEYER Pasithec is not suitable for use in an MRI environment.
2.1.1 Range of Use
Pasithec is applicable for patients of over 2 kg with standard configuration. Pasithec is for use in the
Operating Room and/or Emergency Room of a hospital, drug addiction treatment center, or other
medical facilities where anesthesia is used.
2.1.2 Contraindication
Pasithec is not suitable for pneumothorax patients
2.2 Symbols
Warnings and Cautions indicate all the possible dangers in case of violation of the
stipulations in this manual. Refer to and follow them.
WARNING: Indicates potential hazards to operators or patients.
AC135 Anesthetic Breathing System
AGSS Anesthetic Gas Scavenging Transfer & Receiving System
APL Adjustable Pressure Limit
BDU Basic Data Unit
C Compliance
C·G·O Common Gas Outlet
cmH2O Centimeters of Water
IPPV Intermittent Positive Pressure Ventilation
EEPROM Electrically Erasable Programmable Read Only Memory
FiO2 Fraction of Inspired Oxygen
Flow-t Flow-time Waveform
Freq Frequency
Freq
Minimum Frequency in PS Mode
MIN
GUI Graphical User Interface
I:E Inspiratory to Expiratory Ratio
L Liter
L/min Liters Per Minute
Manual Manual ventilation
ml Milliliter
MRI Magnetic Resonance Imaging
MV Minute Volume
Paw Airway Pressure
Pb Plumbum
PEAK Peak Pressure
PLAT Plat Pressure
MEAN Mean Pressure
Paw-t Pressure-time Waveform
PCV Pressure Control Ventilation
PEEP Positive End Expiratory Pressure
PIP Peak Inspiratory Pressure
PS Pressure Support Ventilation
P
Target Pressure
TARGET
SIMV Synchronized Intermittent Mandatory Ventilation
T
Inspiratory Time
INSP
TP Inspiratory Pause Time
Trigger Flow Trigger
T
Inspiratory Slope Time
SLOPE
UI User Interface
VT Tidal Volume
WDT Watch Dog Timer
∆P Differential Pressure
Enf. Enflurane
Hal. Halothane
Iso. Isoflurane
Sev. Sevoflurane
Des. Desflurane
ETCO2 End-Expiratory CO2 Concentration
INSCO2 Inspiratory CO2 Concentration
MAC Minimum Alveolar Concentration
CAUTION: The anesthetic system is intended to be used with the following monitoring
devices, alarm systems, and protection devices:
+ pressure measuring in accordance with 8.1 of ISO 8835-2;
+ system is to be equipped with an ANESTHETIC GAS SCAVENGING
TRANSFER and RECEIVING SYSTEM complying with ISO 8835-3 before
being put into service.
+ pressure limitation device in accordance with 51.101.1 of IEC60601-2-13;
+ exhaled volume monitor in accordance with 51.101.4 of IEC60601-2-13;
+ breathing system integrity alarm system in accordance with 51.101.5 of
IEC60601-2-13;
+ continuing pressure alarm in accordance with 51.101.6 of IEC60601-2-
13;
+ O2 monitor in accordance with ISO 21647.
+ CO2 monitor in accordance with ISO 21647.
+ ANESTHETIC monitor in accordance with ISO 21647.
WARNING: To avoid explosion hazards, flammable anesthetic agents such as Ether and
Cyclopropane shall not be used in the anesthetic workstation. Only use
anesthetic agents that comply with the requirements for non-flammable
anesthetic agents as specified in this manual. Halothane, Desflurane,
Sevoflurane, Enflurane, and Isoflurane have been found to be nonflammable agents.
WARNING: Independent means of ventilation (e.g. a self-inflating manually powered
resuscitator with mask) should be available whenever the anesthetic system
is in use.
WARNING: Do not use antistatic or electrically-conductive breathing tubes and mask.
WARNING: Contact with a liquid, such as anesthetic agent, results in damage within the
device.
WARNING: The incline angle should not exceed 10 degrees whenever the anesthetic
assistant power and controller are started with the main switch.
O can enter into flowmeter.
Descriptions of each control function at the front of Pasithec:
Item Description
3 Aux. O2 Flowmeter Provides O2 with a maximal flow of 15 L/min to Aux. O2.
8 Flowmeter with Flow
Control Knobs
Turn the knob counterclockwise to increase the flow; turn
clockwise to decrease the flow.
Reading point is top of float inside flow tube.
6 Top Light The top light will illuminate if top light is switched on. The top light
switch has two settings: on and off.
10 Pneumatic and
Electronic Switch
The switch can control electricity and gas and has three settings.
Electricity main switch: OFF, ON, ON; gas way main switch: OFF,
O2+N2O, O2+Air.
Function of electricity main switch: When system is shut off, the
The machine performs a system self test, and after the test, the
startup is complete. While system is in startup state, turn off the
main switch and be sure the main unit system is closed
completely.
Function of gas way main switch: when switch is in the OFF
position, O2, N2O and AIR cannot enter the flowmeter. When
switch is in O2+N2O position, O2 and N
2
When the switch is in O2+Air position, O2 and AIR can enter.
14 Writing Board The writing board can hold up to 10 kg and can be used by a
doctor during an anesthesia operation.
WARNING:When performing closed or semi-closed ventilation with breathing system,
the Fresh gas switch should be placed to Circle Absorber. Otherwise, there
will be anesthetic gas leakage and abnormal operation of the machine.
Descriptions of each control function at the side view of Pasithec:
Item Description
21 O2 Flush (O2+) Press the O2 Flush (O2+) button to supply the breathing
system with O2 at a high flow rate.
22 O2 Sensor Socket Socket to connect Oxygen Sensor for monitoring oxygen
concentration of absorber circle. When monitoring patient
oxygen concentration in inspiratory gas at the back of
inspiratory valve, the socket can be selected.
23 / 24 Driving Gas Outlet (Switch) Provide driving gas to other equipment. Pressure: 280
Front panel consists of display screen, keys, indicators, and a knob.
Figure 3-6 Front Panel
3.4.2 Keys
Manual Key Press the key to change original ventilation mode to manual
mode; Press again to change back to the original ventilation
mode.
Alarm Limits Key
MUTE Key
Spirometry Key This key shall toggle the display between the waveform
MENU Key Press the key and a “Menu” window appeared on the
Normal screen Key The key closes the “Spirometry” and other windows and
Press the key to open alarm window on the screen; Press
again to close the alarm window.
Press the key to mute the alarm for 110 seconds. New
alarms shall override the mute.
window and the two loop display configurations of the
Spirometry Loop Window described in section 4.5. The first
key press shall display the “Pressure-Volume” loop display
configuration. The second key press shall display the “FlowVolume” loop display configuration. After both
configurations have been cycled through the display, a third
key press shall return the display to the Normal Screen.
display screen; for more details refer to section 3.5.
The first menu key press after the initial power up will
display the calibrate menu, with “Start Calibration”
highlighted.
returns the screen to pressure and flow waveforms.
If the “Spirometry” and all other windows are already closed
when the NORMAL SCREEN key is pressed again, no
action shall occur.
AC indicator The indicator lights up when AC power is in use;
the indicator is dark when the AC power fails.
3.4.4 Navigator Knob
The user can adjust the rotary knob to select the menu item and modify the setup. It can be rotated
clockwise or counter-clockwise and pressed like other buttons. The knob may be used to select
options on the screen, in the system menu, and in the parameter menu.
The rectangular mark on the screen that moves with the rotation of the knob is the “cursor”. The
cursor can be used to select any menu item on which it lands.
Operating method:
Move the cursor to the item you wish to select
Press the knob
One of the following four situations will happen:
If the background color of the cursor becomes a contrasting color, the content in the
frame can change with the rotation of the knob.
A pull down menu or dialogue box may appear on the screen
The original menu will be replaced by the new menu.
Save setup
3.4.5 Screen Layout
The display of the ventilator is a color TFT, which can display the monitoring and setting parameters,
waveforms, and alarm information on the screen. See Fig. 3-7.
The screen has three areas: information area, monitoring area, and parameter setup area.
The information area is divided into seven areas: Alarm Indication, Alarm Messages, Date, Time,
Power Source, Patient Type and Ventilation Mode.
3.4.5.1.1 Alarm Indication
The bell icon is displayed when an alarm is present. When it appears, the color of alarm bell is white.
Pressing the alarm mute key places an “X” on the alarm bell icon for 110 seconds. Displayed below
the bell icon is a countdown timer that will display remaining silence time.
3.4.5.1.2 Alarm Messages
Technical Messages and Functional Alarm will be displayed in the alarm message area. High priority
alarms will be red. Mid- and low-priority alarms will be yellow. Up to 2 alarm messages can be
displayed on the screen. For more details, refer to Chapter 9.
3.4.5.1.3 Power Source
Located the left of Ventilation Mode tile are two icons: AC and Battery. The display status of the
Battery includes: Full, Charging and Exhausted. The display status of the AC includes: AC power up
and AC power down.
AC power up: (1) The Battery icon is solid and at 100% capacity when fully charged. (2) If in charging,
the Battery icon shows capacity alternately.
AC power down: (1) The Battery icon shows the current capacity. (2) The Battery can supply power for
the machine for about 15 minutes when the low battery alarm sounds.
3.4.5.1.4 Date
The display mode of Date has three types: MM/DD/YY, DD/MM/YY or YY/MM/DD.
3.4.5.1.5 Time
The display mode of Time has 2 types: 12 hour or 24 hour format.
3.4.5.1.6 Patient Type
The patient type shall be displayed as Adult or Child. By highlighting (black text on white background)
the Patient type tile and pressing, the navigator knob shall toggle the patient type between Adult and
Child. Changing patient type is possible in STANDBY mode only. The default patient type when the
machine is powered up is Adult.
3.4.5.1.7 Ventilation Mode
Pressing the navigator knob when the Mode tile is highlighted displays the current ventilation mode in
white text on a black background, and the “MODE” label remains displayed in black text on a green
background. Rotating the navigator knob clockwise allows the user to scroll through the ventilation
mode selections: STANDBY, IPPV, PCV, SIMV, PS and MANUAL. Rotating the navigator knob
counterclockwise allows the user to scroll through the settings in the reverse order. The default mode
when the machine is powered up is standby.
The monitoring area has two parts: Patient waveform and parameters. See Fig. 3-7.
3.4.5.3 Parameters Setup Area
The parameter setup area contains 8 tiles of fixed vertical height and fixed horizontal width; each tile
contains the tile’s parameter value.
Each tile represents a location that may be highlighted by the navigator knob. Current parameter
settings are displayed in reverse video in the parameter window when a parameter tile is highlighted
(black text on white background). Rotating the navigator knob clockwise allows the user to increase
the setting while rotating the knob counterclockwise decreases the setting. When the selection
reaches its maximum or minimum setting, the minimum or maximum setting is displayed.
Pressing the navigator knob selects the parameter setting which is displayed as white text within a
black field. Parameter settings shall be in normal video unless the parameter tile has been selected or
highlighted. Parameter tiles are populated per table 3-1 below.
A timeout shall occur when a parameter tile is selected or changed but not confirmed for 15 seconds.
Upon a timeout, the parameter setting reverts back to the previously confirmed value.
The parameter timeout shall be available for the following items:
• Ventilation Mode
• Patient Type
Table 3-1
In the following table ”Para.” is equated with “Parameter”.
Vent Mode
Para.
Setup 1
Para.
Setup 2
Para.
Setup 3
Para.
Setup 4
Para.
Setup 5
Para.
Setup 6
Para.
Setup 7
Para.
Setup 8
STANDBY Blank Blank Blank Blank Blank Blank Blank Blank
IPPV VT Freq. I:E TP PEEP Blank Blank Blank
PCV P
SIMV VT Freq. T
PS Blank Freq
MANUAL /
COM A Interface Communication extension interface communicates with the IRMA.
COM B Interface Communication extension interface is used for connecting external
communication equipment (RS232 interface).
SIGNAL Interface Signal interface is used for connecting display screen to main unit.
When calibrating or carrying out other functions, an explanation of the process will be displayed on the
screen.
The following diagram is an example.
Step 1
When the MENU key is pressed, a “Menu” window is displayed on the screen.
Note: The “Menu” window opens in the last viewed menu.
The following example illustrates how to operate the settings.
Step 2
Turn the knob to select the Paw-Low option; the selected option will appear as black text on a green
background.
Turn the knob and select “Return” to set other parameters. Follow the above directions to select the
corresponding submenu.
Press the MENU key to exit the screen.
The default alarm setting in the manual mode is “Enabled”. To adjust the setting: