Heyer Pasithel User manual

A n e s t h e s i a S y s t e m
Operator’s Manual
Rev. 0.2 Draft – 12/09
I
NN OV AT IO N IN DES IG N AN D TEC HN OL OG Y
H E Y E R P a s i t h e c
Contents
1 Statement.......................................................................................................................................................................... 5
1.1 Manufacturer Responsibility...................................................................................................................................... 5
1.2 Security, Reliability and Operating Conditions........................................................................................................... 5
1.3 Return ...................................................................................................................................................................... 6
1.4 Details of the Manufacturer....................................................................................................................................... 6
2 Introduction........................................................................................................................................................................ 7
2.1 Intended Use............................................................................................................................................................ 7
2.1.1 Range of Use.................................................................................................................................................. 7
2.1.2 Contraindication .............................................................................................................................................. 7
2.2 Symbols....................................................................................................................................................................7
2.3 Definition, Abbreviation........................................................................................................................................... 10
3 System Components.........................................................................................................................................................11
3.1 Anesthetic System...................................................................................................................................................11
3.2 Breathing System ................................................................................................................................................... 17
3.2.1 Bellows Assembly Ports................................................................................................................................. 18
3.2.2 Ventilating Circulation.................................................................................................................................... 19
3.3 Vaporizer................................................................................................................................................................ 19
3.4 Anesthetic Ventilator............................................................................................................................................... 19
3.4.1 Front Panel.................................................................................................................................................... 20
3.4.2 Keys.............................................................................................................................................................. 20
3.4.3 Indicator ........................................................................................................................................................ 21
3.4.4 Navigator Knob.............................................................................................................................................. 21
3.4.5 Screen Layout............................................................................................................................................... 21
3.4.6 Rear Panel.................................................................................................................................................... 24
3.5 Menu ...................................................................................................................................................................... 25
3.5.1 Operating Guide............................................................................................................................................ 25
3.5.2 Menu Diagram............................................................................................................................................... 28
4 Operating Guide .............................................................................................................................................................. 34
4.1 Startup.................................................................................................................................................................... 34
4.1.1 System Self Test............................................................................................................................................ 34
4.1.2 Manual Leak Test .......................................................................................................................................... 36
4.1.3 Safety Valve Test........................................................................................................................................... 37
4.1.4 Automatic Leak Test...................................................................................................................................... 38
4.1.5 Compliance Test............................................................................................................................................ 39
4.1.6 Ventilation Mode Setup.................................................................................................................................. 41
4.1.7 Breathing Parameters Setup.......................................................................................................................... 41
4.2 Start Mechanical Ventilation.................................................................................................................................... 41
4.2.1 Stop Mechanical Ventilation........................................................................................................................... 41
4.3 Start Manual Ventilation.......................................................................................................................................... 42
4.3.1 Stop Manual Ventilation................................................................................................................................. 42
4.4 Shutdown ............................................................................................................................................................... 42
4.5 Waveforms ............................................................................................................................................................. 42
5 Pre-use Check List........................................................................................................................................................... 45
5.1 Pre-use Check List Procedure................................................................................................................................ 45
5.1.1 Check System............................................................................................................................................... 45
5.1.2 Main Failure Alarm Test................................................................................................................................. 46
5.2 Test Gas Supply Pipeline........................................................................................................................................ 46
5.3 Monitoring Flow Control.......................................................................................................................................... 46
5.3.1 Monitoring without Oxygen............................................................................................................................ 46
5.3.2 Monitoring with Oxygen................................................................................................................................. 48
5.4 Installing and Testing Vaporizer............................................................................................................................... 49
5.4.1 Installation..................................................................................................................................................... 49
5.4.2 Testing Vaporizer........................................................................................................................................... 49
5.5 Alarm Test.............................................................................................................................................................. 50
5.6 Breathing System Test............................................................................................................................................ 51
5.6.1 Check O2+ Button.......................................................................................................................................... 51
5.7 Ventilator Test......................................................................................................................................................... 51
6 Installation and Connection.............................................................................................................................................. 53
6.1 Install the Absorber Canister................................................................................................................................... 54
6.1.1 When to Replace Absorbent.......................................................................................................................... 54
6.1.2 Disassembling Absorber................................................................................................................................ 55
6.1.3 Filling Absorbent............................................................................................................................................ 55
6.2 Connecting Tubes and Lines................................................................................................................................... 55
6.2.1 Connect CO2 Monitor..................................................................................................................................... 56
6.2.2 Connect Anesthetic Agent Monitor................................................................................................................. 57
6.3 Connecting Gas and Electricity............................................................................................................................... 57
6.3.1 AC Inlet......................................................................................................................................................... 58
6.3.2 Aux. Mains Outlet.......................................................................................................................................... 58
6.3.3 Communication Port...................................................................................................................................... 59
6.3.4 Gas Inlet Module........................................................................................................................................... 59
7 Cleaning and Disinfecting................................................................................................................................................ 60
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7.1 Cleaning and Disinfecting prior to first Use ............................................................................................................. 60
7.2 Cleanable Breathing System Components.............................................................................................................. 61
7.3 Absorber Circle....................................................................................................................................................... 61
7.3.1 Disassembling Absorber Circle...................................................................................................................... 62
7.3.2 Bellows Assembly.......................................................................................................................................... 64
7.3.3 Regular Maintenance .................................................................................................................................... 68
8 User Maintenance............................................................................................................................................................ 69
8.1 Repair Policy .......................................................................................................................................................... 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
8.3.1 Replace O2 Sensor........................................................................................................................................ 71
8.3.2 Calibrate O2 Sensor....................................................................................................................................... 71
8.3.3 Calibrate CO2 Sensor.................................................................................................................................... 74
8.3.4 Calibrate Agents............................................................................................................................................ 76
8.4 Maintaining O2 Sensor............................................................................................................................................ 77
8.5 Replace the Fuses.................................................................................................................................................. 78
8.6 Maintaining Battery................................................................................................................................................. 78
8.7 The IRMA Probe..................................................................................................................................................... 79
9 Alarm and Troubleshooting .............................................................................................................................................. 80
9.1 About Alarm............................................................................................................................................................ 80
9.2 Alarm Message List ................................................................................................................................................ 80
9.2.1 Technical Alarm............................................................................................................................................. 81
9.2.2 Functional Alarm............................................................................................................................................ 83
9.3 Troubleshooting...................................................................................................................................................... 86
10 Specifications and Operation Theory........................................................................................................................... 87
10.1 Physical Specification............................................................................................................................................. 87
10.2 Environment Requirements..................................................................................................................................... 87
10.3 System’s Technical Specifications........................................................................................................................... 88
10.3.1 Gas Supply.................................................................................................................................................... 88
10.3.2 Flowmeter ..................................................................................................................................................... 88
10.3.3 Classification................................................................................................................................................. 88
10.4 Input/Output............................................................................................................................................................ 89
10.4.1 Electrical........................................................................................................................................................ 89
10.4.2 Pneumatic..................................................................................................................................................... 89
10.5 Electromagnetic Compatibility................................................................................................................................. 89
10.6 Operation Theory.................................................................................................................................................... 90
10.6.1 Pneumatic System......................................................................................................................................... 91
10.7 Breathing System Technical Specification............................................................................................................... 92
10.8 Anesthetic Ventilator Specifications......................................................................................................................... 92
10.8.1 Ventilator Performance.................................................................................................................................. 92
10.8.2 Ventilation Mode Settings .............................................................................................................................. 93
10.8.3 Ventilating Parameters Settings..................................................................................................................... 93
10.8.4 Gas Dynamics Performance.......................................................................................................................... 93
10.8.5 Setting Alarm Parameters.............................................................................................................................. 94
10.8.6 Monitoring Performance................................................................................................................................ 95
10.9 O2 Monitoring Specification..................................................................................................................................... 96
10.10 IRMA Probe Specification................................................................................................................................... 96
10.10.1 Intended Use............................................................................................................................................ 96
10.10.2 Technical Specification.............................................................................................................................. 97
10.10.3 System Assembly Instruction .................................................................................................................... 99
10.10.4 Zeroing Procedure.................................................................................................................................. 100
10.10.5 Alarms.................................................................................................................................................... 101
10.10.6 Cleaning................................................................................................................................................. 101
10.10.7 Preventive Maintenance Instructions....................................................................................................... 101
10.10.8 Warnings ................................................................................................................................................ 101
10.10.9 Cautions................................................................................................................................................. 101
11 Warranty ................................................................................................................................................................... 102
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1 Statement
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.
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1.3 Return
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
Carl-HEYER-Strasse 1-3 D-56130 Bad Ems / Germany Tel.: +49 (0) 2603 / 791-3 Fax: +49 (0) 2603 / 70424 E-Mail: info@heyermedical.de
Internet: http://www.heyermedical.de
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2 Introduction
2.1 Intended Use
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.
CAUTION: Indicates potential damage to equipment.
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Instead of illustrations, other symbols may also be utilized. Not all of them may necessarily appear in the equipment and manual. The symbols include:
AC: Alternating current
Type B Applied Part
DC: Direct current
Protective earth
Equipotentiality
Attention: consult accompanying document
Dangerous Voltage
Rotation in two directions
Movement in one direction
Right-turning movement
Lock
Movement in two directions
Left-turning movement
Unlock
Inspiration flow
Expiration flow
SN Serial Number O2+ O2 flush
Reservoir bag port
Fuse
Recyclable
Do not dispose in garbage basket.
View the reading on the top of the float.
Battery
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Bell cancel
Bell
△! Alarm, general
△!! Urgent alarm
EC Representative
0
0
00
PENDING
Variability of rotational adjustment
Non-ionizing electromagnetic radiation
Date of manufacture
Address of manufacturer
The system, with this label under the stipulations in the operating manual, complies with the requirements related from 93/42/EEC.
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2.3 Definition, Abbreviation
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
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3 System Components
3.1 Anesthetic System
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
system is in use.
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2
3
6
1
4
5
Figure 3-1 Front View
Legend:
1 User Interface (UI) 2 Arm
7 8
9
10 11
12 13
14
15
3 Aux. O2 Flowmeter 4 Aux. O2 Outlet 5 Breathing System 6 Flexible Top Light 7 Top Board 8 Flowmeter 9 Vaporizer Mount 10 Pneumatic and Electronic Switch 11 Main tray 12 Cylinder Pressure Gauges 13 Pipeline Pressure Gauges 14 Pull-out Writing Board 15 Drawers
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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.
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16
17
18
19
20
Figure 3-2 Side view
Legend:
16 GCX Mounting Rail 17 UI Signal Cable
21 22 23 24
18 Power Cable 19 Bellows Assembly 20 Absorber Circle Assembly 21 O2 Flush (O2+) 22 O2 Sensor Socket 23 Driving Gas Outlet – Switch 24 Driving Gas Outlet (CGO)
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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
kPa~600 kPa, flow: max. 90 L/min.
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25 26 27 28
29
Figure 3-3 Rear View
Legend:
25 Fuses 26 Aux. Power Sockets 27 Power Cable 28 Pipeline Gas Inlet Module 29 Gas Cylinder Yokes
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3.2 Breathing System
CAUTION: The breathing system used together with the anesthetic gas supply system
shall be in accordance with ISO 8835-2.
Figure 3-4 Breathing System
Legend:
1 Absorber Canister 2 Inspiratory Port 3 Inspiratory Valve 4 Expiratory Port 5 Expiratory Valve 6 Bellows 7 Airway Pressure Gauge 8 Handle 9 Bag Arm 10 APL valve 11 Test Block
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3.2.1 Bellows Assembly Ports
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Figure 3-5 Ports of bellows assembly
12 Exhaust Gas Port 13 Nut (drain plug): Loosen the nut to drain the water when absorbent (natrium lime)
in absorber has been commixed with water.
WARNING: Never connect exhaust gas port with sub-atmospheric system directly, as it
results breathing system leakage. Do not block exhaust gas port.
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3.2.2 Ventilating Circulation
Inhalation Primary Phase:
1 Exhalation Valve 2 Driving Gas 3 Gas of Patient Circuit 4 Pressure-Relief Valve 5 To Patient Circuit
Exhalation Primary Phase:
6 Driving Gas 7 From Patient Circuit
Exhalation End Phase:
8 Excess Gas from Patient
Circuit
3.3 Vaporizer
CAUTION: The vaporizer used with the anesthetic system shall comply with ISO
8835-4.
A checklist for the assembly of the anesthetic system from individual components shall be provided by the assembler of the anesthetic system.
For more detailed information about the vaporizer, please refer to the instructions for the vaporizer when used in the anesthetic system.
3.4 Anesthetic Ventilator
CAUTION: Anesthetic ventilator used in anesthetic system shall comply with ISO 8835-
5.
CAUTION: Monitoring conditions of this system: Ambient temperature: 25°C; Air
temperature: 25°C; Air humidity: 30%; Gas component : O2.
CAUTION: If the temperature of O2 sensor is lower than dew point of breathing gas,
vapor may coagulate on the surface of the sensor and oxygen concentration on the monitor may be lower than the practice value.
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3.4.1 Front Panel
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.
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3.4.3 Indicator
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.
Figure 3-7 Display screen layout
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3.4.5.1 Information 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.
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3.4.5.2 Monitoring Area
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 /
AUTO
Blank Blank Blank Blank Blank Blank Blank Blank
Freq. I:E Blank PEEP Blank Blank T
TARGET
TP PEEP P Trigger T
INSP
Blank Blank PEEP P Trigger T
MIN
SLOPE SLOPE SLOPE
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3.4.6 Rear Panel
H E Y E R P a s i t h e c
Figure 3-8 Rear Panel
Legend:
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.
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3.5 Menu
3.5.1 Operating Guide
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.
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Step 3
Press the knob to enter the setting; the background will appear as white text on a black background.
Step 4
Turn the knob to select the setting.
Step 5
Press the knob to save the setting; the background will appear as black text on a green background.
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Step 6
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:
Step 1: Select “Manual Mode.”
Step 2: Press the knob.
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Step 3: Turn the knob to display “Disabled.”
Step 4: Press the knob to save the “Disabled” setting.
The patient’s pressure, tidal, and asphyxiation alarms will not be displayed.
3.5.2 Menu Diagram
Figure 3-9 to Figure
3-13
displays each submenu in the Menu window. Some functions are optional.
When you press the MENU key, the “Menu” window is displayed on the screen.
Turn the knob to select a submenu.
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Figure 3-9 Alarm submenu (Page 1)
Figure 3-10 Alarm submenu (Page 2)
Figure 3-11 System submenu
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Figure 3-12 Calibrate submenu
Figure 3-13 Service submenu
CAUTION: A password is needed for the Service submenu. Only an authorized
engineer can access this submenu.
Figure 3-14 Gas submenu
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