The HAMILTON-G5 (hereafter referred to as the “device”) provides for intensive care ventilation of adult, pediatric and neonatal patients. This device must be operated only by trained personnel under the supervision of a licensed physician.

Fully closed-loop control.

Optional. On the HAMILTON-G5, you can install the world’s first and unique “fully closed-loop control” option. The device is intended only for adult and pediatric patients. With the HAMILTON-G5 this feature is referred to as INTELLiVENT

-ASV.

The physiological inputs come from the patient. The physician establishes targets and a strategy that are matched with the patient inputs, or what the INTELLiVENT

-ASV feature has automatically established. Then the ventilator automatically adjusts the ventilator settings (output) to get the patient within the target ranges. This automatic input and output continues, each influencing the other, resulting in a “closed-loop” system.

This feature is an improvement on older conventional devices that needed frequent manual intervention to maintain satisfactory ventilation. With this device, when you enter specific patient conditions (with INTELLiVENT

-ASV), the device uses the data received from sensors (CO

, flow, and SpO

) to make suitable automatic adjustments.

In closed-loop ventilation, information from the patient is collected and analyzed by the device in a continuous manner, adjusting the ventilator without frequent human intervention

(see Figure 1-1).

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Figure 1-1. Closed-loop ventilation

The device incorporates three main closed-loop control inputs:

• Automatic minute volume

• PEEP

• Automatic oxygen adjustment

As the situation requires, the operator can control them manually or automatically. This means the operator can let the adjustment controllers in the device determine oxygenation and ventilation for the patient solely on the basis of input from the sensors, or can intervene and determine treatment parameters derived from a clinical judgment.

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Figure 1-2. Controller conceptual design

Ventilation modes. This device offers a fully featured intensive care ventilator and uses conventional volume- and pressure-controlled and spontaneous modes, plus other advanced modes. The three conventional modes include:

• (S)CMV+ and SIMV+, delivered by an adaptive volume controller, combine the attributes of pressure-controlled with volume-targeted ventilation.

• P-CMV and P-SIMV are conventional pressure-controlled modes.

• SPONT is a conventional pressure-controlled mode.

The advanced modes include:

• ASV

(adaptive support ventilation) ensures the patient receives selected minute ventilation with the optimal breath pattern (lowest pressure and volume, optimal rate to minimize work of breathing and intrinsic PEEP).

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• Optional. INTELLiVENT

-ASV is a complete fully closed-loop ventilation solution for oxygenation and ventilation. It relies on ASV® to perform the first step to a fully closed loop solution. It covers all applications from intubation until extubation with simplicity for an early weaning.

• DuoPAP

and APRV are two related pressure-controlled modes where the operator sets two pressure levels and the patient can breathe spontaneously at either level. This is similar to having an upper and lower level of continuous positive airway pressure (CPAP). Both modes provide a combination of controlled and spontaneous breaths at either level, while letting the patient breathe freely throughout the entire breath cycle.

• NIV (noninvasive ventilation) and NIV-ST (spontaneous/ timed noninvasive ventilation) provide pressure support ventilation through a mask or other noninvasive interface.

• APVcmv and APVsimv are dual-control adaptive pressure ventilation modes that combine the attributes of pressure- and volume-controlled ventilation.

• nCPAP-PS provides pressure support ventilation through nasal interface for infants and neonates.

Patient triggered breaths may be flow triggered or pressure triggered. To reduce the patient’s work of breathing while on this device, the ventilator’s tube resistance compensation (TRC) feature offsets the resistance imposed by the tracheal (ET) or tracheostomy tube.

Monitor window.

The Monitoring window on the Cockpit offers the operator a clear view of the various displays showing the patient’s status during ventilation. The device offers a variety of monitoring capabilities. This window displays monitored parameters as numbers. To display individual data elements the

Monitoring window displays data in various forms. These include:

• Graphics (as a combination of real-time waveforms (curves))

• Dynamic loops

• Trend waveforms

• Intelligent Panels

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The Intelligent Panels allow the operator to select various elements for display, to include:

• Global Dynamic Lung/Haemodynamics with haemodynam-

ics-lung interactions (refer to section 8.2 and the

INTELLiVENT

-ASV manual) and show the current status of the lung and the activity and interaction of the patient's lungs and haemodynamics

• Vent status

The Vent Status displays the patient’s level of ventilator dependency. The Ventilation Horizon, Map and Guide allow the operators to view and keep track of the patient’s situation and the controllers’ actions. The data window provides this information in a numeric form. The device’s trending function lets you view up to 96 hours of previously collected data. You can freeze trend waveforms, real-time waveforms, or loops and use the cursor measurement function to determine a value at a selected point.

The Ventilation Map provides additional trending to get an overview in time of changes of physiological input and ventilator actions (modifications of setting) while in automatic ventilation. Additionally you can use the optional P/V Tool Pro

The P/V Tool Pro

is an automated function to measure and display the inflation and deflation pressure-volume curves of the lungs for determination of the lower and upper inflection points and the deflation limb derecruitment point.

The device’s monitored data is based on pressure and flow measurements collected by the HAMILTON MEDICAL proximal flow sensor, placed between the Y-piece and the patient and shows:

• Oxygen measurements by integrated oxygen monitor

• Proximal CO

measurement by the mainstream and sidestream CO

sensor

• Measurement of arterial O

saturation (SpO pulse oximeters

) by one or two

Optionally the pressure measurements can come from an auxiliary pressure sensing site (Paux) or from an esophageal pressure measurement.

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Alarms.

The operator can adjust the device alarms; they can be set individually or automatically using the Auto button shown in the Alarms window (refer to Chapter 10, Responding to alarms). You can switch OFF some alarms. Other alarms are considered critical and you cannot switch these alarms OFF.

This restriction helps ensures the patient’s safety.

User interface.

The device uses a combination of a 15 inch

(38 cm) touch screen display with a separate press-and-turn knob and key buttons. The key buttons (referred to as ‘keys’), when activated are a momentary backlit push buttons. Each element of the user interface is designed for ease of operation and offers ergonomic benefits.

Configuration.

The language, ventilation philosophy, alarms, default patient group, default mode and settings (for each patient group individually) and options and default graphics layout (for each patient group individually) can be preselected in the configuration mode.

Power.

The device is normally powered from AC mains, offering a voltage range of 100 to 240 Volt AC, 50/60 Hz. In the event of an AC power failure, the ventilator power source automatically switches to backup battery. A single optional, hot-swappable extended battery pack can power the device for a minimum of 1 hour, so multiple packs permit operation for a longer period. If the extended battery pack is not installed or is depleted, the internal battery provides power for a minimum of 1 hour.

Mounting.

Variations for mounting the device include:

• Trolley-mount version with space for a VENTILAIR II medical air compressor

• Version suitable for shelf or pendant

The Ventilation Cockpit is detachable and can be attached to the top, front, or side of the ventilation unit, or the device can be installed on a hospital rail system.

Nebulization function.

The ventilator offers pneumatic and micropump nebulization (using Aerogen® technology). The nebulization function allows the device to power an Aeroneb® nebulizer or a pneumatic nebulizer connected to the pneumatic nebulizer outlet.

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The P/V Tool Pro

feature is an automated process that lets you measure and display the inflation and deflation pressurevolume curves of the lungs for determination of inflection points. This option is preinstalled on the device.

The Minute Volume Adjustment feature enables automatic control of %MinVol (Ventilation adjustment).

The PEEP Adjustment feature enables automatic control of

PEEP (as part of the Oxygenation Adjustment).

The Oxygen Adjustment feature enables automatic control of Oxygen.

The CO

sensor with an associated MinVol controller feature continuously monitors airway carbon dioxide and reports

EtCO

and inhaled/exhaled CO

for display and alarm purposes.

The SpO

sensor is a sensor attached to the patient which continuously monitors the oxygen saturation of the blood.

The neonatal feature lets you ventilate neonates.

Added features.

These additional features are available for the device:

• The communications interface lets you monitor the patient from a remote workstation, transmits alarms through a nurse call relay system, and transmits I:E timing signals. This feature is preinstalled on the device.

• The power strip (multiple-socket outlet, MSO) provides

AC power to the VENTILAIR II medical air compressor, and a humidifier.

• Integrated humidifier.

With the use of the HAMILTON-

H900 humidifier, you can monitor and control humidifier settings directly from the ventilator screen. The HAMILTON-

H900 also provides a breathing circuit with integrated heater wires and temperature probe, improving ease of use.

In addition, all humidifier data can be transmitted to any connected PDMS. You can still use other humidifiers, without full system integration.

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• nCPAP-PS.

This feature applies nasal continuous positive airway pressure with additional pressure support to neonates.

• The heliox feature provides for heliox delivery, with adjustments of inspired and exhaled volumes.

1.2 Functional description

The following paragraphs describe the operation of the device hardware.

1.2.1 System overview

In Figure 1-3 the conceptual overview of the HAMILTON-G5

device is shown. The principle functions are to ventilate the patient and implement the physician’s ventilation strategy for a particular patient.

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Figure 1-3. HAMILTON-G5 system overview

The important element in the system operations is the exchange of information between the device and the patient and the operator and the device. This interaction provides for both the patient’s needs and permits the operator to control the system. As the device works, the operator has the tools to execute the orders of the physician. The following list describes in general terms the basic elements and features of the device.

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• The device acts as an electronically controlled pneumatic ventilation system. Power comes from an AC source with internal battery backup. There is an optional extended battery backup available to order which protects against power failure or unstable power and aids in intra-hospital transport.

• The device’s pneumatic system delivers gas, while its electrical systems control the pneumatics, monitor alarms, and distribute power.

• When you input instructions or settings you use the device’s microprocessor system accessing features by way of a touch screen, push button keys, and a press-and-turn knob. Your inputs become instructions for the device’s pneumatics to deliver precisely controlled gas mixtures to a patient. The device receives inputs originating from several sources such as sensors within the ventilator. As the device receives this monitored data, it adjusts gas delivery to the patient. The graphic user interface (GUI) displays this data via the touch screen display using various windows.

• The device’s microprocessor system controls gas delivery and monitors the patient. The gas delivery and monitoring functions are cross-checked by an alarm controller. This cross-check feature helps prevent simultaneous failure of these two main functions and minimizes the possible hazards of software failure.

1.2.2 Gas supply and delivery

The device uses high-pressure oxygen, air and heliox from wall supplies, cylinders, or the VENTILAIR II medical air compressor

(Figure 1-4). These gases enter though water traps with inte-

grated high-efficiency particle filters at the gas inlets.

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Figure 1-4. Gas delivery in the device

Within the ventilator, the gas enters the device’s pneumatic system. An electronic mixer combines oxygen and air/heliox according to the user-set concentration. This mixture fills a reservoir, which is maintained within a prescribed pressure range.

As the gas mixture is delivered to the patient, the pressure drops, and the reservoir is refilled.

Gas in the reservoir supplies the inspiratory valve. The microprocessor controls the size of the inspiratory valve opening and the length of time it is open to meet the user settings. The opening of the valve is then adjusted based on feedback in the form of monitored data.

The device delivers gas to the patient through the inspiratory limb breathing circuit parts, including possibly the inspiratory filter, flex tubes, the humidification system, a water trap, the

Y-piece, the CO

sensor and the flow sensor. An internal high pressure valve supplies the nebulizer flow (oxygen).

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Gas exhaled by the patient passes through the expiratory limb breathing circuit parts, including flex tubes, the flow sensor, the Y-piece, a humidifier or HME, and an expiratory valve cover and membrane. Gas is vented through the expiratory valve cover such that no exhaled gas comes into contact with any internal components of the device. Measurements taken at the flow sensor are used in the pressure, flow, and volume measurements.

An oxygen cell (sensor) monitors the oxygen concentration of the gas to be delivered to the patient, which is the same as the reservoir concentration. This galvanic cell generates a voltage proportional to the partial pressure of oxygen in the delivered gas. Neither the pressure nor the humidity of the inspired gas affects the oxygen measurement. The ventilator alarms if the monitored oxygen concentration is more than 5% above or below the oxygen setting, less than 18%, or more than 105%.

The mainstream/ sidestream CO

sensor continuously monitors carbon dioxide and reports EtCO

and inhaled/exhaled CO

The SpO

sensor attached to the patient continuously monitors the saturation of hemoglobin with oxygen in the blood and a plethysmographic curve which is used to assess heart-lung interaction. A second sensor may be used to secure the SpO

2 information.

The operations of the inspiratory and expiratory valves are coordinated to maintain system pressure levels.

1.2.3 Gas monitoring with the flow sensor

The device accurately measures flow, volume, and pressure in the patient’s airway with the HAMILTON MEDICAL flow sensor.

This proximal flow sensor lets the device sense even weak patient breathing efforts. Between its highly sensitive flow trigger and fast response time, the device helps minimize the patient’s work of breathing.

The flow sensor contains a thin, diamond-shaped membrane within the outer housing and has a pressure port on either side. The membrane allows bidirectional flow through its vari-

able orifice (Figure 1-5).

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Figure 1-5. Flow sensor

The area of the orifice changes depending on the flow rate.

It opens progressively as the flow increases, creating a pressure drop across the orifice. The pressure difference is measured by a high-precision differential pressure sensor inside the ventilator. The pressure difference varies with flow (relationship determined during flow sensor calibration), so the patient’s flow is determined from the pressure drop. The device calculates volume from the flow measurements.

The flow sensor is highly accurate even in the presence of secretions, moisture, and nebulized medications. The device continuously flushes the sensing tubes with mixed gases (rinse flow) to prevent blockage.

1.3 Physical description

1.3.1 Breathing circuits and accessories

NOTE:

To ensure proper ventilation operation, use parts and

accessories specified in Table 1-1 only.

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Figure 1-6 shows the device with its breathing circuit and

accessories. See Appendix H, Parts and accessories, for details on breathing circuits and accessories supplied by HAMILTON

MEDICAL. See Table 1-1 for information on other compatible

breathing circuits and accessories.

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Figure 1-6. Ventilator with accessories

1 Ventilation Cockpit

2 Breathing circuit connections

3 Trolley (option)

4 Breathing circuit

5 Support arm

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Table 1-1. Compatible parts and accessories

Part Use only

Patient tubing circuit

Inspiratory filter • HAMILTON MEDICAL reusable inspiratory bacteria filter

• Other filters that have a 22 mm female conical inlet connector, a 22 mm male conical outlet connector, and that meet the ventilator breathing system specifications in Appendix A, Specifications.

Humidification device

• HAMILTON MEDICAL reusable patient tubing circuits

• Other circuits that meet the ventilator breathing system specifications in Appendix A, Specifications.

• HAMILTON-H900 humidifier, which offers full integration with the ventilator (see Chapter 2, Preparing for ventilation, and Chapter 3, Hardware options)

• HAMILTON-HC 180, 200 humidifier

• Any active humidifier with a flow capability of up to

120 l/min

• Heat and moisture exchanger

Flow sensor

CAUTION

Use HAMILTON MEDICAL parts only.

Expiratory valve membrane and cover

Compressor

Use HAMILTON MEDICAL parts only. See Appendix H,

Parts and accessories.

HAMILTON MEDICAL VENTILAIR II medical air compressor

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Table 1-1. Compatible parts and accessories

Part

Nebulizer

SpO

pulse oximeters

sensor

airway adapter

Compact-

Flash® and

USB storage device

Use only

• Internal nebulizer: Pneumatic nebulizer specified for approximately 6 to 7 l/min

• Integrated Aeroneb® nebulizer: The integrated

Aeroneb® nebulizer system consists of the

Aeroneb® nebulizer and the Aeroneb® module. It is used during the mechanical ventilation of patients to nebulize physician-prescribed medications which are approved for use with a general purpose nebulizer.

For the Aeroneb®, reusable as well disposable consumables are available.

• HAMILTON MEDICAL CAPNOSTAT 5™ mainstream sensor

• HAMILTON MEDICAL LoFlo™ sidestream sensor

• Masimo SpO

pulse oximeter with accessories

• Masimo Rainbow SET options for use with Masimo

SpO

pulse oximeter (offers additional monitoring parameters)

• Nihon Kohden SpO

pulse oximeter with accessories

For details on SpO

Pulse oximetry.

pulse oximeters, see Appendix F,

• Philips CAPNOSTAT 5 mainstream airway adapter

• Philips CO

sidestream airway adapter/sampling kits

HAMILTON MEDICAL parts recommended

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1.3.2 Ventilation cockpit

The screen of the Ventilation Cockpit (interaction panel),

shown in Figure 1-7 and Figure 1-8, provides information

about the status of the patient and ventilator. The basic screen

(Figure 1-9) is the default screen. You can directly access all the

windows for mode, controls, alarms, and monitoring from the basic screen, even during normal ventilation. The special function keys at the bottom of the Cockpit are typically backlit in white. When the key is pressed and the selected function is active, the color of the backlight changes. For example, during the 2-minute alarm silence, the alarm silence key turns red.

Figure 1-7. Ventilation Cockpit front view

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1 Touch screen

2 Alarm lamp.

Lights when an alarm is active. Red = high-priority alarm. Yellow = medium- or low-priority alarm. Blue = heliox application.

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3 Press-and-turn (P&T) knob.

Selects and adjusts ventilator settings and selects monitored data.

4 Print screen key.

Saves a JPG file of the current ventilator screen to a CompactFlash or USB storage device.

5 Standby key.

Activates the standby (waiting) mode. When the mode is activated, the standby activated screen is displayed. For

details, see Section 12.1.

6 Nebulizer on/off key.

Activates nebulization during the breath phases and for the duration selected during configuration. You can switch nebulization off earlier by pressing the key again.

7 Screen lock/unlock key.

Prevents inadvertent touch screen entries. By touching the locked screen an acoustic BEEP sounds and a notice “screenlock active” appears.

8 Alarm silence key.

Silences the ventilator audible alarm for

2 min. Pushing a second time cancels the alarm silence.

9 O2 enrichment key/suctioning tool.

Adults and Pediatric: Delivers 100% oxygen for 2 min. The backlighting changes color to green and the actually applied oxygen concentration is displayed on the oxygen control

(green). Pushing the key a second time or manually changing the oxygen concentration ends the 100% oxygen enrichment period.

Neonatal option:

Delivers 125% of the last oxygen setting for

2 min. The backlit color changes to green and the currently applied oxygen concentration is displayed on the oxygen knob

(green). Pushing the key a second time or manually changing the oxygen concentration ends the oxygen enrichment period.

For further information on the suctioning tool, see

Section 12.3.

10 Manual breath key.

Triggers a mandatory breath when pressed and released during exhalation. The mandatory breath is delivered using the currently active settings.

1. In Japan, 100% oxygen is also applied for the neonatal option

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Figure 1-8. Ventilation Cockpit rear view

1 CompactFlash connector. Used to save a JPG file of the current ventilator screen to CompactFlash storage device and for software updates.

NOTE:

The CompactFlash connector is for data export and program update only! HAMILTON MEDICAL Compact-

Flash is recommended.

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1 General information

2 USB device. Used to save a JPG file of the current ventilator screen to USB storage device and for software updates.

NOTE:

The USB device is for data export and program update only! HAMILTON MEDICAL USB memory is recommended.

3 DVI-I connector. Outputs video signals to digital display devices such as flat panel LCD computer displays and digital projectors.

CAUTION

The DVI-I connector for an external XGA monitor is for training purposes. It is not intended for use on the patient side.

4 Ventilation Cockpit tilt assembly

5 Ventilation Cockpit cable assembly

6 Ventilation Cockpit swivel assembly

7 Storage for Ventilation Cockpit cable assembly

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Figure 1-9. Default screen

1 Alarm silence countdown.

Shows when alarm silence has been activated. Displays the remaining silence time.

2 Message bar . Displays alarm and other messages for user guidance and status report. See Chapter 10, Responding to alarms, for further information.

3 Graphic display.

Real-time waveforms (curves), loops, trend waveforms, or Intelligent Panel, depending on user selection.

4 I-icon.

Displayed when alarms have been activated, but not reviewed. Click the icon to display the Alarm buffer.

5 Date and time.

Current date and time.

6 INTELLiVENT tab . Opens the INTELLiVENT window. (Available as an option.)

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7 Access to Patient, Additions, and Mode windows . Patient window allows you to view/update patient data, and view the ventilator timer; Additions window gives access to sigh and tube resistance compensation (TRC); Mode window allows you to update the ventilation mode.

8 Active mode, patient type, weaning, recruitment and apnea backup status (if active).

9 Freeze button.

Lets you freeze or unfreeze graphics.

10 Trend button.

Additional option to display trends in

INTELLiVENT

-ASV. (Available as an option.)

11 View cursor.

Changes between oxygenation and ventilation horizons, maps and guides.

12 IntelliCuff button.

Access to automatic cuff pressure controller settings. (Available as an option.)

13 Heliox icon.

Indicates the heliox option is active.

14 Controller buttons for ventilation (%MinVol) and oxygenation (PEEP/CPAP and oxygen). When these are functioning automatically they pulse with a blue circle.

15 Input power.

Shows all available power sources. The framed symbol indicates the current source (AC = mains, INT = internal battery, EXT = extended battery pack). The green part of the battery symbols shows the level of battery charge, while the red shows the level of discharge. The AC mains symbol and the internal battery symbol are always displayed, but are crossed out if that source is not available. The extended battery symbol is shown only if the external battery is installed.

16 Humidifier button.

Provides quick access to the Humidifier visualization window (same as touching System > Humidifier ). (Available as an option.)

17 Window tabs.

Open the associated windows.

18 Secondary monitoring parameters (SMP).

A group of numeric patient data. You can display other groups using the group scrolling arrows. The data is divided into groups for display purposes.

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19 Main monitoring parameters (MMP).

Five numeric parameters set during configuration.

20 Alarm limits.

Upper and lower alarm limits, where applicable, for each MMP.

1.3.3 Ventilation unit

Figure 1-10 and Figure 1-11 show the patient breathing circuit

connections and other important parts of the ventilation unit.

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Figure 1-10. Front of ventilation unit (patient breathing circuit connections)

1 Paux connector.

Connects to an auxiliary pressure sensing site, for use as the pressure input in addition to the proximal flow sensor measurement. By default there is no rinse flow through the Paux connector.

Pneumatic NEBULIZER connector

FLOW SENSOR connection.

Always attach the blue tube to the blue connector and the clear tube to the silver connector. The blue tube should always be toward the patient.

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Cuff pressure controller with luer connection

Expiratory valve cover and membrane

From patient port.

The expiratory limb of the patient breathing circuit and the expiratory valve are connected here.

Exhaust port.

Expiratory valve cover opening to ambient air.

Ventilation unit LED panel.

Redundant display of ventilator status. It is intended to provide status information when the Ventilation Cockpit is disconnected, as follows:

An emergency situation exists (red LED)

The ventilator is connected to AC mains power

(blue LED)

Power switch is on (green LED)

9 Sensor or Aeroneb option module with connector

Inspiratory filter

To patient port (inspiratory outlet). The inspiratory filter and the inspiratory limb of the patient breathing circuit are connected here.

1. Not available in all markets.

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Figure 1-11. Rear of ventilation unit

1 Fan filter

2 Serial number label

3 Power switch

4 High-pressure air inlet, DISS or NIST fitting

5 High-pressure oxygen inlet DISS or NIST fitting (for heliox

option, see section 2.13)

6 High-pressure gas water trap with filter

7 Reservoir pressure relief valve exhaust

8 Communications interface connectors (COM1, COM2)

9 Power cord with retaining clip

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10 Potential equalization terminal

11 Oxygen cell with cover

12 Fuse drawer; holds two mains fuses

13 Ventilation Cockpit cable connector

14 Power receptacle

1.4 Symbols

Table 1-2 describes the symbols used on the back panel.

Symbol

Table 1-2. Symbols

Definition

Fuse

Power switch on position

Terminal for the connection of a potential equalization conductor

Manufacturer

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Symbol

Table 1-2. Symbols

Definition

Date of manufacture

Classification of Medical Electrical Equipment, type B, as specified by IEC 60601-1.

Classification of Medical Electrical Equipment, type BF, as specified by IEC 60601-1.

Refer to the operator’s manual for complete information.

CE Marking of Conformity, seal of approval guaranteeing that the device is in conformance with the Council Directive 93/42/EEC concerning medical devices.

The CSA marks with the indicators “C“and “US“ mean that the product complies with Canadian requirements and the requirements of US authorities for safety.

Dispose according to Council Directive 2002/96/EC or

WEEE (Waste Electrical and Electronic Equipment.

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Symbol

Table 1-2. Symbols

Definition

Serial number

This way up

Fragile, handle with care

Keep dry