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HAMILTON-T1. Operator's Manual (2022) - page 8

15 Specifications

Parameter

Configuration range

Default setting

Setups

This information applies to the default adult Quick setup configurations.

You can also specify default neonatal settings.

For information about CPR configuration settings, see Table 15-15.

Mode Ctrls

Vt/IBW (Adult/Ped): 5 to 12 ml/kg

Adult/Ped: 8 ml/kg

Vt/Weight (Neonatal): 5 to 12 ml/kg

Neonatal: 5 ml/kg

Vent Status

Oxygen¹⁴³

22 to 80

40

(%)

PEEP¹⁴⁴

1 to 20

8

(cmH2O)

ΔPinsp

1 to 50

10

(cmH2O)

%MinVol high

100 to 250

150

(%)

%MinVol low

25 to 99

50

(%)

RSB high

50 to 150

100

(1 / (l*min))

RSB low

0 to 49

10

(1 / (l*min))

%fSpont¹⁴⁵

0 to 99

75

(%)

Connectivity

More

Communication protocol:

GALILEO

Hamilton, GALILEO compatible, Hamilton P2,

Philips VueLink Open, DrägerTestProtocol, Hamil-

ton Block Protocol

¹⁴³ The low Oxygen setting is always 21%.

¹⁴⁴ The low PEEP setting is always 0 cmH2O.

¹⁴⁵ The high %fSpont setting is always 100%.

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15 Specifications

15.10 ASV technical data

Table 15-16. ASV technical data

ASV-related data

Specifications

ASV-related operator settings

%MinVol

25% to 350%

Patient height

Adults: 130 to 250 cm / 50 to 100 in

Pediatric: 30 to 150 cm / 12 to 60 in

Internal calculations

IBW

In kg, calculated based on patient height and

sex (see Section 5.3)

MinVol (target)

In l/min, target minute volume is calculated as:

IBW (in kg) x NormMinVent (in l/kg/min) x

%MinVol/100

where NormMinVent is the normal minute

ventilation from Figure 7-18.

fTotal

In b/min

VDaw

2.2 ml/kg IBW

Vt (target)

MinVol / f(target)

ASV graph

Status of patient (numerical)

fControl, fSpont, ΔPinsp

Graphics display (curve)

fTotal versus Vt, target value, current value,

safety window

Alarms

All alarms are functional except apnea alarms

See Chapter 9

Special

ASV: Cannot meet target alarm

Performance specifications

Response time (90% of steady state)

< 1 min (typical)

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ASV technical data

15

ASV-related data

Specifications

Overshoot/undershoot

< 25%

Maximum pressure change per breath

3 cmH2O

Settling time

< 120 seconds

Steady state deviation

< 10%

Lung-protective rules

Minimum Vt

4.4 ml/kg x IBW

Maximum Vt depends on

The maximum tidal volume in ASV is the small-

est value of the following conditions:

• V / Pmedian x (P ASV limit - PEEP)

• 15 ml/kg x IBW

• 1.5 x high Vt alarm limit

Maximum machine rate

The maximum rate in ASV is the smallest value

of the following conditions:

• 1 / (minimum inspiratory time + minimum

expiratory time)

• MinVol (target) / Minimum Vt

• 60 b/min

Minimum target rate

7.5 to 15 b/min (depending on IBW)

Minimum ΔPinsp

5 cmH2O above PEEP/CPAP

Maximum ΔPinsp

High Pressure alarm limit - 10 cmH2O - PEEP

Minimum inspiratory time (TI)

0.5 s or RCexp, whichever is longer

Maximum inspiratory time (TI)

IBW = 30 kg: 2 seconds

IBW < 30 kg: 1.5 seconds

Minimum expiratory time (Te)

0.5 s or 2 x RCexp, whichever is longer

Maximum expiratory time (Te)

12 seconds

I:E range

1:4 to 1:1

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15 Specifications

15.11 Ventilator breathing

system specifications

Table 15-17. Ventilator breathing system specifications

Parameter

Specification

Resistance¹⁴⁶

Adult/Ped circuit (ID15 to

≤ 0.06 cmH2O/l/min

ID22, flow of 30 l/min)

Adult/Ped circuit (ID12 to

≤ 0.12 cmH2O/l/min

ID15, flow of 15 l/min)

Neonatal circuit (ID09 to

≤ 0.12 cmH2O/l/min

ID12, flow of 15 l/min)

Compliance¹⁴⁶

Adult/Ped circuit (ID15 to

≤ 4.0 ml/cmH2O at 60 cmH2O ± 3 cmH2O

ID22)

Adult/Ped circuit (ID12 to

≤ 4.0 ml/cmH2O at 60 cmH2O ± 3 cmH2O

ID15)

Neonatal circuit (ID09 to

≤ 1.5 ml/cmH2O at 60 cmH2O ± 3 cmH2O

ID12)

Volume¹⁴⁶

Adult circuit (ID19)

2.4 l

Neonatal circuit (ID10)

~ 0.9 l

Bacteria filter

Particle size

Captures particles of 0.3 mm (micron) with

> 99.99% efficiency

Resistance

< 2.0 cmH2O at 60 l/min

Flow sensor dead

Adult/pediatric

< 9 ml (single use)

space

< 11 ml (reusable)

Neonatal

< 1.3 ml

¹⁴⁶ As tested, the inspiratory limb includes ambient valve, flow sensor, inspiratory filter, inspiratory tubes, and humidifier. It does not

include the heating wire. The expiratory limb includes expiratory tubes, water trap, expiratory valve, and flow sensor.

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Technical performance data

15

15.12 Technical performance

data

Table 15-18. Technical performance data

Description

Specification

Patient ideal body

3 to 139 kg (6.6 to 306 lb)¹⁴⁷

weight (IBW, deter-

mined from Pat.

height setting)

Weight (used for

0.2 to 30 kg (0.44 to 66 lb)

neonatal patients)

Inspiratory pressure

0 to 60 cmH2O

Maximum limited

60 cmH2O

pressure

Maximum working

Adult/Ped: 60 cmH2O (total inspiratory pressure). Ensured through pres-

pressure

sure limiting

Neonatal: 45 cmH2O (limitation depending on frequency)

Maximum inspiratory

260 l/min (120 l/min with 100% O2)

flow

Tidal volume/target

Adult/Ped: 20 to 2000 ml

tidal volume

Neonatal: 2 to 300 ml

Minute volume

Up to 60 l/min

capability

Inspiratory time

0.2 to 3 seconds

(spontaneous breaths)

Minimum expiratory

20% of cycle time; 0.2 to 0.8 seconds

time

Automatic expiratory

Adult/Ped: Fixed at 3 l/min

base flow

Neonatal: Fixed at 4 l/min

Means of inspiratory

Flow trigger control

triggering

Oxygen mixer

± (volume fraction of 2.5% + 2.5% of actual reading)

accuracy

¹⁴⁷ Actual patient weight can be much greater (e.g., 300 kg or 661 lb).

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15 Specifications

Description

Specification

CO2 measurement

Two types of CO2 sensors are supported: CAPNOSTAT-5 (mainstream)

and LoFlo (sidestream)

Type: CAPNOSTAT 5

Sensing position:

Mainstream

Principle of operation:

Nondispersive infrared (NDIR) technology

Measurements:

See Table 15-10

Rise time:

< 60 ms

Initialization time:

Capnogram displayed in < 15 seconds at an

ambient temperature of 25°C, full specifi-

cations within 2 minutes

Sampling frequency:

100 Hz

CO2 calculation

BTPS

method:

CO2 stability¹⁴⁸:

Short-term drift: ≤ 0.8 mmHg over 4 hours

Long-term drift: Accuracy specification main-

tained over 120 hours

CO2 noise (rms):

≤ 0.25 mmHg at 7.5% CO2

Operating condi-

Temperature: 0°C to 45°C (32°F to 113°F)

tions¹⁴⁹:

Humidity: 10% to 90% relative humidity, non-

condensing

Pressure (barometric + airway pressure): 400

mmHg to 850 mmHg

Shipment/storage

Temperature: -40°C to 70°C (-40°F to 158°F)

conditions:

Humidity: < 90% relative humidity, noncon-

densing

Pressure (atmospheric): 375 mmHg to

795 mmHg

¹⁴⁸ Neither humidity (noncondensing) nor cyclical pressures have any effect on the stated accuracy of the device.

¹⁴⁹ The stated operating conditions apply to both continuous and transient operation of the sensor within the limitations specified in

the Intended use.

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Technical performance data

15

Description

Specification

CO2 measurement

Type: LoFlo

Sensing position:

Sidestream

Principle of operation:

Nondispersive infrared (NDIR) technology

Measurements:

See Table 15-10

Rise time:

200 ms for on-airway adapter kits

Additional 30 ms for sidestream sampling can-

nulas.

Additional 80 ms for extension line and dehu-

midification tubing.

Initialization time:

Capnogram displayed in < 20 seconds at an

ambient temperature of 25°C, full specifi-

cations within 2 minutes

Sampling frequency:

100 Hz

Gas sampling rate:

50 ml/min ±10 ml/min

CO2 calculation

Actual, corrected for temperature and pressure

method:

in the sample cell

CO2 stability¹⁴⁸:

Short-term drift: ≤ 0.8 mmHg over 4 hours

Long-term drift: Accuracy specification main-

tained over 120 hours

CO2 noise (rms):

≤ 0.25 mmHg at 5% CO2

Sensing position:

Inside ventilator

Measurements:

See Table 15-10

Operating condi-

Temperature: 0°C to 40°C (32°F to 104°F)

tions¹⁴⁹:

Humidity: 10% to 90% relative humidity, non-

condensing

Pressure (barometric + airway pressure):

400 mmHg to 800 mmHg

Shipment/storage

Temperature: -40°C to 70°C (-40°F to 158°F)

conditions:

Humidity: 10% to 90% relative humidity, non-

condensing

Pressure (atmospheric): 400 mmHg to

800 mmHg

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15 Specifications

Component

Requirement

Figure 15-4. Oxygen consumption as a function

of minute volume, oxygen set to 100%

Electrical

An electrical supply failure

supply failure

must be detected and the

operator informed.

Internal elec-

The remaining battery

trical power

capacity must be monitored

source nears

and qualitatively indicated.

depletion

At least 5 minutes prior to

depletion, an alarm must be

issued.

MinVol (l/min)

15.12.3 Estimated oxygen consump-

tion relative to minute volume

1

Oxygen consumption of the device. This

accounts for base flow

The following graphs show oxygen

consumption as a function of minute

2

Compressible volume in the breathing cir-

volume.

cuit.

The compressible volume is a significant

Figure 15-3. Oxygen consumption as a function

factor that must be taken into account for

of minute volume, oxygen set to 60%

smaller patients due to smaller tidal

volumes. See Section 3.4.2.1.

3

Oxygen volume delivered to patient.

MinVol (l/min)

1

Oxygen consumption of the device. This

accounts for base flow

2

Compressible volume in the breathing cir-

cuit.

The compressible volume is a significant

factor that must be taken into account for

smaller patients due to smaller tidal

volumes. See Section 3.4.2.1.

3

Oxygen volume delivered to patient.

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15

Functional description of ventilator system

15.13 Functional description of

When a condition is critical enough to

possibly compromise safe ventilation, the

ventilator system

HAMILTON-T1 is placed into the Ambient

state. The inspiratory channel and expira-

The HAMILTON-T1 is an electronically-

tory valves are opened, letting the patient

controlled pneumatic ventilation system

inspire room air through the inspiratory

with an integrated air compressing

channel and exhale through the expiratory

system. It runs on AC or DC power with

valve.

battery backup to protect against power

failure or unstable power and to facilitate

The HAMILTON-T1 has several means to

intra-hospital transport.

ensure that safe patient or respiratory

pressures are maintained. The maximum

The user provides inputs to the

working pressure is ensured by the high

HAMILTON-T1 microprocessor system

pressure alarm limit. If the set high pres-

through a touch screen, keys, and a press-

sure limit is reached, the ventilator cycles

and-turn knob. These inputs become

into exhalation. The ventilator pressure

instructions for the HAMILTON-T1’s pneu-

cannot exceed 60 cmH2O.

matics to deliver a precisely controlled gas

mixture to the patient. The ventilator

receives inputs from the proximal flow

15.13.1 Gas supply and delivery

sensor and other sensors within the venti-

lator. Based on this monitored data, the

The HAMILTON-T1 uses room air and

ventilator adjusts gas delivery to the

high- or low-pressure oxygen (Figure

15-5). The use of medical oxygen is

patient. Monitored data is also displayed

mandatory. Air enters through a fresh gas

by the graphical user interface.

intake port and is compressed together

The ventilator’s microprocessor system

with the oxygen by the blower. Oxygen

controls gas delivery and monitors the

enters through a high¹⁵³- or low¹⁵⁴-pres-

patient. The gas delivery and monitoring

sure inlet.

functions are cross-checked by an alarm

controller. This cross-checking helps mini-

Figure 15-5. Gas delivery in the HAMILTON-T1

mize the possible hazards of software fail-

HAMILTON-T1

ure.

High-pressure

A comprehensive system of visual and

oxygen*

O2 mixer valve

Breathing circuit

audible alarms helps ensure the patient’s

Low-pressure

oxygen*

safety. Clinical alarms can indicate an

Flow sensor

abnormal physiological condition. Techni-

Air

Blower

cal alarms, triggered by the ventilator’s

self-tests including ongoing background

checks, can indicate a hardware or soft-

Expiratory valve

Patient

ware failure. In the case of some technical

To room air

alarms, a special safety ventilation ensures

basic minute ventilation while giving the

* only one oxygen source required

operator time for corrective actions.

¹⁵³ High-pressure oxygen: Maximum allowed pressure is 600 kPa.

¹⁵⁴ Low-pressure oxygen: Maximum allowed pressure is 600 kPa, maximum allowed flow 60 l/min.

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15 Specifications

Within the ventilator, the gas enters the

15.13.2 Gas monitoring with the flow

ventilator’s pneumatic system. If high-

sensor

pressure oxygen is supplied, a mixer valve

provides for the operator-set concentra-

The HAMILTON-T1 accurately measures

tion. If low-pressure oxygen is supplied,

flow, volume, and pressure in the patient’s

the delivered oxygen concentration is

airway with the Hamilton Medical flow

determined by the flow of the oxygen

sensor. This proximal flow sensor lets the

source.

ventilator sense even weak patient breath-

ing efforts. Between its highly sensitive

Gas is supplied to the patient through the

flow trigger and fast response time, the

blower. The microprocessor controls the

ventilator helps minimize the patient’s

speed of the blower and the length of

work of breathing.

time it runs to meet the user settings.

The flow sensor contains a thin membrane

The ventilator delivers gas to the patient

within the outer housing and has a pres-

through the inspiratory limb breathing cir-

sure port on either side. The membrane

cuit parts, which may include one or more

allows bidirectional flow through its vari-

of the following: inspiratory filter, flex

able orifice.

tubes, humidification system, water traps,

Adult/Ped

Y-piece, and flow sensor. An internal

pneumatic nebulizer supplies the nebulizer

flow.

Gas exhaled by the patient passes through

the expiratory limb breathing circuit parts,

Neonatal

which includes one or more of the follow-

ing: flex tubes, flow sensor, Y-piece, and

expiratory valve set. Gas is vented through

the expiratory valve housing such that no

exhaled gas comes into contact with any

internal components of the ventilator. The

The area of the orifice changes depending

expiratory valve is heated to reduce the

on the flow rate. It opens progressively as

possibility of rainout in the expiratory limb.

the flow increases, creating a pressure

drop across the orifice. The pressure dif-

Measurements taken at the flow sensor

ference is measured by a high-precision

are used in the pressure, flow, and volume

differential pressure sensor inside the

measurements.

ventilator. The pressure difference varies

with flow (relationship determined during

The ventilator monitors the oxygen con-

flow sensor calibration), so the patient’s

centration of the gas to be delivered to

flow is determined from the pressure

the patient using a galvanic O2 sensor.

drop. The ventilator calculates volume

The galvanic O2 sensor generates a volt-

from the flow measurements.

age proportional to the partial pressure of

oxygen in the delivered gas.

The flow sensor is highly accurate even in

the presence of secretions, moisture, and

The operations of the blower and expira-

nebulized medications. The ventilator

tory valve are coordinated to maintain

flushes the sensing tubes with mixed

system pressure levels.

gases (rinse flow) to prevent blockage.

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Pneumatic diagram

15

15.13.3 Pneumatic diagram

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15 Specifications

15.14 Symbols used on device

Symbol

Definition

labels and packaging

CE Marking of Conformity,

seal of approval guaranteeing

Table 15-21. Symbols used on device, device

that the device is in confor-

labels, and packaging

mance with the Council Direc-

Symbol

Definition

tive 93/42/EEC concerning

medical devices

Power/Standby key

The TÜV NRTL mark with the

indicators “C“ and “US“

means that the product com-

Female patient

plies with Canadian require-

ments and the requirements of

US authorities for safety.

Dispose according to Council

Male patient

Directive 2002/96/EC or WEEE

(Waste Electrical and Electronic

Equipment)

Neonatal patient

SN

Serial number

This way up at transport and

storage

To patient inspiratory port

Fragile, handle with care at

From patient expiratory port

transport and storage

Alarm Off

Keep dry at transport and

storage

Medical Device

Temperature limitations at

Manufacturer

transport and storage

Humidity limitations at trans-

Date of manufacture

port and storage

Atmospheric pressure limita-

Refer to the operator’s manual

tions at transport and storage

for complete information.

Stacking limitations at trans-

port and storage

Symbol for “Caution”. Applied

parts not protected against

defibrillation.

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Symbols used on device labels and packaging

15

Symbol

Definition

Symbol

Definition

Recyclable material

Type B applied part (classifica-

tion of medical electrical

equipment, type B, as specified

Mass

by IEC 60601-1)

Type BF applied part (classifica-

tion of medical electrical

Single use

equipment, type BF, as speci-

fied by IEC 60601-1)

Autoclavable.

Applicable to neonatal patient

Autoclavable parts can be used

group

inside an autoclave (for exam-

ple, a steam autoclave) with-

Applicable to pediatric patient

out damage. These parts with-

group

stand temperatures up to

Applicable to adult patient

approximately 134°C. The cor-

group

rect way to reprocess auto-

clavable parts is described in

Applicable to neonatal/pedi-

the Reprocessing Guide pro-

atric patient groups

vided by the manufacturer.

Applicable to pediatric/adult

Parts that Hamilton Medical

patient groups

terms as autoclavable can

undergo autoclaving with

Applicable to all patient

steam sterilization without

groups

damage.

Terminal for the connection of

Reusable.

a potential equalization con-

A reusable part is a medical

ductor.

device or part of a medical

device that can be reused if it

Indicates the degree of protec-

undergoes some sort of repro-

tion against electric shock

cessing between use on differ-

according to IEC 60601-1.

ent patients. The correct way

Class II devices have double or

to reprocess reusable parts is

reinforced insulation, as they

described in the Reprocessing

have no provision for protec-

Guide provided by the manu-

tive grounding.

facturer.

IP24

Protected against splashing

Parts that Hamilton Medical

water and solid particles larger

terms as reusable cannot be

than 12.5 mm.

autoclaved with steam sterili-

zation.

IP54

Protected from water spray

from any direction, and from

limited dust ingress.

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15 Specifications

Symbol

Definition

15.15 Standards and approvals

HAMILTON-T1 poses unac-

The HAMILTON-T1 was developed in

ceptable risks to the patient,

accordance with pertinent international

medical staff, or other persons

standards and FDA guidelines.

within the MR environment.

The ventilator is manufactured within an

Chinese RoHS

EN ISO 13485 and EN ISO 9001, Council

Directive 93/42/EEC, Annex II, Article 3

Authorized representative in

certified quality management system.

the European Community/

The ventilator meets the Essential Require-

European Union

ments of Council Directive 93/42/EEC,

Federal Communications Com-

Annex I.

mission (FCC) Licensing

Where standards are mentioned, the

HAMILTON-T1 complies with the versions

Near Field Communication

listed in Table 15-23.

The ventilator meets relevant parts of the

The RCM (Regulatory Compli-

following standards, listed in Table 15-22.

ance Mark) indicates a device’s

compliance with applicable

Table 15-22. Standards

ACMA (Australian Communi-

cations and Media Authority)

IEC 60601-1

Medical electrical equip-

technical standards for

ment, Part 1: General

telecommunications, radio

requirements for basic safety

communications, or broadcast-

and essential performance.

ing equipment.

The device classification is:

Class II, Type BF applied part

(ventilator breathing system,

VBS, CO2 sensor including

Japan only. Ministry of Internal Affairs and

CO2 module connector, and

Communications Approval Label

SpO2 sensor including SpO2

adapter), continuous opera-

tion

IEC

Medical electrical equipment

60601-1-2

- Part 1-2: General require-

ments for basic safety and

essential performance.

• Collateral standard: Elec-

tromagnetic disturbances

• Requirements and tests

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