VS III Clinical Manual

VS III™ Clinical Manual English

Saime SAS (Manufacturer), Z.I., 25 rue de l’Etain, 77176 Savigny-le-Temple, France. ResMed Schweiz AG Viaduktstrasse Basel, Switzerland, +41 61 564 7000, ResMed Corp Poway, CA, USA +1 858 746 2400, ResMed Ltd Bella Vista, NSW, Australia, +61 (2) 8884 1000. ResMed has offices in Austria, Brasil, China, Finland, France, Germany, Hong Kong, India, Japan, Malaysia, the Netherlands, New Zealand, Norway, Singapore, Spain, Sweden, Switzerland and the United Kingdom (see www.resmed.com for details). Protected by the following patent: FR 2839893. Other patents pending. VS III is a registered trademark of Saime SAS. The technical specifications may be changed without notice. © 2008 Saime SAS is a subsidiary of ResMed Inc. Created: 08 2008

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Foreword Contents of the Manual This clinical manual is for VS III™ respirators with software version 1.00 or higher. The manual is divided into sections. A summary of the information contained in each section is given below. • Safety Warnings: Precautions relating to use of the respirator; • Description: Description of the respirator and its accessories; • Ventilation: Description of the ventilation modes and associated parameters; • Setting up: Setting up the respirator; • How to use the respirator: Starting and stopping ventilation and entering ventilation settings; • Accessories: Description of the available accessories and their set up and use; • Maintenance and disinfection: Procedures for cleaning the respirator and accessories and

preventative maintenance schedule; • Troubleshooting: Description of the alarms and troubleshooting advice; • Technical specifications: Technical specifications of the respirator, relevant standards, symbols

appearing on the device; • Appendix: The various types of trigger available, oxygen concentration nomograms, and a list

(with reference numbers) of accessories which can be used with the respirator. All measurements of pressure are given in cm H2O. 1 cm H2O = 0.984 hPa = 0.984 mBar.

Definitions This manual contains special terms and icons that appear in the margins or the body of the text. Their purpose is to draw your attention to specific or important information.

!

Caution

!

Warning

Explains special measures for the safe and effective use of the respirator. Alerts you to possible injury. Note: Is an informative or helpful note.

: Information specific to double circuits.

: New patient.

: Current patient.

: New configuration.

iii

: Display (measurements, parameters, information).

: Screen unlocked in Clinical menu.

(Tables): Yes/No.

iv

Contents Foreword... iii 1 Safety instructions... 1 1.1 General advice 1.2 How to use 1.3 Power supply 1.4 Oxygen 1.5 Electromagnetic compatibility 1.6 Servicing and maintenance 1.7 Storage and transport 1.8 Recycling

1 2 2 2 3 3 3 3

2 Description... 5 2.1 Scope of application 2.2 Contents of the pack

5 5

Generic pack ... 5 Optional accessories available ... 6

2.3 Description of the respirator

6

Front view ... 6 Control panel ... 7 Patient circuit support ... 9 Rear view ... 10 Underside view ... 11

2.4 Functions

11

Large screen ... 11 User interface ... 11 Prog 1 and Prog 2 programs ... 12 Ventilation modes ... 12 Oxygen supply and measurement ... 12 Sensitivity to patient effort (triggers) ... 13 Proximal pressure line ... 13

2.5 Accessories

14

3 Ventilation... 15 3.1 Leak ventilation modes

15

CPAP mode: Spontaneous ventilation with continuous positive airway pressure ... 15 S mode: Spontaneous ventilation without backup rate ... 15 ST mode: Spontaneous ventilation with backup rate ... 16 (A)PC mode: (Assisted) Pressure-Controlled ... 17

3.2 Valve ventilation modes

17

PS.Vs mode: Pressure support with or without backup rate ... 17 (A)PCV mode: (Assisted) Pressure-Controlled Ventilation ... 19 PS.Vt mode: Pressure support with tidal volume ... 20 (A)CV mode: (Assisted) volume-controlled ventilation ... 22

3.3 Ventilation parameters

23

Definitions ... 23 Adjustable parameters for each mode ... 27 Parameters for adjustable threshold alarms ... 28

3.4 Units of measurement and degrees of accuracy

29

Set parameters ... 29 Measurements ... 30

3.5 Default values

31

v

4 Setting up... 33 4.1 Connection to the power supply 4.2 Assembling the patient circuit

33 33

Patient leak circuit ... 33 Patient valve circuit ... 34 Double circuit ... 36

4.3 Accessories

38

5 Instructions for use... 39 5.1 Checks before use 5.2 Flowchart of Clinical menu operations 5.3 Operations

39 40 41

Starting ventilation ... 41 Entering the Clinical menu (Unlocking) ... 42 New patient (while ventilation is stopped) ... 43 New configuration (while ventilation is stopped) ... 44 Current patient ... 45 Options (when ventilation is not running) ... 48 Setting the date and time (Patient menu, while ventilation is stopped) ... 50 Viewing ventilation data ... 51 Turning off (Clinical menu) ... 53

5.4 Actions available to the patient

54

Flowchart of Patient menu operations ... 54 Starting ventilation ... 55 Operations ... 55 Viewing ventilation data ... 55 Turning off ... 56

5.5 Internal battery charge and discharge level

57

Battery charging ... 57 Battery discharging ... 57

6 Accessories... 59 6.1 Mask

59

Description ... 59 Setup and use ... 59

6.2 Patient circuit 6.3 Double circuit support

59 60

Use ... 60

6.4 Oxygen accessories

60

Oxygen coupling ... 60 External Oxygen sensor (O2 sensor) ... 63

6.5 Bacterial filter

65

Description ... 65 Setup and use ... 65

6.6 Humidifier and water traps

65

Description ... 65 Setup and use ... 66

6.7 External battery (ResMed Power Station)

66

Description ... 66 Setup and use ... 66

6.8 Remote alarm

67

Description ... 67 Setup and use ... 67

6.9 EasyDiag™ trends analysis software

68

Description ... 68 Setup and use ... 68

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7 Maintenance and disinfection... 69 7.1 Hospital/Health care facility, Home use and New patient 7.2 List of cleaning/replacement tasks

69 70

1 Mask ... 70 2 Patient circuit ... 70 3 Double circuit support and expiratory valve clapper ... 71 4 O2 sensor ... 72 5 Bacterial filter ... 72 6 Humidifier ... 73 7 Replacing the dust filter ... 73 8 Respirator casing ... 73

7.3 Summary table 7.4 Preventative maintenance

74 76

Replacing the internal filters ... 76 Maintenance of the internal battery ... 76 Preventative maintenance schedule ... 76

8 Alarms and troubleshooting... 77 8.1 Alarm signal 8.2 Alarm types

77 78

Adjustable threshold alarms ... 78 Automatic alarms ... 79 Technical alarms ... 81

8.3 Level of priority and whether alarms can be stopped

82

Level of priority ... 82 Stopping an alarm ... 82

8.4 Ventilation conditions which trigger alarms

83

High Frequency alarm ... 83 Low Vti and Low Vte alarms ... 83 High Vti Alarm ... 83 Low Pressure alarm ... 83 High Pressure alarm ... 84 Low FiO2 alarm ... 84 High FiO2 alarm ... 84 FiO2 < 18% alarm ... 84 Connect Circuit alarm ... 84 Prox. P. Lost alarm ... 84

8.5 Alarm checking procedures 8.6 Troubleshooting

84 84

9 Technical specifications... 87 9.1 Physical characteristics

87

Dimensions ... 87 Weight ... 87

9.2 Power supply

87

Types ... 87 Priority ... 88 Battery life ... 88 Recharging the internal battery ... 88

9.3 Factory default values 9.4 Block diagram (electrical and respiratory circuits) 9.5 Performance

88 90 91

Maximum pressure alarm ... 91 Maximum pressure alarm in single-fault conditions ... 91 Maximum achievable minute volume ... 91 Resistance ... 91 Resistance, volume and compliance of the complete respiratory system ... 92 Circuit compensation ... 92 Alarm sound level ... 92

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9.6 Operating, storage and transport conditions

92

Normal use ... 92 Extraordinary use ... 92 Storage and transport ... 93

9.7 Applicable standards 9.8 Accessories

93 93

Masks ... 93 Patient circuits ... 93 Double circuit support ... 94 Expiratory valve for single circuit ... 94 Oxygen accessories ... 94 Bacterial filter ... 94 Humidifier ... 94 External battery ... 95 Remote alarm ... 95

9.9 Symbols displayed on the screen 9.10 Symbols

95 96

Warnings and information ... 96 Sockets and connections ... 97 Transport and storage ... 97

9.11 Electromagnetic emissions and immunity

97

Electromagnetic emissions ... 97 Electromagnetic immunity ... 98

10 Appendix... 99 10.1 VS triggers

99

Inspiratory triggers ... 99 Expiratory triggers ... 105

10.2 Oxygen concentration (FiO2)

107

Configuration ... 107

10.3 Ventilation conditions which trigger alarms

108

Low Pressure alarm ... 108 High Pressure alarm ... 108 Connect Circuit alarm ... 109

10.4 List of accessories

110

Index... 111

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1 Safety instructions 1.1 General advice This manual must be read and understood in full by the user before the respirator is used on a patient. This manual is intended for use by physicians, HME providers and nursing staff. There is also a service manual for the respirator, which is issued at ResMed training sessions. It must be read and understood by the technicians responsible for servicing the respirator. • The manufacturer accepts no liability for damage which may occur to the respirator due to: • Maintenance or changes which do not comply with the instructions provided or do not have

• • • • • •

• •

• •

the manufacturer's prior approval; • Maintenance or changes carried out by unauthorised persons. Do not use the respirator if it is damaged. Do not use the respirator if the power cord or power supply unit are damaged. The ventilation settings must be prescribed by the patient's physician. The respirator settings must be entered by competent and trained staff under the supervision of a physician. The VS III double circuit is specially designed for ventilation-dependent patients. It allows the expired volumes to be monitored. Monitoring the respirator is of vital importance for ventilation-dependent patients. Ensure that the person caring for the patient is capable of taking the necessary corrective action if an alarm is triggered or if the respirator malfunctions. This respirator is designed for adult and paediatric ventilation. It is not designed for neonatal ventilation (10 mm diameter circuit). When using the VS III double circuit for paediatric ventilation, it is inadvisable to use a tracheotomy cannula less than 3.6 mm in diameter or endotracheal catheters less than 6 mm in diameter. It is recommended that you have another means of ventilation available. Use the respirator with CE-marked accessories only and in compliance with the manufacturer's recommendations. The measurements recorded by the manufacturer were taken using the disposable circuits supplied in the package. The precision of the measurements made by the respirator cannot be guaranteed if other circuits are used.

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1.2 How to use • The respirator must be removed from its travel bag before being connected to mains power. It

• • • • • •

• • •

• • •

is, however, possible to operate the respirator on power from the internal battery or ResMed Power Station while it is still in its travel bag. We recommend that the respirator be operated in its normal in-use position, resting on its feet. The respirator should only be moved or lifted by its handles. Do not block the vents on the respirator. The respirator must not be covered or positioned in a way which could impede ventilation. Before connecting the patient to the respirator, examine the entire patient circuit to eliminate the risk of unwelcome leaks or defective parts. Alarms should be checked and adjusted before the respirator is used for a new patient. They should also be checked and adjusted regularly when the respirator is used in the patient's home. These checks should be included in regular servicing. We recommend the use of a remote alarm to increase the alarm volume, where necessary. If a technical alarm is triggered, switch off the respirator and unplug the mains power and oxygen supplies. The user must ensure that the total resistance of the patient circuit and ventilation accessories does not exceed 6 cm H2O (6 hPa) for a flow rate of 60 L/min (adult ventilation), or for a flow rate of 30 L/min (paediatric ventilation). When the respirator is delivering leak ventilation, the rebreathing of carbon dioxide is limited by mask vents and the flushing of the circuit by a constant air flow. Do not use this respirator in the presence of flammable anaesthetics. Do not use the respirator with antistatic or electrically conductive patient circuits.

1.3 Power supply • The electricity source used for the respirator must comply with the current standards. • If there is interference on the electrical network, operate the respirator on battery power. • To extend the life of the battery, it must undergo a full charge/discharge cycle every six

• •

• • •

months. To ensure maximum safety, we strongly recommend replacing the internal battery every two years (500 full charge/discharge cycles). If the respirator has been disconnected from mains power and stored for an extended period, recharge the internal battery fully. A full recharge takes 12 hours. When the respirator has been disconnected from mains power and stored for an extended period of time, the backup battery will discharge. If the "Low backup batt" alarm is triggered when the respirator is turned on, the battery must be recharged by connecting to mains power. Use the specific power cord supplied with the respirator. Do not open the internal battery compartment. The respirator must not be connected to a multi-socket plug board or an extension cord.

1.4 Oxygen • We recommend that you disconnect the oxygen port when the respirator is in standby mode

or turned off. • Do not expose the external oxygen sensor to temperatures of less than -20°C or higher than

+50°C. • The external oxygen sensor must not be subjected to any violent impact. • Do not dismantle the external oxygen sensor. • The respirator is not capable of compensating for changes in atmospheric pressure. We

recommend that you adjust the alarm thresholds as required. 2/112

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1.5 Electromagnetic compatibility • If the respirator is used in the vicinity of other devices such as defibrillators, diathermy or high-

frequency electrosurgery devices, short wave devices or cell phones, the user must check that it is functioning properly. • The respirator may be affected by electromagnetic fields greater than 10 V/m. • The use of accessories or power cords other than those specified may increase emissions

from the respirator or decrease its immunity.

1.6 Servicing and maintenance • Before the respirator is used for the first time or before it is used on a new patient, it should be

cleaned and disinfected in accordance with the procedure described in “Maintenance and disinfection” on page 69. • To avoid the risk of electrocution, do not dismantle the respirator. All procedures should be

carried out by a technician trained in the maintenance of the respirator. • The respirator is drip-proof (IPX1).

1.7 Storage and transport • The respirator is fragile and must not be subjected to any violent impact. • If the respirator has been stored or transported in conditions different to the recommended

operating conditions, wait until normal operating conditions are restored before turning it on. • The respirator must not be exposed to direct sunlight.

1.8 Recycling • In accordance with directive 2002/96/EC concerning waste electrical and electronic

equipment, this respirator must be sorted and disposed of separately from other types of rubbish. It must not be disposed of with ordinary municipal waste. To dispose of this respirator, you should use an appropriate waste collection system and the waste reuse and recycling systems in your area. • Whether new or worn out, the oxygen sensor contains toxic substances. It must be disposed of in accordance with the applicable waste processing regulations in your region and in accordance with local environmental legislation. Do not burn the sensor: risk of toxic smoke.

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2 Description 2.1 Scope of application The VS III respirator is intended for adult or paediatric (tidal volume greater than or equal to 50 mL) ventilation, in the home or in a clinical environment. It is not intended for neonatal ventilation and should not be used with circuits which have a diameter of 10 mm. The respirator is approved for continuous use. It is capable of delivering both pressure and volume ventilation. It can be used with either a single or a double limb circuit, and with or without an expiratory valve and/or proximal pressure line (pressure line as close as possible to the patient). The VS III double circuit is specially designed for ventilation-dependent patients. It allows the expired volumes (Vte) to be monitored.

2.2 Contents of the pack The VS III is available in two models: single circuit and double circuit.

Generic pack The VS III pack comprises: 1. Respirator 2. Power cord 3. Travel bag with strap 4. Documents (Clinical manual) 5. A single limb respiratory circuit with an expiratory valve connector (VS III single circuit), or a double limb circuit (VS III double circuit) 6. Oxygen coupling 7. Dust filter 8. Double circuit support (VS III double circuit only) 3 VS

III

4

1

P

5 2

Expiratory valve connector

8 7

6

Figure 2.1: Example of pack contents

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Optional accessories available The following accessories are optional extras: • Double circuit support; • External sensor for measuring the oxygen delivered to the patient (as well as the sensor, the

kit contains a connection cord, adapter and T-connector).

Oxygen sensor

Figure 2.2: Double circuit support (left) and oxygen measurement kit (right)

2.3 Description of the respirator Front view Control panel (screen and keypad)

Insufflation outlet to patient (standard 22 mm-diameter) P

Single circuit support (removable) Figure 2.3: VS III single circuit model

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Control panel The control panel comprises a screen and a keypad. LCD screen

Menu button

Alarm Silence button Alarm LEDs (x2)

Adjustment buttons VS III

Enter button

On/Off button Figure 2.4: VS III control panel: screen and buttons LED: Light-Emitting Diode

Keypad Table 2.1: Buttons on the VS III keypad Button On/Off button

Alarm Silence button

Function • Turns the respirator on. • Stops the respirator by displaying an options screen. The user can choose to stop ventilation (if ventilation is being delivered) or turn off the respirator (if ventilation is not being delivered). • Press twice to stop ventilation (press and hold the second time). Silences the audible alarm: • If the alarm can be stopped, after the button is pressed once, the alarm details stay on the screen. Press the button a second time to remove them. • If the alarm can be stopped for two minutes, broken lines appear over the alarm symbol displayed on the screen. • If the alarm cannot be stopped, pressing this button will have no effect and the alarm will continue to sound.

Menu button

• Lets you navigate through the menu screens. • Unlocks the screen from the Patient menu to allow access to the Clinical menu. • Re-locks the screen in the Patient menu (if pressed for at least one second). • Returns to the previous screen or menu.

Enter button

• Press to access the highlighted text or menu screen. • Lets you enter edit mode (adjustment of the selected alphanumeric value).

Adjustment buttons

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Up/down arrows: • Selecting items in a menu: selects the previous item (up arrow) or the following item (down arrow). • Adjusting numerical values in edit mode: increases/decreases the numerical value of a unit. The respirator beeps when the maximum or minimum value is reached.

Description

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LCD screen (respirator operating) Display areas Message display area (date and time, alarms, current program and mode) Indicates the screen is locked in the Patient menu

27/06/2008 16:48

Icons of available power sources

PS.Vs

The current screen is displayed here

0

Instantaneous pressure measurement display (in cm H2O)

cmH2O

60 50 40 30 20 10 0

Start ventilation

Figure 2.5: How information is displayed on the VS III screen (Patient menu)

Screen displayed when ventilation is not being delivered Date

Time Mains power supply

27/06/2008 16:48

Internal battery

0

External battery

cmH2O

Bar graph (see the enlarged image in Figure 2.8 on page 9)

60 50 40 30 20 10 0

Current ventilation mode

PS.Vs

Navigation message (Patient menu): An instruction and the button to press are displayed

Start ventilation

Figure 2.6: Icons and information on the VS III screen (Patient menu)

Screen displayed when ventilation is being delivered Indicates the screen is unlocked in the Clinical menu

27/06/2008 16:48 9 cmH2O

60 50 40 30 20 10 0

PS.Vs

Internal battery discharging icon (shown here as it appears in the Patient menu: enlarged and located in the display area) Pressure progress bar

Stop

Patient menu

Patient demand (trigger)

Current program and mode, screen name or helpful message

PS.Vs Clinical Settings 9 cmH2O

60 50 40 30 20 10 0

Modes Parameters Set Alarms View Monitoring Stop ventilation Clinical menu

Figure 2.7: How the screen looks in each menu: Patient menu (left) and Clinical menu (right)

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Bar graph (detail from the screen which is displayed when ventilation is being delivered) Pressure value (cm H2O)

9

40 30 20 10 0

cmH2O

60 50 40 30 20 10 0

High Pressure alarm threshold

Target pressure PEEP threshold (not shown in CPAP mode) Patient demand

Figure 2.8: Bar graph. PEEP: Positive End Expiratory Pressure. CPAP: Continuous Positive Airway Pressure

For the complete list of icons, see “Symbols displayed on the screen” on page 95.

Patient circuit support VS III single circuit

P

Expiratory valve control (PEEP)

Proximal pressure line Figure 2.9: VS III with single circuit support

VS III double circuit

Expiratory valve

Clapper Double circuit support Double circuit support Figure 2.10: VS III with double circuit support (left) and components of the double circuit support (right)

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Note: An expiratory valve is attached to the double circuit support. The valve comprises: • A 22 mm-diameter (standard) connector; • A flow sensor; • A proximal pressure line.

For instructions on attaching the double circuit support, see “Fitting the double circuit support (respirator turned off)” on page 36. For instructions on assembling the double circuit support, see “Maintenance and disinfection”, Figure 7.2 on page 71.

Rear view For a complete list of symbols which appear on the respirator, including on the rear panel, see “Symbols” on page 96.

Dust filter (air inlet)

28 V %

Connector panel Figure 2.11: VS III rear view

Oxygen port connector

28 V %

O2 sensor connector

Mains connector

External battery connector

Serial link connector

Remote alarm connector

Figure 2.12: Detail of the connectors on the rear panel and their respective symbols

Note: Take care not to obstruct the air vents on the underside of the respirator, (see next figure) symbol.

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Underside view

VSIII type :

SN V30804003

0197

Air vents

Internal battery compartment Serial number

Handles Figure 2.13: Underside view showing the serial number of the respirator

The serial number (marked 'SN') can be seen on the underside of the device. It tells you, in the following order: • The product code; • The year and month of manufacture; • The number of the device in the month.

For example: V30804003 denotes a VS III (V3) made in 2008 (08) in the month of April (04), this device being the third produced in the month (003). For the meaning of the other symbols, see “Symbols” on page 96.

2.4 Functions Large screen The 8.14 cm x 6.1 cm (4") screen lets you see at a glance and adjust all parameters and alarms associated with a ventilation program. PS.Vs View settings 0 cmH2O

60 50 40 30 20 10 0

PEEP

15 cmH2O TgI(P) AUTO 4 cmH2O TgI(V) NO

fmin

15 bpm

Rise t

1

Timin 0.3 s

0.50 L

Timax 2.0 s

PS

Vts

TgE

AUTO

Figure 2.14: Parameter display screen

User interface The user interface is different for each of the three menus: • Patient; • Clinical; • Technical screens (not described in this manual).

Screen messages are given to assist navigation.

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Description

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