Vivo 65 Clinicians Manual Issue D-1 April 2020

Table of Contents 1

Introduction... 9 1.1

What is the Vivo 65? ... 9

1.2

Intended Use... 10

1.3

Contraindications ... 10 1.3.1 Undesirable Side Effects ...11

1.4

About this Manual ...11

1.5 2

3

4

5

Audience ...11

1.4.2

Icons in this Manual ...11

Manufacturer Information... 12

Safety Information ... 14 2.1

General User Precautions... 14

2.2

Electrical Safety ... 16

2.3

Environmental Conditions... 17

2.4

Usage of Patient Circuit ... 19

2.5

Usage of Filters ... 22

2.6

Humidification ... 22

2.7

Cleaning and Maintenance ... 24

2.8

Usage of Oxygen ... 24

Product Description... 27 3.1

Main Components... 27

3.2

The Vivo 65’s Front Panel ... 30

3.3

The Vivo 65’s Side Panels... 31

3.4

Equipment Designation and Safety Labels... 33

Preparing the Vivo 65 for Use ... 36 4.1

Checking the Vivo 65 before First Use ... 36

4.2 4.3

Placing the Vivo 65 ... 37 Connecting the Vivo 65 to Mains ... 38

4.4

Connecting the Patient Circuit ... 39 4.4.1

Connect Patient Circuit Insert ... 39

4.4.2

Connect Dual Limb Circuit for Integrated Exhalation Valve... 42

4.4.3

Connect a Single Limb Circuit with Leakage Port ... 43

4.4.4

Connect a Single Limb Circuit with Active Exhalation Valve ... 43

4.5

Inspecting the Vivo 65 before Use ... 43

4.6

Adjusting the Vivo 65’s Patient Settings ... 45

4.7

Performing the Pre-use Test ... 45

How to Use the Vivo 65 ... 46 5.1

5.2

Doc. 006151 D-1

1.4.1

Turning the Vivo 65 On and Off... 46 5.1.1

Turn On and Enter Operating Mode ... 46

5.1.2

Stopping Treatment and Turning Off ... 47

Using the Menu ... 47

Table of Contents 3 Vivo 65

5.3

5.2.1

Navigating with the Buttons ... 47

5.2.2

Symbols Used in the Menu ... 49

5.2.3

Menu Overview ... 50

5.2.4

The Vivo 65 Display ... 51

5.2.5

The Mode Section... 53

5.2.6 5.2.7

The Setup Section ... 54 Home Adjust... 54

5.2.8

The Alarm Section ... 55

5.2.9

The Monitor Section... 56

5.2.10

The Others Section ... 57

Monitored Values in the Vivo 65... 60 5.3.1

Ppeak ... 61

5.3.2

PEEP... 61

5.3.3

Pmean... 61

5.3.4

Leakage ... 61

5.3.5

MVe ... 61

5.3.6

MVi ... 61

5.3.7

% in TgV... 61

5.3.8

Vte ... 62

5.3.9

Vti ... 62

5.3.10

FiO2 ... 62

5.3.11

% in TgV... 62

5.3.12

Total Rate ... 62

5.3.13

Spont Rate ... 62

5.3.14

% Spont... 62

5.3.15

SpO2 (Oxygen Saturation) ... 63

5.3.16

Pulse Rate... 63

5.3.17 5.3.18

I:E ... 63 Insp. Time ... 63

5.3.19

Rise Time ... 63

5.3.20

EtCO2 ... 63

5.3.21

InspCO2... 63

5.4

Functions and Parameters in the Vivo 65 ... 64

5.5

Modes in the Vivo 65... 73 5.5.1

Standby and Operating Mode... 74

5.5.2

Device Mode ... 74

5.5.3

Patient Mode ... 75

5.5.4

Ventilation and Breath Modes... 75

5.6

Transferring Data between the Vivo 65 and a PC ... 81

5.7

Using Batteries... 83 5.7.1

4 Table of Contents Vivo 65

Power Source Priority ... 84

Doc. 006151 D-1

5.8

6

Charging the Batteries ... 84

5.7.3

Battery Icons ... 85

5.7.4

Internal Battery... 86

5.7.5

Click-on Battery... 86

5.7.6

Battery Operating Time (Internal and Click-on) ... 88

5.7.7 5.7.8

Storing the Internal Battery and the Click-on Battery ... 89 External DC... 90

Using Accessories ... 91 5.8.1

Connecting and Disconnecting the Cables... 91

5.8.2

Using the Vivo 65 with a Nurse Call System... 91

5.8.3

Using the Vivo 65 with the FiO2 Sensor... 92

5.8.4

Using the Vivo 65 with the Remote Alarm ... 94

5.8.5

Using the Vivo 65 with the CO2 Sensor ... 95

5.8.6

Using the Vivo 65 with the SpO2 Module ... 99

5.8.7

Using the Vivo 65 with the Trolley... 100

5.8.8

Using the Vivo 65 with the Protective Cover... 100

Alarms ... 102 6.1

Doc. 006151 D-1

5.7.2

Alarm Function ... 102 6.1.1

Alarm Indication ... 102

6.1.2

Audible Signal Pause and Reactivation ... 103

6.1.3

Alarm Reset ... 104

6.2

Operator’s Position ... 104

6.3

Physiological Alarms... 105 6.3.1

High Pressure Alarm ... 105

6.3.2

Low Pressure Alarm ... 106

6.3.3

High PEEP Alarm ... 107

6.3.4

Low PEEP Alarm... 107

6.3.5 6.3.6

High Vti (High Inspired Tidal Volume Alarm) ... 108 High Vte Alarm (High Expired Tidal Volume)... 109

6.3.7

Low Vti Alarm (Low Inspired Tidal Volume) ...110

6.3.8

Low Vte Alarm (Low Expired Tidal Volume) ... 111

6.3.9

High MVi Alarm (High Inspired Minute Volume Alarm) ...112

6.3.10

High MVe (High Expired Minute Volume Alarm) ...113

6.3.11

Low MVi (Low Inspired Minute Volume Alarm) ...113

6.3.12

Low MVe Alarm (Low Expired Minute Volume ) ...114

6.3.13

High Breath Rate Alarm ...115

6.3.14

Low Breath Rate Alarm...116

6.3.15

Apnea Alarm ...117

6.3.16

Disconnection Alarm...117

6.3.17

Rebreathing Alarm ...119

6.3.18

Obstruction Alarm ... 120

Table of Contents 5 Vivo 65

6.4

6.5

6.3.19

High FiO2 Alarm ... 120

6.3.20

Low FiO2 Alarm ... 121

6.3.21

High SpO2 Alarm... 121

6.3.22

Low SpO2 Alarm... 122

6.3.23

High EtCO2 Alarm ... 122

6.3.24 6.3.25

Low EtCO2 Alarm ... 123 High InspCO2 Alarm (High Inspired CO2) ... 123

6.3.26

High Pulse Rate Alarm... 124

6.3.27

Low Pulse Rate Alarm ... 124

Technical Alarms ... 125 6.4.1

Power Failure Alarm ... 125

6.4.2

High Patient Air Temp. (High Patient Air Temperature) ... 125

6.4.3

High Internal Temperature (High Internal Temp) ... 126

6.4.4

Low Last Power Source Alarm ... 126

6.4.5

Lost Mains Power Alarm ... 126

6.4.6

Crit. Low Last Power Source Alarm... 127

6.4.7

Circuit Type/Insert Mismatch Alarm... 127

6.4.8

Patient Mode/Insert Mismatch Alarm... 128

6.4.9

Exhalation Valve Control Error Alarm ... 128

6.4.10

Vte/MVe Accuracy Unspecified Alarm ... 129

6.4.11

Vte/MVe Sensor Error Alarm ... 129

6.4.12

SpO2/CO2/Remote Start/Stop Failure Alarm (SpO2/CO2 Remote Fail) ... 130

6.4.13

SpO2 Disconnected (SpO2 Sensor Failure/Disconnection Alarm)... 130

6.4.14

SpO2 Signal Inadequacy Alarm (SpO2 Signal) ... 131

6.4.15

CO2 Disconnected (CO2 Sensor Failure/Disconnection Alarm)... 131

6.4.16

CO2 Sensor Accuracy Unspecified Alarm (CO2 Accuracy Unspec)... 131

6.4.17

CO2 Sensor Error Alarm ... 132

6.4.18

FiO2 Disconnected (FiO2 Sensor Failure/Disconnection Alarm)... 132

6.4.19

Ambient Pressure Compensation Lost Alarm ... 132

6.4.20

Temperature Comp. Lost (Ambient Temperature Compensation Lost Alarm)... 133

6.4.21

Humidity Comp. Lost (Humidity Compensation Lost Alarm)... 133

6.4.22

LED Failure Alarm... 133

6.4.23

Low Alarm Battery Alarm ... 134

6.4.24

Alarm for Beeper Failure... 134

6.4.25

Int. Function Failure (Internal Function Failure Alarm) ... 134

Alarm Test ... 134

6 Table of Contents Vivo 65

Doc. 006151 D-1

7

6.5.2

Additional Optional Alarm Tests... 136

Cleaning the Vivo 65 ... 139 7.1.1

Main Unit ... 140

7.1.2 7.1.3

Insert ... 140 Patient Circuit... 141

7.2

Cleaning and Replacing the Patient Air Filters ... 141

7.3

Change of Patients... 142

7.4

Regular Maintenance ... 142

7.5

Service and Repair... 143

7.6

Storage... 143

7.7

Disposal ... 143

Technical Specifications ... 145 8.1

8.2

8.3

8.4 9

Main Test Instructions ... 134

Cleaning and Maintenance ... 139 7.1

8

6.5.1

System Description ... 145 8.1.1

Dual Limb Circuit with Integrated Exhalation Valve ... 145

8.1.2

Single Limb Circuit with Active Exhalation Valve ... 145

8.1.3

Single Limb Circuit with Leakage Port ... 146

8.1.4

MPV Breath Model... 146

8.1.5

Pneumatic Diagram for the Vivo 65 with Dual Limb Circuit ... 147

8.1.6

Pneumatic Diagram for the Vivo 65 with Single Limb Circuit ... 148

8.1.7

Worst Case Accuracy ... 148

Data Parameters ... 149 8.2.1

Settings ... 149

8.2.2

Monitored Values ... 151

8.2.3

Alarms ... 153

8.2.4

Technical Specifications and Conditions ... 153

Emission and Immunity Declaration ... 155 8.3.1

Vivo 65 Essential Performance... 155

8.3.2

Guidance and Manufacturer's Declaration – Electromagnetic Immunity... 156

8.3.3

Guidance and Manufacturer's Declaration – Electromagnetic Emission... 159

8.3.4

Recommended separation distances between portable and mobile RF communications equipment and the ventilator ... 159

8.3.5

Recommended separation distances between external power conductors and the ventilator... 160

Default Settings... 161

Accessories ... 164 9.1

Breas Accessories List... 164

10

Patient Settings ... 176

11

FAA Compliance... 177

Doc. 006151 D-1

Table of Contents 7 Vivo 65

11.1

FAA Compliance ... 177

8 Table of Contents Vivo 65

Doc. 006151 D-1

1

Introduction WARNING! Risk of Personal Injury The Vivo 65 must only be used: • For the intended treatment in accordance with this manual and with the instructions given by the responsible clinical personnel. • In accordance with the operating conditions specified in this manual. • In original and unmodified shape and only with accessories specified or approved by Breas Medical. Every other use may lead to risk of personal injury!

CAUTION! Read this manual thoroughly so that you completely understand how the Vivo 65 is operated and maintained before taking it into use, to ensure correct usage, maximum performance and serviceability. Non-professional caregivers (e.g. family members) should consult the medical equipment provider’s respiratory therapist if they have any questions about the function, proper use, operation, service or maintenance of the Vivo 65. Breas Medical reserves the right to make changes to this product without any prior notification.

1.1

What is the Vivo 65? The Vivo 65 is a pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation. The Vivo 65 can be operated in 13 different combinations of ventilation and breath modes: • PSV – Pressure Support Ventilation • PSV(TgV) – Pressure Support Ventilation with Target Volume • PCV – Pressure Controlled Ventilation • PCV(TgV) – Pressure Controlled Ventilation with Target Volume • PCV(A) – Assisted Pressure Controlled Ventilation • PCV(A+TgV) – Assisted Pressure Controlled Ventilation with Target Volume • PCV-SIMV – Pressure Controlled Ventilation with Synchronized Intermittent Mandatory Ventilation

Doc. 006151 D-1

Introduction 9 Vivo 65 Clinician’s manual

• PCV-MPV – Pressure Controlled Ventilation with MouthPiece Ventilation • VCV – Volume Controlled Ventilation • VCV(A) – Assisted Volume Controlled Ventilation • VCV-SIMV – Volume Controlled Ventilation with Synchronized Intermittent Mandatory Ventilation • VCV-MPV – Volume Controlled Ventilation with MouthPiece Ventilation • CPAP – Continuous Positive Airway Pressure The Vivo 65 can be used with the following patient circuit configurations: • Dual limb circuit (adult or paediatricpediatric), connected to an integrated active exhalation valve, for internal measurement of expired volume, pressure and flow. • Single limb circuit with external leakage port or external active exhalation valve. • Circuit with mouthpiece interface. The internal memory data of the Vivo 65 can be downloaded to a PC, printed out, and analyzed via the Vivo 65 PC software

For more information about the Vivo 65 PC software, please contact your Breas representative.

1.2

Intended Use The Vivo 65 (with or without the SpO2 and CO2 sensor) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg. The Vivo 65 with the SpO2 sensor is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. The Vivo 65 with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas. The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation.

1.3

Contraindications • The use of the Vivo 65 is contraindicated for patients who need to be ventilated with oxygen concentrations (FiO2) higher than achievable when combining inlet from a low pressure oxygen source at 15 l/min with actual ventilator settings. • Generally, after surgery, the surgeon should be consulted to avoid organ damage and help determine ventilator parameters that do not adversely affect hemodynamics or have a negative impact on the patient’s health status.

10 Introduction Vivo 65 Clinician’s manual

Doc. 006151 D-1

• In case of facial surgery, make sure to choose a suitable patient interface, in order to avoid discomfort and injury. 1.3.1

Undesirable Side Effects WARNING! The Vivo 65 is not intended to be used as an emergency transport ventilator or critical care ventilator. If the patient experiences chest discomfort, pain, severe headache or shortness of breath while using the Vivo 65, a physician or responsible clinician shall be contacted immediately.

1.4

About this Manual CAUTION! Always read this manual before setting up and using the Vivo 65 or performing maintenance on the machine, to ensure correct usage, maximum performance and serviceability. Breas Medical reserves the right to make changes to this product without any prior notification.

1.4.1

Audience This manual is primarily intended for care providers, clinical personnel, physicians and others who require a working knowledge of the Vivo 65 system. The manual comprises detailed information on the settings and functions of the Vivo 65, to be handled by trained health care personnel only

Patients and lay caregivers may read the users manual for reference purposes, after appropriate guidance from the responsible care provider. Service personnel may order the Service Manual that contains detailed technical information for maintenance, service, repair and disposal procedure.

1.4.2

Icons in this Manual In this manual, icons are used to highlight specific information. The meaning of each icon is explained in the table below.

Doc. 006151 D-1

Introduction 11 Vivo 65 Clinician’s manual

Icon

Explanation Warning! Risk of death or personal injury. Warning! Risk of Cross-contamination. Warning! Risk of electric shock. Warning! Hot surface, risk of burns. Warning! Flammable material, risk of fire. Caution! Risk of equipment damage, loss of data, extra work, or unexpected results. Note Information that may be valuable but is not of critical importance, tips. Reference Reference to other manuals with additional information on a specific topic.

1.5

Manufacturer Information Legal Manufacturer

Postal Address Breas Medical AB Företagsvägen 1 SE-435 33 Mölnlycke Sweden Web Address www.breas.com Email address breas@breas.com Phone +46 31 868800, Order: +46 31 868820, Technical support: +46 31 868860 Fax +46 31 868810

12 Introduction Vivo 65 Clinician’s manual

Doc. 006151 D-1

Local Representatives Information www.breas.com/contact-us/

Doc. 006151 D-1

Introduction 13 Vivo 65 Clinician’s manual

2

Safety Information

2.1

General User Precautions WARNING! When a patient is treated, there must be a supervising person present during the treatment in order to take care of alarms and conditions that the patient cannot solve on their own. Always have immediate access to an alternative means of ventilation, which is ready for use, to avoid patient death or serious injury. Failure to have an alternate means of ventilation can result in serious injury or patient death if ventilator fails. Failure to have an alternate means of ventilation can result in serious injury or patient death if ventilator fails. The Vivo 65 must be turned off and on at least every 90 days. This is necessary in order for the Vivo 65 to perform a complete self-test. The self-test automatically tests the alarm sound and certain components. If the patient is admitted to a hospital or is prescribed any other form of medical treatment, always inform the medical staff that the patient is on mechanical ventilation treatment. The Vivo 65 must only be used: • for the intended treatment in accordance with this operating manual and with the instructions given by the responsible clinical personnel; • in accordance with the operating conditions specified in this operating manual; • in original and unmodified form and only with accessories specified or approved by Breas Medical. Do not use the Vivo 65 in the event of suspected damage to the device, unexplainable or sudden pressure, performance or sound changes during operation, or if the delivered air from the Vivo 65 is abnormally hot or emits an odour. In these cases, contact the patient’s responsible care provider for an inspection. The Vivo 65 may not work properly if any part has been dropped, damaged or submerged in water. Inadequate use of device or accessories may cause loss of treatment or decreased performance.

14 Safety Information Vivo 65 Clinician’s manual

Doc. 006151 D-1

The Vivo 65 therapy settings must always be based on medical advice and must be carried out by authorised clinical personnel only. Blood gas measurement shall be performed when changing treatment settings or changing to another device. Always perform the procedure in4.5 Inspecting the Vivo 65 before Use, page 43 before use. The Vivo 65 can be used for life-supporting treatment provided an emergency equipment (e.g. resuscitation bag) is available, and that one of the following configurations is used for surveillance of ventilator-dependent patient breathing: • Dual limb patient circuit and insert with integrated exhalation valve: The Vivo 65’s internal measurement and monitoring of exhaled volume must be supervised. • Single limb with leakage patient circuit: The Vivo 65’s monitoring of exhaled volume must be supervised • Single limb with exhalation valve patient circuit: The CO2 sensor or an external EtCO2 monitor (capnometer) must be used. The CO2 sensor must be connected between the patient and the exhalation valve to be able to measure exhaled gases. The CO2 monitor shall fulfil the ISO 80601-2-55 standard (Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors). Make sure that accessories are compatible with the Vivo 65 before use. Clinical personnel must read the manual thoroughly and understand the Vivo 65 operation before setting up and using the machine. Risk of Unnoticed Critical Conditions • All the physiological alarms of the Vivo 65 must be set at safe levels that will effectively warn the user of any risk. The alarm levels should be assessed considering the patient’s treatment settings. • Any change of treatment settings or change of components in the ventilation system may require readjustment of the alarm levels. • The alarm sound level should be set to a clearly audible level. Setting the alarm sound level below that of the ambient sound level can impede recognition of alarm conditions.

Doc. 006151 D-1

Safety Information 15 Vivo 65 Clinician’s manual

CAUTION! • Handle the ventilator with care. • Do not use the ventilator while in the carry bag. • Do not use the ventilator with nitric oxide, helium or helium mixtures.

NOTE Any serious incident that has occurred in relation to this device should be reported to the manufacturer and the competent authority.

2.2

Electrical Safety WARNING! Risk of Electric Shock High voltage contact may cause cardiac arrhythmia. • Do not operate the Vivo 65 if it has a damaged power cord, power supply or casing. • To avoid electrical shock, only clean the Vivo 65 according to instructions in this manual. Do not soak or immerse the Vivo 65 into any fluids. • Use the approved power supply units only. Use of unapproved power supply units may compromise the electrical isolation and lead to risk of electric shock. • Do not use more than one multiple portable socket-outlet or extension cord. If a multiple portable socket-outlet is used, it must not be placed on the floor. • The operator must not touch accessible contacts of connectors and the patient simultaneously. • Nurse Call must only be connected to a safety extra low voltage system with an isolation from mains voltage which complies with the requirements of IEC 606011.

16 Safety Information Vivo 65 Clinician’s manual

Doc. 006151 D-1

WARNING! Risk of Faulty Treatment Electromagnetic Interference may cause electrical equipment to malfunction. • The aspects of electromagnetic compatibility must be considered. – The Vivo 65 should not be used adjacent to or stacked with other equipment; if adjacent or stacked use is necessary, the Vivo 65 should be observed to verify normal operation in that configuration. – Mobile or transportable radio transmitters may interfere with the Vivo 65. – Further guidance for safe installation of the ventilator can be found in the chapter about emission and immunity declaration. • If a portable AC power supply is used, make sure that the voltage variations are within the operating limits of the Vivo 65. • Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Vivo 65, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Use of accessories, transducers and cables other than those specified or provided by Breas could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

2.3

Environmental Conditions WARNING! Risk of Intoxication Do not use the Vivo 65 in a toxic environment.

WARNING! Risk of Fire Do not use the Vivo 65 in environments where explosive gases or flammable anesthetic agents present.

WARNING! The delivered patient air can be as much as 4°C (7°F) higher than ambient temperature. Caution should be exercised if the room temperature is greater that 36°C (97°F).

Doc. 006151 D-1

Safety Information 17 Vivo 65 Clinician’s manual

Risk of Faulty Treatment If a room humidifier is used, place it at least 2 meters away from the Vivo 65. Risk of Faulty Treatment If a room humidifier is used, place it at least 2 meters away from the Vivo 65. The performance of the Vivo 65 may deteriorate at ambient temperatures below -20° C (-4°F) and above 40°C (104°F). However, the treatment shall always be started in an ambient temperature warmer than 5°C (41°F). Risk of Faulty Treatment

Do not use or store the Vivo 65 in a magnetic resonance (MR) environment. Use of the Vivo 65 in an MR environment may result in malfunction of the Vivo 65 and pose unacceptable risk to the patient, medical staff or other persons. Do not expose the Vivo 65 to rain or snowfall. Do not use the Vivo 65 while positioned in a warm place, such as direct sunlight or close to a radiator .

CAUTION! The device complies with the EMC requirements of standards listed in 8.3 Emission and Immunity Declaration, page 155. Necessary measures should be taken in order to assure field levels exceeding 20 V/m are avoided, since this may impair the safety and performance of the Vivo 65. Measures should include but not be limited to: • normal precautions with regard to relative humidity and conductive characteristics of clothing in order to minimize the build-up of electrostatic charges. • avoiding the use of radio emitting devices closer than 1 meter to the Vivo 65. Radio emitting devices include cellular or cordless telephones, microwave ovens and high-frequency surgery apparatus. • avoiding the use of the Vivo 65 in the presence of known EMI sources, including RF emitters (e.g., RFID, diathermy equipment). Please note that some of these RF emitters may not be visible and the Vivo 65 can potentially be exposed to fields from these RF emitters without the user’s awareness. If abnormal performance of the Vivo 65 is observed, and the RF emitters cannot be identified and removed, the Vivo 65 may need to be reoriented or relocated. Avoid using RFID devices closer than 1 meter to the Vivo 65.

18 Safety Information Vivo 65 Clinician’s manual

Doc. 006151 D-1

Avoid using the Vivo 65 within 1 meter of electronic article surveillance (EAS) system antennae.

WARNING! Unsteady indicated values for delivered volumes or pressures and the occurrence of alarm conditions without apparent cause may be an indication of loss of performance due to electromagnetic disturbances. Follow the instructions above and the guidance provided in 8.3 Emission and Immunity Declaration, page 155 to mitigate the effects of electromagnetic disturbances.

CAUTION! The ventilator, any accessories and all replaced parts, must be disposed of in accordance with the local environmental regulations regarding the disposal of used equipment and waste. The performance of the Vivo 65 and treatment of the patient may deteriorate if the operation conditions in 8.2.4.2 Environmental Conditions, page 153 are not fulfilled. Do not use the Vivo 65 immediately after storage or transport outside the recommended operating conditions.

2.4

Usage of Patient Circuit WARNING! For the ventilator to deliver treatment according to settings, it is important that the selection of the patient circuit type (see 5.2.2 Symbols Used in the Menu, page 49)(see Select Patient Circuit Type, page 57)is correctly set. Only use the Vivo 65 with accessories recommended by Breas Medical. The pressurized air from the ventilator causes a continuous flow of air to exhaust from the leakage ports or exhalation valve, flushing exhaled gas from the circuit. If having a patient circuit with leakage port, the ventilator should be turned on and the function of the leakage port should be checked before use. The ventilator should be turned on and the function of the leakage port or exhalation valve should be checked before use. Do not breathe in the connected patient circuit unless the Vivo 65 is turned on and operating properly.

Doc. 006151 D-1

Safety Information 19 Vivo 65 Clinician’s manual

WARNING! Risk of Electric Shock Do not use antistatic or electrically conductive hoses or tubing with the ventilator breathing system. This could result in electrical shock.

WARNING! Always make sure that the patient circuit and joined parts are undamaged and correctly connected, in order to avoid unwanted leakage. Always perform a pre-use test when the patient circuit or insert is replaced or modified. Patient connected parts and all filters must be replaced regularly to ensure correct function of the ventilator. All replaced parts must be disposed of according to local environmental regulations regarding the disposal of used equipment and parts. Risk of Suffocation Periodically check for moisture in the patient circuit. When present, remove the moisture. Before attempting to dry the circuit, disconnect it from the Vivo 65 to ensure no water flows back into the Vivo 65. The frequency at which these checks must be performed will depend on the patient’s condition and the device used. The responsible caregiver should assess this on an individual basis in accordance with the patient’s needs. When using the Vivo 65 invasively, the low volume alarm and the low breath rate alarm must be carefully set, to ensure safe use. The use of equipment such as endotracheal tubes, oral/nasal tubes, adaptors, etc. with small inner diameters or high resistance filters (such as humidifiers) increases the resistance in the patient circuit which may interfere with the operation of the patient disconnect function. It may also interfere with the device trigger function. The impact can be reduced by conducting a pre-use test properly. (See 4.7 Performing the Pre-use Test, page 45.) In case of invasive application, the use of an appropriate external heated humidifier or HME (Heat and Moisture Exchanger, artificial nose)/HCH (Hygroscopic Condenser Humidifier ) is recommended. Make sure that the exhalation valve or the leakage port never is blocked or obstructed.

20 Safety Information Vivo 65 Clinician’s manual

Doc. 006151 D-1

Risk of Constriction Entanglement with cables or tubing constricting airways may cause asphyxiation. Do not leave long lengths of air tubing or cables around the top of the bed. They could twist around the patient’s head or neck while sleeping. Always follow the instructions of the mask manufacturer. The Vivo 65 is equipped with a rebreathing alarm. The alarm is not a substitute for operator vigilance in ensuring that the leakage port or exhalation valve remains clear at all times. Periodically check the patient circuit during therapy. In general, as pressure decreases, the potential of rebreathing increases. Lower pressures produce less flow through the leakage port which may not clear all CO2 from the circuit to prevent rebreathing. To reduce the risk of rebreathing CO2: • Single limb circuit use: make sure that the leakage port or active exhalation valve is present as close as possible to the patient connection. • Dual limb circuit use: make sure that the Y-piece is present as close as possible to the patient connection.

CAUTION! Contact Injuries: Skin irritation may occur due to prolonged exposure to either a mask (if used) or the SpO2 module.

WARNING! Always use a new patient circuit when the Vivo 65 is to be used by a new patient.

NOTE The Vivo 65 and its packaging do not contain any natural rubber latex.

Doc. 006151 D-1

Safety Information 21 Vivo 65 Clinician’s manual