Breas NIPPY 4 Positive Pressure Ventilator User Manual Ver D1 April 2020

Table of Contents 1

Introduction... 9 1.1

What is the Nippy 4? ... 9

1.2

Intended Use...11

1.3 1.4

Contraindications ...11 Intended Environment... 12

1.5

Intended Users... 12

1.6

1.7 2

3

1.5.1

Respiratory Health Care Specialists... 12

1.5.2

Lay Operators ... 12

1.5.3

Service Personnel... 13

About this Manual ... 13 1.6.1

Audience ... 13

1.6.2

Icons in this Manual ... 14

Manufacturer Information... 15

Safety Information ... 16 2.1

General User Precautions... 16

2.2

Electrical Safety ... 19

2.3

Environmental Conditions... 20

2.4

Usage of Patient Circuit ... 21

2.5

Usage of Filters ... 24

2.6

Humidification ... 24

2.7

Cleaning and Maintenance ... 26

2.8

Usage of Oxygen ... 27

Product Description... 29 3.1

Main Components... 29

3.2

Front View ... 31

3.3

Side Views... 32 3.3.1 Detaching and Reattaching the Side Panels ... 33

3.4

Equipment Designation... 35 3.4.1

4

5

Preparing the Nippy 4 for Use ... 38 4.1

Checking the Nippy 4 before First Use ... 38

4.2

Placing the Nippy 4 ... 38

4.3

Connecting the Nippy 4 to Mains ... 40

4.4

Connecting the Patient Circuit ... 41

4.5

Inspecting the Nippy 4 before Use ... 42

4.6

Adjusting the Nippy 4 Patient Settings... 42

4.7

Performing the Pre-use Test ... 43

How to Use the Nippy 4... 45 5.1

Switch the Nippy 4 On and Off... 45 5.1.1

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Additional Symbols ... 35

Switch On and Enter Operating Mode ... 45

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5.1.2

Start the Pressure Ramp ... 45

5.1.3

Stop the Pressure Ramp... 46

5.1.4

Stop Treatment ... 47

5.1.5

Turn off / Enter Sleep Mode ... 47

5.2

Navigating the Display ... 48

5.3 5.4

Symbols Used on the Display ... 49 Display Overview ... 50 5.4.1

5.5

Profiles ... 51 5.5.1

5.6

Home Mode... 50 Selecting a Profile ... 51

Treatment Settings... 51 5.6.1

Changing a Setting ... 51

5.6.2

Settings ... 51

5.7

The Alarms List ... 61

5.8

The Monitored Values Pane... 62

5.9

The Menu ... 64 5.9.1

Opening the Menu ... 64

5.9.2

Humidification Settings ... 64

5.9.3

User Preferences ... 65

5.9.4

Compliance Data (Optional) ... 65

5.9.5

Pre-Use Test ... 66

5.9.6

Alarm/Event Logs... 66

5.10

Monitored Values in the Nippy 4 ... 67

5.11

Transferring Data between the Ventilator and a PC ... 68

5.12

5.13

5.11.1

Transferring Data with a Memory Card... 69

5.11.2

Transferring Data with a Data Cable... 69

Using Batteries... 70 5.12.1 5.12.2

Power Source Priority ... 70 Charging the Batteries ... 71

5.12.3

Battery Icons ... 72

5.12.4

Internal Battery... 72

5.12.5

Click-in Battery... 73

5.12.6

Battery Operating Time (Internal and Click-in) ... 74

5.12.7

Storing the Internal Battery and the Click-in Battery... 75

5.12.8

External DC... 75

Using Accessories ... 76 5.13.1

Connecting and Disconnecting the Cables... 76

5.13.2

Using the ventilator with a Nurse Call System... 76

5.13.3

Using the ventilator with the FiO2 Sensor ... 77

5.13.4

Using the ventilator with the Remote Alarm... 78

5.13.5

Using the Ventilator with the SpO2 module... 79

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6

Using the ventilator with the Remote Start/Stop... 79

5.13.7

Using the ventilator with the Protective Cover... 79

5.13.8

Using the Nippy 4 with the Trolley... 80

5.13.9

Using the Click-in Humidifier... 81

5.13.10

Installing the Water Chamber ... 82

5.13.11 5.13.12

Detaching the Water Chamber ... 84 Using the Patient Circuit with Heated Wire... 87

Alarms ... 89 6.1

Alarm Function ... 89 6.1.1

Alarm Indication ... 89

6.1.2

Audible Signal Pause and Reactivation ... 90

6.1.3

Alarm Reset ... 91

6.2

Operator’s Position ... 91

6.3

Physiological Alarms... 91

6.4

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5.13.6

6.3.1

High Flow Alarm... 92

6.3.2

Low Flow Alarm... 93

6.3.3

High Pressure Alarm ... 94

6.3.4

Low Pressure Alarm ... 95

6.3.5

High EPAP Alarm ... 96

6.3.6

Low EPAP Alarm ... 96

6.3.7

Low Vte Alarm (Low Expired Tidal Volume) ... 97

6.3.8

High Vte Alarm (High Expired Tidal Volume) ... 97

6.3.9

High MVe (High Expired Minute Volume Alarm) ... 98

6.3.10

Low MVe Alarm (Low Expired Minute Volume) ... 98

6.3.11

High Breath Rate Alarm ... 99

6.3.12

Low Breath Rate Alarm... 99

6.3.13

Apnoea Alarm ... 100

6.3.14 6.3.15

Disconnection Alarm... 100 Rebreathing Alarm ... 101

6.3.16

Obstruction Alarm ... 102

6.3.17

High FiO2 Alarm ... 102

6.3.18

Low FiO2 Alarm ... 103

6.3.19

High SpO2 Alarm... 103

6.3.20

Low SpO2 Alarm... 104

6.3.21

High Pulse Rate Alarm... 104

6.3.22

Low Pulse Rate Alarm ... 105

Technical Alarms ... 105 6.4.1

Power Fail Alarm... 105

6.4.2

High Patient Air Temp. (High Patient Air Temperature) ... 106

6.4.3

Low Patient Air Temp. (Low Patient Air Temperature Alarm)... 106

6.4.4

Low Last Power Source Alarm ... 106

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6.5

7

6.4.5

Crit. Low Last Power Source Alarm... 107

6.4.6

Lost Mains Power Alarm ... 107

6.4.7

SpO2 Disconnected (SpO2 Sensor Failure/Disconnection Alarm)... 107

6.4.8

SpO2 Signal Lost Alarm ... 108

6.4.9

Poor SpO2 Signal ... 108

6.4.10

FiO2 Disconnected (FiO2 Sensor Failure/Disconnection Alarm)... 108

6.4.11

Ambient Pressure Compensation Lost Alarm ... 109

6.4.12

Temperature Comp. Lost (Ambient Temperature Compensation Lost Alarm)... 109

6.4.13

Humidity Comp. Lost (Humidity Compensation Lost Alarm)...110

6.4.14

LED Failure Alarm...110

6.4.15

Low Alarm Battery Alarm ...110

6.4.16

Alarm Battery Error Alarm... 111

6.4.17

Internal/Click-In Battery Hot Alarm ... 111

6.4.18

Heated Circuit Temp. Alarm... 111

6.4.19

High Humidifier Temp. Alarm ...112

6.4.20

Humidifier Fault Alarm ...112

6.4.21

Heated Circuit Fault Alarm...113

6.4.22 6.4.23

Internal Function Failure ...113 Air Temp. Sensor Fail Alarm ...113

6.4.24

Internal Error Alarm...114

6.4.25

Database Integrity Fail Alarm ...114

6.4.26

Cooling Fan Error Alarm ...114

6.4.27

Clock Failure Alarm...115

6.4.28

Internal Temp High Alarm ...115

6.4.29

Humidifier/Bypass Loose Alarm ...115

Alarm Test ...116 6.5.1

Alarm Signal Test ...116

6.5.2

Mandatory Alarm Tests ...116

6.5.3

Optional Alarm Tests...119

Cleaning and Maintenance ... 121 7.1

7.2

Cleaning the Nippy 4... 121 7.1.1

Main Unit ... 122

7.1.2

Air Pathway Disinfection ... 122

7.1.3

Patient Circuit... 122

Cleaning and Replacing the Air Filters ... 123 7.2.1

Coarse Filter (grey, washable)... 123

7.2.2

Fine Filter (White, Disposable) ... 124

7.3

Change of Patients... 124

7.4

Service and Repair... 124

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8

7.5

Storage... 125

7.6

Disposal ... 125

Technical Specifications ... 127 8.1

System Description ... 127 8.1.1

8.2

8.3

Data... 128 8.2.1 Worst Case Accuracy ... 128 8.2.2

Settings Specifications... 128

8.2.3

Monitored Values Specifications... 131

8.2.4

Power Supply ... 133

8.2.5

Environmental Conditions... 133

8.2.6

Other ... 134

Emission and Immunity Declaration ... 135 8.3.1

Nippy 4 Essential Performance ... 135

8.3.2

Guidance and Manufacturer's Declaration – Electromagnetic Immunity... 136

8.3.3

Guidance and Manufacturer's Declaration – Electromagnetic Emission... 138

8.3.4

Recommended separation distances between portable and mobile RF communications equipment and the ventilator ... 138

8.3.5

Recommended separation distances between external power conductors and the ventilator... 139 Recommended separation distances between external power conductors and the ventilator... 140

8.3.6 8.4 9

Pneumatic Diagram for the ventilator ... 127

Delivery Settings ... 140

Accessories and Parts ... 143 9.1

Breas Accessories List... 143

10

Patient Settings ... 151

11

FAA Compliance... 152

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Table of Contents 7 Nippy 4

1

Introduction WARNING! Risk of Personal Injury The Nippy 4 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 Nippy 4 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 Nippy 4. Breas Medical reserves the right to make changes to this product without any prior notification.

1.1

What is the Nippy 4? The Nippy 4 is a pressure ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation. The Nippy 4 is capable of running 24 hours/day. The Nippy 4 can be operated in the following combinations of ventilation and breath modes: • Pressure Support (PSV) • Pressure Support with TgV (PSV+TgV) TgV= Target Volume • Pressure Control (PCV) • Pressure Control with TgV (PCV+TgV) TgV= Target Volume • CPAP

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Introduction 9 Nippy 4 User manual

Compatible Patient Circuits The Nippy 4 should be used with a leakage circuit and a suitable patient interface. See 9 Accessories and Parts, page 143 for detailed information about approved patient circuits. The patient circuit shall comply to ISO 17510. The leakage should be at least 12 l/min at 4 cmH2O, to prevent rebreathing of exhaled air. The recommended leakage is 20 to 50 l/min at 10 cmH2O pressure. Compatible Patient Interfaces For invasive use, the patient interface may be a tracheostomy tube (cuffed or uncuffed). For non-invasive use it may be a mask, or a pillow interface. See the patient interface’s instructions for use when selecting the interface to use. Data Log The Nippy 4 has an internal memory with a data log that holds the following data: • Running hours • Technical alarms • Settings • Asset data • Treatment hours • Treatment settings • Device serial number • Physiological alarms • Detailed log, containing at least 24 h data of clinical data (monitored values) • Breath log, containing at least 30 day data of (monitored values) • Usage log (containing at least 1 year data of non-clinical events, alarms and settings) The internal memory data is maintained also during power failure. The data can be transferred to a computer, printed out, and analysed via Breas software products.

For more information about Breas software products, please contact your Breas representative.

Expected Service Life The expected service life of the Nippy 4 is 8 years.

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1.2

Intended Use Nippy 4 is intended to provide non-invasive or invasive ventilation for adult or paediatric patients weighing over 10 kg (22 lbs) who require long-term support or mechanical ventilation for respiratory insufficiency or respiratory failure, with or without obstructive sleep apnea. Nippy 4 is intended for spontaneously breathing patients.

1.3

Contraindications The Nippy 4 is not a life-support ventilator and is contraindicated in patients who are unable to tolerate more than brief interruptions in ventilation. If a patient has any of the following conditions, therapy with positive airway pressure may be contraindicated and the prescribing clinician shall decide if the benefit of ventilatory assistance overweighs the risks: • Untreated pneumothorax • Pneumomediastinum • Inability to maintain a patent airway or adequately clear excessive respiratory secretions • Severe acute systemic complications (shock, unstable arrhythmias, myocardial ischemia) • Severe bullous lung disease • Risk of vomiting • Pathologically low blood pressure, especially if associated with intravascular volume depletion • Cerebrospinal fluid leak, recent cranial surgery or trauma The use of the Nippy 4 is contraindicated in an MRI environment. Adverse Effects If the patient experiences chest discomfort, pain, severe headache or shortness of breath while using the Nippy 4, a physician or responsible clinician shall be contacted immediately. The following side effects may occur during the course of therapy with the Nippy 4, patients are advised to report any new or changing adverse effects to their physician: • Nasal, mouth or throat dryness • Nosebleeds • Abdominal bloating • Ear or sinus discomfort • Eye irritation • Skin rashes

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Introduction 11 Nippy 4 User manual

1.4

Intended Environment The Nippy 4 is intended to be used in clinical settings (e.g. hospitals, sub-acute care institutions), public spaces and home environments as well as during portable applications such as wheelchairs, personal family vehicles, ground ambulances and civil aircraft, excluding helicopters. It is not intended for use during emergency transportation.

1.5

Intended Users This section describes the intended users of the Nippy 4, their qualifications and their related documents.

1.5.1

Respiratory Health Care Specialists Health care professionals such as physicians and respiratory therapists, assigned to form the clinical authority when it comes to operating mechanical ventilators. They have a good understanding of the human respiratory system and a general understanding of mechanical ventilators. They are allowed to change the clinical settings of a ventilator and prescribe new settings. They may also operate software applications for follow-up on patient’s ventilator treatment. Training The respiratory health care specialists shall be trained to a good knowledge of the Nippy 4, its capabilities and the settings that can be made. This training consists of reading the Clinician’s manual in complete and it shall be conducted before operating the Nippy 4. Related Documents The Clinician’s manual is intended for the respiratory health care specialists. It shall be available for training of new personnel and as reference when operating the Nippy 4.

1.5.2

Lay Operators Day-to-day caregivers, patients, relatives and other non-professional users that operate the Nippy 4 within the prescribed settings. They are allowed to operate the Nippy 4 with the Home mode activated. The lay operator may also perform basic maintenance that doesn’t require special equipment or a service environment. In Home mode, the device is locked in order to limit settings accessibility and hide features/controls. The User Manual contains the information intended for patients and lay operators.

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Training The lay operator shall be trained to basic knowledge of the Nippy 4 and in the specific operations they are assigned to perform. The training shall be based on the user manual and the responsible clinical personnel shall assess the level of training required for each lay operator. Related Documents The User manual is intended for lay operator. It shall be available for the training and as reference when operating the Nippy 4. 1.5.3

Service Personnel Certified service personnel with responsibility to maintain the equipment in proper working order. They have a technical education and/or relevant experience of technical work on electrical equipment. If local or national regulations requests additional authorization or competence, these shall be complied to. Certified service personnel may perform any repairs, upgrades or service operations that they have been certified to perform, as long as they have the required equipment and the operation is performed in an appropriate environment. They may also operate software applications for follow-up on ventilators usage and for troubleshooting. Training and Certification Service personnel shall be trained on the Nippy 4 and certified by Breas for being allowed to perform any service, repairs or other operations on the Nippy 4. The training consists of reading the services manual in complete. After completed training the certification test may be performed. Related Documents • The Service Manual. • The Clinician’s Manual. • Service bulletins, available for certified service personnel on the Breas extranet.

1.6

About this Manual CAUTION! Always read this manual before setting up and using the Nippy 4 or performing maintenance on the machine, to ensure correct usage, maximum performance and serviceability.

1.6.1

Audience This manual is intended for patients and other lay users operating the Nippy 4.

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Introduction 13 Nippy 4 User manual

• Care providers, clinical personnel, physicians and others who require a working knowledge of the Nippy 4 will find additional information on settings and functions in the Clinician’s Manual. • Service personnel may order the Service Manual that contains detailed technical information for maintenance, service, repair and disposal procedure.

1.6.2

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. 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.

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1.7

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 UK Sales and Support Information Phone UK Head Office 01789293460 Fax UK Head Office 01789262470 General Enquiries and Ordering orders@nippyventilator.com Tech Support techsupport@nippyventilator.com

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Introduction 15 Nippy 4 User manual

2

Safety Information

2.1

General User Precautions WARNING! Risk of Personal Injury The Nippy 4 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! Risk of Insufficient Ventilation Usage outside the specified operating conditions may cause reduced performance. The Nippy 4 must only be used in accordance with the operating conditions specified in this manual Risk of Reduced Safety and Performance Accessories that have not been tested with the Nippy 4 might affect safety features and performance negatively. Only use the Nippy 4 with accessories approved by Breas Medical. Incompatible parts can result in degraded performance and change of pressure gradient. If unapproved accessories are used, Breas Medical has no responsibility for the safe and effective use of the Nippy 4. The responsible organization is responsible for ensuring the compatibility of the ventilator and all parts used to connect to the patient before use. Changes to the patient circuit, like adding or removing accessories or changing type or length of breathing tube, may affect both circuit compliance and alarm triggering conditions. It’s recommended to perform a pre-use test and re-test the alarm function after making changes to the patient circuit. 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. To prevent disconnection of the patient circuit during use, only tubes in compliance with ISO 5367 or ISO 80601-2-74 should be used.

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The ventilator may not work properly if any part has been dropped, damaged or submerged in water.

WARNING! Risk of Burns Covering breathing tubes with a blanket or heating them with an overhead heater can affect the quality of the therapy or injure the patient.

WARNING! Risk of Faulty Treatment 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. Risk of Faulty Treatment Do not use the Nippy 4 in the event of: • Suspected damage to the device, including the occurrence of Internal Functional Failure alarms. • Unexpected patient symptoms during treatment. • Unexplainable or sudden changes of pressure, performance or sound during operation. • Delivered air being abnormally hot or emitting an odor. Contact your responsible care provider for an inspection. Risk of Faulty Treatment The responsible organization should periodically reassess the settings of the therapy for effectiveness. Before starting treatment, always perform the procedure 4.5 Inspecting the Nippy 4 before Use , page 42. The ventilator is not suitable for a ventilator dependent patient. Risk of Unnoticed Critical Conditions • 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.

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Safety Information 17 Nippy 4 User manual

CAUTION! Clinical personnel must read the Clinician’s manual thoroughly and understand the ventilator operation before setting up and using the ventilator. • 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. Contact Injuries: Skin irritation may occur due to prolonged exposure to either a mask (if used) or the SpO2 module. Ensure that the cooling air intake vents are not blocked. If the vents are blocked, especially in hot use environments, the surface temperature of the patient circuit may rise above 41°C (106°F). In a 40°C (104°F) environment and with the cooling air intake vents blocked, surface temperatures as high as 50°C (122°F) can occur. Before an unsafe temperature is reached, the “High Patient Air Temp” alarm will occur. If this alarm occurs, assure that the ventilator cooling air intake path is free of obstruction and that the patient circuit surface is not heating the patient’s skin.

WARNING! Risk of Electric Shock Modifying or using the ventilator with accessories that are not specified or approved by Breas may cause cardiac arrhythmia. The Nippy 4 must only be used in original and unmodified shape and only with accessories specified or approved by Breas Medical. Inadequate use of device or accessories may cause loss of treatment or decreased performance.

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

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2.2

Electrical Safety WARNING! Risk of Electric Shock High voltage contact may cause cardiac arrhythmia. • Do not operate the Nippy 4 if it has a damaged power cord, power supply or casing. • To avoid electrical shock, only clean the Nippy 4 according to instructions in this manual. Do not soak or immerse the Nippy 4 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.

WARNING! Risk of Faulty Treatment Electromagnetic Interference may cause electrical equipment to malfunction. • The aspects of electromagnetic compatibility must be considered. – The Nippy 4 should not be used adjacent to or stacked with other equipment; if adjacent or stacked use is necessary, the Nippy 4 should be observed to verify normal operation in that configuration. – Mobile or transportable radio transmitters may interfere with the Nippy 4. – 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 Nippy 4. • 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 Nippy 4, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

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Safety Information 19 Nippy 4 User manual

WARNING! Avoid touching the contacts within the ventilator click-in battery compartment. Under certain circumstances touch current limits per IEC 60601-1 may be exceeded.

2.3

Environmental Conditions WARNING! Risk of Intoxication Do not use the Nippy 4 in a toxic environment.

WARNING! Risk of Fire Do not use the Nippy 4 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). Risk of Faulty Treatment If a room humidifier is used, place it at least 2 meters away from the Nippy 4. Risk of faulty Treatment The performance of the Nippy 4 may deteriorate at altitudes or ambient temperatures outside the operation conditions specified in the chapter Technical Specifications. • Do not use the ventilator while positioned in a warm place, such as direct sunlight or close to a radiator as this might lead to temperature outside the specifications. • Do not use the ventilator in an hyperbaric chamber, as this would cause an ambient pressure outside the specifications. • Do not use the ventilator immediately after storage or transport outside the recommended operating conditions.

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Risk of Faulty Treatment

Do not use or store the Nippy 4 in a magnetic resonance (MR) environment. Use of the Nippy 4 in an MR environment may result in malfunction of the Nippy 4 and pose unacceptable risk to the patient, medical staff or other persons. 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 135 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.

2.4

Usage of Patient Circuit WARNING! Risk of Insufficient Ventilation Insufficient ventilation may cause transient hypoxia. The Nippy 4 ventilator is intended to be used with patient circuits with intentional leakage and compliant to ISO 17510. Recommended leak rate: 20 to 50 liters per minute at 10 cmH2O. Failure to use a mask or accessory that minimizes rebreathing of carbon dioxide or permits spontaneous breathing can cause asphyxiation. Risk of Insufficient Ventilation Insufficient ventilation may cause transient hypoxia. Before use: • Make sure that the patient circuit and joined parts are undamaged and correctly connected, in order to avoid unwanted leakage. • Make sure that the leakage port of the circuit or mask is not blocked or obstructed. This port prevents rebreathing by flushing the exhaled air. • The Nippy 4 should be turned on and the function of the leakage port should be checked before use: The pressurized air from the Nippy 4 causes a continuous flow of air through the leakage port, enabling flushing of exhaled air.

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Safety Information 21 Nippy 4 User manual

The pressurized air from the ventilator causes a continuous flow of air to exhaust from the leakage ports, flushing exhaled gas from the circuit. The ventilator should be turned on and the function of the leakage port should be checked before use. When the patient circuit is replaced or modified, check the alarm settings as changes to the patient circuit may affect the alarm triggering. Also consider performing a preuse test for optimizing the therapy. Risk of Suffocation If the patient needs assistance to remove the patient interface, the patient shall not be left alone. This is to avoid the risk of re-breathing of CO2 in case of accidental ventilator failure. Do not breathe through the connected patient circuit unless the ventilator is turned on and operating properly.

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! 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. By conducting a pre-use test (see4.7 Performing the Pre-use Test, page 43) the compatibility of the complete patient circuit configuration with the ventilator can be verified. If a pre-use test is successfully performed the circuit configuration meets the required characteristics. 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 Nippy 4 to ensure no water flows back into the Nippy 4. 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.

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