Breas Nippy 4 Series User manual

Nippy 4 User Manual
Breas Medical AB, Företagsvägen 1, SE-435 33 Mölnlyc e, Sweden
Phone [phone] Order [phone] Technical Support +46 31 86
88 60
Fax [phone] www.breas.com, Date: 2022-11-22 | 20244
Nippy 4,User’s
ENGLISH (GB)
USER MANUAL
7 321820 065530
Breas Nippy 4
User Manual
006553 M-6 en-GB

Table of Contents 1
Doc. 006553 M-6
Table of Contents
1 Introduction.....................................................................................7
1.1 What is the Nippy 4? .................................................................7
1.2 Intended Use.......................................................................... 9
1.3 Contraindications ....................................................................9
1.4 Intended Environment......... . . . . . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . . ... . . . 9
1.5 Intended Users ......................................................................10
1.5.1 Respiratory Health Care Specialists . . .... . . . . . . . ... . . . . . . . .. .. . . . . . ....10
1.5.2 Lay Operators ............................................................10
1.5.3 Service Personnel. . . . . ... . . . . . . . .... . . . . . . .... . . . . . . . .. .. . . . . . ..... . . . . . .10
1.6 About this Manual ...................................................................11
1.6.1 Audience..................................................................11
1.6.2 Icons in this Manual .. . . .. . . .. . . .. . . .. . . .. . . .. . . .. . . .. . . .. . . .. . . .. . . .. . . .. 11
1.7 Manufacturer Information . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . .. .. . . . . . ....12
2 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 ... .. . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . .18
2.5 Usage of Filters......................................................................20
2.6 Humidification........................................................................21
2.7 Cleaning and Maintenance ... . . . . . . . ... . . . . . . . .... . . . . . . .... . . . . . . . .... . . . . . . .... . .22
2.8 Usage of Oxygen ....................................................................23
3 Product Description...........................................................................25
3.1 Main Components...................................................................25
3.2 Front View............................................................................27
3.3 Side Views ...........................................................................28
3.3.1 Detaching and Reattaching the Side Panels ... . . . . . . ... .. . . . . . .... . . . .30
3.4 Equipment Designation . . . . . . . ..... . . . . . .... . . . . . . . .... . . . . . . .... . . . . . . . ... . . . . . . . ..32
3.4.1 Additional Symbols. . . . .... . . . . . . .... . . . . . . . .... . . . . . . .... . . . . . . . ... . . . . . .33
4 Preparing the Nippy 4 for Use . ... . . . . . . . .... . . . . . ..... . . . . . . . .. .. . . . . . .... . . . . . . . ... .. . . . . . .35
4.1 Checking the Nippy 4 before First Use..... . . . . . . . .... . . . . . . .... . . . . . . . ... . . . . . . . ..35
4.2 Placing the Nippy 4..................................................................35
4.3 Connecting the Nippy 4 to Mains ... . . . . . ..... . . . . . . . .. .. . . . . . .... . . . . . . . ... .. . . . . . .37
4.4 Connecting the Patient Circuit ... . . . . . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . .. .. . . . . . ....38
4.5 Inspecting the Nippy 4 before Use .. .. . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . .... . . . . .39
4.6 Adjusting the Nippy 4 Patient Settings ..... .. . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . . .40
4.7 Performing the Pre-use Test . . . . . . . .. . . . .. . . . . .. . . . .. . . . . .. . . . .. . . . . .... . . . . . . . .. . . .40
4.7.1 Actions At Pre-Use Test Failure . . . . . . . . .... . . . . . . .... . . . . . . . .... . . . . . . ..41
5 Howto Use the Nippy 4.......................................................................42
5.1 Switch the Nippy 4 On and Off...... . . . . . ..... . . . . . . . .. .. . . . . . .... . . . . . . . ... .. . . . . . .42

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5.1.1 Switch On and Enter Operating Mode . . . .... . . . . . .... . . . . . . . ... .. . . . . . .42
5.1.2 Start the Pressure Ramp . . . . . . . ... . . . . . . . .... . . . . . . . .. . . . . . . . ..... . . . . . .43
5.1.3 Stop the Pressure Ramp.. . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . .. .. . . . . . ....44
5.1.4 Stop Treatment ... . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . ..... . . . . . . . .... . .44
5.1.5 Turn off / Enter Sleep Mode . .... . . . . . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . ..45
5.2 Navigating the Display ....... . . . . . . . ... . . . . . . . .. .. . . . . . ..... . . . . . . ... .. . . . . . .... . . . .46
5.3 Symbols Used on the Display . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . .. .. . . . . . ..... . . . . . .47
5.4 Display Overview....................................................................48
5.4.1 Home Mode...............................................................48
5.5 Profiles ...............................................................................49
5.5.1 Selecting a Profile .. . . . . . . .. . .. . . .. . .. . . .. . . .. . .. . . .. . .. . . .. . . .. . .. . . .. . ..49
5.6 Treatment Settings ..................................................................49
5.6.1 Changing a Setting... . . . . . . . .. .. . . . . . ..... . . . . . . . .. .. . . . . . .... . . . . . . . ... .49
5.6.2 Settings ...................................................................49
5.7 The Alarms List ......................................................................54
5.8 The Monitored Values Pane . . . . . . . . ... . . . . . . . .. .. . . . . . ..... . . . . . . ... .. . . . . . .... . . . .54
5.9 The Menu ............................................................................56
5.9.1 Humidification Settings ... . . . . . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . .56
5.9.2 Sigh Settings .............................................................57
5.9.3 Pre-Use Test..............................................................57
5.9.4 User Preferences. . ... . . . . . . . .. .. . . . . . ..... . . . . . . . .. .. . . . . . .... . . . . . . . ... .57
5.9.5 Compliance Data (Optional) . .. . . . . . .. . . . . . .. . . . . .... . . . . . . . .. . . . . . . . ....58
5.9.6 Alarm/Event Logs . . ... . . . . . . . .... . . . . . . .... . . . . . . . .... . . . . . . .... . . . . . . . ..58
5.10 Transferring Data between the Ventilator and a PC. .... . . . . . . . ... . . . . . . . .... . . . . .59
5.10.1 Transferring Data with a Memory Card ... . . . . . . . .... . . . . . . . ... . . . . . . . ..60
5.10.2 Transferring Data with a Data Cable ..... . . . . . . . .. .. . . . . . .... . . . . . . . ... .60
5.11 Using Batteries ......................................................................61
5.11.1 Power Source Priority . . . . . . . . . .. . . . . . .. . . . . . . .. . . . . . . . .. . . . . . . .. . . . . . .. . .61
5.11.2 Charging the Batteries . . . . . . .. .. . . . . . ..... . . . . . . . .. .. . . . . . .... . . . . . . . ... .62
5.11.3 Battery Icons .............................................................62
5.11.4 Internal Battery ... . . . . . . . .. . . . . . . . .... . . . . . . .... . . . . . . . .... . . . . . . .... . . . . .63
5.11.5 Click-in Battery . . . .... . . . . . .... . . . . . . . ... .. . . . . . .... . . . . . . . ... . . . . . . . .... .63
5.11.6 Battery Operating Time (Internal and Click-in) . . . . . . . ..... . . . . . .... . . . .64
5.11.7 Storing the Internal Battery and the Click-in Battery . . . . . . .. .. . . . . . ....65
5.11.8 External DC...............................................................65
5.12 Using Accessories...................................................................66
5.12.1 Connecting and Disconnecting the Cables .. . . . . . . . .... . . . . . . . ... . . . . . .66
5.12.2 Using the ventilator with a Nurse Call System. . . . .... . . . . . . . ... .. . . . . . .67
5.12.3 Using the ventilator with the FiO2Sensor...............................67
5.12.4 Using the ventilator with the Remote Alarm . . . . . .... . . . . . . . ... . . . . . . . ..69
5.12.5 Using the Ventilator with the SpO2module .............................69

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5.12.6 Using the ventilator with the Remote Start/Stop. . . . . ... . . . . . . . .... . . . . .70
5.12.7 Using the ventilator with the Protective Cover. . . . . . .... . . . . . . . .... . . . . .70
5.12.8 Using the Nippy 4 with the Trolley...... . . . . . . . ... . . . . . . . .... . . . . . . . ... . .71
5.12.9 Using the Click-in Humidifier . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . . ... . . . . .72
5.12.10 Using the Patient Circuit with Heated Wire . . .... . . . . . ..... . . . . . . . .. . . . .77
6 Alarms .........................................................................................78
6.1 Alarm Function.......................................................................78
6.1.1 Alarm Indication ... . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . ..... . . . . . . . .. .. . .78
6.1.2 Audible Signal Pause . .... . . . . . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . .79
6.1.3 Audible Signal Presilence. .. . . . . . .... . . . . . . . ... .. . . . . . .... . . . . . . . ... . . . . .80
6.1.4 Alarm Reset ..............................................................80
6.2 Operator’s Position..................................................................80
6.3 Physiological Alarms . . . ..... . . . . . . . .. .. . . . . . .... . . . . . . . ... .. . . . . . .... . . . . . . . ... . . . . .80
6.3.1 High Flow Alarm . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . .... . . . . . . . .... . . . . .81
6.3.2 Low Flow Alarm ..........................................................82
6.3.3 High Pressure Alarm .... . . . . . . . .... . . . . . . . ... . . . . . . . .. .. . . . . . ..... . . . . . .83
6.3.4 Low Pressure Alarm . . .... . . . . . . .... . . . . . . . .... . . . . . . .... . . . . . . . ... . . . . . .84
6.3.5 High EPAPAlarm.........................................................85
6.3.6 Low EPAPAlarm .........................................................85
6.3.7 High VteAlarm (High Expired Tidal Volume) . .... . . . . . . . ... . . . . . . . .... .86
6.3.8 Low VteAlarm (Low Expired Tidal Volume).. .... . . . . . . . .... . . . . . . .... . .86
6.3.9 High MVe(High Expired Minute Volume Alarm) .. .. . . . . .. . . .. . . .. . .. . . .87
6.3.10 Low MVeAlarm (Low Expired Minute Volume) .. . . . .. . . . . . . . ..... . . . . . .87
6.3.11 High Breath Rate Alarm.. . ... . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . . ... . .88
6.3.12 Low Breath Rate Alarm . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . . .. . . . . . . . ....89
6.3.13 Apnoea Alarm ............................................................90
6.3.14 Disconnection Alarm . ... . . . . . . ..... . . . . . .... . . . . . . . .... . . . . . . .... . . . . . . . .90
6.3.15 Rebreathing Alarm ... . . . . . . . .. .. . . . . . ..... . . . . . . . .. .. . . . . . .... . . . . . . . ... .91
6.3.16 Obstruction Alarm . .... . . . . . . .... . . . . . . . .... . . . . . . .... . . . . . . . .. .. . . . . . ....92
6.3.17 High FiO2Alarm ..........................................................92
6.3.18 Low FiO2Alarm...........................................................93
6.3.19 High SpO2Alarm.........................................................93
6.3.20 Low SpO2Alarm..........................................................94
6.3.21 High Pulse Rate Alarm. . .. .. . . . . . .... . . . . . . . ... .. . . . . . .... . . . . . . . ... . . . . .94
6.3.22 Low Pulse Rate Alarm .... . . . . . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . .95
6.4 Technical Alarms ....................................................................95
6.4.1 Power Fail Alarm . .. . . . . . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . . ... . .95
6.4.2 High Patient Air Temp. (High Patient Air Temperature) . .... . . . . . . . ... .96
6.4.3 Low Patient Air Temp. (Low Patient Air Temperature
Alarm).....................................................................96
6.4.4 Low Last Power Source Alarm . . . . .. .. . . . . . ..... . . . . . . ... .. . . . . . .... . . . .96
6.4.5 Crit. Low Last Power Source Alarm . .. .. .. ....... .. .. ....... . .. .. .. .....97

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6.4.6 Lost Mains Alarm. . . . . . .... . . . . . . . .... . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . .97
6.4.7 SpO2Disconnected (SpO2Sensor Failure/Disconnection
Alarm).....................................................................97
6.4.8 SpO2Signal Lost Alarm..................................................98
6.4.9 Poor SpO2Signal.........................................................98
6.4.10 FiO2Disconnected (FiO2Sensor Failure/Disconnection
Alarm).....................................................................99
6.4.11 Ambient Pressure Compensation Lost Alarm . . .. .. . . . . . .... . . . . . . . ... .99
6.4.12 Temperature Comp. Lost (Ambient Temperature Compensation
Lost Alarm) ............................................................. 100
6.4.13 Humidity Comp. Lost (Humidity Compensation Lost
Alarm)................................................................... 100
6.4.14 LED Failure Alarm.... . . . . . . . .. .. . . . . . ..... . . . . . . . .. . . . . . . . .... . . . . . . . .. 101
6.4.15 Low Alarm Battery Alarm .... . . . . . . . ... . . . . . . . .... . . . . . ..... . . . . . . . .... 101
6.4.16 Alarm Battery Error Alarm ... . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . . ... 101
6.4.17 Internal/Click-In Battery Hot Alarm .. .. .. .. ....... .. .. ........ .. .. .. ... 102
6.4.18 Heated Circuit Temp. Alarm ..... . . . . . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . 102
6.4.19 High Humidifier Temp. Alarm . . . . . . .... . . . . . . . .... . . . . . ..... . . . . . . . .. . . 103
6.4.20 Humidifier Fault Alarm . . . . . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . .. .. . . . . . .. 103
6.4.21 Heated Circuit Fault Alarm.. . . ... .. . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . 104
6.4.22 Internal Function Failure . .. . . . .. . . . . .. . . . . .. . . . .. . . . . .... . . . . . . . .. . . . .. 104
6.4.23 Air Temp. Sensor Fail Alarm . . ... . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . 105
6.4.24 Internal Error Alarm .. . . . . . . . .. .. . . . . . ..... . . . . . . . .. . . . . . . . .... . . . . . . . .. 105
6.4.25 Database Integrity Fail Alarm.. . . ... . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . 105
6.4.26 Cooling Fan Error Alarm . . . . . . . . .... . . . . . . . ... . . . . . . . .. .. . . . . . ..... . . . . 106
6.4.27 Clock Failure Alarm .. . . . . . . . .. .. . . . . . ..... . . . . . . . .. .. . . . . . .... . . . . . . . .. 106
6.4.28 Internal Temp High Alarm. ... . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . . ... 106
6.4.29 Humidifier/Bypass Loose Alarm . . .. . . . . .. . . .. . . . . .. . . . .. . . . .. . . . .. . . . . 107
6.5 Alarm Test.......................................................................... 107
6.5.1 Alarm Signal Test... .. . . . . . .... . . . . . . . ... .. . . . . . .... . . . . . . . ... . . . . . . . ... 107
6.5.2 Mandatory Alarm Tests . . . . . .... . . . . . . . .... . . . . . . .... . . . . . . . .. . . . . . . . .. 107
6.5.3 Optional Alarm Tests . . . . .. .. .. .. .. . .. .. .. .. .. .. .. .. .. .. .. . .. .. .. .. . .. .. 109
7 Cleaning and Maintenance . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . .. .. . . . . . ..... . . . . .111
7.1 Cleaning the Nippy 4 .. . . . . . . . ..... . . . . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . .111
7.1.1 Main Unit ................................................................111
7.1.2 Air Pathway Disinfection . . . . . . .. . . . .. . . .. . . .. . . .. . . .. . . .. . .. . . .. . . . .. . . 112
7.1.3 Patient Circuit. . . ... . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . ..... . . . . . . . .. .. 112
7.2 Cleaning and Replacing the Filters . . . . . . ... .. . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . 112
7.2.1 Washing a coarse filter.. . . . . . . ... .. . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . 113
7.3 Change of Patients ... . . . . . . . .. .. . . . . . .... . . . . . . . ... .. . . . . . .... . . . . . . . ... . . . . . . . ... 114
7.4 Regular Maintenance . . . . .... . . . . . . . .... . . . . . . .... . . . . . . . .... . . . . . ..... . . . . . . . .. . . 114
7.5 Service and Repair .... . . . . . . .... . . . . . . . .. . . . . . . . ..... . . . . . . . .. . . . . . . . .... . . . . . . ... 114

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7.6 Storage............................................................................. 114
7.7 Disposal............................................................................ 114
8 Technical Specifications . . . . . . . . .... . . . . . . .... . . . . . . . .... . . . . . . .... . . . . . . . .. . . . . . . . ..... . . . . 116
8.1 System Description. . . . . . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . ..... . . . . . . . .... 116
8.1.1 Pneumatic Diagram for the ventilator ..... . . . . . . . .... . . . . . . . ... . . . . . . 116
8.2 Data ................................................................................ 117
8.2.1 Worst Case Accuracy . . . .... . . . . . . . .. .. . . . . . ..... . . . . . . ... . . . . . . . .... . . 117
8.2.2 Modes Specifications . ... . . . . . . . .... . . . . . . . ... . . . . . . . .. .. . . . . . ..... . . . . 117
8.2.3 Parameter Specifications . ... . . . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . . ... 117
8.2.4 Monitored Values Specifications ...... . . . . . . . .... . . . . . ..... . . . . . . . .. . . 121
8.2.5 Power Supply. . . . . .. .. . . . . . .... . . . . . . . ... .. . . . . . .... . . . . . . . ... . . . . . . . ... 122
8.2.6 Environmental Conditions ...... . . . . . . . .... . . . . . . . ... . . . . . . . .. .. . . . . . .. 122
8.2.7 Other.................................................................... 123
8.3 Emission and Immunity Declaration. . . .. .. . . . . . ..... . . . . . . . .. .. . . . . . .... . . . . . . . .. 124
8.3.1 Nippy 4 Essential Performance . . . . . ... . . . . . . . .... . . . . . . .... . . . . . . . ... 124
8.3.2 Guidance and Manufacturer's Declaration – Electromagnetic
Immunity................................................................ 124
8.3.3 Guidance and Manufacturer's Declaration – Electromagnetic
Emission................................................................ 127
8.3.4 Frequencies of portable and mobile transmitters for which the
recommended separation distance is 30 cm (12 inches) . . .. . .. . .. .. 127
8.3.5 Recommended separation distances between external power
conductors and the ventilator...... . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . 128
8.4 Delivery Settings. . . . . . .. . . . . .. . . . . .. . . . . .. . . . .. . . . . .. . . . . .. . . . . .. . . . .. . . . . .. . . . . .. . 128
9 Accessories and Parts . . . . . . . .. . . . . . .. . . . . . .. . . . . . . .. . . . . . .. . . . . . .. . . . . . .. . . . . . .. . . . . . .. . . . . 130
9.1 Patient Circuits and Air Delivery Accessories . . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . 130
9.2 Power Accessories .... . . . . . . .... . . . . . . . .. . . . .. . . . . . .. . . . . .. . . . .. . . . . . .. . . . . .. . . . .. 133
9.3 Monitoring Accessories . . . . . . . ... .. . . . . . .... . . . . . . . ... . . . . . . . .... . . . . . . . ... . . . . . . . 135
9.4 Ventilator Filters and Detachable Parts . . . . . . .. .. . . . . . ..... . . . . . . ... .. . . . . . .... . . 138
9.5 Other Accessories. . . . . . ..... . . . . . . . .. .. . . . . . .... . . . . . . . ... .. . . . . . .... . . . . . . . ... . . . 140
10 Patient Settings ............................................................................. 143
11 FAA Compliance ............................................................................ 145
Index ............................................................................................... 147

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 instruc-
tions 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 per-
formance 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.
U.S. Federal law restricts this device to sale by or on order of a physician.
1.1 What is the Nippy 4?
The Nippy 4 is a pressure ventilator capable of delivering continuous or intermittent ventila-
tory 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 ventilation modes:
• Pressure Support (PSV)
May be combined with Auto-EPAP (AE)
• Pressure Support with TgV (PSV+TgV)
TgV= Target Volume
May be combined with Auto-EPAP (AE)
• Pressure Control (PCV)
May be combined with Auto-EPAP (AE)
• Pressure Control with TgV (PCV+TgV)
TgV= Target Volume
May be combined with Auto-EPAP (AE)
• Mouthpiece - Pressure (PCV-MPV)
• CPAP
Introduction 7
Doc. 006553 M-6 User Manual

Compati le Patient Circuits
The Nippy 4 should be used with a leakage circuit and a suitable patient interface or an
MPV circuit. See 9 Accessories and Parts, page 130 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.
Compati le 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 trans-
ferred to a computer, printed out, and analysed via Breas software products.
For more information about Breas software products, please contact your Breas
representative.
Multiple Use
This is a multiple patient multiple use ventilator. If it should be used by multiple patients,
see the cleaning instructions in 7.3 Change of Patients, page 114 before assigning it to a new
patient. Note that accessories to the ventilator might be for single patient use and should in
that case be replaced at change of patient.
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 ventila-
tion 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 should 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
1.4 Intended Environment
The Nippy 4 is intended to be used in clinical settings (e.g. hospitals, sub-acute care institu-
tions), 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.
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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 understand-
ing 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 Clini-
cian’s manual in full 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 avail-
able for training of new personnel and as reference when operating the Nippy 4. When
using a Clinician’s manual, make sure that it is of the same version as the User’s manual.
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.
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 elec-
trical equipment. If local or national regulations requests additional authorization or compe-
tence, these shall be complied to.
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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 full.
Related Documents
• The Service Manual.
• The Clinician’s Manual.
• Service bulletins, available for certified service personnel on the Breas extranet.
1.6 A out this Manual
CAUTION!
Always read this manual before setting up and using the Nippy 4 or performing mainte-
nance 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.
• Care providers, clinical personnel, physicians and others who require a working
knowledge of the Nippy 4 will find additional information on settings and func-
tions in the Clinician’s Manual. The Clinician’s manual should be of the same revi-
sion as the User’s Manual.
• Service personnel may order the Service Manual that contains detailed technical
information for maintenance, service, repair and disposal procedure. The Service
manual’s revision is independent of the User’s Manual revision.
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.
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Icon Explanation
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.
MR Unsafe. The device should not enter a magnetic resonance (MR)
environment, such as an MRI scanner room.
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.
1.7 Manufacturer Information
Legal Manufacturer
Postal Address
Breas Medical AB
Företagsvägen 1
SE-435 33 Mölnlycke Sweden
Web Address
www.breas.com
Email address
[e-mail]
Phone
[phone], Order: [phone], Technical support: [phone]
Fax
[phone]
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UK Sales and Support Information
UK Responsible Person: Breas Medical Ltd
Phone UK Head Office
[phone]
Fax UK Head Office
[phone]
General Enquiries and Ordering
[e-mail]
Tech Support
[e-mail]
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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 instruc-
tions 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 ventila-
tor 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 treat-
ment 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.
The ventilator may not work properly if any part has been dropped, damaged or sub-
merged 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.
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WARNING!
Risk of Faulty Treatment
If the patient is admitted to a hospital or is prescribed any other form of medical treat-
ment, 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 39.
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.
CAUTION!
Clinical personnel must read the Clinician’s manual thoroughly and understand the venti-
lator 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 SpO2module.
Ensure that the cooling air intake vents are not blocked. If the vents are blocked, espe-
cially 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 tem-
perature 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.
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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 accesso-
ries specified or approved by Breas Medical.
Inadequate use of device or accessories may cause loss of treatment or decreased
performance.
CAUTION!
If you suspect that the device has been mistreated, perform a functional check before
taking it to use. A basic functional check can be performed as described in 4.5 Inspecting
the Nippy 4 before Use , page 39. A complete functional check can be performed by an
authorized service technician.
NOTE
Any serious incident that has occurred in relation to this device should be reported to
the competent authority and the manufacturer.
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 iso-
lation from AC power (Mains) voltage which complies with the requirements of
IEC 60601-1.
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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 chap-
ter 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. Otherwise, degradation of the
performance of this equipment could result.
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.
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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 recom-
mended operating conditions.
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 pro-
vided in 8.3 Emission and Immunity Declaration, page 124 to mitigate the effects of electro-
magnetic 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 leak-
age 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 per-
mits spontaneous breathing can cause asphyxiation.
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