Clinicians Manual
203 Pages
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Page 1
Clinician’s manual Nippy 4+
DOC. 007302 EN-GB D-2 2020-04-28
Table of Contents 1
Introduction... 9 1.1
What is the Nippy 4+? ... 9
1.2
Intended Use...11
1.3 1.4
Contraindications ... 12 Intended Environment... 12
1.5
Intended Users... 12
1.6
1.7 2
1.5.1
Respiratory Health Care Specialists... 12
1.5.2
Lay Operators ... 13
1.5.3
Service Personnel... 13
About this Manual ... 14 1.6.1
Audience ... 14
1.6.2
Icons in this Manual ... 14
Manufacturer Information... 15
Safety Information ... 17 2.1
General User Precautions... 17 2.1.1
3
2.2
Electrical Safety ... 21
2.3
Environmental Conditions... 22
2.4
Usage of Patient Circuit ... 23
2.5
Usage of Filters ... 26
2.6
Humidification ... 27
2.7
Cleaning and Maintenance ... 28
2.8
Usage of Oxygen ... 29
Product Description... 32 3.1
Main Components... 32
3.2 3.3
Front View ... 34 Side Views... 35 3.3.1
3.4
5
Additional Symbols ... 40
Preparing the Nippy 4+ for Use ... 42 4.1
Checking the Nippy 4+ before First Use ... 42
4.2
Placing the Nippy 4+ ... 42
4.3
Connecting the Nippy 4+ to Mains ... 44
4.4
Connecting the Patient Circuit ... 45
4.5
Inspecting the Nippy 4+ before Use ... 46
4.6
Adjusting the Nippy 4+ Patient Settings... 47
4.7
Performing the Pre-use Test ... 48
How to Use the Nippy 4+... 49 5.1
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Detaching and Reattaching the Side Panels ... 36
Equipment Designation... 39 3.4.1
4
Requirements for Life Supporting Treatment ... 20
Switch the Nippy 4+ On and Off... 49
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5.1.1
Switch On and Enter Operating Mode ... 49
5.1.2
Stop Treatment ... 50
5.1.3
Turn off / Enter Sleep Mode ... 50
5.2
Navigating the Display ... 51
5.3
Symbols Used on the Display ... 52
5.4
Home Mode and Clinical Mode... 53 5.4.1 Shifting between Home Mode and Clinical Mode... 53
5.5
Display Overview ... 53
5.6
5.7
5.8
5.9
5.5.1
Clinical Mode ... 53
5.5.2
Home Mode... 54
Treatment Modes ... 55 5.6.1
Selecting a Mode ... 55
5.6.2
Settings and Modes ... 56
5.6.3
Pressure Support Ventilation (PSV) ... 59
5.6.4
Pressure Support Ventilation with Target Volume (PSV+ TgV) ... 59
5.6.5
Pressure Controlled Ventilation (PCV) ... 60
5.6.6
Pressure Controlled Ventilation with Target Volume (PCV +TgV) ... 60
5.6.7
Synchronized Intermittent Mandatory Ventilation -Pressure (SIMV-P)... 60
5.6.8
Mouthpiece - Pressure (PCV-MPV) ... 61
5.6.9
Volume Controlled Ventilation (VCV)... 61
5.6.10
Synchronized Intermittent Mandatory Ventilation -Volume (SIMV-V)... 61
5.6.11
Mouthpiece - Volume (VCV-MPV)... 62
5.6.12
CPAP – Continuous Positive Airway Pressure ... 62
Profiles ... 63 5.7.1
Setting a Profile... 63
5.7.2
Selecting a Profile ... 63
Treatment Settings... 63 5.8.1
Changing a Setting ... 63
5.8.2
Settings ... 64
The Alarms List ... 74 5.9.1
Changing an Alarm Setting ... 74
5.10
The Monitored Values Pane... 75
5.11
The Menu ... 77 5.11.1
Opening the Menu ... 78
5.11.2
Patient Circuit... 78
5.11.3
Adjust Trigger Levels ... 79
5.11.4
Humidification Settings ... 79
5.11.5
User Preferences ... 79
5.11.6
Advanced Settings ... 80
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5.12
5.13
5.14
6
Compliance Data ... 81
5.11.8
Patient Monitor... 82
5.11.9
Pre-Use Test ... 85
5.11.10
Deactivate Profile... 86
5.11.11
Alarm/Event Logs... 86
5.11.12 Device Information ... 87 Transferring Data between the Ventilator and a PC ... 88 5.12.1
Transferring Data with a Memory Card... 88
5.12.2
Transferring Data with a Data Cable... 89
Using Batteries... 89 5.13.1
Power Source Priority ... 90
5.13.2
Charging the Batteries ... 90
5.13.3
Battery Icons ... 91
5.13.4
Internal Battery... 92
5.13.5
Click-in Battery... 92
5.13.6
Battery Operating Time (Internal and Click-in) ... 93
5.13.7
Storing the Internal Battery and the Click-in Battery... 94
5.13.8
External DC... 94
Using Accessories ... 95 5.14.1
Connecting and Disconnecting the Cables... 95
5.14.2
Using the ventilator with a Nurse Call System... 96
5.14.3
Using the ventilator with the FiO2 Sensor ... 96
5.14.4
Using the ventilator with the Remote Alarm... 98
5.14.5
Using the ventilator with the EtCO2 Sensor ... 98
5.14.6
Using the ventilator with the PtcCO2 Cable ... 103
5.14.7
Using the Ventilator with the SpO2 module... 104
5.14.8
Using the Ventilator with the Effort Belts... 104
5.14.9 5.14.10
Using the ventilator with the Remote Start/Stop... 106 Using the ventilator with the Protective Cover... 107
5.14.11
Using the Nippy 4+ with the Trolley ... 108
5.14.12
Using the Click-in Humidifier... 109
5.14.13
Installing the Water Chamber ...110
5.14.14
Detaching the Water Chamber ...112
5.14.15
Using the Patient Circuit with Heated Wire...115
Alarms ...117 6.1
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5.11.7
Alarm Function ...117 6.1.1
Alarm Indication ...117
6.1.2
Audible Signal Pause and Reactivation ...118
6.1.3
Alarm Reset ...119
6.2
Operator’s Position ...119
6.3
Physiological Alarms...119
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6.4
6.3.1
High Flow Alarm... 120
6.3.2
Low Flow Alarm... 121
6.3.3
High Pressure Alarm ... 122
6.3.4
Low Pressure Alarm ... 123
6.3.5
High EPAP Alarm ... 124
6.3.6 6.3.7
Low EPAP Alarm ... 124 High Vti (High Inspired Tidal Volume Alarm) ... 125
6.3.8
Low Vti Alarm (Low Inspired Tidal Volume) ... 125
6.3.9
High MVi Alarm (High Inspired Minute Volume Alarm) ... 126
6.3.10
Low MVi (Low Inspired Minute Volume Alarm) ... 126
6.3.11
High Vte Alarm (High Expired Tidal Volume) ... 127
6.3.12
Low Vte Alarm (Low Expired Tidal Volume) ... 127
6.3.13
High MVe (High Expired Minute Volume Alarm) ... 128
6.3.14
Low MVe Alarm (Low Expired Minute Volume) ... 128
6.3.15
High Breath Rate Alarm ... 129
6.3.16
Low Breath Rate Alarm... 130
6.3.17
Apnoea Alarm ... 131
6.3.18
Disconnection Alarm... 131
6.3.19
Rebreathing Alarm ... 133
6.3.20
Obstruction Alarm ... 134
6.3.21
High FiO2 Alarm ... 134
6.3.22
Low FiO2 Alarm ... 135
6.3.23
High SpO2 Alarm... 135
6.3.24
Low SpO2 Alarm... 136
6.3.25
High EtCO2 Alarm ... 136
6.3.26
Low EtCO2 Alarm ... 137
6.3.27
High InspCO2 Alarm (High Inspired CO2) ... 137
6.3.28 6.3.29
High Pulse Rate Alarm... 138 Low Pulse Rate Alarm ... 138
6.3.30
PtcCO2 Alarm... 139
Technical Alarms ... 140 6.4.1
Power Fail Alarm... 140
6.4.2
High Patient Air Temp. (High Patient Air Temperature) ... 140
6.4.3
Low Patient Air Temp. (Low Patient Air Temperature Alarm)... 141
6.4.4
Low Last Power Source Alarm ... 141
6.4.5
Crit. Low Last Power Source Alarm... 141
6.4.6
Lost Mains Power Alarm ... 142
6.4.7
Exhalation Valve Control Error Alarm ... 142
6.4.8
SpO2 Disconnected (SpO2 Sensor Failure/Disconnection Alarm)... 143
6.4.9
SpO2 Signal Lost Alarm ... 143
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6.5
7
Poor SpO2 Signal ... 143
6.4.11
CO2 Disconnected (CO2 Sensor Failure/Disconnection Alarm)... 144
6.4.12
CO2 Accuracy Error Alarm ... 144
6.4.13
Check CO2 Adapter Alarm ... 144
6.4.14
CO2 Sensor Error Alarm ... 145
6.4.15
FiO2 Disconnected (FiO2 Sensor Failure/Disconnection Alarm)... 145
6.4.16
Ambient Pressure Compensation Lost Alarm ... 145
6.4.17
Temperature Comp. Lost (Ambient Temperature Compensation Lost Alarm)... 146
6.4.18
Humidity Comp. Lost (Humidity Compensation Lost Alarm)... 146
6.4.19
LED Failure Alarm... 146
6.4.20
Low Alarm Battery Alarm ... 147
6.4.21
Alarm Battery Error Alarm... 147
6.4.22
Internal/Click-In Battery Hot Alarm ... 148
6.4.23
Heated Circuit Temp. Alarm... 148
6.4.24
High Humidifier Temp. Alarm ... 149
6.4.25
Humidifier Fault Alarm ... 149
6.4.26
Heated Circuit Fault Alarm... 150
6.4.27 6.4.28
Internal Function Failure ... 150 Air Temp. Sensor Fail Alarm ... 150
6.4.29
Internal Error Alarm... 151
6.4.30
Database Integrity Fail Alarm ... 151
6.4.31
Cooling Fan Error Alarm ... 151
6.4.32
Clock Failure Alarm... 152
6.4.33
Internal Temp High Alarm ... 152
6.4.34
Humidifier/Bypass Loose Alarm ... 152
Alarm Test ... 153 6.5.1
Alarm Signal Test ... 153
6.5.2
Mandatory Alarm Tests ... 153
6.5.3
Optional Alarm Tests... 156
Cleaning and Maintenance ... 158 7.1
7.2
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6.4.10
Cleaning the Nippy 4+... 158 7.1.1
Main Unit ... 159
7.1.2
Air Pathway Disinfection ... 159
7.1.3
Patient Circuit... 159
Cleaning and Replacing the Air Filters ... 160 7.2.1
Coarse Filter (Grey, Washable) ... 160
7.2.2
Fine Filter (White, Disposable) ... 161
7.3
Change of Patients... 161
7.4
Regular Maintenance ... 161
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8
7.5
Service and Repair... 162
7.6
Storage... 162
7.7
Disposal ... 163
Technical Specifications ... 164 8.1
System Description ... 164
8.2
8.1.1 Pneumatic Diagram for the ventilator ... 165 Data... 165
8.3
8.4 9
8.2.1
Worst Case Accuracy ... 165
8.2.2
Settings Specifications... 165
8.2.3
Monitored Values Specifications... 169
8.2.4
Power Supply ... 171
8.2.5
Environmental Conditions... 171
8.2.6
Other ... 172
Emission and Immunity Declaration ... 173 8.3.1
Nippy 4+ Essential Performance ... 173
8.3.2
Guidance and Manufacturer's Declaration – Electromagnetic Immunity... 174
8.3.3
Guidance and Manufacturer's Declaration – Electromagnetic Emission... 177
8.3.4
Recommended separation distances between portable and mobile RF communications equipment and the ventilator ... 177
8.3.5
Recommended separation distances between external power conductors and the ventilator... 178
8.3.6
Recommended separation distances between external power conductors and the ventilator... 179
Delivery Settings ... 179
Accessories and Parts ... 183 9.1
Breas Accessories List... 183
10
Patient Settings ... 195
11
FAA Compliance... 197
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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 and volume 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 • Mouthpiece - Pressure (PCV-MPV) • SIMV-Pressure (SIMV-P)
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Introduction 9 Nippy 4+ Clinician’s manual
SIMV= Synchronized Intermittent Mandatory Ventilation • Volume Control (VCV) • Mouthpiece - Volume (VCV-MPV) • SIMV-Volume (SIMV-V) SIMV= Synchronized Intermittent Mandatory Ventilation • CPAP Compatible Patient Circuits The Nippy 4+ can be used with a leakage circuit, an MPV circuit or a circuit with active exhalation valve. See 9 Accessories and Parts, page 183 for detailed information about approved patient circuits. For leakage 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, mouthpiece or pillow interface. See the patient interface’s instructions for use when selecting the interface to use.
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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.
1.2
Intended Use The Nippy 4+ ventilator (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 paediatric through adult patients weighing more than 10 kg (22 lbs.) The Nippy 4+ with the SpO2 is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. The Nippy 4+ 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. Nippy 4+ is not intended to be used as an emergency transport or critical care ventilator.
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Introduction 11 Nippy 4+ Clinician’s manual
1.3
Contraindications • The use of the Nippy 4+ 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. • In case of facial surgery, make sure to choose a suitable patient interface, in order to avoid discomfort and injury. • The Nippy 4+ is not intended to be used as an emergency transport ventilator or critical care ventilator. Undesirable Side 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 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.
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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 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 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. 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.
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Introduction 13 Nippy 4+ Clinician’s manual
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 User 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 primarily intended for care providers, clinical personnel, physicians and others who require a working knowledge of the Nippy 4+ system. The manual comprises detailed information of the settings and functions of the Nippy 4+, to be handled by trained health care personnel only.
• Patients and lay caregivers may read the user 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.
1.6.2
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.
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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.
1.7
Manufacturer Information Legal Manufacturer
Postal Address Breas Medical AB Företagsvägen 1 SE-435 33 Mölnlycke Sweden Web Address www.breas.com Email address [email protected] Phone +46 31 868800, Order: +46 31 868820, Technical support: +46 31 868860 Fax +46 31 868810
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Introduction 15 Nippy 4+ Clinician’s manual
UK Sales and Support Information Phone UK Head Office 01789293460 Fax UK Head Office 01789262470 General Enquiries and Ordering [email protected] Tech Support [email protected]
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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 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. 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.
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Safety Information 17 Nippy 4+ Clinician’s manual
To prevent death or serious injury, monitor the patient and the ventilator regularly in order to determine the need to provide emergency ventilation when an alarm sounds or the ventilator malfunctions. If using the ventilator in a transport case, only use the protective cover listed as approved accessory to prevent adverse ventilator performance, which can consequently result in patient death. Measured values for volume and expired CO2 may differ from the actual patient values due to unintentional leaks. Do not obstruct the gas intake port. 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 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.
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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. The ventilator therapy settings must always be based on medical advice and must be carried out by authorised clinical personnel only. When changing treatment settings or changing to another device a clinical assessment must be performed to determine if blood gas measurement needs to be performed. Before starting treatment, always perform the procedure 4.5 Inspecting the Nippy 4+ before Use , page 46. Risk of Unnoticed Critical Conditions • All the physiological alarms of the Nippy 4+ 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.
CAUTION! Clinical personnel must read the Clinician’s manual thoroughly and understand the ventilator operation before setting up and using the ventilator.
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Safety Information 19 Nippy 4+ Clinician’s manual
• 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.
2.1.1
Requirements for Life Supporting Treatment Life supporting-supporting treatment requires that: • An emergency equipment (e.g. resuscitation bag) is available. • One of the following means of surveillance is used: – Using the EtCO2 sensor accessory, or an external EtCO2 monitor (capnometer). This surveillance method can be used for ventilation with active exhalation valve circuits as well as leakage port circuits. The CO2 sensor must be connected between the patient and the exhalation valve or leakage port to be able to measure exhaled gases. If using an external CO2 monitor, it shall fulfil the ISO 80601-2-55 standard (Medical electrical equipment
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– Particular requirements for the basic safety and essential performance of respiratory gas monitors). – Supervising the ventilator’s monitoring of exhaled volume. This surveillance method can be used for ventilation with leakage circuits only.
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.
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