Instructions for Use
216 Pages
Preview
Page 1
Instructions for use
Savina
WARNING To properly use this medical device, read and comply with these instructions for use.
Ventilator Software 3.1n
Typographical conventions 1
Consecutive numbers indicate steps of action, with the numbering restarting with "1" for each new sequence of actions.
Bullet points indicate individual actions or different options for action. –
Dashes indicate the listing of data, options, or objects.
(A) Letters in parentheses refer to elements in the related illustration. A Letters in illustrations denote elements referred to in the text. Any text shown on the screen and any labeling on the device are printed in bold and italics, e.g., PEEP, O2, or Audio paused 2 min.. The "greater than" symbol > indicates the navigation path in a dialog window, e.g., Configuration > Configuration 2/4. In this example, Configuration represents the dialog window title and Configuration 2/4 the second page of four pages in the dialog window.
Screen reproductions Illustrations of products and screen content in this document may differ from the actual products depending on configuration and design.
Use of terms Dräger uses the term "accessories" not only for accessories in the sense of IEC 60601-1, but also for consumables, removable parts, and attached parts.
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Instructions for use Savina SW 3.1n
Trademarks Trademark
Trademark owner
Trademark
Trademark owner
Savina®
Dräger
Descogen®
Antiseptica
AutoFlow
®
Dismozon
LPO® Actichlor® BruTab 6S ®
Buraton
Mikrozid
®
Oxycide Ecolab
Virkon®
Brulin
1)
BIPAP
Schülke & Mayr
1)
Bode Chemie
®
Medentech
®
Ecolab USA
Klorsept
Dräger-Spirolog®
®
DuPont
Trademark used under license
®
Perform®
Safety information definitions WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the medical device or other property. NOTE A NOTE provides additional information intended to avoid inconvenience during operation.
Instructions for use Savina SW 3.1n
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Definition of target groups For this product, users, service personnel, and experts are defined as target groups.
Service personnel
These target groups must have received instruction in the use of the product and must have the necessary training and knowledge to use, install, reprocess, maintain, or repair the product.
Service personnel are persons who are responsible for the maintenance of the product.
The product must be used, installed, reprocessed, maintained, or repaired exclusively by defined target groups.
Service personnel must be trained in the maintenance of medical devices and install, reprocess, and maintain the product.
Experts
Users
Experts are persons who perform repair or complex maintenance work on the product.
Users are persons who use the product in accordance with its intended use.
Experts must have the necessary knowledge and experience with complex maintenance work on the product.
Abbreviations and symbols For explanations refer to sections "Abbreviations" and "Symbols" in chapter "Overview".
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Instructions for use Savina SW 3.1n
Contents
Contents Typographical conventions... Trademarks... Safety information definitions... Definition of target groups...
2 3 3 4
For your safety and that of your patients. . .
7
Getting started...
65 66 66 67 70
General safety information... 8 Product-specific safety information... 12
Safety information... Switching on Savina... Device check after reprocessing... Checking operational readiness... Selecting Tube or Mask/NIV application mode... Starting therapy...
Application... 15
Operation...
75
Intended use... 16 Environment of use... 16
Setting ventilation... Non-Invasive Ventilation (NIV)... Suction maneuver with oxygen enrichment. . . Medication nebulization... Manual inspiration – Insp. hold... Bright and dark screen background... Key lock... Low Pressure Oxygen (LPO)... Transporting patients... Interrupting ventilation – Standby mode... Ending operation... Storing Savina...
76 79 81 82 86 87 87 88 91 92 93 94
Alarms...
95
Overview... 17 Savina... Trolley... Range of functions... Abbreviations... Symbols... Product labels...
18 24 25 26 29 30
Operating concept... 33 Control and display unit... 34 Dialog windows... 36 Main screen... 40 Assembly and preparation... 41 Safety information... 42 Preparing the trolley... 42 Mounting an additional monitor... 46 Preparing Savina... 48 Mains power supply... 54 Power supply from on-board power supply or batteries... 55 Gas supply... 57 Nurse call... 59 MEDIBUS protocol... 61 Removing and refitting the filter cover... 62 Connecting a potential equalization cable... 64 Intrahospital transport... 64
Instructions for use Savina SW 3.1n
73 74
Display of alarms... 96 Suppressing the acoustic alarm signal... 98 Acknowledging an alarm message... 98 Setting the alarm limits... 99 Show alarm history... 101 Inactive alarm limits and monitoring functions... 101 Monitoring... 103 General information... 104 FiO2 monitoring... 104 Flow monitoring... 107 Configuration... 109 General information... 110 Adjusting screen contrast... 110 Selecting measured values for the main screen... 110 Setting the volume of the alarm signal... 111 5
Contents
Configuring ventilation functions... 111 Configuring country-specific settings... 112 Configuring the data interface... 113 Displaying information about the device... 113 Enabling options... 113 Troubleshooting... 115 Failure of the power supply... 116 Failure of the gas supply... 116 High ambient temperature... 116 Alarm – Cause – Remedy... 117 Cleaning, disinfection and sterilization... 135 Information on reprocessing... 136 Disassembly... 137 Reprocessing methods... 140 Reprocessing list... 144 After reprocessing... 146
EMC Declaration... 180 Connections to IT networks... 185 Principles of operation... 187 Ventilation modes... 188 Additional settings... 195 Non-invasive ventilation (NIV)... 200 Low Pressure Oxygen (LPO)... 201 Automatic leakage compensation... 203 Measurements... 205 Pneumatic functional description... 206 References... 208 Index... 209 Labels for options... 213
Maintenance... 147 Information on maintenance... 148 Inspection... 149 Preventive maintenance... 150 Repair... 151 Replacing the microfilter... 152 Replacing the dust filter set... 153 Replacing O2 sensors... 154 Replacing the diaphragm of the reusable expiratory valve... 155 Disposal... 157 Safety information... 158 Disposal of packaging material... 158 Disposal of batteries... 158 Disposal of O2 sensors... 159 Disposal of the medical device... 159 Technical data... 161 Ambient conditions... 162 Setting values... 162 Performance characteristics... 164 Displayed measured values... 167 Monitoring... 170 Operating data... 172 Factory settings... 176 Alarm system of Savina... 177 Automatic alarm limits... 178 6
Instructions for use Savina SW 3.1n
For your safety and that of your patients
For your safety and that of your patients General safety information...
8
Strictly follow these instructions for use... 8 Maintenance... 8 Safety checks... 8 Accessories... 9 Not for use in areas of explosion hazard... 9 Connected devices... 9 Device combinations... 9 Patient safety... 10 Patient monitoring... 10 Information on electromagnetic compatibility . . 10 Disposable products... 11 Sterile accessories... 11 Installing accessories... 11 Storing the instructions for use... 11 Product-specific safety information... 12 Functional safety... 14 Monitoring ventilation... 14 Backup ventilation with an independent manual ventilation device... 14
Instructions for use Savina SW 3.1n
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For your safety and that of your patients
General safety information The following WARNING and CAUTION statements apply to general operation of the medical device. WARNING and CAUTION statements specific to subsystems or particular features of the medical device appear in the respective sections of these instructions for use or in the instructions for use of another product being used with this medical device.
Strictly follow these instructions for use WARNING Risk of incorrect operation and of incorrect use Any use of the medical device requires full understanding and strict observation of all sections of these instructions for use. The medical device must only be used for the purpose specified under "Intended use" on page 16 and in conjunction with appropriate patient monitoring (see page 10). Strictly observe all WARNING and CAUTION statements throughout these instructions for use and all statements on medical device labels. Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use.
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Maintenance WARNING Risk of medical device failure and of patient injury The medical device must be inspected and serviced regularly by service personnel. Repair and complex maintenance carried out on the medical device must be performed by experts. If the above is not complied with, medical device failure and patient injury may occur. Observe chapter "Maintenance". Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerService. For maintenance Dräger recommends the use of authentic Dräger repair parts.
Safety checks The medical device must be subject to regular safety checks. See chapter "Maintenance".
Instructions for use Savina SW 3.1n
For your safety and that of your patients
Accessories
Device combinations
WARNING Risk due to incompatible accessories
This device can be operated in combination with other Dräger devices or devices from other manufacturers. Observe the accompanying documentation of the individual devices.
Dräger has tested only the compatibility of accessories listed in the current list of accessories. If other, incompatible accessories are used, there is a risk of patient injury due to medical device failure. Dräger recommends that the medical device is only used together with accessories listed in the current list of accessories.
If a device combination is not approved by Dräger, the safety and the correct functioning of the individual devices can be compromised. The operating organization must ensure that the device combination complies with the applicable editions of the relevant standards for medical devices. Savina as from serial number ASFF-1000
Not for use in areas of explosion hazard WARNING Risk of fire The medical device is not approved for use in areas where combustible or explosive gas mixtures are likely to occur.
Connected devices WARNING Risk of electric shock and of device malfunction Electrical connections to equipment not listed in these instructions for use or these assembly instructions must only be made when approved by each respective manufacturer. Before operating the medical device, strictly comply with the instructions for use of all connected devices or device combinations.
Instructions for use Savina SW 3.1n
Device combinations approved by Dräger meet the requirements of the following standards: – IEC 60601-1, 3rd edition (general requirements for safety, device combinations, softwarecontrolled functions) – IEC 60601-1-2 (electromagnetic compatibility) – IEC 60601-1-8 (alarm systems) Or: – IEC 60601-1, 2nd edition (general requirements for safety) – IEC 60601-1-1 (device combinations) – IEC 60601-1-2 (electromagnetic compatibility) – IEC 60601-1-4 (software-controlled functions) – IEC 60601-1-8 (alarm systems) Savina up to serial number ASFF-0999 Device combinations approved by Dräger meet the requirements of the following standards: – IEC 60601-1, 2nd edition (general requirements for safety) – IEC 60601-1-1 (device combinations) – IEC 60601-1-2 (electromagnetic compatibility) – IEC 60601-1-4 (software-controlled functions) – IEC 60601-1-8 (alarm systems)
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For your safety and that of your patients
Patient safety The design of the medical device, the accompanying documentation, and the labeling on the medical device are based on the assumption that the purchase and the use of the medical device are restricted to persons familiar with the most important inherent characteristics of the medical device. Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device. The instructions for use do not contain any information on the following points: –
Risks that are obvious to users
–
Consequences of obvious improper use of the medical device
–
Potentially negative effects on patients with different underlying diseases
Medical device modification or misuse can be dangerous. CAUTION Risk of patient injury Do not make therapeutic decisions based solely on individual measured values and monitoring parameters.
Information on electromagnetic compatibility General information on electromagnetic compatibility (EMC) according to international EMC standard IEC 60601-1-2: Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC information provided on see page 180. Portable and mobile radio frequency communication equipment can affect medical electrical equipment. WARNING Risk of device malfunction Do not connect connectors with an ESD warning symbol and do not touch their pins without implementing ESD protective measures. Such protective measures can include antistatic clothing and shoes, touching a potential equalization pin before and during connection of the pins, or using electrically insulating and antistatic gloves. All users concerned must be instructed in these ESD protective measures.
Patient monitoring The user of the medical device is responsible for choosing a suitable patient monitoring system that provides appropriate information on medical device performance and patient condition. Patient safety can be achieved by a wide variety of means ranging from electronic surveillance of medical device performance and patient condition to direct observation of clinical signs. The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical device.
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Instructions for use Savina SW 3.1n
For your safety and that of your patients
WARNING Risk of device failure Electromagnetic fields can compromise proper operation of the device. Electromagnetic fields are generated by, e.g., radio frequency communication equipment such as: – Cellular phone – Radio frequency electrosurgical equipment – Defibrillators – Shortwave therapy equipment Only use radio frequency devices at a sufficient safety distance. See electromagnetic compatibility information on page 180.
Disposable products
Installing accessories CAUTION Risk of device failure Install accessories to the basic device in accordance with the instructions for use of the basic device. Make sure that there is a safe connection to the basic device. Strictly observe instructions for use and assembly instructions.
Storing the instructions for use CAUTION Risk of incorrect use Instructions for use must be kept accessible to the user.
WARNING Risk of patient injury due to failure of accessories Disposable products are developed, tested and manufactured for disposable use only. Reuse, reprocessing, or sterilization can lead to a failure of accessories and cause injury to the patient. Do not reuse, reprocess, or sterilize disposable products.
Sterile accessories CAUTION Risk of medical device failure and of patient injury Do not use sterile-packaged accessories if the packaging has been opened, is damaged, or if there are other signs of non-sterility.
Instructions for use Savina SW 3.1n
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For your safety and that of your patients
Product-specific safety information WARNING Risk of incorrect use
WARNING Risk of fire
This medical device is only intended to be used by the target group "users".
Adjust the volume of alarm signals so that they can be perceived.
The flow sensor can ignite medications or other substances based on highly flammable substances. – Do not nebulize medications or other substances that are easily flammable or spray them into the device. – Do not use substances containing alcohol. – Do not allow flammable or explosive substances to enter the breathing system or the breathing circuit.
WARNING Risk of malfunctions
WARNING Risk of failure of flow measurement
Prohibited modifications to the medical device lead to malfunctions.
WARNING Risk of electric shock
Deposits that were not removed during reprocessing can damage the measuring wires in the flow sensor or cause a fire. – Before inserting the flow sensor check for visible damage, soiling, and particles. Repeat this check regularly. – Replace flow sensors when damaged, soiled, or not particlefree.
If the connectors of the interfaces and the patient are touched simultaneously, there is a risk of electric shock.
WARNING Risk of fire
Do not simultaneously touch the connectors of the interfaces and the patient.
When using O2 pressure reducers that are not approved, excess pressure can cause a fire.
WARNING Failure to hear alarm signals in a loud environment Alarm situations go unnoticed.
This medical device must not be modified without permission from the manufacturer.
WARNING Risk of patient injury Penetrating liquid may cause malfunction of the device, which may endanger the patient.
When supplying the ventilator with oxygen from a compressed gas cylinder, only use pressure reducers that comply with ISO 10524. Open pressure reducers slowly by hand. Do not use tools.
Do not place any containers with liquid on or above the device. During surface disinfection, make sure no liquids penetrate into the device.
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Instructions for use Savina SW 3.1n
For your safety and that of your patients
WARNING Risk of fire
WARNING Risk of fire
Do not use the medical device in conjunction with flammable gases or flammable solutions that can mix with air, oxygen, nitrous oxide, or other sources of ignition since the medical device could ignite.
Due to oxygen enrichment in the ambient air and overheating, the medical device can ignite.
Do not allow the medical device to come into contact with sources of ignition. WARNING Risk of patient injury Magnetic resonance imaging (MRI, NMR, NMI) may impair correct functioning of the medical device. Do not use the medical device during magnetic resonance imaging.
A distance of at least 10 cm (3.9 in) must be maintained between the rear of the medical device and walls or large-scale obstacles. Do not cover the rear during operation or standby mode so that air circulation is ensured. Only use the medical device in adequately ventilated rooms. CAUTION Risk of unnoticed change in the inspiratory O2 concentration
WARNING Risk of patient injury
If an additional flow (e.g., NO, nitrous oxide) is delivered from an external flow source, the actual O2 concentration may deviate from the displayed value.
Hyperbaric chambers may impair correct functioning of the medical device.
If required, use additional monitoring, e.g., external SpO2 monitoring.
Do not use the medical device in hyperbaric chambers. WARNING Risk of electric shock There are live components under the housing cover. Do not remove the cover.
CAUTION Risk of overheating of the medical device Sources of heat such as direct sunlight, heat radiators, or spotlights may cause the medical device to overheat. Keep sources of heat away from the medical device. Only use the medical device in adequately ventilated rooms. CAUTION Risk of patient injury Positive-pressure ventilation can lead to negative effects, such as barotrauma or strain on the circulatory system. Monitor the patient's condition.
Instructions for use Savina SW 3.1n
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For your safety and that of your patients
CAUTION Risk of electric shock If a faulty device without safety extra-low voltage (SELV) is connected to the medical device, there is a risk of electric shock when the housing is touched. Only connect devices with safety extra-low voltage (SELV) to the connections for the serial port and the nurse call.
Functional safety The essential performance consists in a controlled and monitored patient ventilation with user-defined settings for the monitoring functions – minimum breathing gas flow, – maximum airway pressure, – minimum and maximum O2 concentration in the breathing gas, or, if a set limit is exceeded, an appropriate alarm. The integrated monitoring also generates an alarm in the following situations: – Failure of the external power supply – Discharge of the internal battery – Failure of the O2 supply (HPO mode) The medical device is equipped with basic safety features to reduce the possibility of patient injury while the cause of an alarm is remedied.
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Monitoring ventilation The following parameters are monitored by the integrated monitoring: – Airway pressure – Expiratory minute volume – Respiratory rate – Apnea – Inspiratory O2 concentration – Inspiratory breathing gas temperature – Inspiratory tidal volume Changes in these parameters may be caused by: – Acute changes in the patient's condition – Incorrect settings and faulty handling – Device malfunctions – Failure of power and gas supplies If the built-in monitoring fails, use substitute monitoring.
Backup ventilation with an independent manual ventilation device WARNING Risk of patient injury If a fault is evident at the medical device, its life-support functions may be affected. Ventilation of the patient using an independent ventilation device must be started without delay, if necessary with PEEP and/or an increased inspiratory O2 concentration (e.g., with the manual resuscitator MR-100).
Instructions for use Savina SW 3.1n
Application
Application Intended use... 16 Environment of use... 16
Instructions for use Savina SW 3.1n
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Application
Intended use Savina® Long-term ventilator for intensive care. For patients requiring a tidal volume of 50 mL and up.
Environment of use Savina is intended for the following environments of use: –
In intensive care wards, in recovery rooms and generally for hospital use
–
During the transfer of patients within the hospital
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Instructions for use Savina SW 3.1n
Overview
Overview Savina... 18 Ventilator with trolley... Control and display unit... Patient connection panel... Rear of the device up to serial number ASFF-0999... Rear of the device as from serial number ASFF-1000...
18 19 21 22 23
Trolley... 24 Range of functions... 25 Ventilation functions... Monitoring functions... Displays on the screen... Additional functions... Power supply... Gas supply... Data transfer... Medication nebulization...
25 25 25 25 26 26 26 26
Abbreviations... 26 Symbols... 29 Product labels... 30
Instructions for use Savina SW 3.1n
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Overview
Savina
Ventilator with trolley
A B
MT-0030-2008
C
A Control and display unit B Patient connection panel C Trolley
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Instructions for use Savina SW 3.1n
Overview
Control and display unit
A
U
B
Trigger
T S
Suction
R
Insp. hold
O2
Audio
Pinsp.
VT mL L
Nebul.
paused
2 min
mbar
Tinsp.
Alarm Reset
PASB
sec
abovePEEP
f
PEEP
bpm
mbar
Lock
C D E F G
O2 Vol.% Curves
Q
Settings
Alarms
Values
Config.
H
ext. int.
IPPV
SIMV
BIPAP
Start/ Standby
K
I
J 003
P O N ML
CPAP ASB
A Screen
O Settings
key
B Keys for ventilation parameters VT, Tinsp., f, O2, Pinsp., ΔPASB above PEEP, PEEP with a display of the current values
P Curves
key
C The red LED flashes for alarms with high priority D Yellow LED: – Flashes for alarms with medium priority – Lights up for alarms with low priority E
Audio paused 2 min. or
Q
key
R Insp. hold key S O2 ↑ Suction key T
Nebul. key
U Trigger LED
2 min key
F Alarm Reset key G
Lock key
H LED indicating the power supply (for more information, see page 20) I J
Start/Standby or
Standby key
Rotary knob
K Keys for ventilation modes IPPV, SIMV, CPAP/ASB, BIPAP L Config.
key
M Values
key
N Alarms
key
Instructions for use Savina SW 3.1n
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Overview
Indication of power supply
V W
ext. int.
016
X
V Mains power W External battery or DC on-board power supply X Internal battery Meaning of the LED colors: Each LED lights up: Mains power External battery DC on-board power supply Internal battery
20
Green
Yellow
Red
Off
Present
-
-
Not present
Battery operation or fully charged
Charging
Overheated or defective
Not present
Present
-
Overheated or defective
Not present
Battery operation or fully charged
Charging
Overheated or defective
Not being charged
Instructions for use Savina SW 3.1n