Savina 300 Instructions for Use Sw 5.n Edition 2

Information about this document

Information about this document

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 illustrations denote elements referred to in the text.

>

The greater-than symbol indicates the navigation path in a dialog window. Bold, italicized text indicates labels on the device and texts that are displayed on the screen.

(A) Letters in parentheses refer to elements in the related illustration.

Illustrations 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 300 SW 5.n

Information about this document

Trademarks Trademark

Trademark owner

Trademark

Trademark owner

Savina®

Dräger

Buraton®

Schülke & Mayr

®

®

ATC

Mikrozid

AutoFlow®

Perform®

LPO®

acryl-des®

Spirolog®

Descogen® Dismozon

TM

®

Medentech

®

Ecolab USA

MEDIBUS.X ®

Klorsept

Actichlor

Ecolab

Oxycide

BruTab 6S®

Brulin

Virkon®

Clorox

1)

®

Dispatch

®

Antiseptica

DrägerService®

Bode Chemie

DuPont

BIPAP 1)

Licensed trademark

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.

NOTE A NOTE provides additional information intended to avoid inconvenience during operation.

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.

Instructions for use Savina 300 SW 5.n

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Information about this document

Target groups

Duties of the operating organization

Service personnel

The tasks described in this document specify the requirements that have to be met by each respective target group.

Task

Requirement

Installation

Specialist knowledge in electrical engineering and mechanics

The operating organization of this product must ensure the following: –

The target group has the required qualifications (e.g., has undergone specialist training or acquired specialist knowledge through experience).

–

The target group has been trained to perform the task.

–

The target group has read and understood the chapters required to perform the task.

Description of target groups The target groups may only perform the following tasks if they meet the corresponding requirements. Users Task

Requirement

Basic service work (inspection, maintenance according to the "Maintenance" chapter)

Experience in the servicing of medical devices

Specialized service personnel Task

Requirement

Installation

Specialist knowledge in electrical engineering and mechanics

Basic and complex service work (inspection, Experience in the servicing maintenance, repair) of medical devices Experience in complex service work on this product Dräger recommends arranging a service contract with DrägerService.

Use of the product in Specialist medical accordance with the knowledge in ventilation intended use Reprocessing personnel Task

Requirement

Reprocessing

Specialist knowledge in the reprocessing of medical devices

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Instructions for use Savina 300 SW 5.n

Contents

Contents Information about this document...

2

Contents...

5

For your safety and that of your patients. . .

7

General safety information... 8 Product-specific safety information... 11

Selecting the breathing circuit and the humidification type... 62 Checking operational readiness... 63 Selecting the therapy type and the application mode... 69 Selecting the start settings for ventilation... 70 Starting the therapy... 72

Application... 15

Operation...

73

Intended use... 16 Contraindications... 16 Environment of use... 16

Setting ventilation... Non-invasive ventilation (NIV)... Suction maneuver with oxygenation... Medication nebulization... Manual inspiration – Inspiration hold... Special maneuvers... O2 therapy... Day/Night screen switch-over... Key lock... Low Pressure Oxygen (LPO)... Transporting patients... Interrupting ventilation – standby mode... Ending operation... Storing Savina 300...

74 79 80 82 85 86 87 89 89 90 93 94 95 96

Alarms...

97

Overview... 17 Savina 300... 18 Trolley... 21 Range of functions... 22 Abbreviations... 24 Symbols... 28 Product labels... 30 Operating concept... 31 Control and display unit... 32 Fixed function keys... 32 Screen... 33 Assembly and preparation... 37 Safety information... 38 Preparing the trolley... 38 Mounting an additional monitor... 42 Preparing Savina 300... 43 Connecting the power supply... 51 Connecting the gas supply... 53 Connecting the nurse call... 54 Using the MEDIBUS or MEDIBUS.X protocol... 55 Removing and refitting the filter cover... 57 Connecting a potential equalization cable... 57 Intrahospital transport... 58 Getting started... 59 Safety information... 60 Switching on Savina 300... 60 Instructions for use Savina 300 SW 5.n

Display of alarms... 98 Suppressing the acoustic alarm signal... 100 Acknowledging the alarm message... 100 Setting the alarm limits... 101 Trends and data... 103 Opening the dialog window... 104 Displaying measured values and set values . . 104 Displaying trends... 105 Displaying the logbook... 107 Displaying waveforms and measured values on the main screen... 108 Monitoring... 111 General information... 112 Flow monitoring... 112 FiO2 monitoring... 114 CO2 monitoring... 116 5

Contents

Configuration... 123 Information on configuration... 124 Configuring ventilation functions... 125 Configuring start settings... 126 Configuring device settings... 130 Configuring country-specific settings... 131 Configuring the data interface... 132 Displaying and enabling options... 132 Scanning the QR code... 133 Troubleshooting... 135 Failure of the power supply... 136 Failure of the gas supply... 136 High ambient temperature... 136 Alarm – Cause – Remedy... 137 Reprocessing... 163 Disassembly... 164 Information on reprocessing... 167 Classifications for reprocessing... 169 Reprocessing list... 170 Reprocessing procedures... 172 After reprocessing... 176 Service... 177 Safety information... 178 Definition of service terminology... 179 Inspection... 179 Maintenance... 181 Repair... 182 Replacing the microfilter... 182 Replacing the dust filter set... 183 Replacing O2 sensors... 184 Replacing the diaphragm of the reusable expiratory valve... 184

Performance characteristics... 193 Displayed measured values... 195 Monitoring... 199 Operating data... 201 Alarm system of Savina 300... 206 Automatic alarm limits... 207 Device combinations... 209 EMC declaration... 209 Connections to IT networks... 212 Open-source software... 213 Principles of operation... 215 Ventilation modes... 216 Additional settings... 228 Therapy types and application modes... 236 Special maneuvers... 237 Low Pressure Oxygen (LPO)... 238 Automatic leakage compensation... 240 Measurements... 242 Pneumatic functional description... 243 Overview of the menu structure... 246 References... 250 Index... 251 Labels for options... 255 Password for Savina 300 SW 5.n... 263 Information on the password... 263

Disposal... 185 Safety information... 186 Disposal of packaging material... 186 Disposal of batteries... 186 Disposal of O2 sensors... 187 Disposing of the medical device... 187 Technical data... 189 Ambient conditions... 190 Set values... 190 6

Instructions for use Savina 300 SW 5.n

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 Service... 8 Accessories... 8 Not for use in areas of explosion hazard... 8 Connected devices... 8 Patient safety... 9 Patient monitoring... 9 Electromagnetic compatibility (EMC)... 9 Disposable products... 10 Sterile-packaged accessories... 10 Installing accessories... 10 Storing the instructions for use... 10 Training... 10 Product-specific safety information... 11 Functional safety... 13 Monitoring ventilation... 13 Backup ventilation with an independent manual ventilation device... 13

Instructions for use Savina 300 SW 5.n

7

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 9). 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.

Service WARNING Risk if service is not performed regularly If service is not performed regularly, malfunctions may occur, which can result in personal injury and property damage.

Accessories WARNING Risk due to incompatible accessories The use of incompatible accessories may adversely affect the functional integrity of the product. Personal injury and property damage may occur as a consequence. Use only compatible accessories. The accessories that are compatible with this product are listed in the list of accessories supplied with the product.

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.

Perform the service in accordance with the chapter "Service". 8

Instructions for use Savina 300 SW 5.n

For your safety and that of your patients

Patient safety

Electromagnetic compatibility (EMC)

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.

Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility. During installation and before initial operation, follow the information in section: "EMC declaration" (page 209).

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.

Patient monitoring

This device can be affected by other electrical devices. WARNING Risk due to electrostatic discharge Malfunctions that endanger the patient may occur if no protective measures against electrostatic discharge are employed in the following situations: – When touching the pins of connectors that carry the ESD warning symbol. – When establishing connections with these connectors. To prevent malfunctions, observe the following measures and train the relevant personnel: – Observe the ESD protective measures. Such measures may include wearing antistatic clothing and shoes, touching a potential equalization pin before and while making the connection, or using electrically insulating and antistatic gloves. – Observe the requirements for the electromagnetic environment. Observe the following section: "Electromagnetic environment" (page 210).

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.

Instructions for use Savina 300 SW 5.n

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For your safety and that of your patients

WARNING Risk due to electromagnetic disturbance Wireless communication devices (e.g., cellular phones) and medical electrical equipment (e.g., defibrillators, electrosurgical devices) emit electromagnetic radiation. When such devices are operated too close to this device or its cables, the functional integrity of this device may be compromised by electromagnetic disturbances. As a result, the patient could be put at risk. Maintain a distance of at least 0.3 m (1.0 ft) between this device and wireless communication devices, to ensure that the essential performance of this device is fulfilled. Maintain an adequate distance between this device and other medical electrical equipment.

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.

Disposable products Training WARNING Risk of patient injury due to failure of accessories

Training for users is available from the Dräger organization responsible, see www.draeger.com.

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-packaged 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.

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Instructions for use Savina 300 SW 5.n

For your safety and that of your patients

Product-specific safety information WARNING Risk of incorrect use

WARNING Risk of patient injury

This medical device is only intended to be used by the target group "users".

Penetrating liquid may cause malfunction of the device, which may endanger the patient.

WARNING Risk of not hearing alarm signals

Do not place any containers with liquid on or above the device. During surface disinfection, make sure no liquids penetrate into the device.

If the alarm volume is too low, alarm signals may not be heard. – Set the alarm volume loud enough so that the alarm signals can be heard in the environment where the device is located. – The user must remain within earshot of the alarm signals. WARNING Risk due to modifications Modifications to the product may lead to malfunctions and unforeseen risks. This may result in injury to the patient or the user or in property damage. Do not modify this product. WARNING Risk of electric shock If the connectors of the interfaces and the patient are touched simultaneously, there is a risk of electric shock. Do not simultaneously touch the connectors of the interfaces and the patient.

Instructions for use Savina 300 SW 5.n

WARNING Risk of fire 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 failure of flow measurement 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.

11

For your safety and that of your patients

WARNING Risk of fire

WARNING Risk of fire

When using O2 pressure reducers that are not approved, excess pressure can cause a fire.

Due to oxygen enrichment in the ambient air and overheating, the medical device can ignite.

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. 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. Do not allow the medical device to come into contact with sources of ignition.

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 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 values.

WARNING Risk of patient injury

If required, use additional monitoring, e.g., external SpO2 monitoring.

Magnetic resonance imaging (MRI, NMR, NMI) may impair correct functioning of the medical device.

CAUTION Risk of overheating of the medical device

Do not use the medical device during magnetic resonance imaging.

Sources of heat such as direct sunlight, heat radiators or spotlights may cause the medical device to overheat.

WARNING Risk of patient injury

Keep sources of heat away from the medical device. Only use the medical device in adequately ventilated rooms.

Hyperbaric chambers may impair correct functioning of the medical device. Do not use the medical device in hyperbaric chambers. WARNING Risk of electric shock

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.

There are live components under the housing cover. Do not remove the cover. 12

Instructions for use Savina 300 SW 5.n

For your safety and that of your patients

CAUTION Risk of malfunction The touch screen has a sensitive surface. Damage to the surface results in malfunctions of the touch-sensitive controls. Never use sharp objects to operate the screen. Do not damage the surface of the screen during cleaning or transport. CAUTION Risk of electric shock

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 – End-expiratory CO2 concentration

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.

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

Only connect devices with safety extra-low voltage (SELV) to the connections for the serial port and the nurse call.

If the built-in monitoring fails, use substitute monitoring. During O2 therapy, the monitoring functions of the medical device are limited.

Functional safety The essential performance consists in a controlled and monitored patient ventilation with user-defined settings for the monitoring functions – minimum ventilation 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)

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).

The medical device is equipped with basic safety features to reduce the possibility of patient injury while the cause of an alarm is remedied.

Instructions for use Savina 300 SW 5.n

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Instructions for use Savina 300 SW 5.n

Application

Application Intended use... 16 Contraindications... 16 Environment of use... 16

Instructions for use Savina 300 SW 5.n

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Application

Intended use Savina 300 is a ventilator intended for the ventilation of adults and pediatric patients. Savina 300 offers mandatory ventilation modes, ventilation modes supporting spontaneous breathing, and airway monitoring.

Contraindications When using small minute volumes, it takes longer for a modified oxygen concentration to reach the patient. For the ventilation of neonates, the use of special neonatal ventilators is therefore recommended.

Environment of use Savina 300 is intended for the following environments of use: –

In intensive care wards, in recovery rooms and generally for hospital use

–

–

Mechanical safety and EMC compatibility are tested on the basis of the following standards: Type of transport

Standards

During the transfer of patients within the hospital

Secondary transport

EN 1789 Section 6.4.1: Mechanical Safety

–

During secondary transport from one hospital to another

Transfer flight

–

During transfer flights with airplanes

RTCA/DO-160G: All applicable sections related to electromagnetic transmissions and mechanical safety

For secondary transport and transfer flights, the following must be considered: –

Savina 300 is in use without a trolley.

–

There is no monitor mounted on Savina 300.

–

Savina 300 is used without CO2 monitoring.

16

Other specific requirements for transport ventilators in the following standards are not fulfilled: EN 13718-1, EN 1789, ISO 10651-3

Instructions for use Savina 300 SW 5.n

Overview

Overview Savina 300... 18 Ventilator with trolley... Control and display unit... Patient connection panel... Rear...

18 18 19 20

Trolley... 21 Range of functions... 22 Therapy types... Ventilation functions... Monitoring functions... Displays on the screen... Additional functions... Power supply... Gas supply... Data transfer... Medication nebulization... Transport of patients...

22 22 22 23 23 23 23 23 23 23

Abbreviations... 24 Symbols... 28 Product labels... 30

Instructions for use Savina 300 SW 5.n

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Overview

Savina 300

Ventilator with trolley

Control and display unit

A A

B

D

B A Touch screen B Fixed function keys C Rotary knob

C

001

D Power supply display

A Control and display unit B Patient connection panel C Trolley

18

Instructions for use Savina 300 SW 5.n

003

C

Overview

Power supply display

016

E F G

ext int

E External battery F Mains power G Internal battery Meaning of the LED colors: Each LED lights up: Green Mains power

Yellow

Red

Off

Present

-

Insufficient

Not present

External battery

Battery operation or battery charge at least 75 %

Charging

Overheated or defective

Not present

Internal battery

Battery operation or battery charge at least 75 %

Charging

Overheated or defective

Not being charged

Patient connection panel C Inspiratory valve with inspiratory port Insp. (GAS OUTPUT) D Fastening screw for cover plate (behind cover: O2 sensors)

A

E Water trap of expiratory valve

B

H

F Expiratory valve with expiratory port Exp. (GAS RETURN)

G

F

E

D

C

A Socket for breathing gas temperature sensor

070

G Flow sensor flap (behind flap: flow sensor) H Gas outlet Exhaust, non-conical connection (EXHAUST – NOT FOR SPIROMETER)

B Nebulizer port (nebulizer gas outlet for pneumatic medication nebulizer) Instructions for use Savina 300 SW 5.n

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Overview

Rear

Rear without filter cover

T S R

M L K

N

Q

J I H

O P

B C

N Cable for external battery

D

O Potential equalization cable P Power cable

F

E

004

G

Q Connection for power cable, mains power fuse

A Filter cover

R Power supply unit

B Rating plate

S Connection for external battery

C Labels for options

T Potential equalization pin

D Cable guide and holder for power cable E LPO port for connecting a low-pressure oxygen source, e.g., an O2 concentrator F Label for LPO G HPO port for O2 compressed gas hose O2 H Port for CO2 sensor I

COM port (serial RS232 interface)

J

Connection for nurse call

K Main switch for switching on

or off

L Fuse for the internal battery M Storage recess for fuse

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Instructions for use Savina 300 SW 5.n

027

A