Primus Instructions for Use Sw 4.n

Working with these Instructions for Use The title of the main chapter in the header line helps with orientation and navigation.

Typing conventions

The instructions for the user combine text and illustrations, providing a comprehensive overview of the system. The information is presented as sequential steps of action, allowing the user to learn directly how to use the device.

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Any text shown on the screen and any labeling on the device are printed in bold and italics, e.g. PEEP, Air, or Alarm Settings.

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The sign > is used in menu sequences. First the main menu is indicated, then the menu option to be selected and further submenus (if applicable), e.g. System Setup > Ventilation > Basic Settings.

The text provides explanations and instructs the user step-by-step in the practical use of the product, with short, clear instructions in easy-to-follow sequence. 1

Consecutive numbers indicate steps of action, with the numbering restarting with “1” for each new sequence of actions.

Trademarks Registered trademarks –

DrägerService®

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Drägersorb®

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D-Vapor®

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

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Spirolog®

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SpiroLife®

The illustrations establish the relationship between the text and the device. Elements mentioned in the text are highlighted. Unnecessary details are omitted.

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Vapor®

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WaterLock®

Schematic renderings of screen images guide the user and allow to reconfirm actions performed. The actual screen images differ in look or in configuration.

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Durasensor®

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OxiMax®

A Letters denote elements referred to in the text.

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z Bullet points indicate individual actions or different options for action. –

Dashes indicate the listing of data, options, or objects.

are registered trademarks of Dräger.

are registered trademarks of Nellcor. Neodisher® Medizym

is a registered trademark of Chemische Fabrik DR. WEIGERT GmbH & Co. KG. Pending trademark applications VacuSmartTM is a pending trademark application of Dräger.

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Instructions for Use Primus SW 4.n

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.

Abbreviations and Symbols Please refer to "Abbreviations" on page 26 and "Symbols" on page 29 for explanations.

Instructions for Use Primus SW 4.n

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Instructions for Use Primus SW 4.n

Contents

Contents For Your Safety and that of your Patients . .

7

General WARNINGS and CAUTIONS...

9

Intended use... 14

Starting Operation... 80 Setting fresh-gas concentrations... 81 Setting the Vapor... 83 Ventilation... 84 Using non-rebreathing systems... 101 Changing patients... 102

Overview... 17

Alarms... 109

Components... 18 Ancillary functions... 25 Abbreviations... 26 Symbols... 29

Alarm displays... 110 Alarm priorities and alarm signals... 111 Suppressing alarms... 112 Limit-based alarms activated in respective ventilation modes... 113 Enabling/disabling CO2 alarms... 115 HLM mode... 116 Enabling/disabling SpO2 alarms (optional) . . . 117 Displaying and setting alarm limits... 118

Application... 13

Operating concept... 31 Screen ergonomics... 32 Keys with permanent functions (hard keys) . . . 33 Keys with variable functions (soft keys)... 34 Selecting and setting... 34 Color concept... 37 System LED indicators... 38 Menu Structure Overview... 39 Assembly... 45 Before first use... 46 Information about transport within the clinic . . . 47 Accessory Weight Limits... 48 Primus as a wall/ceiling device (optional)... 49 Connecting the gas supply... 51 Connecting the anesthetic gas scavenging system AGS... 53 Connecting the endotracheal aspiration system (optional)... 54 Connecting the patient system... 55 Connecting the flexible arm for the manual breathing bag (optional)... 59 Park holder for vaporizer units (optional)... 59 Connecting the electrical connections... 60 Getting started... 63 Device check... 64 Self test... 72 Emergency start... 77 Operation... 79 Instructions for Use Primus SW 4.n

Monitoring... 121 Selecting the standard screen... 122 Monitoring mode... 123 Screen layout... 123 Displayed parameters... 124 Gas measurement... 125 Using the volumeter function... 128 Econometer (optional)... 129 Loops (optional)... 130 Selecting the data screen... 131 Selecting the trend screen... 132 Selecting the logbook... 133 Using the timer function... 134 SpO2 measurement (optional)... 135 Configuration... 139 Configuring the default settings... 140 Basic settings and audible signals... 141 Parameters... 142 Interfaces/logbook... 143 Screen layout... 144 Setting alarm limits... 145 Ventilator and gas delivery... 147 System information... 149 Configuration during operation... 151

5

Contents

Setting the patient's age and weight during operation... 154 Fault – Cause – Remedy... 155 Power failure... 156 Gas failure... 157 Ventilator failure... 158 Fresh gas delivery failure... 159 Ventilator and fresh gas delivery failure... 159 Gas measurement failure... 160 Screen error... 160 System failure... 161 Alarm messages... 162 Cleaning... 179 Removing components... 180 Scope of validity... 187 Sequence of steps... 187 What is meant by hygiene and care?... 187 Disinfecting/cleaning/sterilizing... 188 Care list Primus anesthesia workstation... 190 Assembly... 193 Maintenance... 201 Definitions... 202 Emptying or replacing the water trap... 203 Replacing the O2 sensor... 205 Disposal... 207 Disposing of batteries and O2 sensors... 208 Disposing and emptying of water trap... 208 Disposing of the used device... 208 Technical Data... 209 Technical Data... 210 EMC Declaration... 227 Index... 231

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Instructions for Use Primus SW 4.n

For Your Safety and that of your Patients

For Your Safety and that of your Patients Strictly follow these Instructions for Use... Maintenance... Accessories... Not for use in areas of explosion hazard... Safe connection with other electrical equipment... Safe networking of computers... Patient safety... Patient monitoring...

8 8 8 8 8 9 9 9

General WARNINGS and CAUTIONS...

9

Note on EMC/ESD risk for the device function... 10 Accessories in sterile packaging... 11 Software... 11

Instructions for Use Primus SW 4.n

7

For Your Safety and that of your Patients

Strictly follow these Instructions for Use

Accessories

WARNING Strictly follow these Instructions for Use.

WARNING Only the accessories indicated on the list of accessories 86 03 522 (13th edition or higher) have been tested and approved for use with the medical device. Accordingly it is strongly recommended that only these accessories be used in conjunction with the specific medical device. Otherwise the correct functioning of the medical device may be compromised.

Any use of the medical device requires full understanding and strict observation of all portions of these instructions. The medical device is only to be used for the purpose specified under "Intended use" on page 14 and in conjunction with appropriate patient monitoring (see page 15). Strictly observe all WARNING and CAUTION statements throughout these Instructions for Use and all statements on medical device labels.

Maintenance WARNING The medical device must be inspected and serviced regularly by trained service personnel. Repair of the medical device may also only be carried out by trained service personnel. Dräger Medical recommends that a service contract be obtained with DrägerService and that all repairs also be carried out by them. Dräger Medical recommends that only authentic Dräger Medical repair parts be used for maintenance. Otherwise the correct functioning of the medical device may be compromised. See chapter "Maintenance".

Not for use in areas of explosion hazard WARNING This medical device is neither approved nor certified for use in areas where combustible or explosive gas mixtures are likely to occur.

Safe connection with other electrical equipment WARNING Risk of electric shock. Electrical connections to equipment not listed in these Instructions for Use should only be made following consultation with the respective manufacturers of the equipment involved. WARNING Risk of explosion, fire. If an oxygen leak is suspected within or near the anesthesia machine, do not initiate operation. Disconnect all oxygen supplies and contact a trained service technician.

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Instructions for Use Primus SW 4.n

For Your Safety and that of your Patients

Safe networking of computers When networking with electrical devices, the operator is responsible for ensuring that the resulting system meets the requirements set forth by the following standards: –

EN 60601-1 (IEC 60601-1) Medical electrical equipment Part 1: General requirements for safety

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EN 60601-1-1 (IEC 60601-1-1) Medical electrical equipment Part 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems

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EN 60601-1-2 (IEC 60601-1-2) Medical electrical equipment Part 1-2: General requirements for safety Collateral standard: Electromagnetic compatibility; Requirements and tests

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EN 60601-1-4 (IEC 60601-1-4) Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems

Follow Assembly Instructions and Instructions for Use.

Patient safety The design of the medical device, the accompanying literature, and the labeling on the medical device take into consideration that the purchase

and use of the medical device are restricted to trained professionals, and that certain inherent characteristics of the medical device are known to the trained operator. Instructions, warnings, and caution statements are limited, therefore, largely to the specifics of the Dräger design. This publication excludes references to various hazards which are obvious to a medical professional and operator of this medical device, to the consequences of medical device misuse, and to potentially adverse effects in patients with abnormal conditions. Medical device modification or misuse can be dangerous.

Patient monitoring The operators of the medical device must recognize their responsibility for choosing appropriate safety monitoring that supplies adequate information on medical device performance and patient condition. Patient safety may be achieved through a wide variety of different means ranging from electronic surveillance of medical device performance and patient condition to simple, direct observation of clinical signs. The responsibility for the selection of the best level of patient monitoring lies solely with the medical device operator.

Dräger Medical GmbH

General WARNINGS and CAUTIONS The following WARNINGS and CAUTIONS apply to general operation of the device. WARNINGS and CAUTIONS specific to subsystems or particular features appear with those topics in later sections of these Instructions for Use or in the devicespecific Instructions for Use. Instructions for Use Primus SW 4.n

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For Your Safety and that of your Patients

WARNING Risk of use error. Various potentially dangerous situations may occur which demand the attention of trained personnel. The workstation may only be used under the permanent supervision of qualified medical personnel so that assistance can be provided immediately in the event of any malfunctions. WARNING Risk of fire. In order to prevent a fire hazard, explosive anesthetics, such as ether or cyclopropane, must not be used. WARNING Risk of device failure and/or danger to patient. Magnetic fields may negatively influence the proper function of the anesthesia machine, thus endangering the patient. Primus must not be used with magnetic resonance imaging (MRT, NMR, NMI)! WARNING Risk of fire. To prevent a fire hazard, drugs or other substances based on inflammable solvents, such as alcohol, must not be introduced into the patient system. Adequate ventilation must be ensured if highly inflammable substances are used for disinfection.

Note on EMC/ESD risk for the device function

Electromedical devices are subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC information included, see page 227. Portable and mobile RF communications equipment can affect medical electrical equipment. WARNING Connector pins with an ESD warning sign should not be touched and no connections should be made between these connectors without implementing ESD protective measures. Such precautionary procedures may include antistatic clothing and shoes, the touch of a ground stud before and during connecting the pins or the use of electrically isolating and antistatic gloves. All staff involved in the above shall receive instruction in these ESD precautionary procedures. WARNING Risk of electric shock. Connecting devices to the auxiliary outlets of the anesthesia machine can cause an increase in leakage current beyond permissible values if the protective conductor of a device fails. Check the leakage current when connecting devices to the auxiliary outlets. If connecting a device (or devices) increases the leakage current to a value which exceeds the permissible value, do not use the auxiliary outlets of the anesthesia machine: use a separate wall socket. The system must meet the requirements for medical electrical equipment in accordance to IEC/EN 60601-1-1 and IEC/EN 60601-1-2.

General information on electromagnetic compatibility (EMC) pursuant to international EMC standard IEC60601-1-2: 2001

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Instructions for Use Primus SW 4.n

For Your Safety and that of your Patients

Accessories in sterile packaging Do not use accessories in sterile packaging if the packaging has been opened, damaged or if there are other signs that the accessories are not sterile. Reprocessing and resterilization of single-use accessories is not permitted.

WARNING Risk of burns. Conductive breathing hoses or face masks may cause burns during HF surgery. Do not use these types of hoses and masks in combination with HF surgery.

Software

CAUTION Risk of mechanical failure.

The device's software has been developed and tested carefully in accordance with Dräger's high quality standards. It is therefore highly improbable that software errors can become a hazard to the patient.

The shock and vibrations caused by transportation may lead to a mechanical failure. The application of a wall or ceiling mount is designated for buildings.

Additionally, independent protective functions are extensively implemented in the software, as well as in electronics and mechanics, for all safety-related functions of the device. Through this, the probability that an error in the software or other functions can be detected before it affects the patient's safety is very high. Regular automated or manual tests ensure the effectiveness of all protective measures.

CAUTION Risk of physical injury.

CAUTION Risk of patient injury. An incorrect diagnosis or misinterpretation of measured values, or other parameters, may endanger the patient. Do not base therapy decisions on individual measured values or monitoring parameters only. WARNING Risk of patient injury. If ventilation of the patient is no longer assured due to an obvious fault in the equipment, the patient must immediately be ventilated with a separate emergency ventilator. Always keep a manual ventilator at hand.

Instructions for Use Primus SW 4.n

Do not use the anesthesia machine for mobile facilities such as ambulances, helicopters or ships.

To avoid physical injury, e.g. pinching, pay special attention to edges, moving parts and corners when working with drawers, the ventilator module, doors, the writing tray and/or swivel arms for mounted devices, as well as other accessories, such as gas cylinders, vaporizer units, CLIC absorbers and CLIC adapters. CAUTION Risk of device failure. Compressed gas supply (central supply or cylinder): To avoid damaging the device(s) attached to a gas supply, use only medical gases. Pay particular attention to national and international standards regulating the use of medical gases. Dräger Medical cannot be held liable for any damage which occurs as a result of these instructions not being observed.

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Instructions for Use Primus SW 4.n

Application

Application Intended use... 14 Utilization... 14 Ventilation modes... 14 The following measured values are displayed... 14 The following parameters are displayed as curves... 15 The following are displayed as bar graphs... 15 Monitoring... 15

Instructions for Use Primus SW 4.n

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Application

Intended use WARNING Risk of device failure and/ or danger to patient. If the intended use of this anesthesia machine is not adhered to, it may fail and/or the patient may be endangered.

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Spontaneous breathing (Spont.)

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Pressure-assisted spontaneous breathing in Press. Support CPAP (optional)

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Volume AF (Volume Mode AutoFlow) (optional). With activation of: Synchronization,

Use the anesthesia machine only as specified in the intended use of these Instructions for Use.

Press. Support (Pressure support) (optional)

Primus – Anesthesia Workstation for adults, children, and neonates with automatic and manual ventilation, as well as spontaneous breathing with or without pressure support.

The following measured values are displayed –

Peak pressure PEAK, mean pressure PMEAN, plateau pressure PLAT, and PEEP

Utilization

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Expiratory minute volume MV, difference between insp. and exp. minute volume MVLEAK, patient compliance CPAT,

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Inhalation anesthesia in rebreathing systems

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Inhalation anesthesia in semi-closed to virtually closed systems with "low flow" and "minimal flow" techniques (for minimal gas and anesthetic agent consumption)

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Inhalation anesthesia in non-rebreathing systems, with a separate fresh-gas outlet for connecting, e.g. a Bain system or Magill system, with a fresh-gas flow of 0.2 to 18 L/min (optional).

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Inspiratory and expiratory concentration of O2, N2O, anesthetic gas, and CO2

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ΔO2:

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Ventilation modes

tidal volume VT, breathing rate freq.

difference between insp. and exp. O2 concentration Optional: –

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Volume-controlled ventilation in Volume Mode.

Functional oxygen saturation (SpO2) and pulse rate

With activation of: Synchronization, Press. Support (Pressure support) (optional) –

Pressure-controlled ventilation in Pressure Mode. With activation of: Synchronization, Press. Support (Pressure support) (optional)

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Manual ventilation (Man.) Instructions for Use Primus SW 4.n

Application

The following parameters are displayed as curves –

Airway pressure PAW

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Inspiratory and expiratory flow

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Inspiratory and expiratory concentration of O2, CO2, and anesthetic gas

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Special alarm response in HLM mode

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Automatic agent alarm activation for multiples of MAC (xMAC)

Optional: –

Oxygen saturation

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Pulse rate

Optional: –

Plethysmogram

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PAW-V loops and V-Flow loops

The following are displayed as bar graphs –

Inspiratory, expiratory, and leakage tidal volume

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Volumeter

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Pressure

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Econometer for indicating fresh-gas utilization (optional)

Trends showing the measured values over time and a logbook are also available.

Monitoring by means of adjustable alarm limits which can automatically be adapted to the momentary ventilation situation. With monitoring for –

Airway pressure PAW

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Expiratory minute volume MV

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Apnea

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Inspiratory and expiratory anesthetic gas concentration

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Detection of anesthetic gas mixtures (simultaneous detection of up to two anesthetic agents)

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Inspiratory O2 and N2O concentrations

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Inspiratory and expiratory CO2 concentrations

Instructions for Use Primus SW 4.n

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Instructions for Use Primus SW 4.n

Overview

Overview Components... 18 Front... 18 Rear... 19 Gas inlets... 20 Screen with user interface... 21 Interface panel... 22 Flexible arm for manual breathing bag (optional)... 23 Gas flow diagram... 24 Ancillary functions... 25 MEDIBUS Protocol... 25 Abbreviations... 26 List of abbreviations used in the software and on the device... 26 List of general abbreviations... 28 Units... 28 Symbols... 29

Instructions for Use Primus SW 4.n

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Overview

Components Front

P A O N

B C D E F G H

M L

I J

001

K A B C D E F G H

Screen with user interface Rotary knob System power switch O2 emergency delivery Safety O2 O2 flush button O2+ Writing table Breathing system Release button for ventilator module*

*

available since November 2004

18

I

J K L M N O P

Absorber (optional disposable Dräger absorber Drägersorb CLIC) Drawer Castors with locking brake Endotracheal aspiration system (optional) Water trap with sample line connection Vapor units with Interlock system External fresh-gas outlet (optional) Top shelf (for external monitors)

Instructions for Use Primus SW 4.n

Overview

Rear

L A B C

K J

D E F G

I

002

H

A Connectors for reserve gas cylinder pressure sensors B O2 sensor (not applicable for consumption-free O2 measurement) C Filter for fan D Pins for grounding cables of auxiliary units E Auxiliary outlets with fuse switches F Scavenging nozzle G Anesthetic gas scavenging system AGS H Power cord I Pin for grounding cable J Gas inlets K Connection for optional halogen lamp (remove cap before use.) Use the lamp specified in the list of accessories only! Instructions for Use Primus SW 4.n

L Interface panel

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Overview

Gas inlets

G

A

F

B

D

C

003

E A B C D E

Connection for central gas supply O2 Connection for O2 cylinder O2 outlet for oxygen flow tube (optional) Connection for central gas supply AIR AIR outlet for endotracheal aspiration system (optional) F Connection for N2O cylinder G Connection for central gas supply N2O

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Instructions for Use Primus SW 4.n