Instructions for Use
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Page 1
Instructions for use
Perseus A500
WARNING To properly use this medical device, read and comply with these instructions for use.
Anesthesia workstation Software 1.1n
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, for example, PEEP, etCO2, or Screen layout.
Use of terms Dräger uses the term "Accessory" not only for accessories in the sense of IEC 60601-1, but also for consumable parts, removable parts, and attached parts. The product "Perseus A500" is also referred to as "Perseus".
Screen layouts and illustrations of the device The actual screen layout or the device may differ in appearance or in configuration from the illustrations.
The "greater than" symbol > indicates the navigation path in a dialog window, for example, System setup > Alarms > Alarm limits. In this example, System setup represents the dialog window title, Alarms represents a horizontally aligned tab, and Alarm limits a vertically aligned tab.
Trademarks Trademark
Trademark owner
Trademark
Perseus®
Dismozon®
Infinity®
Mikrobac®
DrägerService®
Korsolex®
Dräger-Vapor® D-Vapor®
Dräger
Drägersorb® MEDIBUS.X®
2
BODE Chemie
Neodisher Mediclean®
Dr. Weigert
Buraton®
Schülke & Mayr
Trademark
WaterLock® Selectatec®
Trademark owner
Datex-Ohmeda
BIPAP1) 1) Trademark used under license
Instructions for use Perseus A500 SW 1.1n
Safety information definitions WARNING
CAUTION
A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury.
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.
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. The target groups must understand the language of the present document.
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.
Users Users are persons who use the product in accordance with its intended use.
Instructions for use Perseus A500 SW 1.1n
Service personnel must be trained in the maintenance of medical devices and install, reprocess, and maintain the product.
Experts Experts are persons who perform repair or complex maintenance work on the product. Experts must have the necessary knowledge and experience with complex maintenance work on the product.
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Abbreviations, symbols, and product labels Explanations are listed in Chapter ''Annex'' in sections ''Abbreviations'', ''Symbols'', and ''Product labels''.
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Instructions for use Perseus A500 SW 1.1n
Contents
Contents For your safety and that of your patients...
7
General safety information ... 8 Product-specific safety information... 10 Application ... 12 Intended use... 13 Indications/Contraindications... 13 Further information on application ... 14
Adjusting the alarms... 93 Changing the patient data ... 96 Exporting data ... 96 Other settings ... 97 Ending the therapy ... 99 Patient change ... 100 System test ... 102
Hardware ... 16 Functional scope ... 29 Gas flow plan... 32
Information on the availability of individual device functions... 103 Testing the system ... 103 Performing the tests ... 105 Processing the checklist... 106
Operating concept... 35
Ending operation... 111
Screen ... 36 Color concept ... 38 Selecting and setting ... 39
Switching off the device... 112
Overview... 15
42 43 47 48 53
Display of alarms... 115 Response to alarms ... 116 Adopting alarm settings when changing the ventilation mode ... 120 Alarm delay and alarm escalation ... 121 Activation of alarms after breath detection ... 124 Intelligent alarm behavior ... 124
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Configuration... 125
Assembly and preparation ... 41 Mounting of accessories... Before first operation ... Transport within the hospital... Connecting the gas supply ... Ensuring the gas supply ... Preparation for an operation day / after cleaning and sterilization ... Selecting and connecting patient-specific accessories... Connecting or exchanging consumables...
58 65
Getting started ... 68 Switching on Perseus ... 69 Checking for the readiness of operation... 70 Operation in case of emergency... 71 Operation... 72 Safety information... Starting the therapy ... Adjusting the therapy... Special forms of therapy... Using fields with special functions ... Organizing the screen display ... Displaying additional data... Setting the sound volume ... Instructions for use Perseus A500 SW 1.1n
Alarms ... 114
73 74 77 80 82 87 90 92
Device settings ... 126 Defining start settings... 126 Transferring device configurations ... 144 Activating applications... 145 Overview of the configurable screen contents 146 Troubleshooting ... 153 Leakages... 154 Power supply failure ... 155 Failure of the gas supply ... 157 Failure of fresh-gas delivery (electronically controlled gas mixture) ... 158 Ventilator failure ... 159 Failure of the gas measurement... 159 Failure of flow measurement ... 159 Screen fault/user interface failure... 160 Complete failure ... 160
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Contents
Problems with the anesthetic gas receiving system (AGS) ... 161 Problems with the pressure reducers ... 162 Problems with the Vapor View option... 162 Alarm – Cause – Remedy ... 162
Influence of patient category, weight, and age on device behavior ... 248 Infinity ID accessory support ... 248 Schematic diagram of alarm tones... 250 Combination lock on the drawer (optional)... 251
Cleaning, disinfection and sterilization... 184
Annex ... 253
Disassembly ... 185 Reprocessing procedures ... 187 Reprocessing list ... 191 Assembling the parts... 194 Before using on patients again... 194
Abbreviations... 254 Symbols... 256 Product labels... 259 Overview of the menu structure ... 261
Maintenance... 195
Configuration password for Perseus A500 Software 1.1n... 265
Overview ... 196 Inspection ... 196 Preventive maintenance... 198 Repairs ... 199
Password ... 265
Disposal ... 200 Disposing of the medical device... 201 Disposing of accessories... 201 Technical data ... 202 General information... 203 Ambient conditions ... 203 Fresh-gas delivery... 204 Fresh-gas delivery (electronically controlled gas mixer)... 204 Fresh-gas delivery (mechanically controlled gas mixer)... 205 Ventilator ... 205 Breathing system... 207 External fresh-gas outlet ... 209 Anesthetic gas receiving system ... 209 Measurement systems and displays ... 210 Display of calculated values ... 215 Operation characteristic values ... 217 Device outlets... 221 Relevant standards ... 223 Diagrams ... 226 EMC declaration... 229 Device combinations ... 233 Connections to IT networks... 234 Software license compliance (optional) ... 236 Principles of operation ... 237 Description of the ventilation modes ... 238 Minimum O2 delivery ... 247 6
Instructions for use Perseus A500 SW 1.1n
For your safety and that of your patients
For your safety and that of your patients General safety information ...
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Strictly follow these instructions for use... 8 Maintenance ... 8 Safety checks ... 8 Accessories ... 8 Patient safety... 9 Patient monitoring... 9 Information on electromagnetic compatibility .. 9 Training... 10 Keeping the instructions for use ... 10 Product-specific safety information ... 10 Functional safety ... 11 Handling Infinity ID components... 11
Instructions for use Perseus A500 SW 1.1n
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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 its subsystems or particular features appear in the respective sections of these instructions for use or in the instructions for use of any other product being used with this device.
Strictly follow these instructions for use WARNING Risk of incorrect operation and 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'' (see page 13) 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.
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. Dräger recommends DrägerService for a service contract and for repairs. Dräger also recommends using original Dräger parts for maintenance. If the above is not complied with, medical device failure and patient injury may occur. Observe chapter ''Maintenance''.
Safety checks The medical device must be subject to regular safety checks. See chapter ''Maintenance''.
Accessories WARNING Risk due to incompatible accessories Dräger has only tested the compatibility of accessories that appear in the current list of accessories or in separate declarations by Dräger. If other, incompatible accessories are used, there is a risk of patient injury due to medical device failure. Dräger recommends using the medical device only with accessories from the current list of accessories.
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Instructions for use Perseus A500 SW 1.1n
For your safety and that of your patients
WARNING Risk of operating errors and incorrect use Strictly observe the instructions for use of all accessory parts, e.g.: – Water traps – Flow sensors – CLIC adapter – CLIC absorber – Soda lime – Breathing hoses – Masks – Filter – Endotracheal suction – Vaporizer – Manual resuscitator – AGSS terminal unit
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 inherent characteristics of the medical device. Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device. These instructions for use do not provide any information on the following: –
Dangers that are obvious to the user
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Consequences of intentional misuse of the medical device
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Possible negative impacts on patients with various underlying diseases
Medical device modification or misuse can be dangerous.
Patient monitoring The user of the medical device is responsible for choosing suitable monitoring that provides appropriate information about medical device performance and the patient's condition. Patient safety may be achieved by a wide variety of means ranging from electronic surveillance of medical device performance and patient condition to simple, direct observation of clinical signs. The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical device.
Information on electromagnetic compatibility General information on electromagnetic compatibility (EMC) according to the 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 (see page 229). Portable and mobile RF communications equipment can affect medical electrical equipment. WARNING Risk of electric shock Do not connect connectors with an ESD warning symbol and do not touch the pins of such connectors without implementing ESD protective measures. Such protective measures may 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 relevant users must be instructed in these ESD protective measures.
Instructions for use Perseus A500 SW 1.1n
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For your safety and that of your patients
WARNING Risk of device failure Electromagnetic fields, e.g., those generated by radio frequency communication equipment such as mobile phones, highfrequency electrical surgery equipment, defibrillators or shortwave therapy devices can disrupt the function of the medical device. Only operate radio frequency devices at a sufficient safety clearance of at least 20 cm (7.9 in).
Training User training is offered by the responsible Dräger organization, see www.draeger.com.
Keeping the instructions for use CAUTION Risk of incorrect use The instructions for use must be kept in an accessible location for users.
Product-specific safety information WARNING
WARNING
Risk due to device failure
Risk of fire
Device failure can compromise the correct therapy functionality of the device.
To avoid a fire hazard, do not introduce drugs or other substances based on flammable solvents, such as alcohol, into the breathing system and do not use explosive anesthetic agents such as ether or cyclopropane or spray them into the device.
To ensure immediate remedial action in case of device failure, the device may only be operated under permanent supervision of users. Always have a manual resuscitator ready.
If highly flammable substances are used for disinfection, adequate ventilation is required.
WARNING Dräger recommends that the user remains in the vicinity of the anesthesia machine, i.e. within a distance of up to 4 meters (12 feet). This facilitates fast recognition and response in the event of an alarm. WARNING Risk of malfunction Unallowed modifications to the medical device can lead to malfunctions. This medical device must not be modified without permission from Dräger. 10
CAUTION Risk of crushing Movable device parts or attached components may cause crushing due to clamping. Pay special attention to edges, movable parts, and corners when working with the following components: – Column cover – Breathing system cover – Drawers – Extensible writing tray – Swivel arms for mounted devices – Accessories such as gas cylinders, vaporizers, CLIC absorber, and CLIC adapter Instructions for use Perseus A500 SW 1.1n
For your safety and that of your patients
WARNING Risk due to electromagnetic fields Although the medical device does not exceed the applicable limiting values for electromagnetic fields, such radiation can interfere with the functioning of pacemakers. All wearers of pacemakers should maintain a distance of at least 25 cm (10 in) between pacemaker and medical device.
Functional safety The essential performance features comprise: –
Supplying the anesthesia workstation with O2 If the O2 supply (central gas supply or gas cylinder) fails, an alarm is issued.
–
Supply of the patient with adequately oxygenated breathing gas If the breathing gas contains insufficient levels of O2, an alarm is issued.
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Patients are not supplied with excessively high anesthetic gas concentrations If excessively high anesthetic gas concentrations are delivered, an alarm is issued.
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Monitoring of the airway pressure and the expiratory minute volume Alarms are issued depending on the set alarm limits.
Handling Infinity ID components Ownership or purchase of this medical device with RFID technology only includes the right to use the medical device and RFID technology in conjunction with products approved by Dräger and in strict compliance with these instructions for use. No intellectual property rights or any rights to the use of the medical device or RFID technology are hereby granted, either explicitly or implicitly, which are contrary to the above-mentioned conditions.
Instructions for use Perseus A500 SW 1.1n
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Application
Application Intended use ...
13
Indications/Contraindications...
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Indications ... Contraindications...
13 13
Further information on application...
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Environment of use ...
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Instructions for use Perseus A500 SW 1.1n
Application
Intended use The Perseus anesthesia workstation is intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. Perseus is equipped with airway monitoring, gas measurement and device monitoring, O2 insufflation, and an anesthetic gas receiving system.
Ventilation is accomplished on the patient through a laryngeal mask airway, a full-face mask, or an endotracheal tube. The integrated breathing system can be used with partial rebreathing (low-flow or minimum-flow). A non-rebreathing system such as the Kuhn or Medec Water System may be used at the external fresh-gas outlet (optional).
Anesthesia is achieved through a mixture of pure oxygen and Air (medical compressed air) or pure oxygen and nitrous oxide, with the addition of volatile anesthetic agents.
Indications/Contraindications
Indications Perseus is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions.
Contraindications –
Perseus applies medications such as oxygen, nitrous oxide, or volatile anesthetic agents, among others. For contraindications to the applied medications, strictly follow the instructions for use of the medication.
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Do not use soda lime based on potassium hydroxide. Otherwise, there is a risk of CO formation.
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Only use pelletized soda lime. Otherwise, there is a risk of faulty measurement or faulty delivery as well as progressive damage to the breathing system due to dust.
Instructions for use Perseus A500 SW 1.1n
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For patients with suspected malignant hyperthermia: Do not use any volatile anesthetic agents or Perseus with residual concentrations of these gases above 5 ppm.
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Do not perform low-flow anesthesia on patients with ketoacidosis or patients under the influence of alcohol. This will raise the risk of acetone accumulation in the patient.
The user is responsible for setting the gas delivery and ventilation according to the individual patient status. Patient status must be continually monitored for any potential changes.
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Application
Further information on application
Environment of use Perseus is designed for use in rooms in which therapeutic or diagnostic interventions can be performed. WARNING Risk of explosion and fire This medical device is neither approved nor certified for use in areas where oxygen concentrations greater than 25 Vol%, combustible or explosive gas mixtures are likely to occur. WARNING Risk of device malfunctions and/or patient injury and user injury Magnetic fields can negatively influence the correct functioning of the medical device and therefore endanger the patient or user. Do not use the medical device in rooms where devices for magnetic field applications are used (e.g., magnetic resonance imaging). In addition, do not use Perseus in the following environments: –
Outside buildings
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On intensive care units
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During patient transport
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In vehicles, airplanes, or helicopters
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Instructions for use Perseus A500 SW 1.1n
Overview
Overview Hardware ... 16 Front ... Screen ... Plug-in connection with Vapor View option for up to 3 vaporizers ... Breathing system... Side view from left ... Device column ... Rear... Interfaces... Gas inlets... Hanger yokes (optional) for gas cylinders with pin-index connections... Auxiliary power sockets ... Gas mixing unit (electronically controlled) ... Gas mixing unit (mechanically controlled) ...
16 17 17 18 19 20 21 23 24 25 26 27 28
Functional scope ... 29 Device versions, options, and accessories... Gas delivery... Ventilation modes ... Additional operation modes ... Monitoring... Display on the screen ... Protocoling... Gas supply... Gas scavenging... Data exchange, interfaces...
29 29 29 29 29 30 30 30 30 30
Gas flow plan ... 32 Breathing system... 32 Gas supply (electronically controlled gas mixer)... 33 Gas supply (mechanically controlled gas mixer)... 34
Instructions for use Perseus A500 SW 1.1n
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Overview
Hardware
Front
A
M L K
B C D
J I H
F 10335
G
E
A Screen with integrated workplace illumination
L External fresh-gas outlet (optional)
B Gas mixing unit (electronically controlled gas mixer shown here)
M Plug-in connection with Vapor View option for up to 3 vaporizers
C Work surface D Extensible writing tray with compartment for instructions for use (optional) E Central brake F Castors with central brake G Footrest H Trolley I
Anesthetic gas receiving system with flow indicator
J
CO2 absorber
K APL valve 16
Instructions for use Perseus A500 SW 1.1n
Overview
Screen
A
E
D
B 10340
C
A Touch screen to call up functions or dialog windows B Audio paused key to suppress the alarm tones of all active alarms for 2 minutes C Rotary knob with background illumination to select and confirm settings D
E
key for switching the workplace illumination on and off and dimming the illumination intesity in 3 steps (dark, medium, and bright) key for switching the device on or off
Plug-in connection with Vapor View option for up to 3 vaporizers
B
10397
A
A Sensor unit B Illumination unit Instructions for use Perseus A500 SW 1.1n
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Overview
Breathing system
A B
C
D
E
F
I A Water trap with connection for sample line CAUTION Pressure gauge indication possibly inaccurate
H
F Expiratory port G Holder, e.g., for breathing bag hose H CO2 absorber I
Anesthetic gas receiving system
Always compare the pressures indicated on the pressure gauge with those on the status display. Only use the pressure gauge as the primary source of information if the pressure indicator on the status display has failed. B Pressure gauge (optional) for indicating the pressure in the internal breathing system, see also (G) on page 27 and (H) on page 28 C Inspiratory port D Bag elbow with circuit plug, e.g., to occlude the Y-piece during an automatic test E APL valve 18
Instructions for use Perseus A500 SW 1.1n
10370
G
Overview
Side view from left
C
A
10337
B
A GCX rail for mounting additional workstation components B Strain relief for AGS hose, adjustable height C External fresh-gas outlet (optional)
Instructions for use Perseus A500 SW 1.1n
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Overview
Device column The following illustration shows the left side of the device:
A
B
F E D
10369
C A Column cover B GCX rail C Recesses for cables which lead e.g., into the device arms D Screw for closing the cable conduit lid E Tabs to hold the cable F Cable conduit
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Instructions for use Perseus A500 SW 1.1n