Page 1 Status: 27. January 2014, 18:46 Instructions for use Primus Anesthesia workstation WARNING To properly use this medical device, SW 4.5n read and comply with these instruc- tions for use.
Page 2 Trademark Trademark owner Trademark Trademark owner ® ® DrägerService Neodisher Dr. Weigert Medizym ® Drägersorb ® D-Vapor ® Spirolog Dräger ® SpiroLife ® Vapor ® VacuSmart ® WaterLock ® Durasensor Nellcor ™ OxiMax Covidien Instructions for use Primus SW 4.5n...
Page 3 Service personnel Service personnel are persons who are responsible for the maintenance of the product. Service personnel must be trained in the mainte- nance of medical devices and install, reprocess, and maintain the product. Instructions for use Primus SW 4.5n...
Page 4 Abbreviations and symbols Explanations are listed in chapter "Overview" in the sections "Abbreviations" and "Symbols". Instructions for use Primus SW 4.5n...
Page 5: Table Of Contents
Screen layout ......166 Self test....... 82 Instructions for use Primus SW 4.5n...
Page 6 Index ....... . 269 Instructions for use Primus SW 4.5n...
Page 7 Product-specific safety information ..12 Functional safety ..... . . 14 Instructions for use Primus SW 4.5n...
Page 8: For Your Safety And That Of Your Patients
Dräger recommends that the medical device is only used together with accessories listed in the current list of accessories. Instructions for use Primus SW 4.5n...
Page 9: Not For Use In Areas Of Explosion Hazard
– Before operating the medical device, strictly comply with the instructions for use of all connected devices or device combinations. For further information, see "Device combinations" on page 267. Instructions for use Primus SW 4.5n...
Page 10: Patient Safety
The responsibility for selecting the best level of pa- tient monitoring lies solely with the user of the med- ical device. Instructions for use Primus SW 4.5n...
Page 11: Sterile Accessories
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. Disposable articles must not be reprocessed and resterilized. Instructions for use Primus SW 4.5n...
Page 12: Product-Specific Safety Information
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. Instructions for use Primus SW 4.5n...
Page 13 The appli- cation of a wall or ceiling mount is designated for buildings. Do not use the anesthesia machine for mobile fa- cilities such as ambulances, helicopters or ships. Instructions for use Primus SW 4.5n...
Page 14: Functional Safety
If excessively high anesthetic gas concentra- tions are delivered, an alarm is issued. – Monitoring the airway pressure and the expira- tory minute volume Alarms are issued depending on the set alarm limits. Instructions for use Primus SW 4.5n...
Page 15: Application
Further information on application..18 Environment of use..... . 18 Instructions for use Primus SW 4.5n...
Page 16: Intended Use
Optional: – Functional oxygen saturation (SpO ) and pulse rate Ventilation modes – Volume-controlled ventilation in Volume Mode. Optional activation of: Synchronization, Press. Support (Pressure support) (optional) – Pressure-controlled ventilation in Pressure Mode. Instructions for use Primus SW 4.5n...
Page 17: The Following Parameters Can Be Displayed
– Inspiratory tidal volume, expiratory tidal volume, and leakage tidal volume – Volumeter – Pressure – Econometer for indicating fresh-gas utilization (optional) Trends showing the measured values over time and a logbook are also available. optional Instructions for use Primus SW 4.5n...
Page 18: Indications And Contraindications
Magnetic fields may negatively influence the proper function of the medical device, thus endangering the patient or user. The medical device must not be used in the vi- cinity of magnetic resonance imagers (MRI, NMR, NMI). Instructions for use Primus SW 4.5n...
Page 19: Overview
Units ....... . . 31 Symbols......32 Instructions for use Primus SW 4.5n...
Page 20: Components
M Water trap with sample line connection H Release button for ventilator module* N Vapor units with Interlock system O Ext. fresh-gas outlet (optional) P Top shelf (for external monitors) available since November 2004 Instructions for use Primus SW 4.5n...
Page 21: Rear
E Auxiliary outlets with fuse switches F Scavenging nozzle G Anesthetic gas receiving system AGS - only use the AGS specified in the list of accessories. H Power cord Potential equalization pin J Gas inlets Instructions for use Primus SW 4.5n...
Page 22: Gas Inlets
E AIR outlet for endotracheal aspiration system (optional) F Connection for N O cylinder* G Connection for central N O gas supply* This connection is not available with the "Operation with- out nitrous oxide" option. Instructions for use Primus SW 4.5n...
Page 23: Screen With User Interface
Key for calling up the standard screen J Soft keys for ventilation settings K Rotary knob: "select, set, confirm" L Key for switching over to Standby M LEDs for power supply/battery power N Keys for selecting the ventilation mode Instructions for use Primus SW 4.5n...
Page 24: Interface Panel
Interface panel Available since January 2005, interfaces which are not used were removed. Socket for SpO sensor (optional) COM 1 MEDIBUS, MEDIBUS.X interface COM 2 MEDIBUS, MEDIBUS.X interface IV System Connection for Dräger IV System Instructions for use Primus SW 4.5n...
Page 25: Flexible Arm For Breathing Bag (Optional)
Overview Flexible arm for breathing bag (optional) A Flexible arm B Knurled screws (for mounting on the breathing system) C Circuit plug (for selftest) Instructions for use Primus SW 4.5n...
Page 26: Auxiliary O 2 Flow Tube (Optional)
Auxiliary oxygen can be used in any ventilation mode, in standby mode, or even if the machine is switched off, as long as the central O gas supply is connected. Instructions for use Primus SW 4.5n...
Page 27: Gas Flow Diagram
K Absorber L Exp. valve M PEEP/P N Sample line sensor P Exp. flow sensor Q Gas measurement R Insp. valve S Insp. flow sensor T Piston pump ventilator U Ext. fresh-gas outlet (optional) Instructions for use Primus SW 4.5n...
Page 28: Additional Functions
The system must fulfill the requirements for medical electrical equipment in accordance with the relevant standards, see "Technical Data", page 261. Instructions for use Primus SW 4.5n...
Page 29: Abbreviations
Pressure Support mode -Flush Hal. Halothane Airway pressure Heart lung machine PAW-V loop Pressure/volume loop Ratio of inspiratory time to expira- PEAK Peak pressure tory time PEEP Positive end-expiratory pressure inCO Inspiratory CO concentration Instructions for use Primus SW 4.5n...
Page 30 Ratio of inspiratory pause time to INSP inspiratory time Trigger Trigger level Rise time SLOPE V-Flow loop Volume flow loop Volume AF Volume mode AutoFlow Volume/ Volume Mode Vol. Mode Volume-controlled ventilation Tidal volume Measured inspiratory tidal volume INSP Instructions for use Primus SW 4.5n...
Page 31: List Of General Abbreviations
For readability only the units hPa and cmH O are used. Kilopascal Supply pressures: bar = kPa x 100. Pounds MAN/AUTO Manual/mechanical ventilation mbar Millibar Milliliter mmHg Millimeter of mercury Medizinproduktegesetz (German Law on Medical Devices) Instructions for use Primus SW 4.5n...
Page 32: Symbols
Alarm tone suppressed for structions for use 2 minutes Exit menu, Alarm monitoring inactive return to preceding menu Remaining battery capacity Alarm monitoring temporarily in- (uninterruptible power supply active UPS) Apnea alarm disabled Battery supply Instructions for use Primus SW 4.5n...
Page 33 Marker on surfaces on which there Crushing hazard is an increased risk of tipping when sitting. Fuse Order number Serial number Batch designation Protect from sunlight! Temperature limit Relative humidity Instructions for use Primus SW 4.5n...
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Page 35: Operating Concept
LED indicators of the device ... . . 42 Menu structure overview ....43 Instructions for use Primus SW 4.5n...
Page 36: Screen Ergonomics
– confirm the selected carrier gas or a ventila- tion mode – set and confirm the parameters for fresh gas and ventilation modes – set and confirm the monitoring functions. Instructions for use Primus SW 4.5n...
Page 37: Keys With Permanent Functions (Hard Keys)
Display in succession the three basic mon- itoring screens: standard screen, data screen, and trend screen. Briefly press the key until the required screen is displayed. Return to the standard screen. Instructions for use Primus SW 4.5n...
Page 38: Keys With Variable Functions (Soft Keys)
For example Man.Spont. mode. 1 Push the hard key Man.Spont. (A). The LED in the key flashes. In addition, a flashing help text is displayed in the prompt field. 2 Confirm = push the rotary knob (B). Instructions for use Primus SW 4.5n...
Page 39: Selecting/Setting Ventilation Parameters
Confirm the PEEP value = push the rotary knob (B). The color changes from yellow to dark green. Selecting/setting monitoring functions Confirm the symbol (C) to exit the menu = push the rotary knob Press the key (D). Instructions for use Primus SW 4.5n...
Page 40: Selecting/Setting Configuration Parameters
4 Select and confirm the arrow (F) to exit MEDIBUS V4 Alarm the menu. Caution 2 Turn the rotary knob and select the menu time interval (D). Confirm the selection with the ro- tary knob. Instructions for use Primus SW 4.5n...
Page 41: Color Concept
If other set values (C) change automatically when setting a parameter, these changed settings only appear in yellow in the area around the parameter value (D). Instructions for use Primus SW 4.5n...
Page 42: Led Indicators Of The Device
Malfunction of the correspond- The Primus can be supplied via the mains green ing input pressure reducer power or via a battery. The LED of the active power supply lights up green. B Reserve gas cylinders Instructions for use Primus SW 4.5n...
Page 43: Menu Structure Overview
Standby alarm limits self test results soda lime changed undo change Leak Test logbook page 1 page 2 delete trend do not delete delete Instructions for use Primus SW 4.5n...
Page 44 (optional) date/time language Parameter scaling amplitude units Gas measurement Optional parameters interfaces logbook logbook entries triggered by COM 1 MEDIBUS COM 2 MEDIBUS Select MEDIBUS screen layout layout 1 layout 2 layout 3 Instructions for use Primus SW 4.5n...
Page 45 General information activate option trace 1 trace 2 trace 3 remote service monitor. mode Instructions for use Primus SW 4.5n...
Page 46 (optional) Alarms on/off 1) Only available in modes Volume, Volume AF, Pressure, Press. Support. 2) Only available in modes Man.Spont., Ext. Outlet 3) Only available, when HLM mode is active Instructions for use Primus SW 4.5n...
Page 47 Operating concept paramet. settings scaling amplitude units agent monitoring logbook entries logbook entries triggered by system info general info trace 1 trace 2 trace 3 exit config. start timer Instructions for use Primus SW 4.5n...
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Page 49: Assembly And Preparation
Connecting the power supply ....70 Fuses for auxiliary outlets....70 Instructions for use Primus SW 4.5n...
Page 50: Before First Use
The power cable must only be connected to a The mains voltage must correspond to that speci- power socket with a protective conductor, see fied on the rating plate on the back of the machine. ''Technical Data''. Instructions for use Primus SW 4.5n...
Page 51: Information About Transport Within The Clinic
(e.g., in doors or elevators). – Do not attempt to drag the device over hoses, cables, or other obstructions on the floor. Instructions for use Primus SW 4.5n...
Page 52 ISO 80601-2-13 and IEC 60601-1. To position the Primus ceiling device, tilt it back and move it on its rear castors. Instructions for use Primus SW 4.5n...
Page 53: Accessory Weight Limits
10 cm clearance of max. (4 in) 10 cm (4 in) A maximum weight of 35 kg (77 lbs) may be applied to the rear of the device (gas cylinders, holders and accessories). Instructions for use Primus SW 4.5n...
Page 54 Maximum weight per arm = 15 kg (33 lbs). CAUTION Risk of inadvertent movement If not properly secured, the device may move in- advertently during operation. Apply the brakes on the device to ensure it cannot be moved accidentally. Instructions for use Primus SW 4.5n...
Page 55: Primus As A Wall/Ceiling Device (Optional)
E Swivel shelf NOTE F Swiveling axis When mounting accessories or adding compo- nents at a later date, observe the maximum load of 160 kg (353 lbs) for the wall mount. Instructions for use Primus SW 4.5n...
Page 56: Characteristics - Ceiling Device
CAUTION Risk of device failure If the anesthesia machine is operated when tilted, components may be damaged or may function improperly. Do not operate the anesthesia machine if it is tilted more than 5°. Instructions for use Primus SW 4.5n...
Page 57: Connecting The Gas Supply
3 Make sure all supplies are connected correctly and functioning properly. With the "Operation without nitrous oxide" option connec- tion of an N O gas supply is not possible. Instructions for use Primus SW 4.5n...
Page 58: Connecting The Backup Gas Cylinders
Risk of supply failure If the valves remain open when connected to the central gas supply, gas may be withdrawn from the reserve gas cylinders. Close cylinder valves whenever the central supply is sufficient. Instructions for use Primus SW 4.5n...
Page 59: Connecting The Anesthetic Gas Scavenging System Ags
2 Connect the scavenging hose to the scaveng- connected optionally to the left-hand side of the ing nozzle (B) of the AGS. workstation. 3 Connect the scavenging hose to the scaveng- ing connector (C). Instructions for use Primus SW 4.5n...
Page 60: Connecting The Endotracheal Aspiration System (Optional)
(CS) for Air. Optionally, the Air connecting hose of the en- dotracheal aspiration system can be connected to the AIR outlet (A) at the back of the Primus. Instructions for use Primus SW 4.5n...
Page 61: Connecting The Patient System
Use a Y-piece filter or filter on the inspiratory port. NOTE Primus (without accessories) is not made with nat- ural rubber latex. To minimize the risk of exposure to latex, use latex- free breathing bags and breathing hoses. Instructions for use Primus SW 4.5n...
Page 62 3 Connect both breathing hoses to the Y-piece (C). 4 Connect breathing bag (D) to breathing bag hose. 5 Attach the breathing bag hose to the bag elbow and hang breathing bag on the hook. Instructions for use Primus SW 4.5n...
Page 63 Y-piece and to the water trap. 8 Use the clip (G) for the sample line to ensure the sample line is correctly routed. This clip should be attached to the expiratory port of the breathing system. Instructions for use Primus SW 4.5n...
Page 64 When ventilating pediatric patients and ne- onates, do not use HME filters or other filters at the Y-piece if sample gas is being taken at the tube adapter. Note the resistance of the breathing system and connected accessories. Instructions for use Primus SW 4.5n...
Page 65 If the expiration times are too short, the lungs might not be emptied completely, result- ing in a dynamic overfilling of the lungs (air trap- ping). In pressure-controlled ventilation, an increased re- sistance can reduce the inspiratory or expiratory volume. Instructions for use Primus SW 4.5n...
Page 66 (60 L/min), for children (30 L/min), or for ne- onates (5 L/min). If necessary, take into consideration additional parts such as water traps or additional hoses. Instructions for use Primus SW 4.5n...
Page 67: Connecting The Flexible Arm For The Breathing Bag (Optional)
To avoid contaminating the ambient environment and endangering the patient, always double- check to make sure the correct vaporizer is being opened before doing so. Instructions for use Primus SW 4.5n...
Page 68: Connecting The Electrical Connections
Risk of device failure In the event of a power failure, any devices con- nected to auxiliary power outlets will not be pow- ered by the UPS. Pay special attention to all power indicators of connected devices. Instructions for use Primus SW 4.5n...
Page 69: Establishing Potential Equalization
2 Connect the potential equalization cable to a potential equalization connector of the hospital (e.g., wall, ceiling supply unit, operating table). 3 Establish potential equalization to additional de- vices using the potential equalization pin (B). Instructions for use Primus SW 4.5n...
Page 70: Connecting The Power Supply
If a fuse is tripped (position 0): Remedy the fault, then press the switch at the automatic fuse to the position I. The fuse is active again. Only available in countries with socket outlets conforming to DIN 49440 Instructions for use Primus SW 4.5n...
Page 71: Getting Started
Self test results ......86 Emergency start ..... . . 87 Instructions for use Primus SW 4.5n...
Page 72: Device Check
Power on The test steps to be performed are grouped in five categories: A Gas Supply – Pipeline pressure – Cylinder pressure – O flush functional? – Safety O control functional? Instructions for use Primus SW 4.5n...
Page 73: Central Gas Supply Cs
Always perform a complete self test, unless acting in an emergency situation. If canceled for an emergency, perform a complete self test as soon as practicable. Instructions for use Primus SW 4.5n...
Page 74: Reserve Gas Cylinders
4 Turn safety knob (D) back to its original position to discontinue O emergency delivery and press it inwards. See page 258 for precise details on cylinder pressures. Instructions for use Primus SW 4.5n...
Page 75: Auxiliary O 2 Flow Tube (Optional)
Make sure that all connectors (e.g., Y-piece, breathing hoses including the breathing bag, breathing system, external fresh-gas outlet, oxygen therapy, anesthetic gas receiving system) are leak-free so that ox- ygen leakage cannot endanger the user or the patient. Instructions for use Primus SW 4.5n...
Page 76: Vaporizers
The Vapor 2000 is shown and described here. vaporizer to a position other than 0, and make sure the left vaporizer remains locked in its 0 position. Repeat test for other vaporizer. 5 Turn both handwheels to 0 positions. Instructions for use Primus SW 4.5n...
Page 77 D-Vapor must be mounted very care- fully. Avoid catching the D-Vapor power cable be- hind/underneath the housing. Make sure that the D-anesthetic vaporizer is upright. Always perform a leak test after mounting the vapor- izer. Instructions for use Primus SW 4.5n...
Page 78: Breathing System
Check List, during the Self Test and on the Self Test Results page. When the time remaining for use is 0 days, the component will be marked conditionally functional during the Self Test and an alarm will be generated in Standby. Instructions for use Primus SW 4.5n...
Page 79: Anesthetic Gas Scavenging System Ags
(B). The operation indicator of the terminal unit is green. 3 The AGS is functioning when the float in the flow tube is between the two marks (C). Instructions for use Primus SW 4.5n...
Page 80: Emptying The Water Trap
20 mL) without cannula into the connector (F). 3 Extract water, remove syringe and dispose of full syringe with ordinary domestic waste. 4 Slide the water trap back into its holder until it engages tangibly. Instructions for use Primus SW 4.5n...
Page 81: Preparing Primus For The Selftest
1 Fit the Y-piece onto the circuit plug (A). 2 Make sure the sample line (B) is connected to the Y-piece and to the water trap (C). 3 Set the APL valve (D) to position Man and to 30 hPa (cmH Instructions for use Primus SW 4.5n...
Page 82: Self Test
NOTE Dräger recommends that the device is monitored The self test is started. It proceeds automatically during the automatic self test. Thus, errors found and takes approx. 5 minutes. can be remedied very quickly. Instructions for use Primus SW 4.5n...
Page 83 The error should be remedied as soon as pos- sible! WARNING Risk of device failure and patient injury Functions coded red must be remedied before starting, e.g., if there is no O supply. The device cannot be operated in this state. Instructions for use Primus SW 4.5n...
Page 84: System Compliance
C PEEP/P valve sensor E Exp. valve F Exp. flow sensor G Insp. flow sensor H Insp. valve Piston pump ventilator J Fresh-gas decoupling valve K Absorber L Vapor M Fresh gas N Breathing bag Instructions for use Primus SW 4.5n...
Page 85: Locating And Eliminating Leakages
O-ring with the leak test key, see page 119. missing or handwheel not set to 0. Possible causes of leaks include e.g.: – Absorber not firmly screwed to the breathing system Instructions for use Primus SW 4.5n...
Page 86: Proposals On How To Systematically Rule Out Components When Looking For Leaks
In addition, a message containing instructions for further action appears in the middle of the screen (B). Press the soft key self test results (C) to dis- play more specific results. The Self Test Results screen is displayed. Instructions for use Primus SW 4.5n...
Page 87: Emergency Start
10 seconds. Manual ventilation is in- ery to the required O flow, between 0 and 12 L/ terrupted for this time, but spontaneous breath- min. ing can continue. 4 Start manual ventilation. Instructions for use Primus SW 4.5n...
Page 88 To start Primus: Set the safety knob for O emergency delivery to 0 and press it inwards. Select the fresh-gas setting and ventilation mode, see "Operation" on page 89. Instructions for use Primus SW 4.5n...
Page 89: Operation
Reusable absorber ..... . 118 Disposable absorber Drägersorb CLIC ..118 Instructions for use Primus SW 4.5n...
Page 90: Operation
MV during operation. 1 Press the soft key weight (C). 2 Set and confirm the weight using the rotary Press the soft key restore default settings (A) knob. and push the rotary knob to confirm. Instructions for use Primus SW 4.5n...
Page 91: Setting Fresh-Gas Concentrations
The fresh-gas flow is not enabled until a ventilation mode has been started (soft keys = dark green). Setting ranges and factory settings Fresh-gas Setting ranges Factory parameters setting Carrier gas Air or N Instructions for use Primus SW 4.5n...
Page 92: Setting The O 2 Concentration
200 mL/min when using O as carrier gas. The SORC function is not active when Air is se- lected as carrier gas and 100 % Air can be metered throughout the entire flow range. Instructions for use Primus SW 4.5n...
Page 93: Fresh Gas Failure Detection
The device will then ven- tilate with limited V or P , if possible. INSP Increase the fresh-gas flow. Seal any possible leaks. Instructions for use Primus SW 4.5n...
Page 94: Setting The Vapor
If the handwheel is set to T: 2 Press 0 key (B), engage handwheel at 0. Wait 5 seconds for pressure to balance. 3 Press 0 key and turn handwheel (C) counter- clockwise to set the required anesthetic gas concentration. Instructions for use Primus SW 4.5n...
Page 95: Ventilation
Route all cables away from the APL valve. Do not hang lines, hoses or cables, e.g., the sam- ple line, on or near the APL valve. Release pressure from the breathing system by lifting the valve head. Instructions for use Primus SW 4.5n...
Page 96: Pressure Control Valve Apl (Up To And Including January 2005)
Pressure control valve APL To relieve the pressure quickly: (up to and including January 2005) Man.Spont. ventilation mode Choose between manual ventilation and spontane- ous breathing on the APL pressure control valve. Press the pop-off valve. Instructions for use Primus SW 4.5n...
Page 97: Start Manual Ventilation/Spontaneous
See page 128 for a list of alarms which are active in the Man.Spont. mode. Start manual ventilation/spontaneous breathing 1 Press the Man.Spont. key (A); its LED and the status line flash. 2 Confirm via rotary knob (B). Instructions for use Primus SW 4.5n...
Page 98: O 2 -Flush
For flushing and rapidly filling the breathing system and breathing bag with O while bypassing the va- porizer. Press the O + (A) button. O flows into the breathing system without anesthetic agent as long as the button is held down. Instructions for use Primus SW 4.5n...
Page 99: Volume Mode
Δ . The maximum time interval for controlled ventilation is set via the frequency. To maintain a constant frequency, a time interval triggered prema- turely is compensated in the next cycle. Instructions for use Primus SW 4.5n...
Page 100 When finally confirmed, the patient corresponds to the last 25 % of the ap- the indication PressSupp in the status area (G) plicable expiratory time. of the ventilation mode lights up steadily instead of flashing. Instructions for use Primus SW 4.5n...
Page 101 INSP [sec.] Insp. pause time: 0 to 60 Insp. time INSP PEEP 0 to 20 [hPa (cmH max. P –10 Trigger sensitivity OFF, Trigger 0.3 to 15 (Pressure [L/min] Support) (Volume Mode/Pres- sure Mode) Instructions for use Primus SW 4.5n...
Page 102 I:E remains constant. Only applies if trigger = OFF, see "Ventilator and gas delivery" on page 170. 4) The resultant ratio of inspiration to expiration I:E is also displayed in parallel. 5) Optional Instructions for use Primus SW 4.5n...
Page 103: Volume Mode Autoflow - Volume Af (Optional)
Volume AF, the first manda- tings are not possible, e.g., T 6.9 s at Freq. INSP tory breath is volume controlled in order to identify 100/min. the necessary pressure level, if not known from a previous ventilation mode. Instructions for use Primus SW 4.5n...
Page 104 A mandatory breath triggered by the patient is rep- resented by a continuous vertical black line in the pressure curve and in the flow curve (trigger indica- Instructions for use Primus SW 4.5n...
Page 105 3 to 100 4) The resultant ratio of inspiration to expiration I:E 3)0.4) Freq. is also displayed in parallel. 5) Optional [1/min] Inspiratory time 0.2 to 6.7 INSP 4) [sec.] PEEP 3 to 20 [hPa (cmH Instructions for use Primus SW 4.5n...
Page 106: Pressure Mode Ventilation Mode
. The maximum time interval for controlled ventilation is set via the frequency. To maintain a constant frequency, a time interval trig- gered prematurely is compensated in the next cy- cle. Instructions for use Primus SW 4.5n...
Page 107 A mandatory breath triggered by the patient is rep- resented by a continuous vertical black line in the pressure curve and in the flow curve (trigger indica- Instructions for use Primus SW 4.5n...
Page 108 [sec.] Insp. pause time: 0 to 60 Insp. time INSP PEEP 0 to 20 [hPa (cmH max. P –5 INSP Trigger sensitivity OFF, Trigger 0.3 to 15 (Pressure [L/min] Support) (Volume Mode/Pres- sure Mode) Instructions for use Primus SW 4.5n...
Page 109 4) Depending on the configuration, the pressure limit value can also be changed automatically together with INSP adjustment of the PEEP value. See "Starting the preset ventilation mode" on page 112 and "Ventilator and gas delivery" on page 170. 5) Optional Instructions for use Primus SW 4.5n...
Page 110: Pressure Support Mode (Optional)
4 years. Inspiration is ended as soon as the current inspira- tion flow drops below 25 % of the inspiratory peak flow. Any leakage is compensated simultaneously by means of the actual airway pressure. Instructions for use Primus SW 4.5n...
Page 111: Continuous Positive Airway Pressure Cpap - In Pressure Support Mode (Optional)
2) The inspiratory time is limited by adjustment of Freq Apnea ventilation with minimum frequency is not to yield a maximum ratio of 1:1 for I:E, thus ensuring an adequate expiratory time. appicable in the CPAP mode. Instructions for use Primus SW 4.5n...
Page 112: Presetting The Ventilation Mode
In this example, the system returns to volume-con- 2 Adjust the ventilation parameter Frequency via trolled ventilation. the rotary knob and push the rotary knob to con- firm. Instructions for use Primus SW 4.5n...
Page 113: Changes In Peep
Pressure Support mode. The configured default settings are used in all other may be reduced simultaneously if T SLOPE INSP cases. reduced. When changing from Pressure Support mode (op- tional) to automatic ventilation modes: Instructions for use Primus SW 4.5n...
Page 114 Mode) is used for the first time, the pre-config- ured default settings can be adopted. This also ap- plies when the patient is ventilated in an automatic ventilation mode (e.g., Pressure Mode) before switching to manual ventilation Man.Spont.. Instructions for use Primus SW 4.5n...
Page 115: Using Non-Rebreathing Systems
Certain alarms are disabled automatically in order Place a T-piece with filter between the mask to avoid artifact, see table on page 128. pipe and fresh gas connection port. Where applicable, use a Luer Lock connector on a filter. Instructions for use Primus SW 4.5n...
Page 116: Ending The External Fresh Gas Mode
Ventilation via the internal rebreathing system in Primus is restored directly in this way. When changing from the external non-rebreathing system to the rebreathing system in Primus: Reconnect the sample line to the Y-piece. Instructions for use Primus SW 4.5n...
Page 117: Changing Patients
Restored default settings may contain set- tings inappropriate for a new patient. After default settings have been restored, make sure the ventilation and monitoring set- tings are appropriate to the patient connected. available since November 2004 Instructions for use Primus SW 4.5n...
Page 118: Reusable Absorber
2 Slide the disposable absorber off the mount (B). 3 Dispose of the spent absorber. Refer to the instructions for use of the Drägersorb CLIC absorber for information on disposal. Only without configured CLIC absorber. Instructions for use Primus SW 4.5n...
Page 119: Leak Test
(leak (Man.Spont.)). esthesia machine. If the Vapor is to be included in the test: 1 Set the vaporizer hand wheel to ≥0.2 Vol%. 2 Seal Y-piece. 3 Connect sample line to Y-piece. Instructions for use Primus SW 4.5n...
Page 120: End Of Operation
Risk of supply failure If the valves remain open when connected to the central gas supply, gas may be withdrawn from the reserve gas cylinders. Close cylinder valves whenever the central supply is sufficient. Instructions for use Primus SW 4.5n...
Page 121: Switch Off The Anesthetic Gas Scavenging
Drain any water which may have collected in the ventilator diaphragm. See "Removing the ventilator diaphragm" on page 212. The green LED (A) lights up. Switch off the anesthetic gas scaveng- ing system AGS Disconnect the anesthetic gas scavenging hose. Instructions for use Primus SW 4.5n...
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Page 123: Alarms
Setting the alarm tone ....135 Alarms in the Standby mode....135 Instructions for use Primus SW 4.5n...
Page 124: Alarm Displays
(C) is acti- vated on the right-hand side of the screen. When this soft key is pressed, the upper curve dis- play (D) is replaced by up to six additional alarm fields for 15 seconds. Instructions for use Primus SW 4.5n...
Page 125: Alarm Priorities And Alarm Signals
"-" a short time inter- val. Tone sequence* Standard: In case of a short alarm duration, only half of the se- E-E-E--E-B -----E-E-E--E-B quence (5 tones) is annunciated. *** The third tone is one octave lower. Instructions for use Primus SW 4.5n...
Page 126: Suppressing Alarms
Conf. in Standby or permanently via the alarm menu. PEAK PLAT PEEP If all the alarms connected to a measurement func- tion have been disabled, the measured value will be marked with the symbol (A). Instructions for use Primus SW 4.5n...
Page 127: Alarm Behaviour When Changing Ventilation
(D) next to the date with an indication of the si- lence time remaining (minutes:seconds). To enable the alarm tone: Press the key (C), the yellow LED turns off. Instructions for use Primus SW 4.5n...
Page 128: Limit-Based Alarms Activated In Respective Ventilation Modes
Factory setting Pressure, Press. Support Man.Spont. Alarm Support CPAP – – Pulse [1/min] etCO [mmHg] – – inCO [mmHg] [L/min] – – [Vol%] inHal [Vol%] – – inIso [Vol%] – – inEnf [Vol%] – – Instructions for use Primus SW 4.5n...
Page 129 FreqMIN of less than 6/min or when set to OFF. All apnea CO alarms in Man.Spont. and in the Monitoring mode are only active if ventilation has already been detected (AutoWakeUp). Instructions for use Primus SW 4.5n...
Page 130: Enabling/Disabling Co 2 Alarms
The alarms for etCO and inCO can be activated or deactivated in Standby for switching to Man.Spont.. When the alarm limits are enabled the value is adopted from the automatic ventilation mode, see page 167. Instructions for use Primus SW 4.5n...
Page 131: Hlm Mode
1 Press the soft key config. (A) on the standard or data screen. The submenu volumes/ alarms is opened. 2 Select and confirm the column alarms on/off (B) via the rotary knob. Instructions for use Primus SW 4.5n...
Page 132: Enabling/Disabling Spo
3 Select and confirm the line SpO (C) via the ro- tary knob. 4 Select and confirm on or off via the rotary knob. Suppressed alarm limits are identified by the sym- in the parameter field. Instructions for use Primus SW 4.5n...
Page 133: Displaying And Setting Alarm Limits
0.1 to 8.4 To set an alarm limit: [Vol%] 0 to 8.3 Place the cursor on the alarm limit by turning the rotary knob and push to confirm. The alarm limit is highlighted in yellow. Instructions for use Primus SW 4.5n...
Page 134: Adapting Alarm Limits
When ventilation settings have been made, Primus can automatically adapt the alarm limits for minute volume MV and the airway pressure P to the cur- rent parameters in Volume Mode, Volume AF, Pressure Mode, and Pressure Support (op- tional). Instructions for use Primus SW 4.5n...
Page 135: Setting The Alarm Tone
All technical alarms, e.g., failure of device compo- nents and a number of special operating states, are also indicated by Primus when in Standby. A corresponding message appears in the alarms field, but without any acoustic warning. Instructions for use Primus SW 4.5n...
Page 136 This page was intentionally left blank. Instructions for use Primus SW 4.5n...
Page 137: Monitoring
Mini trend for CPAT/PEEP ....151 Selecting the data screen ....152 Instructions for use Primus SW 4.5n...
Page 138: Selecting The Standard Screen
The three curves are displayed in the middle (D) screen can always be selected during operation: (for other standard screens, see page 152). By pressing the key (B), By pressing the key (A) repeatedly. Display (example): Volume Instructions for use Primus SW 4.5n...
Page 139: Monitoring Mode
Select, edit, and confirm the curve or module to be changed and confirm with the rotary knob. All three screen layouts with three curves and indi- vidual modules can only be configured in the menu Standby Conf., see page 166. Instructions for use Primus SW 4.5n...
Page 140: Displayed Parameters
– Curve display – Numerical display insp. : Inspiratory anesthetic gas con- centration exp. : Expiratory anesthetic gas con- centration : Minimum alveolar concentration – Trend curve for anesthetic gases and MAC Instructions for use Primus SW 4.5n...
Page 141: Flow And Volume
PLAT - PEEP hose compliance determined in fresh-gas mixer with bar graphs for O and N O or the self test. Air. (only on the data screen) see page 147 for a detailed description Instructions for use Primus SW 4.5n...
Page 142: Indicators For The Active Ventilation Source
Graphical display for the following measured and calculated values: – PAW-V – V-Flow see page 148 for a detailed description see page 149 for a detailed description *** see page 150 for a detailed description Instructions for use Primus SW 4.5n...
Page 143: Gas Measurement
The MAC values are dependent on the age of the CAL. patient. The values indicated in the table relate to an age of 40 years. Instructions for use Primus SW 4.5n...
Page 144: Age-Dependent Mac Values
Primus automatically adjusts the MAC calculation according to the ambient pressure. NOTE The age "1" is used when the age is set to "<1". Special attention is required for patients younger than one year. 40 years Instructions for use Primus SW 4.5n...
Page 145: Xmac Display (Mac Multiple)
A secondary anesthetic agent becomes the main anesthetic agent if its xMAC value exceeds the MAC value of the main anesthetic agent by 0.2 MAC. 10 years Instructions for use Primus SW 4.5n...
Page 146: Automatic Agent Alarm Activation
It adapts to increasing concentrations but not to de- creasing concentrations. Primus generates an alarm when the expiratory xMAC value falls below the alarm limit (B). Instructions for use Primus SW 4.5n...
Page 147: Using The Volumeter Function
47 s Expiratory phase Volumeter (minute volume measurement). Numerical indication of the expiratory minute vol- ume. The scales of the bar graphs can be configured dur- ing operation and in Standby, see page 164. Instructions for use Primus SW 4.5n...
Page 148: Econometer (Optional)
– the patient’s uptake, – leakage, and – the CO volume absorbed. surplus efficient deficit fresh-gas flow If data for calculation are not available, the legend appears in gray and the bar graph is not active. Instructions for use Primus SW 4.5n...
Page 149: Loops (Optional)
The scale of the P and flow axis depends on the scale selected for the real-time curves. The scale of the volume axis depends on the scale of the volum- eter. Instructions for use Primus SW 4.5n...
Page 150: Mini Trends (Optional)
Press the soft key screen layout (A). The scaling depends on the expiratory tidal volume Select a parameter module and select the corre- and is automatically adjusted. sponding mini trend. MV*CO 1000 1000 Instructions for use Primus SW 4.5n...
Page 151: Mini Trend For O 2 Uptake
The scaling for PEEP is set to 20 mbar. uptake The scaling for C depends on the expiratory tidal volume V and is automatically adjusted. 1000 1000 1000 Instructions for use Primus SW 4.5n...
Page 152: Selecting The Data Screen
P (B). The bottom right-hand field (C) shows the pressure values for the central supply of O O, and Air as well as for the O and N O backup gas cylinders. Instructions for use Primus SW 4.5n...
Page 153: Selecting The Trend Screen
/ CO C Recruitment (optional) /PEEP trend / MV*CO trend / Uptake trend D SpO Pulse (optional) Press the key repeatedly until the trend screen is displayed. The trend page agents (A) is displayed first. Instructions for use Primus SW 4.5n...
Page 154: Zoom Function
This soft key is ineffective if there is insufficient trend data available (e.g., less than 30 minutes of operation). To delete: Press the soft key delete (B). Instructions for use Primus SW 4.5n...
Page 155: Selecting The Logbook
Press the soft key page 2 (C). ters, such as SpO and pulse. To return to the standard screen: Volume Volume Press the soft key logbook (A). Press the soft key exit logbook (D). Press the key. Instructions for use Primus SW 4.5n...
Page 156: Using The Timer Function
Only the DEC-8 or DEC-4 extension lead (purple plug connector) may be used. The new sensors are downward-compatible with all modules already used in the field in older Dräger machines. Note the instructions for use of the sensors. Instructions for use Primus SW 4.5n...
Page 157 8 hours Preferred Ball of the Finger Nose Forehead measuring foot point Select the appropriate sensor. At the back of the workstation: Plug the sensor connector into the socket marked SpO Instructions for use Primus SW 4.5n...
Page 158: Safety-Relevant Information
Do not rely on measurement data if the SpO Do not position the SpO sensor where it might be sensor is used under these conditions. affected in this way. Instructions for use Primus SW 4.5n...
Page 159: Applying The Durasensor Ds-100 A
– In the presence of shock, low blood pressure, severe vasoconstriction, major anemia, hypo- Follow the specific instructions for use when using thermia, arterial occlusion proximal to the sen- other Nellcor sensors! sor and asystolia, the pulse signal may fail. Instructions for use Primus SW 4.5n...
Page 160 CAUTION Risk of inaccurate data If simulators are used as calibrators, the SpO module may produce incorrect data. Simulators must not be used as a calibrator. Instructions for use Primus SW 4.5n...
Page 161: Configuration
Screen layout ......177 Setting the patient's age and weight during operation ..... . . 178 Instructions for use Primus SW 4.5n...
Page 162: Configuring The Default Settings
3 Select and confirm the figures successively from the line displayed (E) via the rotary knob. The password is represented by asterisks (* * * *) below the line of numbers. Instructions for use Primus SW 4.5n...
Page 163: Basic Settings And Audible Signals
Factory setting: 24 h ciently high. – language of the display texts The NO O SUPPLY alarm is always announced at Factory setting: English (GB) the maximum volume. Only in connection with breathing sound module. Instructions for use Primus SW 4.5n...
Page 164: Parameters
Calibration can be repeated or aborted if 0 to 2 years: 150 mL, unsuccessful. A 21 Vol% O calibration is per- >2 to 10 years: 500 mL, formed automatically if the calibration is >10 years: 1000 mL. aborted. Instructions for use Primus SW 4.5n...
Page 165: Interfaces/Logbook
These values cannot be configured; this is informa- Entries are made when a tion only. warning is issued. caution alarms: yes/no Entries are made when a caution message is is- sued. Instructions for use Primus SW 4.5n...
Page 166: Screen Layout
Each curve/module can only be displayed once. If certain screen layout configurations. a curve/module is selected twice, the preceding se- lection automatically becomes “blank“. Always take national standards into account when configuring the screen layout. Instructions for use Primus SW 4.5n...
Page 167: Setting Alarm Limits
Alarm Factory setting inCO 1 to 10 high: yes/no [mmHg] MV: yes/no inAgent low: yes/no 0.1 to 20.0 12.0 etCO : yes/no [L/min] 0 to 19.9 inCO : yes/no apnea alarm cas- cade: yes/no Instructions for use Primus SW 4.5n...
Page 168 (patients <6 years) : yes/no Risk of insufficient monitoring Further information, see page 169. If the setting MV alarms in HLM? is set to no, MV alarms and flow apnea monitoring are deacti- vated. Special attention is required. Instructions for use Primus SW 4.5n...
Page 169 The new default alarm limits are effective when- ever the workstation is switched on and after se- lecting restore default settings in Standby. Certain alarms are disabled automatically in Man.Spont., Monitoring, and Ext. Outlet, see ta- ble on page 128. Instructions for use Primus SW 4.5n...
Page 170: Ventilator And Gas Delivery
The trigger sensitivity can be set separately in the available ventilation modes. Connected gas supplies Factory setting line: yes/no J Air line : yes/no O line: yes/no cylind.: yes/no M Air cylind.: yes/no O cylind.: yes/no Instructions for use Primus SW 4.5n...
Page 171 INSP When no is set: Parameter value P remains unaffected INSP by changes in the ventilation parameter PEEP. Factory setting: yes – T changes with Freq. if synchroniza- INSP tion is off: (C) yes/no Instructions for use Primus SW 4.5n...
Page 172 550 to 800 – restore factory default presets (H). Select and confirm to restore the factory set- tings. The default settings are activated immediately upon exiting the configuration menu. Press exit (I), to exit the menu. Instructions for use Primus SW 4.5n...
Page 173: System Information
Only use the Remote Service Link on medical devices which are not otherwise in use. This is a law according to the MPG. F activate option Instructions for use Primus SW 4.5n...
Page 174 3 Connect the Remote Service Link to the COM 1 interface. The service data of Primus can now be transferred. For further operation, see instructions for use for the Remote Service Link. After exiting remote service 4 Switch off Primus. Instructions for use Primus SW 4.5n...
Page 175: Configuration During Operation
All alarms are still audible with the breathing sound volume set to the maximum. E pulse volume (optional) 0 = off 9 = maximum volume Only in connection with breathing sound module. Instructions for use Primus SW 4.5n...
Page 176 Entries are made when a caution message auto: A suitable scaling is selected auto- is issued. matically in accordance with the set age. 0 to 2 years: 150 mL, >2 to 10 years: 500 mL, >10 years: 1000 mL. Instructions for use Primus SW 4.5n...
Page 177: Screen Layout
F trace 1, trace 2, trace 3 ble modules. Description of internal equipment states and pa- rameters. Press the soft key exit sys. info (G) to exit the system information. Instructions for use Primus SW 4.5n...
Page 178: Setting The Patient's Age And Weight During Operation
In the modes Man.Spont., Ext. Outlet, and Moni- toring the keys are directly accessible. Man.Spont. Select the soft key age (D) or weight (E) to change and confirm with rotary knob. Instructions for use Primus SW 4.5n...
Page 179: Remedying Faults
System failure ......187 Alarm – Cause – Remedy....188 Instructions for use Primus SW 4.5n...
Page 180: Power Failure
If the power supply is restored, the anesthesia ma- chine behaves as described in "Ventilator and fresh gas delivery failure" on page 185; see also the Instructions for use Primus SW 4.5n...
Page 181: Gas Failure
If the fresh-gas volume is insufficient, the missing quantity is refilled with ambient air if the breathing bag is removed. 1 Remove breathing bag. 2 Perform automatic ventilation. Instructions for use Primus SW 4.5n...
Page 182 Risk of supply failure If the valves remain open when connected to the central gas supply, gas may be withdrawn from the reserve gas cylinders. Close cylinder valves whenever the central supply is sufficient. Instructions for use Primus SW 4.5n...
Page 183: Ventilator Failure
Set the APL valve to a correct pressure limit- ing value and ventilate the patient manually. WARNING Risk of patient injury If pressure and volume monitoring fails, the patient cannot be adequately monitored. Ensure adequate substitution monitoring. Instructions for use Primus SW 4.5n...
Page 184: Fresh Gas Delivery Failure
WARNING Risk of patient injury If the fresh-gas delivery fails, the anesthesia machine automatically discontinues the fresh-gas flow. An O flow must be delivered to the patient. Check vaporizer setting. Set O emergency supply. Instructions for use Primus SW 4.5n...
Page 185: Ventilator And Fresh Gas Delivery Failure
Primus automatically switches to the Monitoring mode. 1 Check setting of vaporizer unit. 2 Set the safety knob of the O emergency deliv- ery to the required flow. Range: 0 to 12 L/min. This flow streams through the vaporizer. Instructions for use Primus SW 4.5n...
Page 186: Gas Measurement Failure
O emergency delivery. User interface failure If the soft keys or the rotary knob are not opera- tional: 1 Select the Monitoring mode, see page 139 2 The patient must be ventilated manually. Instructions for use Primus SW 4.5n...
Page 187: System Failure
In both cases, to ensure alternative delivery of 100 % O and anesthetic agent: 1 Check the vaporizer setting (D). 2 Press the safety knob (E) to unlock it and turn it to set the required flow. Instructions for use Primus SW 4.5n...
Page 188: Alarm - Cause - Remedy
AIR CYLIND. EMPTY * AIR reserve gas cylinder Use a new AIR reserve gas Advisory empty and central AIR sup- cylinder. ply not available or not con- (24/7) Use the central gas supply. nected. Instructions for use Primus SW 4.5n...
Page 189 (detected by pres- be ventilated manually! sure, volume, and CO mon- Check patient's spontaneous itoring). breathing ability. Check ventilation setting. Check fresh-gas setting. Make sure everything is con- nected. Check hose system and tube! Instructions for use Primus SW 4.5n...
Page 190 (24) Check patient's spontaneous Warning breathing ability. (31) Make sure everything is con- nected. Check hose system and tube. Breathing/ventilation has Patient must immediately stopped. be ventilated manually! Check ventilation setting. Instructions for use Primus SW 4.5n...
Page 191 Connect to mains power. sory = 10 to 20 %; Caution = (13) Check patient's condition! <10 %) of the uninterruptible Prepare manual ventilation Note power supply is almost ex- hausted. with 100 % O Instructions for use Primus SW 4.5n...
Page 192 Check alarm limit for correct setting. Caution ET CO HIGH The upper alarm limit for the Check ventilation. end-expiratory CO concen- (18) tration has been exceeded for at least two breaths. Instructions for use Primus SW 4.5n...
Page 193 Note Switch external fresh-gas (30/10) outlet on and off several times. If breathing bag of the non- rebreathing system does not fill, switch to internal breath- ing system. Use operational outlet. Call DrägerService. Instructions for use Primus SW 4.5n...
Page 194 Caution/ INCORRECT FG FLOW Set fresh-gas flow cannot be Check setting of vaporizer Advisory delivered. unit. (14/10) Make sure the emergency delivery is closed. Set fresh-gas flow to be- tween 3 and 10 L/min. Instructions for use Primus SW 4.5n...
Page 195 Dead space ventilation. Check ventilation settings. Note INSP. FLOW SENSOR FAIL Insp. flow sensor is defec- Replace flow sensor, tive. see page 221. Instructions for use Primus SW 4.5n...
Page 196 Warning (31) = insp. gas concentration > upper alarm limit for > 180 seconds. Insp. anesthetic gas concen- Check the vaporizer and tration exceeds the upper fresh-gas settings. alarm limit for at least 2 breaths. Instructions for use Primus SW 4.5n...
Page 197 LOSS OF DATA * Data loss of the settings and/ Check the current settings or the system configuration. and the default settings. – Repeat settings if necessary. (14/–) Call DrägerService. Alarm can be canceled by pressing Instructions for use Primus SW 4.5n...
Page 198 Confirm alarm, if case is alarm limit of the automatic closed. (14/7) agent alarm. Check vaporizer fill level. Check correct position of va- porizer. Check for leakages in breathing system. Instructions for use Primus SW 4.5n...
Page 199 O supply not avail- (25/7) able or not connected. Use the central gas supply. Note O SENSOR FAIL O gas measurement sys- Use external measuring sys- tem has failed. tem. (in Standby only) Call DrägerService. Instructions for use Primus SW 4.5n...
Page 200 10 seconds. sensor. NiBP measurement on the Measure blood pressure on same arm. the other arm. Advisory/ CYLIND. CONNECT.? * Pressure sensor for reserve Check pressure sensor con- gas cylinder not connected. nection. – (8/–) Instructions for use Primus SW 4.5n...
Page 201 Internal fault in the power Call DrägerService. supply. Operation of the workstation can continue for the time be- ing. Note PRESSURE ERROR Pressure sensor is defective. Perform self test. (in Standby only) Call DrägerService. Instructions for use Primus SW 4.5n...
Page 202 Correct alarm limit if neces- sary. Warning PULSE RATE LOW Pulse below lower alarm Check patient's condition! limit. (31) Check ventilation. Caution SAFETY O OPEN emergency delivery is Close O emergency supply. open. (18) Instructions for use Primus SW 4.5n...
Page 203 Push the ventilator in until it locked correctly. engages in the right position. Note Anesthetic gas scavenging (27/10) system is not active when the ventilator unit is discon- nected. The ambient air may become contaminated with anes- thetic agents! Instructions for use Primus SW 4.5n...
Page 204 For more details see page 128. , or symbol One or both alarm limits for Set alarm limits, the measured value con- see page 167. next to measured values cerned has/have been disa- bled. Instructions for use Primus SW 4.5n...
Page 205 Remedying faults Priority Message Cause Remedy Grayed out values The set value differs from the delivered value. Grayed out measured values The specified accuracy can- not be maintained. Instructions for use Primus SW 4.5n...
Page 206 This page was intentionally left blank. Instructions for use Primus SW 4.5n...
Page 207: Cleaning, Disinfection And Sterilization
AGS ......226 Connecting the secretion aspirator..227 Before using on patients on again ..228 Instructions for use Primus SW 4.5n...
Page 208: Disassembly
Wa- terLock and comply with the hospital’s hygiene re- The sample line is a single-use article which must quirements. be disposed of in accordance with the hospital's hy- giene regulations. Instructions for use Primus SW 4.5n...
Page 209: Removing The Breathing Circuit
Note the regulations of the hospital for infec- tious patients! Note the instructions for use. Instructions for use Primus SW 4.5n...
Page 210: Pulling Out The Ventilator Module
2 Empty out the soda lime in accordance with the instructions for use of the absorber, see page 118. 2 Unscrew the knurled screws (A) on the socket of the arm. 3 Disconnect the arm from the breathing system. available since November 2004 Instructions for use Primus SW 4.5n...
Page 211: Removing The Breathing System
5 Press the button (C); the mounting swings open. 6 Slide the disposable absorber off the mounting (D). 2 Pull the breathing system up (B) and out by the Note the Drägersorb CLIC instructions for use. handle. Instructions for use Primus SW 4.5n...
Page 212: Removing The Ventilator Diaphragm
NOTE If the ventilator diaphragm is reprocessed together with light-colored, transparent silicone compo- nents, discoloration of these silicone components may occur. Do not reprocess the specified components to- gether. Instructions for use Primus SW 4.5n...
Page 213: Removing The Flow Sensors
SpiroLife flow sensors. 3 Lift off the metal valve plate (C). 4 Prepare the housing parts for conditioning in a cleaning and disinfecting machine. 5 Place the metal valve plate in the cleaning and disinfecting machine. Instructions for use Primus SW 4.5n...
Page 214: Removing The Anesthetic Gas Scavenging
4 Prepare the individual parts for conditioning in a Note the instructions for use of the anesthetic gas cleaning and disinfecting machine. scavenging system AGS. Flow tubes must not be placed in the washer! 5 Remove the container for buffer volume. Instructions for use Primus SW 4.5n...
Page 215: Removing The Secretion Aspiration System
If other procedures, chemicals, and/or val- 4 Remove the filter (E) at the bottom of the en- ues are used, the user assumes all responsibility. dotracheal aspiration system. (See "Maintenance" on page 229.) Instructions for use Primus SW 4.5n...
Page 216: Reprocessing Procedure
2 Perform surface disinfection (scrub-and-wipe Machine cleaning: disinfection). – Neodisher Medizym by Dr. Weigert 3 After the contact time has elapsed, remove dis- infectant residues. Machine disinfection: – Thermal, 93 °C (199.4 °F) for 10 min Instructions for use Primus SW 4.5n...
Page 217: Semicritical Medical Devices
3 Check parts for visible dirt and damage. If nec- The valve plate must be sterilized after wash- essary, repeat manual disinfection. ing in order to dry it. 4 Thoroughly shake out residual water. Allow items to dry thoroughly. Instructions for use Primus SW 4.5n...
Page 218: Visual Inspection
Only sterilize cleaned and disinfected items. For sterilization, use a vacuum steam sterilizer (in accordance with DIN EN 285), preferably with frac- tionated vacuum. Instructions for use Primus SW 4.5n...
Page 219: Reprocessing List
The instructions of the hospital's hygiene officer shall prevail! 2) Drain any water which may have collected in the ventilator diaphragm. Larger quantities of condensation may impair operation of the workstation and/or lead to failure of the equipment! Instructions for use Primus SW 4.5n...
Page 220 2) The valve plate must be sterilized after washing in order to dry it. Correct operation of the workstation may be impaired and lead to failure of the workstation if the control areas in the valve plate are not dried completely. Instructions for use Primus SW 4.5n...
Page 221: Assembly
1 Insert the flow sensors (A) with the electric con- 2 Fit the metal valve plate (B) onto the bottom nection in the slot. section. 2 Push in the expiratory and inspiratory ports (B), with the nose of the port in the slot. Instructions for use Primus SW 4.5n...
Page 222 4 Insert the ventilator diaphragm (C) so that the 6 Tighten the sealing screws (E) on the ventilator Dräger legend is visible from above. cover using the key supplied. 5 Hang the breathing system (D) into the ventila- tor module. Instructions for use Primus SW 4.5n...
Page 223: Filling And Fitting The Absorber
87. Recommendation: Only use Drägersorb 800 Plus or Drägersorb FREE! NOTE Do not use powdered lime, as a higher dust load can impair the functionality of Primus. Instructions for use Primus SW 4.5n...
Page 224: Installing The Flexible Arm (Optional) And Breathing Bag
1 Position the socket of the arm on the breathing by pressing the soft key soda lime changed, system and tighten it with the two knurled see page 87. screws (A). 2 Check that the arm is fixed securely! Instructions for use Primus SW 4.5n...
Page 225: Inserting The Ventilator Module
See "Connecting the patient system" on page 61. 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. Instructions for use Primus SW 4.5n...
Page 226: Connecting The Anesthetic Gas Scavenging
NOTE Primus (without accessories) is not made with nat- ural rubber latex. To minimize the risk of exposure to latex, use latex- free breathing bags and breathing hoses. Instructions for use Primus SW 4.5n...
Page 227: Connecting The Secretion Aspirator
Note the instructions for use of the anesthetic gas scavenging system AGS. 3 Grip the silicone sleeve of the bottle cover and fit it on the bottle (D). Instructions for use Primus SW 4.5n...
Page 228: Before Using On Patients On Again
Observe the instructions for use of the endotra- cheal aspiration system. Before using on patients on again 1 Re-assemble all equipment, see "Assembly and preparation" on page 49. 2 Check readiness for operation, see "Getting started" on page 71. Instructions for use Primus SW 4.5n...
Page 229: Maintenance
Replacing the water trap....235 Replacing the O sensor ....236 Instructions for use Primus SW 4.5n...
Page 230: Overview
Measures intended to determine and assess the actual state of a medical de- vice Preventive maintenance Recurrent specified measures intended to maintain the functional condition of a medical device Repair Measures intended to restore the functional condition of a medical device af- ter a device malfunction Instructions for use Primus SW 4.5n...
Page 231: Inspection
4 Using the instructions for use, check that all – Perform self test. components and accessories needed to use the product are available. – Check O measurement. Instructions for use Primus SW 4.5n...
Page 232: Preventive Maintenance
AGS filter Replace when blocked. Replace Users Filter of the endo- Replace every two weeks. Replace Users tracheal aspiration system Upper diaphragm of At least every 12 months Replace Users ventilator unit Instructions for use Primus SW 4.5n...
Page 233 Service personnel inlet PEEP diaphragm, Every 2 years Replace Service personnel breathing system Man.Spont.-Auto- Every 2 years Replace Service personnel matic reversing dia- phragm Bacterial/viral filter, Every 2 years Replace Service personnel patient gas module Instructions for use Primus SW 4.5n...
Page 234: Repair
TERY LOW is displayed. Technical customers documentation according to IEC/EN 60601 is available upon request. Repair Dräger recommends that all repairs are carried out by DrägerService and that only authentic Dräger repair parts are used. Instructions for use Primus SW 4.5n...
Page 235: Emptying Or Replacing The Water Trap
Observe the hospital's hygiene regulations! 2 Mark the new water trap with the current date. Use the space provided for this purpose. 3 Push the new water trap into place until it en- gages. Instructions for use Primus SW 4.5n...
Page 236: Replacing The O 2 Sensor
2 Remove the spent O sensor (B) from the screw and insert the new O sensor into the screw. Screw the screw back into place. Dispose of the spent O sensor, refer to the in- structions for use. Instructions for use Primus SW 4.5n...
Page 237: Disposal
2002/96/EC......238 Disposal of Non-Rechargeable Batteries . . . 238 Instructions for use Primus SW 4.5n...
Page 238: Disposing Of The Medical Device
Therefore, the battery in the device must be removed by a suitably qualified per- son before disposal of the device. Observe the ap- plicable laws and regulations for battery disposal. Instructions for use Primus SW 4.5n...
Page 239: Technical Data
Device combinations ....267 Connections to IT-networks ... . . 267 Information on connecting to the IT-network . . 268 Instructions for use Primus SW 4.5n...
Page 240: Technical Data
50 %. If more than one of the ambient con- ditions are changed, the accuracy may change by up to 100 %. All patient-related volumes and flow val- ues have been standardized to the current ambient conditions (ATPD) Instructions for use Primus SW 4.5n...
Page 241: Ambient Conditions
1) Depending on the type of anesthetic agent delivery unit used, this data may vary. 2) The longer-term storage at a temperature outside this range may shorten the life of the batteries. 3) The maximal permissible fresh-gas flow may be limited depending on the anesthetic agent vaporizer used. Instructions for use Primus SW 4.5n...
Page 242: Ventilator
±10 % of set value or at least ±3 hPa (±3 cmH Inspiration pressure P INSP In Pressure Mode (PEEP +5) to 70 hPa [(PEEP +5) to 70 cmH Accuracy ±10 % of set value or at least ±3 hPa (±3 cmH Instructions for use Primus SW 4.5n...
Page 243 Max. 150 L per minute +10 % 1) Due to gas measurement sampling, leakage (both at the patient and in the device), and resistance/compliance of the pa- tient and the breathing circuit, the maximum delivered tidal volume may be limited. Instructions for use Primus SW 4.5n...
Page 244: Breathing System
Typical 2.3 mL/hPa (2.3 mL/cmH 1) Due to gas measurement sampling and leaks (both at the patient and in the device), the end-expiratory PEEP value may be lower than specified at the end of long expiratory phases. Instructions for use Primus SW 4.5n...
Page 245 4.2 hPa (±6 cmH O), with hose set for adults (–4.4 cmH (4.2 cmH M30146 As per ISO 8835-2, dry, sole breathing –3.5 hPa 3.2 hPa system without patient hoses (–3.5 cmH (3.2 cmH Instructions for use Primus SW 4.5n...
Page 246 Pressure and flow characteristics of the breathing system without breathing hoses and filters (in ac- cordance with ISO 8835-2 and ISO 80601-2-13) flow [L/min] Pinsp [hPa] max. Pexp [hPa] max. Minimal Limited Pressure –3 hPa (in accordance with ISO 8835-5 (–3 cmH and ISO 80601-2-13) Instructions for use Primus SW 4.5n...
Page 247: Fresh-Gas Outlet For Non-Rebreathing Systems (Optional)
Graduated connection for use with various hose diameters Flow range 0 to 10 L per minute Resolution of the displayed value 0.5 L per minute Accuracy of the flow display ±10 % of full scale Instructions for use Primus SW 4.5n...
Page 248: Measuring Systems
0 to 9.8 kPa x 100 (0 to 140 psi) Resolution of the displayed value 0.1 kPa x 100 (1.5 psi) Accuracy ±4 % or ±0.2 kPa x 100 (±4 % or ±3 psi) Instructions for use Primus SW 4.5n...
Page 249 0 to 99.9 L per minute Resolution of the displayed value 0.1 L per minute Accuracy ±8% of measured value or ±0.1 L/min, the greater value ap- plies 1) Valid for Silverline pressure regulators. Instructions for use Primus SW 4.5n...
Page 250 ±15 % or ±20 mL per minute, the greater value applies MV*CO Measuring range 0 to 9999 mL per minute Resolution of the displayed value 1 mL per minute Accuracy ±20 % or ±20 mL per minute, the greater value applies Instructions for use Primus SW 4.5n...
Page 251 Delay for sampling (typical value; Less than 4 seconds Less than 4 seconds depends on sample line used) 1) The respective value depends on the PGM used which is displayed on System Information page. Instructions for use Primus SW 4.5n...
Page 252 – paramagnetic (consumption-free) Measuring range 0 to 100 Vol% Resolution of the measurement 0.1 Vol% Resolution of the displayed value 1 Vol% (for insp. O , exp. O Accuracy ±(2.5 Vol% +2.5 % rel.) Instructions for use Primus SW 4.5n...
Page 253 ±(2 Vol% + 8 % rel.) MAC (xMAC) Range 0 to 9.9 Resolution of the displayed value Accuracy Derived value from gas measurement values 1) At respiratory frequencies up to 60 per minute and an insp./exp. ratio of 1:1. Instructions for use Primus SW 4.5n...
Page 254 1) Exception: At a Desflurane concentration of more than 4 Vol% a mixture will be detected at the latest when the concen- tration of the second anesthetic gas increases to over 10 % of the Desflurane concentration. 2) The respective value depends on the PGM used which is displayed on System Information page. Instructions for use Primus SW 4.5n...
Page 255 A tone is generated for each pulse detected. The pitch of the tone is proportional to the oxygen saturation; Increasing sat- uration increases the pitch. Pitch of tone The pitch of the tone is according to Nellcor specifications. Instructions for use Primus SW 4.5n...
Page 256: Interfaces
1 stop bit IV System (Dräger Base) Power supply for IV System SA bus For internal use only; available depending on configuration For connecting an SpO sensor System alarm delay time = 600 ms (typical value). Instructions for use Primus SW 4.5n...
Page 257: Operating Data
At least 10 hours (to reach full power) Charging power Maximum 70 W Auxiliary power outlets 2 outlets with automatic circuit breakers rated at 4 A each or 3 outlets with fuses rated at 2 A each Instructions for use Primus SW 4.5n...
Page 258 43 cm x 29 cm (16.9 in x 11.4 in) Breathing system (W x H x D) 37.5 cm x 40.5 cm x 34.5 cm (14.8 in x 15.9 in x 13.6 in) Deviations possible depending on the configuration. Instructions for use Primus SW 4.5n...
Page 259 Oval pole swivel arm + approx. 4 kg (9 lbs) Pump mount + approx. 6 kg (13 lbs) Permitted total weight 300 kg (662 lbs) Breathing system without soda lime 4.4 kg (9.7 lbs) Instructions for use Primus SW 4.5n...
Page 260: Classification
Universal Medical Device Nomenclature 10-134 System – nomenclature for medical de- vices GMDN code Global Medical Device Nomenclature – 37710 global nomenclature for medical devices Use of latex Primus is not made with natural rubber latex. Instructions for use Primus SW 4.5n...
Page 261: Relevant Standards
Part 1: Medical electrical equipment General requirements for basic safety and essential perform- ance IEC 60601-1-2 Part 1-2: Medical electrical equipment General requirements for safety - Collateral standard: Elec- tromagnetic compatibility - Requirements and tests Instructions for use Primus SW 4.5n...
Page 262: Emc Declaration
Dräger, the correct operation of the device in this configuration must be tested before the product is used. In any case, strictly observe the instructions for use of the other devices. Instructions for use Primus SW 4.5n...
Page 263: Electromagnetic Emissions
Harmonic emissions Not applicable directly connected (without transformer) to the public (IEC 61000-3-2) low-voltage power supply network that supplies buildings used for domestic purposes. Voltage fluctuations / Not applicable flicker (IEC 61000-3-3) Instructions for use Primus SW 4.5n...
Page 264: Electromagnetic Immunity
Recommended minimum distance to (IEC 61000-4-3) 10 V/m portable and mobile radio frequency transmitters with transmission power to the medical device including its EIRP lines: (1.84 m x √P EIRP (6.04 ft x √P EIRP Instructions for use Primus SW 4.5n...
Page 265 3 V/m in the frequency range from 150 kHz to 2.5 GHz and less than 1 V/m above 2.5 GHz. 2) ISM bands in this frequency range are: 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; 40.66 MHz to 40.70 MHz. Instructions for use Primus SW 4.5n...
Page 266: Recommended Separation Distances To Portable And Mobile Radio Frequency Communication Devices
GSM 1800, GSM 1900 (limited to 1 W ERP) 0.38 m (1.2 ft) UMTS, DECT (limited to 0.25 W ERP) 0.19 m (0.62 ft) Bluetooth, WLAN 2450, RFID 2450 (limited to 0.1 W ERP) 0.20 m (0.66 ft) Instructions for use Primus SW 4.5n...
Page 267: Device Combinations
Examples of subsequent changes to the network: – Changing the network configuration Instructions for use Primus SW 4.5n...
Page 268: Information On Connecting To The It-Network
– Alarms or data is transmitted with a delay. – False alarms are triggered. – During an interruption of the network connec- tion: – Alarms are not transmitted. – Suppressed alarms or alarm tones are not reactivated, but remain suppressed. Instructions for use Primus SW 4.5n...
Page 269: Index
Index Index Controlled ventilation ....99 CPAP ....... 111 Absorber .
Page 270 Index HF surgical devices ..... . 68 Parameter settings ..... 176 HLM mode .
Page 271 Index SORC (Sensitive Oxygen Ratio Controller) ..92 Virtual flow tubes ....141, 147 ....... . 165 Volume Mode .
Page 272 These instructions for use only apply to Primus SW 4.5n with the Serial No.: If no Serial No. has been filled in by Dräger, these instructions for use are provided for gen- eral information only and are not intended for use with any specific machine or device.

Dräger Primus SW 4.5n Instructions For Use Manual

Abbreviations and Symbols

For Your Safety and that of Your Patients

General Safety Information

Product-Specific Safety Information

Application

Intended Use

Further Information on Application

Indications and Contraindications

Overview

Components

Additional Functions

Abbreviations

Symbols

Operating Concept

Screen Ergonomics

Keys with Permanent Functions

Keys)

Selecting and Setting

Keys with Variable Functions (Soft Keys)

Color Concept

LED Indicators of the Device

Menu Structure Overview

Assembly and Preparation

Before First Use

Information about Transport Within the

Clinic

Accessory Weight Limits

Primus as a Wall/Ceiling Device (Optional)

Connecting the Gas Supply

Connecting the Anesthetic Gas Scavenging System AGS

System (Optional)

Scavenging System AGS

Connecting the Endotracheal Aspiration

Connecting the Patient System

Connecting the Flexible Arm for the Breathing Bag (Optional)

Park Holder for Vaporizer Units (Optional)

Breathing Bag (Optional)

Connecting the Electrical Connections

Getting Started

Device Check

Self Test

Emergency Start

Operation

Operation

Setting Fresh-Gas Concentrations

Setting the Vapor

Ventilation

Using Non-Rebreathing Systems

Changing Patients

Alarms

Alarm Displays

Alarm Priorities and Alarm Signals

Suppressing Alarms

Limit-Based Alarms Activated in Respective Ventilation Modes

Enabling/Disabling CO 2 Alarms

Respective Ventilation Modes

HLM Mode

(Optional)

Enabling/Disabling Spo 2Alarms

Displaying and Setting Alarm Limits

Monitoring

Selecting the Standard Screen

Monitoring Mode

Screen Layout

Displayed Parameters

Gas Measurement

Using the Volumeter Function

Econometer (Optional)

Loops (Optional)

Mini Trends (Optional)

Selecting the Data Screen

Selecting the Trend Screen

Selecting the Logbook

Spo 2 Measurement (Optional)

Using the Timer Function

Configuration

Remedying Faults

Cleaning, Disinfection and Sterilization

Disassembly