blend pak 3000 plus manual

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blend pak 3000 plus manual

Checking your browser before accessing This process is automatic. Your browser will redirect to your requested content shortly. General knowledge and understanding of the features and functions of the AS3000 Anesthesia Delivery System are prerequisites for its proper use. NOTE: Do not operate this system before reading these instructions. Information for servicing this instrument is contained in the AS3000 Anesthesia Delivery System Service Manual, part number 0070-00-0683. For additional information or assistance, please contact an authorized representative in your area. CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a physician or other practitioner licensed by state law to use or order the use of this device. NOTE: Figures in this manual are provided for reference purposes only. Screens will likely differ based on the system configuration and selected parameters. Warnings, Cautions, and Notes Please adhere to all warnings, cautions, and notes that are listed throughout this manual. A WARNING is provided to alert the user to potential serious outcomes (death, injury, or serious adverse events) to the patient or the user. A CAUTION is provided to alert the user to use special care necessary for the safe and effective use of the device. They may include actions to be taken to avoid effects on patients or users that may not be potentially life threatening or result in serious injury, but about which the user should be aware. Cautions are also provided to alert the user to the adverse effects on this device due to misuse and the care necessary to avoid such effects. A NOTE is provided when additional general information is applicable. WARNING: Possible explosion hazard. Do not operate machine near flammable anesthetic agents or other flammable substances. Do not use flammable anesthetic agents (i.e., ether or cyclopropane.

) WARNING: The use of anti-static or electrically conductive breathing tubes, when utilizing high frequency electric surgery equipment, may cause burns, and is therefore not recommended in any application of this machine. WARNING: Possible fire hazard. Fuses (i.e., additional sockets) must only be replaced by fuses of the same type and with the same rating. WARNING: Possible electric shock hazard. The machine may only be opened by authorized service personnel. WARNING: Do not use a broken unit or accessory. Periodically check all cables (e.g., AC line cord and patient connection cables) for damage that may occur through normal use. Replace cable if damaged in any way. WARNING: The patient should be visually monitored by qualified personnel. In certain situations, life-threatening circumstances may occur which may not necessarily trigger an alarm. WARNING: Always set the alarm limits so that the alarm is triggered before a hazardous situation occurs. Incorrectly set alarm limits may result in operating personnel not being aware of drastic changes in the patient’s condition. WARNING: This machine must only be operated by trained, skilled medical staff. WARNING: Connection of equipment to the auxiliary mains socket outlet(s) may increase the leakage currents to values exceeding the allowable limits. WARNING: Disconnect the power plug from the mains supply before removing the rear panels or servicing the AS3000 unit. WARNING: Malfunction of the central gas supply system may cause more than one or even all devices connected to it to stop their operation simultaneously. WARNING: The anesthesia system will cease to deliver gas at pressures below the minimum specified gas pipeline supply pressure. WARNING: Use extreme care while handling the absorbent as it is a caustic irritant. WARNING: Use care in lifting and manipulating vaporizers during the mounting process as their weight may be greater than expected, based on their size and shape.

WARNING: Use care in lifting and manipulating the breathing system block during removal from its mounting arm as handling may be awkward due to its weight and shape. WARNING: Do not use talc, zinc stearate, calcium carbonate, corn starch or similar material to prevent sticking of the bellows, as these materials may enter the patient's lungs or airway, causing irritation or injury. WARNING: All gas supplies should be of medical grade. WARNING: Single use respiratory hoses and face masks should not be reused. WARNING: To avoid endangering a patient, do not perform testing or maintenance when the machine is in use. WARNING: Review the performance specifications of the disposal system with which the transfer and receiving systems are intended to be used, to ensure compatibility. WARNING: The AS3000 should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the AS3000 should be observed to verify normal operation in the configuration in which it will be used. WARNING: Ensure that the current alarm presets are appropriate prior to use on each patient. WARNING: Ensure that both O2 and N2O flow controllers are turned OFF fully at the start and at the end of each case. WARNING: Due to the size and weight of the A3000, it should only be moved by qualified personnel. Remove all monitoring equipment mounted to the side of the AS3000 prior to transport. Do not attempt to roll the AS3000 over hoses, cords or other obstacles. WARNING: Remove all equipment from the top shelf of the AS3000 before moving. WARNING: Do not remove the absorber canister while the ventilator is running in an automatic ventilation mode. This should only be done in STANDBY mode with no patient connected. CAUTION: Before starting the machine, users must be familiar with the information contained in these Operating Instructions and must have been trained by an authorized representative.

CAUTION: If the machine does not function as described, it must be examined and repaired as necessary by qualified service personnel before being returned to use. CAUTION: Handle the machine with care to prevent damage or functional faults. CAUTION: Ensure that the gas supply of the machine always complies with the technical specifications. CAUTION: If faults occur during the initial calibration or testing, the machine should not be operated until those faults have been corrected by a qualified service person. CAUTION: After servicing, functional, sensor, and system tests must be performed before clinical use. CAUTION: After changing the CO2 pre-paks, perform a fresh-gas system leak test. CAUTION: After changing the loose fill absorbent, perform a fresh-gas system leak test. CAUTION: Only vaporizers with Interlock-System may be used with the AS3000 unit. CAUTION: After each exchange of a vaporizer, perform a fresh-gas system leak test. CAUTION: Use cleaning agent sparingly. Excess fluid could enter the machine, causing damage. CAUTION: Do not autoclave any parts of the AS3000 unless specifically identified as autoclaveable in this manual. Clean the AS3000 only as specified in this manual. CAUTION: Do not autoclave the airway pressure limiting (APL) valve. CAUTION: This Anesthesia System is NOT suitable for use in a magnetic resonance imaging (MRI) environment. CAUTION: Do not use acetic hydroperoxide or formaldehyde steaming. CAUTION: The valve disc is fragile and must, therefore, be handled with care while removing the valve cage from the valve assembly. CAUTION: The valve disc is fragile and must, therefore, be handled with care while removing it from the valve cage. CAUTION: If moisture remains in the bellows after cleaning, it may become tacky. CAUTION: Communications connectors are for Service Technician use only. Any computer connected to this equipment must comply with IEC 60950. CAUTION: Do not wash the inner surface of the oxygen sensor.

CAUTION: Do not autoclave the oxygen sensor. CAUTION: Prior to use after cleaning or disinfecting, power up the system as described in section 2.6 and follow the on-screen prompts to perform the Leak Test and the Compliance Test. CAUTION: The PAW gauge and oxygen sensor cannot withstand immersion or the heat and pressure of autoclaving. CAUTION: When installing absorber Pre-Paks assure the bottom of the Pre-Pak rests on the top of the gasket inside the absorber canister. Unknown oxygen concentrations may be delivered to the patient unless oxygen monitoring is used. CAUTION: Verify that the bellows is fully inflated before starting an automatic ventilation mode on the patient. NOTE: The AS3000 is intended to be operated with its integral Breathing Pressure limitation devices in use. NOTE: The AS3000 is intended to be operated with its integral Exhaled Volume monitoring in use. NOTE: The AS3000 is intended to be operated with its integral Breathing System integrity Alarm System in use. NOTE: The AS3000 is intended to be operated with its integral Continuing Pressure Alarm in use. NOTE: The AS3000 is intended to be operated with its integral O2 monitoring in use. NOTE: The AS3000 is intended to be operated with an external CO2 monitor complying with ISO 21647. Connection to the CO2 monitor should be via a sample line from the Patient Circuit. NOTE: Any Anesthesia Vapor Delivery Device is to be used with an Anesthetic Agent Monitor complying with ISO 21647. Connection to the Agent monitor should be via a sample line from the Patient Circuit. NOTE: The AS3000 batteries are not user serviceable components. Only an authorized service representative can replace the batteries. If the system is not used for an extended period, contact a service representative to have the batteries disconnected. The batteries may be subject to local regulations regarding disposal. At the end of the battery life, dispose of the batteries in accordance with any local regulations.

Intended Use The AS3000 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient's ventilation. The AS3000 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in both adult and pediatric populations. Unpacking Remove the machine from the shipping carton and examine it for signs of shipping damage. Save all packing materials, invoice, and bill of lading. These may be required to process a claim with the carrier. Check all materials against the packing list. Electronic PEEP is available in all ventilation modes. User control over inspiratory flow (SLOPE) is possible in PCV, SIMV, and PS modes. Automatic fresh gas compensation limits the effect on the patient of user changes in fresh gas flow rate. Nitrous oxide will not be delivered unless oxygen pressure is present. A mechanical safety system assures that at least 21% O2 is present when setting mixtures of O2 and N2O. All AS3000 units noted with Model No. 0998-00-3024-02 are designed to maintain a safe O2:N2O ratio by allowing nitrous oxide to be set to a flow rate that is proportional to a previously adjusted flow of oxygen. The N2O flow is limited by the flow of O2 so that a safe ratio of no less than 21% oxygen can be maintained. This version is designed to maintain oxygen flow at its previously set level when N2O is decreased. When the user is adjusting N2O and O2 flow rates, always adjust the oxygen flow first to enable the nitrous oxide flow. To add N2O to the fresh gas flow, the user must fully open the N2O flowmeter valve, but only after opening the O2 flowmeter valve. All AS3000 units noted with Model No. 0998-00-3024-01 maintain a safe O2:N2O ratio by adding O2 flow as the user increases the N2O flow. This will assure that the desired oxygen flow is achieved. 1.1.

3 Vaporizer Mounting The AS3000 contains a 2-position Selectatec type vaporizer mounting system. Lighting incorporated above the vaporizers enables them to be seen in a darkened environment. 1.1.4 Breathing System The AS3000 breathing system is heated to minimize condensation inside the block and to return the patient's moisture. The breathing system provides access to the APL valve and breathing bag along with a view of the mechanical breathing pressure gauge. The APL valve has a single turn knob that provides a clear view of the manual breathing pressure setting. The absorber assembly incorporates a cam lock device that opens and closes to provide access to the absorber canisters. CO2 absorbent pre-paks or loose fill can be used (see Chapter 4, Accessories). A water trap that can be drained is also provided on the absorber assembly. Two (2) flow sensors in the breathing system measure inspired and exhaled gases for control and monitoring. Spirometry is standard. Inspired oxygen concentration is monitored via a fuel-cell type sensor and breathing pressure is also monitored. The breathing system can be swiveled for ease of positioning. A test plug is provided between the two main hose connections to allow for automated leak testing during startup. Connection to the Anesthesia Gas Scavenging System (AGSS) is made from the bottom rear of the breathing system. 1.1.5 Power Management The advanced power management system of the AS3000 provides AC power for its main system functions while also charging its internal batteries. In the case of an AC power failure, the AS3000 will operate for a minimum of 45 minutes on battery power. A recessed main switch is provided to power the system ON and OFF. The four (4) auxiliary AC outlets provided on the rear of the machine operate independent of the main switch position. 1.1.6 Workplace Ergonomics The AS3000 is a full-featured anesthesia delivery work station.

The raised perimeter of its stainless steel work surface controls items that might otherwise roll or slide off its edge. The work surface light has high and low brightness settings. Its wrap-around handle enables fine positioning of the machine. Three (3) large drawers are available for storage. The top drawer is lockable with a key. Rail mounts are provided on both sides of the machine to enable positioning of system elements and mounting of patient monitors and most standard attachment arms for other devices. A non-slip footrest and brakes for the front wheels are provided. The top shelf can be used for additional equipment. Non-compliance with this information voids all guarantee claims. NOTE: This manual only describes the operation of the machine. Information about service and repair is contained in the AS3000 Service Manual. The machine must be operated by qualified and trained personnel only. All operators must fully observe these operating instructions and relevant additional documentation. The following figure is an example of the User Interface with the display during system power-up. Date and Time Alarm Message Area Patient Type Tile 4 5 3 2 Alarm Icon Area Power Source Ventilation MODE Tile 6 1 7 8 Waveform Area Parameter Area 9 User Message Area 10 Parameter Setup Tiles FIGURE 1-3 Display 1. Alarm Icon Area When any parameter enters an alarm state, an Alarm Icon Pressing the MUTE key displays an Alarm Mute Icon is displayed in this area.See sections and for table listings of the individual messages and their associated priority levels. High priority messages are red. Medium and low priority messages are yellow. Up to 2 messages can be displayed in this area. From the Time sub-menu of the System menu tab, the time can be adjusted and configured to display in 12-hour or 24-hour format. The default format is 12-hour. 4.

Power Source A Plug Icon and Battery Indicator are always present and will illuminate as follows: Plug Icon While the system is functioning on AC power, the plug icon is constantly illuminated. During battery operation, the plug icon flashes. Battery Indicator Full Battery Low Battery When batteries are installed and the system is functioning on battery power, the battery indicator provides a visual reference for the approximate charge level of the batteries. 5. Patient Type Tile NOTE: The ventilation mode must be set to STANDBY in order to change the patient type. The default patient type on powerup is Adult. During normal operation, this tile displays the current ventilation mode. It is also used to choose a different ventilation mode. The tile will flash to indicate that a new mode is pending. The parameter setup tiles associated with the selected ventilation mode will be displayed. Time and Flow vs. Time. NOTE: When in STANDBY ventilation mode, the X and Y-axes for Pressure vs. The ventilation MODE tile is flashing. Ventilator setting is not possible. The attempted parameter setting is not possible. Pressure, Volume and Apnea Alarms are OFF. Alarms have been turned off in MANUAL mode. Automatic Ventilation not available. During the initial power-up System Self Test, failures have been encountered with the PEEP valve, Inspiratory sensor or Inspiratory valve. Current ventilation mode is xxx. Indicates the current ventilation mode when the ventilation mode tile is flashing. 10. Parameter Setup Tiles The eight (8) parameter setup tiles are used to display and adjust the parameter settings. The range of settings for each parameter has a maximum and minimum value. The range of settings for both the Adult and Child patient types is Off and 3 to 30 cmH2O, in increments of 1 cmH2O. The range of settings for both the Adult and Child patient types is Off and 5 to 60%, in increments of 5%.

The range of settings for both the Adult and Child patient types is 5 to 70 cmH2O, in increments of 1 cmH2O. The default for the Adult patient type is 20 cmH2O. The default for the Child patient type is 10 cmH2O. The range of settings for both the Adult and Child patient types is 3 to 50 cmH2O, in increments of 1 cmH2O. The default for the Adult patient type is 5 cmH2O. The default for the Child patient type is 5 cmH2O. Each successive key press will toggle between manual mode and the previously selected ventilation mode. 4 3. ALARM LIMITS key Press this key to open the Alarm menu tab. If the Alarm menu tab is already open when the ALARM LIMITS key is pressed again, the Alarm menu tab 5 will close. 6 4. MUTE key Press this key to mute (silence) audio alarm tones for all currently alarming parameters for 120 seconds or until the alarm conditions are no longer present. Any 7 new alarms that occur while the alarm tone is muted will disable the mute and sound the new alarm tone. While the alarms are muted, an Alarm Mute icon with a 120 second countdown timer is presented in the upper left corner of the display. 8 FIGURE 1-4 Keypad Area 5. SPIROMETRY key This key toggles the waveform area between the Pressure vs. Time and Flow vs. Time waveforms and the two (2) loop display configurations of the Spirometry Loop Window described in section 2.11. The first key press displays the “Pressure-Volume” loop display configuration. The second key press displays the “Flow-Volume” loop display configuration. After both configurations have been cycled through the display, a third key press returns the display to the Pressure vs. The first key press after initial power-up opens the Calibrate menu tab with the Start Calibration button highlighted. From the currently displayed waveform(s), subsequent pressing of the MENU key opens the last viewed menu tab.

If a menu tab is already open when the MENU key is pressed, that menu tab will close, returning the waveform area to the currently displayed waveform(s). 7. NORMAL SCREEN key Press this key at any time to return the display to the normal operating mode. Press the center of the knob to select a highlighted item. See section 1.7. and passive valves (such as the APL valve). See section 1.8 for an in depth description. 6. Pressure Gauges Indicate the pressure at pipeline inlets and at cylinder 7. O2 Flush Button inlets for O2, Air, and N2O. Provides high flow O2 to the inspiratory limb of the breathing system. High pressure O2 outlet for connecting external devices such as a jet ventilator. 1 2 1 - 16 Use the tops of the floats when reading the flowmeter tubes. An interlock within the vaporizers provides for use of one vaporizer to deliver one agent at a time. Indicates the patient airway pressure 5. Oxygen Sensor Galvanic fuel cell 6. O2 Cell Plug Used to seal the oxygen sensor port when it is not in use. 7. Bag Arm Provides the interface to the manual ventilation bag. 1 2 1 - 18 2 The bellows dome is a transparent cover with graduation marks from 300 to 1500. These marks are for qualitative purposes only. Tidal volume (VT) should be read exclusively from the display of the user interface. The APL valve and PAW gauge numerics are for reference only. Y-Piece Seal Provides a parking position to seal the breathing circuit ypiece during the compliance test. 11. APL (Airway Pressure Limiting) Valve2 Rotary regulator for setting the pressure control during manual ventilation. Set to OPEN during Spontaneous breathing. 12. Inspiratory Limb Inhaled breathing circuit connection 13. Inspiration Valve Valve allows flow of inspiratory gas to the patient. 1 2 1.8.2 The bellows dome is a transparent cover with graduation marks from 300 to 1500. Calibrated patient airway pressure is displayed on the user interface.

Bottom View 2 1 4 3 5 FIGURE 1-9 AS3000 Breathing System, Bottom View PART(S) DESCRIPTION 1. Drive Gas Hose Provides drive gas to the bellows. 2. CO2 Absorber Canisters The two chambers hold CO2 absorbent material (either 3. Waste Gas Hose Hose that routes exhaust gases from the breathing system to loose fill or pre-paks).However, all of these settings can be changed for specific patient or departmental needs. The AS3000 offers controlled ventilation for Adult and Child patient sizes, with default ventilation parameters and alarm related settings for each. Select the patient size from the Patient Type Tile (item 5 in section 1.4.1) based on the ventilation requirements of the patient. Tube and filter systems should also be fitted to the patient. NOTE: Patient size should be set to match the actual patient before operating the system since certain operating characteristics are based on the selected patient size. The following sections outline installation, configuration, check-out, and pre-operation testing procedures. Refer to special procedures or precautions in this manual. NOTE: This is a guideline which can be modified to accommodate variations in local clinical practice. Such local modifications should have appropriate peer review. Refer to section 3.1.11 for removal instructions: a. Remove the AGSS from the AS3000. While viewing the float, turn the AGSS upside down to verify whether the float moves freely along its shaft. Replace the float as necessary. Reconnect the AGSS to the AS3000. b. Connect the vacuum hose to the vacuum port. Adjust the position of the float to be between the Min and Max lines by turning its flow adjustment knob (counterclockwise increases flow, clockwise decreases flow). c. Drain any moisture from the waste gas hose.Connect the waste gas hose to the AGSS waste gas port. 5. Check that: a. Flow-control valves are off b. Vaporizers are off c. Vaporizers are filled (not overfilled) d. Filler caps are sealed tightly e.

Two vaporizers cannot be turned on at the same time 6. Check oxygen (O2) cylinder supply: a. Disconnect pipeline supply (if connected) and return cylinder and pipeline pressure gauges to zero with O2 flush valve. b. Open O2 cylinder; check pressure. A typical full cylinder pressure is 1900 psig. Replace the cylinder if its pressure is less than 1000 psig. c. Close O2 cylinder and observe gauge for evidence of high-pressure leak. d. With the O2 flush valve, flush to empty the piping. A typical full cylinder pressure is 745 psig. Replace the cylinder if its pressure is less than 600 psig. c. Close N2O cylinder and observe gauge for evidence of high-pressure leak. 8. Check Air cylinder supply: a. Disconnect pipeline supply (if connected) and return cylinder and pipeline pressure gauges to zero with the flow control knob. b. Open Air cylinder; check pressure. Place the system in STANDBY ventilation mode. 24. Check for appropriate level of patient suction. 25. Check, connect, and calibrate other electronic monitors. 26. Turn on and set other appropriate alarms for equipment to be used. NOTE: The following step should be performed every 3 days or when prompted by the machine. 27. Perform the Oxygen Sensor Calibration as detailed in section 2.9. NOTE: The following step should be performed weekly or whenever a new vaporizer is installed or when CO2 absorbent is replaced. 28. Test for leaks in the machine and vaporizers by performing the High Pressure Leak Test as described in step 16 of this section. If the bellows is deflated and at the bottom of its travel at the start of an automatic ventilation mode, the bellows may become deformed. Inflating the Bellows On initial power-up, the bellows is automatically inflated if the Leak Test is performed. However, in between patients, if the bellows is at the bottom of its travel: 1. Install a breathing circuit and connect the Y-piece to the Test port. 2. Select CMV mode and confirm the selection. 3.

Immediately push the O2 button until the bellows is completely filled. 4. Return to STANDBY mode and remove Y-piece from Test port. A System Self Test will be automatically initiated and will be indicated on the Display. When the Leak test is complete, select Continue to proceed to the Compliance test. When the Compliance test is complete, select Continue and the system will proceed to displaying the Pressure vs. Time and Flow vs. Time waveforms in STANDBY ventilation mode. NOTE: If the Leak test result is greater than 1000 ml and the user selects MANUAL, Automatic Ventilation will be disabled. NOTE: Bypassing the Compliance test is not recommended. Hang the vaporizer on the mounting bar as shown in FIGURE 2-1. Note that the locking mechanism handle is in the unlocked position. Select the Start Calibration button. FIGURE 2-3 Calibrate Menu Tab 3. After the Start Calibration button has been selected, the screen shown in FIGURE 2-4 or FIGURE 2-6 will be displayed, instructing the user to remove the oxygen sensor (item 5, FIGURE 1-8) from the breathing system and expose it to room air for at least three minutes before proceeding. The O2 sensor voltage is displayed during the calibration. NOTE: The O2 sensor voltage is not displayed for UI versions 2.24 and lower. 4. Flush the O2 sensor with air from the auxiliary output for 5-10 seconds to ensure that no O2 bubbles are trapped in the sensor. 2 - 12 NOTE: Do not shake the O2 sensor during calibration. NOTE: Keep the O2 sensor in a vertical position, connector side up, during calibration. NOTE: Place the O2 sensor on top of the heated block during calibration to minimize the temperature difference from within the heated block. The progress bar shown in FIGURE 2-5 or FIGURE 2-7 will be displayed. If the oxygen sensor must be replaced, select the Exit button, replace the oxygen sensor, and then repeat the calibration. It is the default system startup operating mode and is used between ventilation operations. 2.10.

2 MANUAL MANUAL mode is the operating mode used for manually ventilating a patient or to let a patient breathe spontaneously. The message “Pressure, Volume and Apnea Alarms are OFF.” is displayed in the lower left corner of the main screen when operating in MANUAL Mode with the ALARM control set to OFF. Set the ALARM control to ON to remove this message and enable Pressure, Volume and Apnea alarms in MANUAL Mode. See section “Functional Alarm Messages” for a list of Alarm Messages Setting the APL Valve For Manual Ventilation Rotate the APL valve adjustment knob to the desired pressure. NOTE: Clockwise rotation increases the pressure, and counterclockwise rotation decreases the pressure. The patient can be ventilated by hand using the breathing bag. The pressure will be limited to the value set on the APL valve. For Spontaneous Breathing Rotate the APL valve adjustment knob fully counterclockwise, until the SP marking on the knob lines up with the index mark on the bottom section of the valve (see item 11 in FIGURE 1-8). The valve will then be open for spontaneous patient breathing. This is a volume mode where the user sets the desired tidal volume to be delivered to the patient’s lungs and the desired frequency. The breathing cycle is specified by the user’s selection of frequency, I:E ratio, inspiratory pause time, PEEP, and tidal volume. Compliance compensation is applied in CMV mode so that the tidal volume delivered to the patient more closely corresponds to the tidal volume setting. System compliance is determined during startup testing. To achieve the best performance, the patient hoses used during startup testing of compliance should match the hoses to be used during the procedure. Note that in certain cases, when the ventilator is operating near its performance limits, compliance compensation will not be possible.