Millennium Users Quick Reference Guide Rev 4

TABLE OF CONTENTS PERFORMANCE VERIFICATION ...3 SET-UP FOR CLINICAL APPLICATION ...14 SYSTEM ALARMS...18 TROUBLESHOOTING ...22 WARNINGS, CAUTIONS, NOTES ...24 ROUTINE MAINTENANCE ...28 CLEANING & STERILIZATION ...28 SYSTEM SPECIFICATIONS ...30 6-MONTH MAINTENANCE PROCEDURE ...33 2-YEAR MAINTENANCE PROCEDURE ...33 Please refer to the Sechrist Millennium® Infant/ Pediatric Ventilator User’s Manual for detailed instructions. If a User’s Manual is not available, contact your local distributor or Sechrist Industries, Inc. Phone: (714) 579-8400 Fax: (714) 579-0814 E-mail: [email protected]

EC

REP

AR-MED A Division of Quintiles Ltd Runnymede Malthouse Business Centre Off Hummer Road Egham Surrey TW20 9BD United Kingdom

P/N 100288 Rev. 4

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Before attempting to use the Sechrist Millennium® in a patient care setting, you must make yourself thoroughly familiar with the instructions in the User’s Manual and all product labeling.

PERFORMANCE VERIFICATION The performance verification procedure provides a means of determining whether the Sechrist Millennium® meets its performance specifications. The procedure should be performed by qualified technical personnel and should be conducted prior to each clinical application or at least once per month, whichever is soonest. The procedure can be conducted more frequently if desired. If the Sechrist Millennium® fails any facet of the verification procedure, the ventilator should be removed from use pending further evaluation and possible service. It is recommended that hospital personnel maintain records documenting completion of the performance verification procedure.

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Preliminary Setup: •

Connect the Sechrist Millennium® to an appropriate power source. (Note that both visual and audible alarms will be activated momentarily during ventilator power-up).

•

Connect the ventilator to both oxygen and medical air sources. (Check that the inlet gas pressures are set at approximately 50 psi.)

•

Connect an appropriate patient circuit to the ventilator, using a test lung, e.g. Sechrist Infant Test Lung P/N 20113.

•

Adjust the pressure relief valve to its maximum setting by turning the white adjuster fully clockwise.

•

Set the flow rate to 12 lpm.

•

Set the %O2 to 60.

Verify Power On: •

Depress the System ON/OFF button.

•

Verify that “STBY” mode is displayed.

•

Wait approximately 114 seconds (± 5 seconds) and verify that the message “W03: Standby Too Long” is displayed.

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Verify Operation Of Optional Battery Backup: •

This test assumes the BATTERY is charged. Charging occurs during all normal operation of the ventilator. If the ventilator has not been used for an extended period of time (> 3 months) the batteries should be charged before performing the test.

•

Set ventilator mode to A/C.

•

Disconnect the power adapter from its power source.

•

Observe that both the audible and visual alarms are activated, and that “A02: Internal Battery Power” is displayed in the message window. Reset the alarm by depressing the Alarm Reset button.

•

Observe that the green DC POWER ( ) indicator is not illuminated, the ) indicator is green BATTERY ( illuminated and the ventilator functions normally.

•

Continue ventilator operation using the auxiliary battery source for 15 minutes. ) indicator turns If the BATTERY ( amber and “W01: Low Batt./DC Input

P/N 100288 Rev. 4

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Voltage” warning is activated, the BATTERY was not fully charged. (NOTE: the BATTERY should be fully charged prior to conducting the performance verification). •

If the BATTERY was fully charged (about 6 hours), but the BATTERY indicator turns amber and “W01: Low Batt./DC Input Voltage” warning is activated, it indicates that the BATTERY could not hold the charge and should be replaced. (Refer to Sechrist authorized service for BATTERY replacement).

•

If the ventilator operates normally during the test period, reconnect the power adapter to its power source.

Verify All Displays and Alarms: •

Depress and hold the TEST button.

•

While the TEST button is depressed, verify that all displays, alarms (audible and visual), power indicators, and alarm silence indicator are activated.

•

Adjust the High Press alarm to 80 cmH2O (0.8 kPa).

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•

Tee a reference manometer into the proximal pressure sensing line near TM the SmartSync sensor.

•

Set the mode to A/C.

Verify Bargraph and Digital Displays of Pressure: •

Using various inspiratory and expiratory pressure settings, verify that the ventilator displays of pressure are accurate; ± 3 cmH2O (± 0.3 kPa).

Verify Maximum and Minimum Inspiratory Pressures: • • • •

Turn the Inspiratory Pressure control knob fully clockwise. Verify that the maximum inspiratory pressure is 70 cmH2O ± 2 cmH2O (7 kPa ± 0.2 kPa). Turn the Inspiratory Pressure control knob fully counterclockwise. Verify that the minimum inspiratory pressure is 5 cmH2O ± 2 cmH2O (0.5 kPa ± 0.2 kPa).

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Verify Maximum and Minimum Expiratory Pressures: •

Turn the Expiratory Pressure control knob fully clockwise.

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Verify that the maximum expiratory pressure is 20 cmH2O ± 1 cmH2O (2 kPa ± 0.1 kPa).

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Turn the Expiratory Pressure control knob fully counterclockwise.

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Verify that the minimum expiratory pressure is 0 cmH2O ± 1 cmH2O (0 kPa ± 0.1 kPa).

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Set an inspiratory time (Ti) of 0.40 seconds.

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Set a respiratory rate (f) of 20 BPM. Verify that the dump valve opens.

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Turn the Expiratory Pressure and Waveform controls fully counterclockwise. If necessary, reset alarms. Turn the Inspiratory Pressure to obtain a Peak pressure of 35 cmH2O (3.5 kPa). Set the Press alarm limit to 30 cmH2O (3 kPa).

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Verify that the audible and visual alarms are activated. Verify that “A03: High Insp Pres” is displayed.

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•

Verify that the displayed peak pressure is within the range of 30 ~ 35 cmH2O (3 ~ 3.5 kPa).

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Set the High Press alarm limit to 80 cmH2O (8 kPa).

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Verify that the audible alarm ceases.

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Clear the alarm message by depressing the Alarm Reset button.

Verify PEEP: •

Set the inspiratory pressure to 30 cm H2O (3 kPa).

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Place the ventilator in the A/C mode with a Ti of 0.50 and a rate of 40.

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Set the expiratory pressure to each of the following settings allowing the ventilator to cycle for at least one minute at each expiratory pressure setting.

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5 cmH2O (± 1 cmH2O); 0.5 kPa (± 0.1 kPa)

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10 cmH2O (± 1 cmH2O); 1 kPa (± 0.1 kPa)

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15 cmH2O (± 1 cmH2O); 1.5 kPa (± 0.1 kPa)

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•

Verify that there are no significant changes in inspiratory pressure with changes in expiratory pressure.

Verify Mixer Alarm/Bypass: •

Disconnect the oxygen source from the gas inlet.

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The audible alarm should sound and “A01: Low /Loss of Inlet Gas” should be noted in the message window.

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A bypass situation should be noted by continued gas flow from the ventilator.

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Reconnect the oxygen source and the alarm condition should cease.

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Clear the alarm message by depressing the Alarm Reset button.

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Disconnect the medical air source.

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The audible alarm should sound and the message window should read “A01: Low /Loss of Inlet Gas”.

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A bypass situation should be noted by continued gas flow from the ventilator.

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Reconnect the medical air source.

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Clear the alarm message by depressing the Alarm Reset button.

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Verify Mixer Calibrations: •

Select a flow setting of 7 lpm.

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Using a calibrated (± 1%) oxygen analyzer, verify that the oxygen concentration of the mixer output flow within ± 3% of the selected value throughout the control range.

•

Verify the delivered %O2 at settings of 30, 60, 90 and 100. NOTE: The mixer has a specified accuracy of ± 3%. If the analyzer has a specific accuracy of ± 1%, then the mixer setting and the analyzer reading should agree within ± 4% points.

Verify Trigger Function: •

Set the sensitivity to 8 reference bars.

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Using a test lung, simulate patient effort and verify that “TRIG” is displayed in the upper left corner of the display screen.

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Disconnect the test lung and verify that the “A04: Low Insp Pres” alarm is activated.

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•

Reconnect the test lung and verify that the audible alarm ceases.

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Clear the alarm message by depressing the Alarm Reset button.

Verify Senseline Disconnect: •

Set the Mode to A/C and the sensitivity to 5 reference bars. Set the inspiratory pressure to 5 cm H2O and the expiratory pressure to 0.0 cm H2O

•

Disconnect the proximal sense line form the exhalation block.

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Verify that alarm A05 “Check Sense Lines” is activated.

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Also verify that alarms A07 “Apnea” and A04 “Low Inspiratory Pressure are activated following the set alarm delay time.

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Reconnect the proximal sense line and press the Alarm Rest button to clear the alarms.

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Disconnect the Reference Sense line from the exhalation block.

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Verify that alarm A05 “Check Sense Lines” is activated.

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•

Reconnect the reference sense line and press the Alarm Rest button to clear the alarms.

Adjust the Pressure Relief Valve: •

Turn the Inspiratory Pressure control fully clockwise.

•

Rotate the relief valve adjuster until the displayed inspiratory pressure reads 25 ± 2 cmH2O (2.5 ± 0.2 kPa).

If the Sechrist Millennium® meets all of the criteria of the preceding performance verification procedure, it can then be considered suitable for use. If the unit does not meet the criteria of this procedure, service is required. WARNING Failure to successfully complete any component of the performance verification may indicate a ventilator in need of repair or servicing. This ventilator should be removed from clinical use until a complete evaluation and/or repair can be made.

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SET-UP FOR CLINICAL APPLICATION (See the User’s Manual) After successfully completing performance verification, the Sechrist Millennium® may be set up for use. •

Connect the ventilator to appropriate medical oxygen and air sources.

•

Connect the ventilator to an appropriate hospital grade electrical outlet.

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Connect an appropriate patient circuit to the ventilator.

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Connect the inspiratory limb of the circuit to the identified 15-mm “To Patient“ connection of the ventilator.

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Connect the circuit to the desired humidification system.

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Connect the expiratory limb of the patient circuit to the 15-mm connection on the exhalation valve.

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Connect the SmartSync™ sensor to the patient wye, proximal to the patient.

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•

Connect the sensing line from the patient wye to the lower (reference pressure) connecting port on the exhalation valve/block.

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Connect the proximal pressure line from the SmartSync™ sensor to the upper (proximal pressure) connecting port of the exhalation valve/block.

TM

Proximal Pressure (SmartSync ) pressure line connection

wye Reference Pressure (wye) pressure line connection

TM

SmartSync

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Depress the System On/Off button.

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The Millennium® will default to the STBY mode where Ti, f, PIP, PEEP, Sensitivity and alarms can be adjusted

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prior to implementing a specific mode of ventilation. •

Set the flowmeter to the desired continuous flow setting.

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Set the gas mixer to the desired %O2.

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Occlude the patient circuit at the SmartSync™ sensor and set the Inspiratory Pressure to the desired PIP.

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In the same fashion, set the desired expiratory pressure.

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Using the Waveform control, select the desired gas flow waveform.

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Set the Ti to the desired setting, between 0.1 to 3.0 seconds.

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Set the respiratory rate to the desired setting between 2 to 150 breaths per minute.

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Set the alarm delay to the desired delay time between 3 and 15 seconds. Set the high pressure, low pressure, low Peep and high respiratory rate alarms to the desired settings.

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•

Set the pressure relief valve to an acceptable value above the high pressure limit alarm.

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Set the trigger sensitivity to the desired level from OFF to most sensitive.

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Set the mode selector to the desired mode to implement ventilation.

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To turn the ventilator off, the System ON/OFF button must be held for 2 seconds. After the 2-second depression of the System ON/OFF button, the unit will be turned off; both audible and visual alarms will be activated and will continue until the user depresses the Alarm Reset button.

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SYSTEM ALARMS (See the User’s Manual) The Alarm Select button can be used to view and adjust the following alarm limits sequentially, including “blanking” the Alarm Limit display: • • • • •

High inspiratory pressure alarm limit Low/prolonged inspiratory pressure Low PEEP/baseline pressure alarm High respiratory rate alarm Blank alarm display

Alarm Activation and Correction: When an alarm status flashes in the Message Window, the main audible and visual alarms are activated. When an alarm violation no longer exists, the alarm status in the Message Window and the main visual alarm remains activated, but the main audible alarm will reset automatically. Depress the Alarm Reset button to clear visual alarm indicators.

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SYSTEM ERROR MESSAGE TABLE Code

MESSAGE

Corrective Action

E01

CM Watchdog Fail

Discontinue usage; refer unit for evaluation & service

E02

IM Watchdog Fail

“ Ditto “

E03

CM EEPROM Fail

“

“

E04

IM EEPROM Fail

“

“

E05

Dump Driver Fail

“

“

E06

Exh Driver Fail

“

“

E07

IM Inter Comm Fail

“

“

E08

CM Inter Comm Fail

“

“

E09

IM ADC Error

“

“

E10

CM ADC Error

“

“

E11

IM EPROM Fail

“

“

E12

CM EPROM Fail

“

“

E13

Prolonged Insp Time

“

“

P/N 100288 Rev. 4

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ALARM MESSAGE TABLE Code

MESSAGE

Corrective Action

A01

Low/Loss of Inlet Gas

Check gas inlet press.

A02

Internal Battery Power

Press Alarm Reset button to clear

A03

High Insp Pres

Check high pressure alarm setting

A04

Low Insp Pres

Check low pressure alarm setting

A05

Check Sense Lines

Verify sense lines disconnect; patient circuit/ SmartSyncTM occlusion.

A06

Prolonged Insp Pres

Check Low Pressure alarm setting

A07

Apnea

Check sensitivity setting

A08

Low PEEP / Baseline Pressure

Check Low PEEP alarm setting

A09

High Resp Rate

Check high rate alarm setting

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WARNING (ALERT) MESSAGE TABLE Code

MESSAGE

Corrective Action

W01

Low Batt / DC Input Voltage (Alert)

Check power supply connection; make sure battery is charged3

W02

Low 5V DC (Alert)

Check power supply

W03

Standby Too Long (Alert)

Exit the standby mode

Activation of Simultaneous Alarms: Alarm status in the Message Window will be “queued or stacked” with the highest priority alarm being displayed. When the displayed alarm is cleared, the next highest priority alarm message is displayed. For a listing of alarm prioritization, see User’s Manual.

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TROUBLESHOOTING (See the User’s Manual) PROBLEM

POSSIBLE CAUSE

Seemingly improper Prolonged Insp. Press Alarm

Low Inspiratory Pressure alarm setting

Blank Display

Contrast and/or brightness settings.

Inability to trigger/ “synch”

Sensitivity setting too low Pressure sensing lines misplaced

Inaccurate flow settings

Internal tapered bore and float contamination.

P/N 100288 Rev. 4

CORRECTIVE ACTION Set Low Inspiratory Pressure alarm above expiratory pressure level. Adjust brightness and/or contrast controls on the rear of the unit. Increase sensitivity Make certain that the SmartSync line is connected to the Proximal Pressure port of the exhalation block. Clean flow tube and float.

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PROBLEM

Inaccurate %O2

POSSIBLE CAUSE

Dirt or moisture contamination.

Inaccurate pressure readings

Calibration necessary

Inability to generate sufficient expiratory pressure

Patient circuit leaks Exhalation valve leakage Contamination of inlet filters Inappropriate setting of pressure relief valve.

P/N 100288 Rev. 4

CORRECTIVE ACTION Return mixer to authorized Sechrist service representative for cleaning and recalibration Refer unit to a Sechrist authorized service representative. Check for leaks in the patient circuit and exhalation valve. Replace inlet filters. Verify safety relief valve setting.

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WARNINGS, CAUTIONS, NOTES (See the User’s Manual) Patient Care Warnings: • •

• •

•

Constant attendance by qualified personnel is required whenever this device is in clinical use. The use of this life support system, which incorporates built-in alarm systems, does not provide absolute assurance of warning for every type of malfunction or concern that may occur. The SmartSync™ sensor is a singlepatient use item and therefore should not be re-used or sterilized. Always monitor oxygen concentrations with an accurate oxygen analyzer equipped with a high and a low alarm to assure that the desired oxygen concentration is being delivered to the patient. Oxygen concentrations must be analyzed at or near the patient airway. An independent device for manual ventilation must always be available when the Sechrist Millennium® is in clinical use.

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Equipment Utilization Warnings: •

•

• • •

• •

Do not attempt to operate this ventilator before thoroughly reading and understanding the descriptions and instructions contained within the User’s Manual. The product should only be maintained and serviced by Sechrist factorytrained personnel or by written instructions directly from Sechrist Industries. This product must not be modified in any fashion without written authorization from Sechrist Industries. A defective or malfunctioning ventilator must never be placed into clinical service. The user of this product shall have sole responsibility for any malfunction, which results from improper usage, faulty maintenance, improper and/or unauthorized repairs, damage or alteration performed by anyone other than Sechrist Industries. Only parts provided or approved by Sechrist Industries are to be used as replacements. If the Sechrist Millennium® fails to perform as described, remove the unit

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•

•

•

•

•

from service and refer it to a Sechrist authorized service technician. The unit should not be utilized until proper performance has been verified. The internal air-oxygen mixer is designed for use with medical air and oxygen only. Do not modify these inlets for use with other breathing or anesthetic gases. Never use the Sechrist Millennium® ventilator without the safety pressure relief valve installed and appropriately adjusted. Verify that the exposed valve stem operates freely and is not obstructed in any manner. Do not tape or occlude the vent holes in the valve body or the valve will become inoperative. Oxygen vigorously accelerates combustion; do not use any instruments or equipment that may have been exposed to oil or grease contamination. Do not occlude or obstruct the orifices on the bottom of the exhalation block assembly. Obstruction of these ports will result in ventilator malfunction. Liquid water in the compressed air supply can cause malfunction of this equipment.

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• •

Do not attempt to use a power supply other than the configuration provided with this ventilator. The Sechrist Millennium® will not be fully operational without the use of the SmartSync™ Patient Sensing Device.

Caution: •

•

Routine maintenance procedures contained within the User’s Manual may involve opening the ventilator enclosure, which constitutes an electrical shock hazard. Qualified service personnel must perform these procedures. Compressed air must be clean and dry in order to prevent mixer malfunction, damage to the pneumatic components and/or unit malfunction. Whenever using compressed air, an air inlet water trap must be used.

NOTE: The flow meter is not back-pressure compensated.

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ROUTINE MAINTENANCE (See the User’s Manual) The Sechrist Millennium® and its associated patient circuits, patient sensing device, and exhalation block are shipped clean, not sterile. SmartSync™ Patient Sensing Device: SmartSync™, (reorder number 20417) is a single-patient use device. It is packaged clean and should not be sterilized or reused. Exhalation Block Diaphragm: P/N IV305-05 is a single-patient use component and should be disposed of following each patient use.

CLEANING & STERILIZATION (see User’s Manual for details) Exhalation Blocks: P/N 21564 is reusable and can be cleaned and sterilized per hospital standard procedure using a germicidal detergent such as Legphene, and sterilants: CidexPlus™, EtO or steam autoclave. P/N 100288 Rev. 4

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Legphene For Legphene, use 1oz. per 1 gallon water dilution. Disassemble and immerse the entire block and its component parts. Clean with a soft bottlebrush. Rinse thoroughly in clean water and shake off excess water. CidexPlus™ Follow the instructions on the package. Use CidexPlus™ undiluted. After cleaning, immerse the entire block and its component parts into the CidexPlus™ for at least 20 minutes at 25°C ± 5° C (77°F ± 10°F). Rinse thoroughly in water. EtO Disassemble the Exhalation Block before sending it, per standard hospital procedures, through the EtO process. Pre-Vacuum Steam Sterilization Disassemble the Exhalation Block before wrapping and sending it through a prevacuum steam sterilization cycle at 132.7°C for 6 minutes.

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SYSTEM SPECIFICATIONS (See the User’s Manual) Recommended Applications: Neonatal, infant & pediatric patients <50 Kg Flow: 2-32 lpm; flush 40 lpm %O2: 21 to 100 Modes of Operation: A/C, SIMV/IMV, CPAP with backup ventilation, and Standby Inspiratory Time: 0.1 to 3.0 seconds I:E Ratio: Normal Range: 1:1.0 to 1:10 (sensitivity off) 1:1.0 to 1:99 (sensitivity set) Inverse Range: 1.0:1 to 4.0:1 Rate: 2 to 150 breaths per minute Expiratory Pressure: 0 to 20 cmH2O Inspiratory Pressure: 5 to 70 cmH2O

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Manual Breath: electronic x 1 Waveform: Adjustable from square to tapered Alarm Delay: 3 to 15 seconds Alarm Mute: 114 seconds (± 5 seconds) Safety Pressure Relief Valve: 15 to 85 cmH2O (± 5 cmH2O) Indicators: D.C. Power Battery Power Alarm Mute Set Respiratory Rate Set Inspiratory Time Mode Message Display Peak Inspiratory Pressure PEEP/Baseline Pressure Calculated I:E Ratio Mean Airway Pressure Proximal Airway Pressure Bar Graph Peak Pressure Pointer Measured Respiratory Rate Dimensions: 13.5H x 11W x 9.5D (in) 34.29Hx 27.94W x 24.13D (cm) P/N 100288 Rev. 4

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Weight: 21 lbs (9.5Kg) Gas Consumption: 14 lpm above the continuous flow setting AC Power Requirements: Voltage: 100 - 250 VAC Frequency: 50 - 60 Hz Current: 0.85 Amps. DC Power Protection: 1 amp time delay fuse Battery Backup (optional P/N 21561): 2 hours of power (minimum) TM SmartSync Pressure Sensor Maximum sensitivity: -0.10 cmH2O Deadspace: 1.5cc Weight: 5 grams Data Transmission: Fiber-optic link Environmental Conditions: Normal Operation: + 50° F to + 100° F, 0 to 90% RH, Non-condensing, at 8,000ft. maximum. Storage and Transportation: + 40° F to + 120° F, 0 to 90% RH, Non-condensing, at 40,000 ft. maximum.

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6-MONTH MAINTENANCE PROCEDURE (See the User’s Manual) WARNING To be performed by competent individuals having experience in the maintenance and/or repair of devices of this nature. Parts designated in this manual should only be replaced with parts manufactured or sold by Sechrist Industries. The 6-month maintenance procedure involves the replacement of various filters and o-rings. Please see the User’s Manual for detailed instructions.

2-YEAR MAINTENANCE PROCEDURE (See the Service Manual) Every 2-years, the Millennium® ventilator should be overhauled only at Sechrist Industries manufacturing facility or by personnel trained and authorized by Sechrist Industries.

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