DRW Medical NAPA LP-15 User Manual
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DRW Medical NAPA LP-15 User Manual

Airway pressure monitor
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NAPA™ LP-15
A
P
M
IRWAY
RESSURE
ONITOR
User's Manual

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Summary of Contents for DRW Medical NAPA LP-15

  • Page 1 NAPA™ LP-15 IRWAY RESSURE ONITOR User’s Manual...
  • Page 2 Copyright © DRW Medical, LLC All rights reserved. DRW Medical, LLC 2710 Concord Road Aston, PA 19014 Phone: 1-800-230-6002 www.drwmedical.com...

  • Page 3: Table Of Contents

    Introduction – Functional Description ......13 Principles of Operation ..........13 Controls, Displays, and Indicators ........16 NAPA LP-15 Airway Pressure Monitor Front Panel ... 16 NAPA LP-15 Airway Pressure Monitor Side Panel ..19 NAPA LP-15 Airway Pressure Monitor Rear Panel ..19 Symbols Used on the Monitor ........
  • Page 4 Connecting the NAPA LP-15 Airway Pressure Monitor to AC Mains Power ..............23 Attaching LP-15 to Pole Mount ......... 24 Normal Operation of the NAPA LP-15 Airway Pressure Monitor (FIGURE 8) ............... 26 Connecting the NAPA LP-15 Airway Pressure Monitor to the Patient Circuit (FIGURE 9) ...........
  • Page 5 Monitor Pressure Accuracy Check (Biomedical Engineer User) (FIGURE 14) ........... 40 Maintenance ..............42 Cleaning the NAPA LP-15 Airway Pressure Monitor . 42 Troubleshooting ............44 Gain Calibration (Performed only by Manufacturer) 45 NAPA Airway Pressure Monitor DC Power Supply .. 456 Catalog Item Numbers: NAPA LP-15 Airway Pressure Monitor Parts &...
  • Page 6 NAPA LP-15 A IRWAY RESSURE ONITOR ANUAL (This page intentionally left blank) NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...

  • Page 7: General Information

    1. General Information About This Manual This user’s manual has been prepared to provide information on the correct operation of the NAPA LP-15 Airway Pressure Monitor. It contains performance specifications, installation, operation and maintenance information. This manual is intended for trained health-care professionals.

  • Page 8: Safety Information

    The NAPA LP-15 Airway Pressure Monitor is intended for use by clinicians with training using airway pressure monitoring devices. • The NAPA LP-15 Airway Pressure Monitor is not a life monitor and an attendant is needed at all times to monitor the patient. •...
  • Page 9 Safety and EMC • Do not use oil or grease on the NAPA LP-15 Airway Pressure Monitor for any reason. • Do not use the NAPA LP-15 Airway Pressure Monitor near open flames.
  • Page 10 NAPA LP-15 A IRWAY RESSURE ONITOR ANUAL • Use the NAPA LP-15 Airway Pressure Monitor only with its original power supply (Catalog Number 51002). • The use of portable and mobile radio frequency (RF) communications equipment can affect this and other pieces of medical equipment.

  • Page 11: Safety Notes

    • NOTE: Be aware there is a two-minute delay prior to alarm activation following power-up. • NOTE: The NAPA LP-15 Airway Pressure Monitor has been designed for stationary hospital use only. • NOTE: No high priority alarm conditions are provided by the monitor because the NAPA LP-15 Airway NAPA LP-15 Airway Pressure Monitor User’s Manual...

  • Page 12: Intended Use

    CAUTION: Federal law (U.S.) restricts the sale of this device to, or by the order of, a physician. Contraindications NAPA™ LP-15 Airway Pressure Monitor contraindicated when the patient’s airway pressures are above 35 cm H NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...

  • Page 13: Essential Performance

    Neonatal Continuous Positive Airway Pressure therapy (e.g. Bubble CPAP) or as an independent backup pressure monitor for devices without pressure measurement capability. The NAPA LP-15 Airway Pressure Monitor alarms when the mean NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...
  • Page 14 The NAPA LP-15 Airway Pressure Monitor also includes an alarm silence feature. NOTE: The NAPA LP-15 Airway Pressure Monitor has been designed for pole-mounted hospital use only.
  • Page 15 NAPA LP-15 A IRWAY RESSURE ONITOR ANUAL Overview of NAPA LP-15 Airway Pressure Monitor Features • Software measures, monitors, and continuously displays a two-second mean airway pressure from 0- 35.0 cm H • Measures pressures from atmosphere as 0.0. •...

  • Page 16: Controls, Displays, And Indicators

    NAPA LP-15 A IRWAY RESSURE ONITOR ANUAL 5. Controls, Displays, and Indicators NAPA LP-15 Airway Pressure Monitor Front Panel NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...
  • Page 17 NAPA LP-15 A IRWAY RESSURE ONITOR ANUAL The NAPA LP-15 Airway Pressure Monitor Front Panel (FIGURE 2) includes the following elements: SOFT KEYS: • ON/OFF POWER BUTTON • MENU-ENTER o Allows you to scroll through the three primary settings: ▪...
  • Page 18 LIGHTS/INDICATORS: • Δ HIGH PRESSURE ALARM INDICATOR: Flashes when high pressure limit is exceeded • ∇ LOW PRESSURE ALARM SIGNAL: Flashes when low pressure limit is exceeded NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...

  • Page 19: Napa Lp-15 Airway Pressure Monitor Side Panel

    NAPA LP-15 A IRWAY RESSURE ONITOR ANUAL NAPA LP-15 Airway Pressure Monitor Side Panel The NAPA LP-15 Airway Pressure Monitor Side Panel (FIGURE 3) includes the following elements: • Light for power status • DC Power Connector NAPA LP-15 Airway Pressure Monitor Rear Panel The NAPA LP-15 Airway Pressure Monitor Rear Panel includes the following elements, pictured in Section 6.2,...

  • Page 20: Symbols Used On The Monitor

    Zero Pressure Sensor Key LED Indicator: High Pressure Alarm LED Indicator: Low Pressure Alarm Symbols Used on the Monitor Label and Packaging The following symbols are used on the monitor label: NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...
  • Page 21 Refer to Instructions for Use Manufacturer Manufacturing Date MR Unsafe Attention to Proper Disposal IP Protection; IP2x denotes mechanical ingress protection (parts >12.5mm); IPx1 IP21 denotes water ingress protection (vertical drip) NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...
  • Page 22 Prescription Use Only UDI (Universal Device Identifier) (01) DI; (11) Mfgr Date; (21) Serial Number Temperature Storage Limits Humidity Storage Limits Atmospheric Pressure Storage Limits Keep Dry NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...

  • Page 23: Setup And Operation

    The NAPA LP-15 Airway Pressure Monitor comes with a power supply that accepts mains power and provides a 5V DC output. FIGURE 4 below shows how the NAPA LP-15 Airway Pressure Monitor connects to AC (wall) power. The ON/OFF button turns monitoring on and off (when the monitor is connected to AC power.

  • Page 24: Attaching Lp-15 To Pole Mount

    ONITOR ANUAL Attaching LP-15 to Pole Mount The NAPA LP-15 Airway Pressure Monitor is designed to be used on a pole mount. The NAPA LP-15 Airway Pressure Monitor comes with a pole mount bracket and pole mount clamp. See the illustrations (FIGURES 5, 6, 7) below for proper attachment of the pole mount bracket to the rear of the NAPA LP-15 Airway Pressure Monitor.
  • Page 25 NAPA LP-15 A IRWAY RESSURE ONITOR ANUAL FIGURE 6 NAPA LP-15 Airway Pressure Monitor side view Mounting Bracket Tab The pole mount bracket includes a tab as shown in FIGURE 6. Insert Tab into Clamp FIGURE 7 The tab is inserted into the pole mount as shown in FIGURE 7.

  • Page 26: Normal Operation Of The Napa Lp-15 Airway Pressure Monitor (Figure 8)

    FIGURE 8 1. Press the On/Off button to turn the NAPA LP-15 Airway Pressure Monitor on. 2. To zero the NAPA LP-15 Airway Pressure Monitor, press “Zero Pressure Sensor” with the pressure tubing open to atmosphere. 3. Refer to Section 7 to set alarm limits.

  • Page 27: Connecting The Napa Lp-15 Airway Pressure Monitor To The Patient Circuit (Figure 9)

    NAPA LP-15 A IRWAY RESSURE ONITOR ANUAL 4. The NAPA LP-15 Airway Pressure Monitor is now ready to attach to the patient circuit. NOTE: Be aware there is a two-minute delay prior to alarm activation following power-up. Connecting the NAPA LP-15 Airway Pressure...
  • Page 28 FIGURE 9 1. Attach the “Transducer Protector” end of the pressure tubing to the twist connector on the bottom of the NAPA LP-15 Airway Pressure Monitor. (The NAPA LP-15 Airway Pressure Monitor is designed for use with pressure tubing that includes a filter/transducer protector to protect the monitor from moisture.)
  • Page 29 NAPA LP-15 A IRWAY RESSURE ONITOR ANUAL Step 4. The NAPA LP-15 Airway Pressure Monitor will now display mean airway pressure. (See FIGURE 10) FIGURE 10 NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...

  • Page 30: Monitor Schematic

    RESSURE ONITOR ANUAL BCPAP System with NAPA LP-15 Airway Pressure Monitor Schematic FIGURE 11 shows the NAPA LP-15 Airway Pressure Monitor connected to the patient circuit. FIGURE 11 NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...

  • Page 31: Alarms And Alarm Limits

    ANUAL 7. Alarms and Alarm Limits NAPA LP-15 Airway Pressure Monitor Alarms Overview The NAPA LP-15 Airway Pressure Monitor provides both visual and audible alarms when the following alarm conditions occur: Low Pressure Alarm: The NAPA LP-15 Airway Pressure Monitor provides a low pressure visual and audible alarm when the monitor detects pressure below the selected “low”...

  • Page 32: Alarm Condition Types

    RESSURE ONITOR ANUAL Alarm Condition Types The NAPA LP-15 Airway Pressure Monitor provides medium priority alarms as a series of 3 beeps for the low and high pressure alarm condition with a YELLOW flashing Indicator as described above. NOTE: No high priority alarm conditions are...

  • Page 33: Alarm Limits

    NAPA LP-15 Airway Pressure Monitor front panel. This position allows the operator to take actions appropriate to the monitor’s displayed information.

  • Page 34: Adjusting Alarm Settings (Figure 12)

    3. Press the Δ and ∇ keys to adjust the value of each setting. (You can hold down the Δ and ∇ keys to quickly scroll up or down through the selectable values.) NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...

  • Page 35: Alarm Suspend

    5. Once all settings have been confirmed, press ENTER to exit ALARM SET mode and confirm all settings. 6. The NAPA LP-15 Airway Pressure Monitor will exit the ALARMS SET menu if there are no operator inputs for one (1) minute. In this case, the very last alarm set value will not be updated and will remain as previously set.

  • Page 36: Performance Check

    NAPA LP-15 A IRWAY RESSURE ONITOR ANUAL 8. Performance Check The NAPA LP-15 Airway Pressure Monitor can be checked for function and pressure accuracy as described below: • Zeroing the Pressure Sensor [8.1] should be carried out routinely by all users •...
  • Page 37 0.0 display. Always ZERO the monitor before use with the pressure sensor open to room air. NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...

  • Page 38: Functional Test (All Users) (Figure 13)

    13. This will confirm mean airway pressure and High and Low alarm settings. FIGURE 13 Before using the NAPA LP-15 Airway Pressure Monitor, follow these steps to verify that the monitor is functioning properly: 1. Connect AC power and turn the monitor on. The NAPA LP-15 Airway Pressure Monitor will require 2 minutes to enable alarms.
  • Page 39 8. Tubing used for testing can be removed and the device can be connected to the patient circuit. Unit is now ready for patient use. NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...

  • Page 40: Monitor Pressure Accuracy Check

    Engineer User) FIGURE 14 NAPA LP-15 Airway Pressure Calibrated Monitor Manometer FIGURE 14 Use syringe to pressurize the system. The NAPA LP-15 Airway Pressure Monitor display calibrated manometer should show pressures that are within ± 0.5 O or ± 2%, whichever is greater NAPA LP-15 Airway Pressure Monitor User’s Manual...
  • Page 41 • If the unit does not display “0.0” after performing either an automatic or manual restart, return the unit to the manufacturer for service. NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...

  • Page 42: Maintenance

    Cleaning the NAPA LP-15 Airway Pressure Monitor 1. After use, disconnect NAPA LP-15 Airway Pressure Monitor from the patient’s breathing circuit. 2. Clean all exposed surfaces of the NAPA LP-15 Airway Pressure Monitor by wiping with mild detergent and clean cloth...
  • Page 43 NAPA LP-15 A IRWAY RESSURE ONITOR ANUAL CAUTION: • Do not submerge the NAPA LP-15 Airway Pressure Monitor in cleaning solution. • Do not allow liquid to penetrate the monitor. • Do not use alcohol on the device. • Do not autoclave.

  • Page 44: Troubleshooting

    No sound Alarm suspend Wait two minutes generated inadvertently for alarm to resume pressed LED Display Display failure Contact missing segments manufacturer NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...

  • Page 45: Gain Calibration (Performed Only By Manufacturer)

    NOTES: • Should the unit fail to respond properly to a technical check of the pressure (see Section 8.3), a factory service calibration needs to be performed. NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...

  • Page 46: Napa Airway Pressure Monitor Dc Power Supply

    Power Supply that is used to operate the device. (FIGURE 15) The NAPA LP-15 Airway Pressure Monitor Power Supply is a high performance AC to DC external power supply designed for medical applications. It accepts mains power 120V AC and provides a 5V DC output.

  • Page 47: Monitor Parts & Accessories List

    AC-PSX** Power Supply Extension Kit, 6’ • * Included standard with every device ** Accessory does not come with the device, but recommended for use with the device. NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...

  • Page 48: Product Specifications

    Alarm Signal Volume (50 - 80 dB(A)) at 1 m, dependent on Operator-Controlled Setting (1 – 20) Packaging and Sterilization Characteristics: Packaging: Packaging and simulated ship tests conform to ISTA 2A standards NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...
  • Page 49 Liquid Ingress Protection: IP21 Protected against foreign objects and moisture Standards Compliance: The NAPA LP-15 Airway Pressure Monitor has been tested to meet the following medical safety standards: IEC 60601-1 Electrical Safety IEC 60601-1-2 Electromagnetic compatibility IEC 60601-1-11 Environmental Operating/Storage and Shock...

  • Page 50: Customer Service And Product Support

    Please call 610-996-5308 Or email products@DRWMedical.com Full service and repair is available from the manufacturer. Manufacturer DRW Medical, LLC 811 Lincoln Drive Brookhaven PA 19015 USA and Canada: 1-800-230-6002 www.drwmedical.com NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...

  • Page 51: Electromagnetic Compatibility

    IRWAY RESSURE ONITOR ANUAL 13. Electromagnetic Compatibility 13.1 EMC Overview The NAPA LP-15 Airway Pressure Monitor has been tested to comply with IEC 60601-1-2:2014 (4TH EDITION) test standards for Electromagnetic Compatibility (EMC) and Electromagnetic Interference (EMI). device needs special precautions...
  • Page 52 • Where electromagnetic devices (i.e., electrocautery) are used, patient monitoring may be interrupted due to electromagnetic interference. NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...

  • Page 53: Emc Declaration

    Electromagnetic emissions The NAPA LP-15 Airway Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or user of the NAPA LP-15 Airway Pressure Monitor should assure that it is used in such an environment. EMISSIONS...
  • Page 54 Harmonic AC Input ≤ 16 emissions Amps IEC 61000-3- Voltage AC Input ≤ 16 fluctuations/ Amps flicker emissions IEC 61000-3- NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...
  • Page 55 Compliance Guidance and manufacturer’s declaration - Electromagnetic immunity The NAPA LP-15 Airway Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or user of the monitor should assure that it is used in such an environment.
  • Page 56 IEC 61000-4- typical location in a typical commercial or hospital environment. NOTE: UT is the a.c. mains voltage prior to the application of the test level NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...
  • Page 57 Electromagnetic immunity The NAPA LP-15 Airway Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or user of the NAPA LP-15 Airway Pressure Monitor should assure that it is used in such an environment. Immunity...
  • Page 58 (m). Field strength from fixed RF transmitters, as determined by an electromagnetic site survey , should be less than the compliance level in NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...
  • Page 59 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the NAPA LP-15 Airway Pressure Monitor is used exceeds the applicable RF compliance level above, the equipment should be observed to verify normal operation.
  • Page 60 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated by using the equation applicable to the frequency of the transmitter, where P is NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...
  • Page 61 NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...
  • Page 62 NAPA LP-15 A IRWAY RESSURE ONITOR ANUAL (This page intentionally left blank.) NAPA LP-15 Airway Pressure Monitor User’s Manual P/N 13005-S, Rev. 9, 5/12/20...
  • Page 64 Copyright © DRW Medical, LLC All rights reserved. DRW Medical, LLC 2710 Concord Road Aston, PA 19014 Phone: 1-800-230-6002 www.drwmedical.com...

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