Operation Manual
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Operation Manual (800 ppm INOMAX® (nitric oxide) for inhalation) Series 3 software
PartNo. No.20003 20530 Rev Rev-03 Part - 01 2014-07
User Responsibility This Product will perform in conformity with the description contained in this operating manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This Product must be checked prior to use following the Pre-Use Checkout procedure described in section two. A defective Product should not be used. Parts that are broken, missing, visibly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, the manufacturer recommends that a telephone request for service advice be made to the local distributor. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by the manufacturer or local distributor. The Product must not be altered.
The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than INO Therapeutics, LLC. Caution: U.S. Federal and Canadian law restrict this device to sale by or on the order of a licensed medical practitioner. Outside the U.S.A. and Canada, check local laws for any restrictions that may apply. Inhaled Nitric Oxide mixtures must be handled and stored in compliance with federal, state and local regulations. INO Therapeutics, LLC products have unit serial numbers with coded logic which indicate the year of manufacture and a sequential unit number for identification.
Important: Before using the INOmax DSIR, read through this manual. Read through the manuals for the ventilator, humidifier and any other accessory items used. Follow the manual instructions and obey the Warnings and Cautions. Keep this manual readily available to answer questions.
SN 20051234
The first four numeric digits indicate the year of product manufacture, and the next four digits are the sequential unit number produced.
Ref 10007
INOmax DSIR part number
Open Source Software A CD-ROM is available upon request containing the full source code to the open source software used within this product. Portions of this software are copyright © 1996-2002 The FreeType Project (www.freetype.org). All rights reserved. Korean fonts Baekmuk Batang, Baekmuk Dotum, Baekmuk Gulim, and Baekmuk Headline are registered trademarks owned by Kim Jeong-Hwan. ©2014 Ikaria, Inc. INOMAX®, INOmax DSIR®, INOmax® DS, INOmeter®, INOblender®, INOcal®, INOmax Total Care® and INOvent® are registered trademarks of INO Therapeutics, LLC and their respective owners. INO Therapeutics LLC is a wholly-owned subsidiary of Ikaria, Inc.. No license is conveyed, either expressed or implied, with the purchase or usage hereof under any patent or patent application covering this product, including but not limited to U.S. Patent 5,485,827, 5,873,359, 5,558,083 and any respective foreign equivalents thereof.
Part No. 20530 Rev-03 2014-07
Contents 1/ General Information... 1-1 Indications for Use... 1-1 Introduction to this Manual... 1-2 INOmeter Operation... 1-18 Theory of Operation... 1-22 Environmental Effects... 1-26 2/ Automated Pre-Use Checkout... 2-1 Initial connections... 2-2 High Pressure Leak Test and Automated Purge... 2-5 Integrated Pneumatic Backup INOMAX Delivery Test... 2-7 Performance Test... 2-8 INOblender Test... 2-9 Depressurizing the Regulator Supply Line... 2-10 3/ Patient Application... 3-1 INOblender Operation... 3-4 INOblender Used as a Stand-Alone Device... 3-5 INOblender use with the NeoPuff... 3-6 Integrated Pneumatic Backup NO Delivery... 3-7 Changing INOMAX Cylinders and Purging the Regulator Assembly... 3-10 Oxygen Dilution Chart... 3-13 Duration Chart INOMAX Cylinder 88-Size... 3-14 Duration Chart INOMAX Cylinder D-Size... 3-15 Monitoring the Environment... 3-19 Entering Patient Information... 3-20 Connection to Various Breathing Systems... 3-24 Acutronics Medical Systems AG Fabian +nCPAP Evolution... 3-25 Acutronics Medical Systems AG Fabian HFO... 3-26 A-Plus Medical Babi-Plus Bubble CPAP Circuit... 3-27 Bagging Systems While Using the Injector Module... 3-28 Bunnell Life Pulse High Frequency Ventilator Circuit... 3-32 Connecting INOmax DSIR Sample Tee to the Bunnell Life Pulse Circuit... 3-33 Connecting INOmax DSIR Injector Module to the Bunnell Life Pulse Circuit... 3-33 Circle Anesthesia System... 3-34 Dräger Babylog VN500/Infinity Acute Care System and Heinen & Löwenstein Leoni-plus Ventilator... 3-36 Fisher & Paykel Healthcare Bubble CPAP... 3-37 Fisher & Paykel Healthcare Infant Circuit Nasal Cannula... 3-38 Fisher & Paykel Healthcare Optiflow Breathing Circuit... 3-39 Hamilton Arabella Nasal CPAP... 3-40 ICU Ventilator Circuit... 3-41 Sensormedics 3100A/B High Frequency Oscillatory Ventilator with a Filtered Circuit... 3-42 Sensormedics 3100A/B High Frequency Oscillatory Ventilator with a Rigid or Flexible Circuit.. 3-43 SLE Life Support SLE5000... 3-44 Spontaneous Breathing Patient on a Mask Circuit ... 3-45 Spontaneous Breathing Patient on a Nasal Cannula... 3-46 Teleflex Medical Comfort Flo Humidification System... 3-47 Vapotherm 2000i... 3-48 Vapotherm Precision Flow... 3-49 Viasys Infant Flow CPAP System; Cardinal Airlife nCPAP System... 3-50 Viasys Infant Flow SiPAP... 3-52
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4/ Transport... 4-1 Transport Options ... 4-1 A. Intrahospital transport (within the hospital) when moving the INOmax DSIR as a unit (cart and cylinders) ... 4-1 B. Intrahospital transport (within the hospital) when removing the INOmax DSIR and INOblender from the cart... 4-2 C. When using the INOblender as a stand-alone device... 4-6 INOblender Test Using the INOmax DSIR to Analyze Output... 4-8 INOblender Stand-Alone Pre-use Checkout... 4-10 D. InterHospital Transport (Between Hospitals) when using a separate INOmax DSIR and INOblender for transport...4-11 Duration Chart... 4-12 INOMAX Cylinder D-Size... 4-12 Transport Regulator/Cap Assembly Application... 4-13 Connection to a Dual-Limb Transport Ventilator Circuit... 4-16 Connection to a Single-Limb Transport Ventilator Circuit... 4-17 Cylinder Leak Check... 4-19 5/ Alarms... 5-1 Alarm History... 5-3 Alarm Help... 5-5 6/ Calibration... 6-1 Low Calibration... 6-2 Oxygen Sensor High Calibration... 6-4 NO Sensor High Calibration... 6-7 NO2 Sensor High Calibration...6-11 7/ Maintenance... 7-1 Cleaning the INOmax DSIR ... 7-2 Replacing the O2, NO and NO2 Sensors... 7-6 Replacing the Water Separator Cartridge... 7-8 Cylinder Leak Check... 7-10 Preventative Maintenance...7-11 Parts and Accessories... 7-12 8/ Product Specifications... 8-1 Ventilator Compatibility... 8-1 RS232 Data Output... 8-7 Electromagnetic Compatibility Information... 8-9 9/ Appendix... 9-1 Manual Pre-Use Checkout... 9-1 Initial connections... 9-2 High Pressure Leak Test... 9-5 Manual Purge and Alarm Verification... 9-6 Integrated Pneumatic Backup INOMAX Delivery Test... 9-7 Performance Test... 9-7 INOblender Test... 9-8
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Part No. 20530 Rev-03 2014-07
WARNING: Caution:
Warnings tell the user about dangerous conditions that can cause injury to the operator or the patient if you do not obey all of the instructions in this manual.
Cautions tell the user about how to properly use the equipment and conditions that could cause damage to the equipment. Read and obey all warnings and cautions.
Note:
Notes provide clarification or supplemental information.
Blue arrow denotes required user action.
WARNING: Integrated Pneumatic Backup
• The integrated pneumatic backup is intended for short term use when the electronic delivery system fails until a replacement NO delivery device can be brought to the bedside. • The integrated pneumatic backup delivers a variable concentration of NO to the patient depending on the ventilator flow being used. • When using the integrated pneumatic backup with breathing circuit gas flows of 5 L/min, the delivered NO dose will be approximately 40 ppm. Breathing circuit gas flows less than 5 L/min will deliver an NO dose greater than 40 ppm. • The integrated pneumatic backup (250 mL/min.) should not be used with the Bunnell Life Pulse as ventilator flow rates are normally below the recommended ventilator flows.
Changing Cylinders • Always secure a cylinder when not using it. • Never lift a cylinder by its valve or valve protection cap or by using a chain, sling or magnet. • Never drop a cylinder. • Never use a hammer, pry or wedge to loosen a valve or protection cap. The valve and protection cap should operate by hand. • Never let oil, grease or other combustible come in contact with a cylinder or valve. • Never remove or deface cylinder labeling or markings. • Never modify equipment without first contacting the manufacturer. • Never use an adaptor to connect a cylinder to the system. • Never use equipment not designed to use INOMAX mixtures. • Never attempt to repair a leak on a cylinder valve or its safety relief device. • Never operate equipment that is leaking. • Never ship a leaking cylinder. • Never store cylinders; - Where damage can result from the elements, such as standing water or temperatures over 125 degrees F. - Where they can experience extreme low temperatures. - Where they can contact corrosive substances. - Where they can be cut or abraded by an object. - Next to a walkway, elevator or platform edge. - Unless they are properly secured. Part No. 20530 Rev-03 2014-07
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WARNING:
High Frequency Oscillatory and Jet Ventilator Circuits • Some high frequency ventilator circuits require a one-way valve to prevent high NO delivery. • Place the Bunnell Life Pulse in Standby prior to suctioning the patient to avoid NO delivery transiently exceeding the set dose by up to 30 ppm. Press ENTER to reestablish ventilation as soon as the catheter is removed from the airway. This will limit the extent of over delivery above the NO set dose. • Do not use dose settings above 40 ppm with the Acutronics Fabian HFO ventilator. Bidirectional flow through the Injector Module may cause over-delivery which can lead to measured NO values greater than 100 ppm
Maintenance • For continued protection against hazard, replace the fuses only with the correct fuse type and rating. • Handle and dispose of sensors according to facility biohazard policies. Do not incinerate. • If the Injector Module has been used in the wet/humidified part of the breathing circuit, it should be sterilized between each patient use. • INOmax DSIR should only be connected to RS-232 ports that have: - 4 kV input to output isolation - 4 kV input to mains isolation, and - an internal “reference voltage” “U” (as defined in section 20.3 of IEC606011 ed. 2) of less than or equal to 50 VDC or 50 VRMS and dielectric isolation certified in accordance with IEC 60601-1. Interface cabling must not go outside of the room (e.g., into walls where potential isolation issues could exist). Adherence to the above provides compliance to clause 20.3 “Value of test Voltage” in edition 2 and clause(s) 8.5.4 “Working Voltage” and Clause 8.8.3 “Dielectric Strength" in edition 3. • RS232 cable must be shielded. The RS232 cable shield shall have a minimum of 90% coverage. The shield shall only be connected at one end of the cable to minimize noise induced by ground currents.
Manually Bagging a Patient with an Injector Module • The hyperinflation bag will, under some conditions, contain NO2 in excess of one ppm. Use of large tidal volume breaths may expose the patients to the NO2 present in the bag for part of the breath. In general, if the inspiratory flow rate induced by the manual ventilation does not exceed the fresh gas flow rate, the patient should not be exposed to the concentrations of NO2 present in the hyperinflation bag. • Adult and infant hyperinflation bags generate more NO2 when used at lower minute ventilation. If use of the bag is interrupted (for example to adjust the tracheal tube), before resuming ventilation of the patient, the user should squeeze the bag several times to empty residual gas from the bag. • Because of the potential for inhalation of excessive concentrations of NO2, and the difficulty in monitoring the peak inhaled NO2 concentrations, ventilation with a hyperinflation bag or self-inflating bag is intended only for short term use. • The monitoring system within the INOmax DSIR will not detect generation of NO2 within the hyperinflation bag or self-inflating bag devices and the alarms for excessive NO2 cannot warn of NO2 produced within the manual bag system.
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WARNING:
Manually Bagging a Patient with an Injector Module continued • To minimize the delivered concentration of NO2, the following steps should be taken for use with the manual resuscitator bags: - Concentrations greater than 20 ppm NO should not be used because of excessive NO2 generation. - Use the smallest bag adequate to deliver the desired tidal volume. - Oxygen tubing lengths greater than 72 inches should not be used (between the injector module and the bag). - Use the highest fresh gas flow rate (up to 15 L/min) that is practical. - Use the lowest practical inspired oxygen concentration. - After starting fresh gas flow, squeeze the bag several times to empty residual gas in the bag prior to using the system to ventilate a patient.
Manually Bagging a Patient with the INOblender
• The purge procedure must be followed to help ensure NO2 is purged from the system before the manual resuscitator bag is connected to the patient. • The manual bag should be squeezed repeatedly during use to avoid NO2 building up in the bag. • If the bag is not squeezed repeatedly while delivering INOMAX, the bag should be removed from the patient and the bag purge procedure performed before continuing. • The INOblender should be upright when setting the oxygen flowrate for accurate setting. • Do not use pneumatically powered nebulizers with the INOblender. This will result in significant over delivery of INOMAX in excess of 80 parts per million (ppm). - The INOblender outlet pressure has been validated for use up to 400 millibar (5.8 psig) pressure. The amount of back-pressure generated by pneumatic nebulizers is significantly greater (20-30 psig) and will result in over delivery of INOMAX in excess of 80 ppm. The user adjusted dose setting on the INOblender will not correlate with, or have an effect on the actual delivered dose. - In addition, the INOblender flowmeter is not back-pressure compensated and will display a lower flow rate than actual when pressure is applied to the outlet.
Purging Cylinders • A new INOMAX cylinder and regulator must be purged before use to ensure the patient does not receive an excess level of NO2. • If the INOmax DSIR is not going to be used on a patient within 10 minutes, depressurize the regulator supply line. • If the INOmax DSIR is not used and is pressurized for more than 10 minutes, repeat purge procedure. • If the INOmax DSIR is depressurized and not used within 12 hours, repeat pre-use procedure.
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WARNING: Use Outside of Product Labeling
• The INOmax DSIR must only be used in accordance with the indications, usage, contraindications, warnings and precautions described in the INOMAX (nitric oxide) drug package inserts and labeling. Refer to this material prior to use. • The manufacturer does not recommend that the INOmax DSIR be utilized with helium/oxygen mixtures in any situation. The INOmax DSIR is intended to deliver INOMAX therapy gas only in conjunction with the delivery of air and oxygen. The use of helium/oxygen mixtures will lead to over-delivery of INOMAX which may lead to interruption of therapy. • The use of devices which radiate high-intensity electrical fields may affect the operation of the INOmax DSIR. Constant surveillance of all monitoring and life support equipment is mandatory whenever interfering devices are in operation on or near a patient. • Do not connect items which are not specified as part of the system. • The approved patient population for the INOmax DSIR, as specified in the drug labeling for INOMAX (nitric oxide) for inhalation, is limited to neonates. The INOmax DSIR is not intended to be used in other patient populations.
Transport • If the INOmax DSIR or INOblender is to be used in a transport vehicle, they should be affixed to the transport mounting post (part number 10009), which is part of the transport mounting bracket assembly (part number 50041). • The transport mounting post and/or the transport mounting bracket assembly should be secured to the transport isolette/transport gurney in a manner which will secure the INOmax DSIR/INOblender.
Troubleshooting or Calibrating • If an alarm occurs, safeguard the patient first before troubleshooting or repair procedures. • Use caution when troubleshooting the INOmax DSIR delivery system while in use for a patient. When possible replace the unit in question and perform troubleshooting procedure once the unit is removed from the patient. • If changing an NO sensor while delivering NO to a patient, install the NO sensor only when the NO high range calibration screen is displayed otherwise there is a risk that the system will shut down. • INOMAX can be administered during the sensor calibration process. However, inspired gases are not monitored and gas monitoring alarms are disabled. • Loss of communication between the INOmax DSIR and the INOMAX cylinder for more than one hour will result in interruption of INOMAX delivery.
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WARNING:
Part No. 20530 Rev-03 2014-07
Ventilators and Breathing Devices • The INOmax DSIR subtracts gas from the breathing circuit via the gas sampling system at 230 mL per minute which can cause the ventilator to auto-trigger. Adjusting the flow sensitivity may be necessary. The trigger sensitivity of the ventilator should be checked after connecting the INOmax DSIR to the breathing circuit. • Set the INOmax DSIR alarm thresholds for the current patient conditions to monitor any inadvertent changes in treatment. • Be certain all cables and hoses are positioned to help prevent damaging or occluding them. • The use of pediatric and neonatal ventilator settings with adult size breathing circuits can result in high levels of NO2. Always use the size of breathing circuit that is appropriate for the patient. • The humidifier chamber volume should not be more than 480 mL to prevent elevated NO2 values. • When handling any component of the patient circuit that comes in contact with patient’s fluids wear personal protective equipment (PPE). • Patient disconnect and high pressure alarms are required for the ventilator. • Patient circuit pressure and gas loss will result if cap is not in place (secured). • Use only “Latex-Free” breathing circuits and ventilators when using the INOmax DSIR. • If the INOmax DSIR is to be used in a transport vehicle, it should be affixed to the transport mounting post. • Avoid recirculation of gases. Undesired recirculation of gases will occur if fresh gas flows are less than the patient minute volume and may result in: - Higher NO2 levels due to the limited ability of the carbon dioxide absorbent to remove NO2. - Higher NO concentrations than those set due to NO recirculated through the absorber. - Reduction in O2 concentration because nitrogen is the balance gas for nitric oxide and will be present in the re-circulated gases. • Only use parts/accessories designated for use with this system.
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Part No. 20530 Rev-03 2014-07
General Information
1/ General Information
PartNo. No.20003 20530 Rev Rev-03 Part - 01 2014-07
General Information
1/ General Information
Part No. 20530 Rev-03 2014-07
1/ General Information Indications for Use
• The INOmax DSIR (delivery system) delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators.
• The INOmax DSIR provides continuous integrated monitoring of inspired O2, NO2 , and NO and a comprehensive alarm system. • The INOmax DSIR incorporates a battery that provides up to six hours of uninterrupted INOMAX delivery in the absence of an external power source. • The INOmax DSIR includes a backup NO delivery capability that provides a fixed flow of 250 mL/min of NO which along with user supplied 10 L/min of oxygen provides 20 ppm in the gas flow to a patient's breathing circuit. It may also use the INOblender for backup. • The target population is controlled by the drug labeling for INOMAX which is currently neonates; refer to the drug label for specific information. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
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1-1
Introduction to this Manual Definitions and abbreviations Term
Definition
% v/v
% volume/volume
Breathing circuit
Part of ventilator or breathing system that connects to the INOmax DSIR®.
Breathing system
Non-invasive breathing devices.
Control wheel
Rotary control used to change and confirm settings.
Cylinder
Aluminum cylinder containing INOMAX® therapy gas.
HFOV
High frequency oscillatory ventilation.
INOblender®
Back up to the INOmax DSIR. Allows manual ventilation of the patient, providing uninterrupted delivery of INOMAX.
INOMAX
Nitric oxide for inhalation.
INOmeter®
Counter mounted on a cylinder that records the amount of time the INOMAX cylinder valve is open.
Infrared (IR)
Infra-red technology by which the INOmax DSIR communicates with the INOmeter mounted on each cylinder.
N2
Nitrogen.
NO
Nitric oxide.
NO2
Nitrogen dioxide.
O2
Oxygen.
ppm
Parts per million.
Pre-use circuit
Connectors and tubing assembly required for INOmax DSIR for pre-use checkout.
psig
Pounds per square inch gauge.
Set NO
Dose of INOMAX set by the user.
This manual shows the Set NO displays associated with the 0-80 ppm range.
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Sample Line Inlet Main Power Indicator Display Screen Alarm Speaker (under front label) Integrated Pneumatic Backup Switch Control Wheel Injector Module Tubing Outlet Injector Module Cable Inlet
Figure 1-1 INOmax DSIR Front View
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9. Water Trap Bottle 10. Purge Port 11. INOMAX Gas Inlets 12. Blender Gas Outlet 13. Ethernet Port 14. Infrared Connector 15. USB Port 16. Water Separator Cartridge
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17. Water Trap Bottle 18. Sample Gas Outlet Port 19. Clamp Assembly 20. Electrical Cord Inlet 21. Equipotential Terminal 22. ON/Standby Switch 23. RS232 Port
Figure 1-2 INOmax DSIR Rear View
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1. INOmax DSIR 2. INOmax DSIR Mounting Post 3. Clamp Assembly 4. INOMAX Regulator (2) 5. INOblender 6. Small Part Bin 7. INOmeter 8. INOMAX Cylinder 9. Cylinder Holding Bracket 10. Cylinder Mounting Strap 11. Oxygen Cylinder Bracket 12. Caster Lock Lever 13. Caster (4)
Figure 1-3 INOmax DSIR and Cart
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1-5
Navigating the Display Screens
Note:
The specific level is identified by the highlighted card on the Menu Button. The red arrows indicate going back to a previous screen.
Main Screen (first level)
Recent Alarms Screen (second level)
Patient Information Screen (second level)
Menu Screen (second level)
Navigating the Menu Screen (see page 1-8)
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Menu Screen (second level)
Low Calibration Screen
Settings Screen
Pre-Use Wizard
Alarm History Screen
High Calibration Screen
Automated Purge Screen
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Main Display Screen • On the main screen the user can view alarm messages, monitored values and graphical information. • By pressing the “Menu Button” on the touch screen (top right hand corner), the user can access the menu screen (see Figure 1-5 ).
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Alarm Silence Button Upper Alarm Limit Button Lower Alarm Limit Button Monitored Value Menu Button Text Message Area
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7. Monitor Area 8. Graphical Area 9. Patient Information Button 10. Sample Line Icon 11. Water Trap Bottle Icon 12. Inspiratory Limb Icon
13. Injector Module Icon 14. Delivery Line Icon 15. Integrated Pneumatic Backup Line Icon 16. Integrated Pneumatic Backup Switch Icon 17. Delivery Setpoint Display 18. NO Delivery Setpoint Button 19. Cylinder Icon
Figure 1-4 Main Display Screen 1
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Menu Screen (second level) • On the menu screen the user can access the Pre-Use Checkout (#1) and the Auto Purge (#2) wizards.
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Pre-Use Checkout Button Auto Purge Button Return to Previous Level Button Monitor Area Alarm History Button
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6. Settings Button 7. High Calibration Button 8. High Calibration Due Date 9. Low Calibration Button 10. Last Low Calibration Date
Figure 1-5 Menu Screen (second level)
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Note:
The Pre-Use Checkout and Auto Purge buttons are inactive (greyed out) if a dose is set.
• To review the complete alarm history, press the Alarm History button (#5), (refer to Section 5/ Alarms). • To initiate a low (room air) or high calibration, press either the Low Cal (#9) or High Cal (#7) buttons. (refer to Section 6/ Calibration). • Press the Settings button (#6) to view circuit flow and calculated delivery graphs, change display brightness, change alarm volume, change time zone and view software revision (see Figure 1-6).
Part No. 20530 Rev-03 2014-07