Operators Guide
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Page 1
Z Vent Ventilator Operator’s Guide
9650-002360-05 Rev. B
The issue date for the ZOLL Ventilator Operator’s Guide (REF 9650-002360-05 Rev. B) is January, 2019. Copyright © 2019 ZOLL Medical Corporation. All rights reserved. ZOLL, Z Vent, and Smart Help are trademarks and/or registered trademarks of ZOLL Medical Corporation in the United States and/or other countries. All other trademarks are the property of their respective owners.
Masimo Pulse Oximeter This device uses Masimo SET® technology to provide continuous pulse oximeter and heart rate monitoring and is covered under one or more of the following U.S.A. patents: 5,758,644, 5,823,950, 6,011,986, 6,157,850, 6,263,222, 6,501,975 and other applicable patents listed at www.masimo.com/patents.htm.
Limited Copyright Release Permission is hereby granted to any military/governmental agency to reproduce all materials furnished herein for use in a military/governmental service training program and/or other technical training program.
Contents
Chapter 1
General Information
Product Description ... 1-1 How to Use this Guide ... 1-1 Operator’s Guide Updates ... 1-2 Unpacking... 1-2 Assembly ... 1-2 Product Symbols... 1-2 Symbols on the Z Vent Ventilator Graphical User Interface... 1-5 Conventions ... 1-7 Abbreviations ... 1-8 Indications for Use ... 1-9 Ventilation ... 1-9 Pulse Oximetry (SpO2) ... 1-9 Features ... 1-9 Warnings... 1-10 General ... 1-10 Ventilator ... 1-10 Pulse Oximeter ... 1-11 Batteries ... 1-12 User Safety ... 1-12 Patient Safety ... 1-12 MR Conditional Equipment ... 1-13 Cautions ... 1-14 FDA Tracking Requirements ... 1-14 Notification of Adverse Events ... 1-15 Software License ... 1-15 NO IMPLIED LICENSE ... 1-15 Limited Warranty ... 1-15 Technical Support ... 1-16 Returning a Ventilator for ZOLL Service ... 1-17
Chapter 2
Product Overview
Z Vent Ventilator Description ... 2-2 Main Features ... 2-2 Controls and Indicators ... 2-3 Controls ... 2-3 9650-002360-05 Rev. B
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Indicators ... 2-4 Display Screen ... 2-4 Message Area ... 2-5 Parameter Windows ... 2-5 Shared Icon Area ... 2-5 Auxiliary Parameter Boxes ... 2-5 Fresh Gas/Emergency Air Intake and Attachments ... 2-6 Oxygen Reservoir Bag Assembly ... 2-6 Top Panel ... 2-7 Pulse Oximeter Compatibility ... 2-8 Power Sources ... 2-8 Operating Using External DC Power ... 2-8 Operating Using Battery Power ... 2-8 Pneumatic Design ... 2-9 Oxygen Input: High Pressure Gas Supply ... 2-10 High Pressure Oxygen Supply Hose ... 2-10 Patient Circuits... 2-12 Intended Use ... 2-13 Use of Heat and Moisture Exchangers ... 2-13 Attaching a Patient Circuit to the Ventilator ... 2-14 Specifications ... 2-15 Pediatric/Adult, 6 ft Patient Circuit ... 2-15 Pediatric/Adult, 12 ft Patient Circuit ... 2-15 Infant/Pediatric, 6 ft Patient Circuit ... 2-15 Infant/Pediatric, 12 ft Patient Circuit ... 2-16 Reusable Circuit ... 2-16
Chapter 3
Setting Up the Z Vent Ventilator
1. Attach the Patient Circuit ... 3-2 2. Attach the High Pressure Oxygen Supply (Optional) ... 3-3 3. Inspect Fresh Gas/Emergency Air Intake Filters ... 3-3 4. Connect Fresh Gas/Emergency Air Intake Attachments (Optional) ... 3-4 3-Liter Reservoir Bag Assembly ... 3-4 Bacterial/Viral (BV) Filter ... 3-5 Chemical/Biological C2A1 Filter ... 3-5 5. Select the Ventilator’s Power Source... 3-6 Connecting the Power Supply ... 3-7 6. Power On the Ventilator ... 3-8 7. Select Start Menu Option... 3-8 8. Change Operating Mode (Optional)... 3-9 9. Change Parameter Values... 3-10 10. Perform Operational Test ... 3-11 11. Attach the Pulse Oximeter (Optional)... 3-11 12. Attach Patient... 3-12
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Chapter 4
Using the Z Vent Ventilator
Initial Operation with Default Parameter Settings ... 4-2 Default Parameter Settings for Adult, Pediatric and Mask CPAP ... 4-2 Adult Default Parameter Setting Values ... 4-2 Making a Choice From the Start Menu ... 4-3 Changing Parameter Settings... 4-4 Navigating the Parameter Windows Using Parameter Buttons ... 4-5 Changing a Parameter Setting ... 4-6 Example 1 - Changing a Primary Parameter ... 4-6 Example 2 - Changing a Secondary Parameter ... 4-6 Example 3- Changing a Context Menu Parameter ... 4-6 Saving Changed Parameters for Future Use... 4-7 Using the Last Settings Enabled on the Ventilator... 4-7 Mode Parameter Window Options ... 4-8 Primary Parameter ... 4-8 Secondary Parameters and Alarm Thresholds/Limits ... 4-8 Breath Target ... 4-8 Leak Compensation ... 4-9 Context Menu ... 4-9 Mode Parameter Window Reference ... 4-10 BPM Parameter Window Options ... 4-11 Secondary Parameters and Alarm Thresholds/Limits ... 4-11 Context Menu ... 4-11 Control Parameter (I:E or Ti) ... 4-12 Rise Time ... 4-12 Cycle Off % Parameter ... 4-13 Spont Ti Limit Parameter ... 4-13 BPM Parameter Window Reference ... 4-14 Vt Parameter Window Options ... 4-15 Secondary Parameters and Alarm Thresholds/Limits ... 4-15 Context Menu ... 4-16 Vt Parameter Window Reference ... 4-17 PIP Parameter Window Options ... 4-17 Secondary Parameters and Alarm Thresholds/Limits ... 4-17 Context Menu ... 4-18 PIP Parameter Window Reference ... 4-19 FIO2 Parameter Window Options ... 4-20 Secondary Parameters and Alarm Thresholds/Limits ... 4-20 Context Menu ... 4-20 FIO2 Parameter Window Reference ... 4-21 SpO2 Parameter Window Options... 4-21 Secondary Parameters and Alarm Thresholds/Limits ... 4-22 Context Menu ... 4-22 SpO2 Parameter Window Reference ... 4-23 HR (Heart Rate) ... 4-24 Secondary Parameters and Alarm Thresholds/Limits ... 4-24 Context Menu ... 4-24 HR Parameter Window Reference ... 4-25
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Manual Breath ... 4-26 Plateau Pressure ... 4-26 Plateau Pressure Maneuver ... 4-26 Popup Messages ... 4-27 Popup Message List ... 4-29 Transitions ... 4-36 Using the Menu... 4-36 Alarm Configuration ... 4-36 Powerup ... 4-37 Specifying Powerup Settings ... 4-37 Specifying Custom Settings ... 4-37 Specifying a Language ... 4-38 LCD Contrast ... 4-38 LCD Brightness ... 4-38 UTC Offset ... 4-39 Unit Info ... 4-39 Alarm History ... 4-40
Chapter 5
Alarms
Alarm Overview ... 5-1 Muting Alarms ... 5-3 Alarm Priorities ... 5-3 High Priority ... 5-3 Medium Priority ... 5-3 Low Priority (Advisory) ... 5-3 Popup Messages ... 5-4 Alarm Types ... 5-4 Patient Safety Alarms ... 5-4 Environmental and Use Alarms ... 5-7 Self-Check Alarms ... 5-9 Managing Alarms ... 5-11 Alarm Muting ... 5-12 Start Up Muting ... 5-12 Preemptive Muting ... 5-12 Disabling Alarms from the Alarm Configuration Menu ... 5-14 Patient Detect Mode ... 5-14 Backup Modes ... 5-15 Apnea Backup Mode ... 5-15 Alarm Summary ... 5-16 High Priority Alarms ... 5-16 Medium Priority Alarms ... 5-22 Low Priority Alarms ... 5-31
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Chapter 6
Operating Environments
Using the Ventilator in Harsh Environments ... 6-1 Airborne Particulates ... 6-1 Extreme Temperature Environments ... 6-2 Operating at High Temperatures ... 6-2 Operating at Low Temperatures ... 6-2 Altitude ... 6-3 Rain and Snow ... 6-3 Using the Ventilator in Hazardous Environments ... 6-3 Bacterial/Viral Filter Use ... 6-4 Chemical/Biological Filter Use ... 6-4 Check Valve on Patient Circuit when in Hazardous Environments ... 6-5 Using the Ventilator in an MRI Environment ... 6-6
Chapter 7
Maintenance
Inspecting the Ventilator ... 7-1 Cleaning... 7-2 Post-Contaminated Environment Cleaning ... 7-2 Fresh Gas/Emergency Air Intake Filters ... 7-3 Inspecting and Replacing the Foam Filter ... 7-3 Inspecting and Replacing the Disk Filter ... 7-3 Replacing Ventilator Filters ... 7-4 Replacing the Foam Filter ... 7-4 Replacing the Disk Filter ... 7-4 Battery Maintenance ... 7-5 Battery Storage ... 7-7 Ventilator Storage ... 7-7 Battery Replacement and Shipping Regulations ... 7-8 Calibration Checks... 7-8 Electrical Safety Check... 7-8 Troubleshooting ... 7-9
Appendix A
Specifications
General ...A-1 Pulse Oximeter ...A-3 Device Classification...A-3
Appendix B Accessories Appendix C Pulse Oximeter Principles Appendix D Troubleshooting Patient Circuits Troubleshooting Procedure...D-1
Index
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Chapter 1 General Information This chapter provides general information about the ZOLL Z Vent™ ventilator and the ZOLL Z Vent Ventilator Operator’s Guide, which we provide with this product. Specifically, this chapter provides: • • • • • •
A brief description of the Z Vent ventilator. Information about this manual (ZOLL Z Vent Ventilator Operator’s Guide). A table that describes the symbols that appear on the Z Vent ventilator and in this manual. The Z Vent ventilator Indications for Use. A list of Warnings and Cautions regarding the use of the ventilator. Information regarding FDA tracking requirements, and the product’s warranty and software license. • How to contact ZOLL Medical Corporation for service to this product.
Product Description The ZOLL Z Vent ventilator is a small, extremely durable, full-featured portable mechanical ventilator designed to operate in hospitals or severe and under-resourced environments. It can be used in prehospital, aeromedical, field hospital and hospital settings.
How to Use this Guide The ZOLL Z Vent Ventilator Operator’s Guide provides information that users need for the safe and effective use and care of the ventilator. It is important that all persons using this device read and understand all the information contained within. Please thoroughly read the warnings section. Procedures for device care are located in Chapter 7, “Maintenance”.
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Chapter 1 General Information
Operator’s Guide Updates An issue or revision date for this manual is shown on the front cover. If more than 3 years have elapsed since this date, contact ZOLL Medical Corporation to determine if additional product information updates are available. All users should carefully review each manual update to understand its significance and then file it in its appropriate section within this manual for subsequent reference. Product documentation is available through the ZOLL web site at www.zoll.com. From the Products menu, choose Product Manuals.
Unpacking Carefully inspect each container for damage. If the shipping container or cushion material is damaged, keep it until the contents have been checked for completeness and the device has been checked for mechanical and electrical integrity. If the contents are incomplete, if there is mechanical damage, or if the ventilator does not pass its Self-Check test when turned on, U.S.A. customers should call ZOLL Medical Corporation (1-978-421-9655). Customers outside of the U.S.A. should contact the nearest ZOLL authorized representative. If the shipping container is damaged, also notify the carrier. If there is no apparent sign of mechanical damage, read instructions contained within this manual before attempting operation.
Assembly The device only requires that you attach the breathing circuit to begin ventilation using either battery or external power. Both the ventilator and breathing circuit are supplied clean and are ready for use on a patient.
Product Symbols The following symbols appear on the ventilator or in this manual: Symbol
Description Off
On
Direct Current: Identifies the location to connect external DC Power.
Mute / Cancel: Identifies button which mutes the active alarms or cancels the parameter selection.
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Product Symbols Symbol
Description Accept /Select: Identifies button which accepts the parameter selection.
ESD: Warns that connector pins should not be touched.
Identifies the dial that allows the selection of parameter values.
Do Not Re-Use: This item should not be re-used.
Do Not Discard: Follow all governing regulations regarding the disposal of any part of this medical device.
Serial Number: Numbers following “SN” indicate the serial number.
Defibrillation Proof: Indicates the degree of protection against electrical shock.
BF Symbol: Protection against electric shock, Type B with floating (F-type) parts.
MR Symbol: Identifies the use of the device’s ability to perform in a MRI environment.
Power Input Orientation: Locates the DC input identifying its point of insertion.
Manufacturer: This symbol identifies the name and address of the manufacturer.
Manufacturer Date: Manufacturer Date Symbol identifies the device’s date of manufacture.
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Chapter 1 General Information Symbol
Description Consult Instruction: Consult the instructions for use or operation manual.
Refer to instruction manual.
Menu icon. This icon identifies the button that, when pressed, displays a menu of options that you can select to configure the ventilator.
280 - 600 kPa High Pressure O2 Connector (top faceplate icon). O2 (40 - 87 PSIG)
HAUST NOT OCC
Exhalation Valve (top faceplate icon).
Exhaust Do Not Occlude (top faceplate icon).
Transducer (top faceplate icon).
Gas Output -- Patient Circuit Connector (top faceplate icon).
Contains Phthalates
Non-Sterile
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Symbols on the Z Vent Ventilator Graphical User Interface
Symbols on the Z Vent Ventilator Graphical User Interface The following symbols appear on the ventilator’s Graphical User Interface (GUI): Symbol
Description Heart: Provides indication that the pulse oximeter is in use.
Alarm Bell: Identifies the number of off-screen alarms.
Alarm Bell Outline: Identifies alarm limit settings; Identifies the on-screen alarms.
+ LC
O2 reservoir mode is in use.
Leak Compensation (LC) feature is ON.
LC
Leak Compensation Feature is OFF.
___
Patient Detect Mode: Backup Ventilation Started.
__
Not receiving a reading from the pulse oximeter.
Attention: High Priority Alarm Active.
Caution: Medium Priority Alarm Active.
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Chapter 1 General Information Symbol
Description Warning: Low Priority Alarm Active.
Mute: Active Alarm Audible Signal Muted.
Speaker: Active Alarm Audible Signal.
Oxygen Supply: Oxygen Supply Connected.
External Power: Indicates the device is operating using an external power source.
No External Power: Indicates the device is operating without an external power source.
Internal Battery: Provides indication of battery capacity and charging.
EXT BATT
Indicates that an external battery is powering the ventilator.
No Internal Battery: Indicates when internal battery is not an available power source.
Head with Mask: the device is in the non-invasive positive pressure ventilation modes, CPAP or BL, with Leak Compensation turned on.
off on
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Feature OFF -- feature or alarm not selected.
Feature ON -- feature or alarm has been selected.
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Conventions Symbol
Description
srch
Search (Pulse oximeter searching for a patient signal.)
stby
Standby (Pulse oximeter in standby.).
Conventions This guide uses the following conventions: • Within text, the names and labels for physical buttons and soft-keys appear in boldface type
(for example, “Press the Accept button”).
• This guide uses uppercase italics for text messages displayed on the screen
(for example, EXTERNAL POWER FAILURE).
Warning!
Warning statements alert you to conditions or actions that can result in personal injury or death.
Caution
Caution statements alert you to conditions or actions that can result in damage to the device.
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Chapter 1 General Information
Abbreviations A/C - Assist/Control
ID - Internal Diameter
AEV - Automatic Electrical Ventilator
L - Liters
ACLS - Advanced Cardiac Life Support
LC - Leak Compensation
ALS - Advanced Life Support
LCD - Liquid Crystal Display
ATLS - Advanced Trauma Life Support
LED - Light Emitting Diode
ACV - Assist-Control Ventilation
LPM - Liters Per Minute
AMC - Alarm Message Center
ml - Milliliters
APOD - Advanced Probe Off Detection
mm - Millimeter
ATPD - Ambient Temperature and Pressure Dry
MRI - Magnetic Resonance Imaging
b/min - Beats Per Minute
O2 - oxygen
B/V - Bacterial/Viral Filter
Paw - Airway Pressure
BL - Bilevel positive airway pressure
PEEP - Positive End Expiratory Pressure
BPM - Breaths per Minute
PIP - Peak Inspiratory Pressure
cm H2O - Centimeters of Water
PPV - Positive-Pressure Ventilation
CPAP - Continuous Positive Airway Pressure
PS - Pressure Support
CPR - Cardiopulmonary Resuscitation
psig - Pounds per Square Inch Gage
CPU- Central Processor Unit
RF - Radio Frequency
dBA - Decibel
RGA # - Returned-Goods-Authorization number
DISS - Diameter Index Safety System
RTC - Real Time Clock
EMC - Electromagnetic Compatibility
SIMV - Synchronized Intermittent Mandatory Ventilation
EMV - Emergency Medical Ventilator
SPM - Smart Pneumatic Module
ESD - Electrostatic Discharge
SpO2 - oxyhemoglobin saturation,%
FIO2 - Fraction of Inspired Oxygen
USP - United States Pharmacopoeia
HME - Heat and Moisture Exchanger
VAC - Volts AC
HMEF - Heat and Moisture Exchanger/Bacterial Viral filter combined
VDC - Volts DC
HP O2 - High Pressure Oxygen
VT - Tidal Volume
Hz - Hertz (as in frequency, cycles per second)
WOB – Work Of Breathing
I:E- Inspiratory/Expiratory Ratio
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Indications for Use
Indications for Use Ventilation The ZOLL Z Vent ventilator is indicated for use in the management of infant through adult patients weighing greater than or equal to 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. The ZOLL Z Vent ventilator is appropriate for use in hospitals, outside the hospital, during transport and in severe environments where they may be exposed to rain, dust, rough handling, and extremes in temperature and humidity. With an appropriate third-party filter in place, they may be operated in environments where chemical and/or biological toxins are present. When marked with an “MRI conditional” label, the ZOLL Z Vent ventilator is suitable for use in an MRI environment with appropriate precautions. The ZOLL Z Vent ventilator is intended for use by skilled care providers with knowledge of mechanical ventilation, emergency medical services (EMS) personnel with a basic knowledge of mechanical ventilation, and by first responders under the direction of skilled medical care providers.
Pulse Oximetry (SpO2) The ZOLL Z Vent ventilator pulse oximeter with Masimo SET technology is intended for use for continuous noninvasive monitoring of the oxygen saturation of arterial hemoglobin (SpO2), and pulse rate. The pulse SpO2 oximeter and accessories are indicated for use with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, or in mobile environments.
Features • Portable ventilator that you can use in the hospital, aeromedical and ground transport, mass
casualty situations, and extreme environments.
• Multiple modes of ventilation for use with acute or chronic respiratory failure in both
intubated and non-intubated patients.
• Intuitive user interface minimizes user training and protects existing settings from
inadvertent contact and manipulation.
• Smart Help™ messages guide the user through on-screen commands when responding to
alarms.
• Lightweight < 4.4 kg - for easy transport. • Rechargeable battery provides over 10 hours of operation (at factory default with pulse • • • • • •
oximeter operating). Operating temperature range for extreme conditions: -26 C to 55 C. Altitude compensation from 110 to 37.6 kPa (-2,250 to 25,000 ft). Self-contained system able to operate with or without external oxygen. Gas manifold design allows operation with both high and low-pressure oxygen sources. All oxygen is delivered to the patient breathing circuit. Sealed gas path with chemical/biological filter connected to assure safe breathing gas supply. Case and control panel protects components from weather and fluids.
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Chapter 1 General Information
Warnings General • The Z Vent ventilator is intended for use by qualified personnel only. You should read this
manual before using the device.
• Before using the ventilator on a patient, you must test the device in its normal configuration
to ensure proper operation.
• Do not modify this equipment without authorization of the manufacturer. • This operator’s guide is not meant to supersede any controlling operating procedure
regarding the safe use of assisted ventilation.
• Follow all governing regulations regarding the disposal of any part of this medical device,
the handling of materials contaminated by body fluids, and shipment of the Li-ION batteries.
Ventilator • The Z Vent ventilator can operate from its internal battery or from an external power source.
When using external power, position the power cord to avoid accidental disconnect.
• The use of accessories and cables other than those sold by ZOLL may result in increased
emissions or decreased immunity of this device.
• Portable and mobile RF communication equipment may affect the performance of this • • • •
•
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device. We describe the EMC performance for this device in Appendix A Specifications of this guide. The ventilator may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating of the device or shielding the location. Do not connect to an electrical outlet controlled by a wall switch or dimmer. The protection against defibrillator depends on the use of accessories (including Pulse Oximeter) that are specified by ZOLL. Grounding: • Do not under any circumstances remove the grounding conductor from the power plug. • Do not use extension cords or adapters of any type. The power cord and plug must be intact and undamaged. • If there is any doubt about the integrity of the protective earth conductor or power supply, operate on internal battery power. As with all medical equipment, carefully route the patient circuit, patient cabling, and external power cords to reduce the possibility of patient entanglement or strangulation. The product design includes materials with phthalates in the pressure lines of both the manifold design and patient circuit. Patient mask accessories used with the device also are made with materials containing phthalates. Phthalates are NOT present in the inspiratory line (Gas Hose) of the patient circuit.
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Warnings • Do not use in MRI environment unless MRI marking is present. • Do not operate the ventilator on a patient when the USB port is connected to any other
device (the USB port is only for servicing the ventilator).
• The ZOLL-supplied patient circuit’s labeling provides the resistance and compliance values
for the circuits under normal operating conditions. If added accessories are used (e.g. HME, filters etc.), you should assure they do not degrade the performance of the device.
Pulse Oximeter • Do not use the pulse oximeter as an apnea monitor. • A pulse oximeter should be considered an early warning device. As a trend towards patient •
•
• •
deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient’s condition. Measurements: if the accuracy of any measurement does not seem reasonable, first check the patient’s vital signs by alternate means and then check the pulse oximeter for proper functioning. Inaccurate measurements may be caused by: • Incorrect sensor application or use. • Significant levels of dysfunctional hemoglobin (e.g. carboxyhemoglobin or methemoglobin). • Intra-vascular dyes such as indocyanine green or methylene blue. • Exposure to excessive illumination, such as surgical lamps (especially ones with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight (exposure to excessive illumination can be corrected by covering the sensor with a dark or opaque material). • Excessive patient movement. • Venous pulsations. • Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line. • The pulse oximeter is defibrillator-proof. The pulse oximeter can be used during defibrillation, but the readings may be inaccurate for a short time. Interfering Substances: carboxyhemoglobin may erroneously increase readings. The level of increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual arterial pigmentation may cause erroneous readings. Alarms: Check alarm limits each time the pulse oximeter is used to ensure that they are appropriate for the patient being monitored. Loss of pulse signal can occur in any of the following situations: • The sensor is too tight. • Excessive illumination from light sources such as a surgical lamp, a bilirubin lamp, or sunlight. • A blood pressure cuff is inflated on the same extremity as the one with an SpO2 sensor attached. • The patient has hypotension, severe vascoconstriction, severe anemia, or hypothermia. • Arterial occlusion proximal to the sensor. • The patient is in cardiac arrest or is in shock.
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Chapter 1 General Information • Sensors:
• Before use, carefully read the Masimo LNCS® sensor directions for use. • Use only Masimo oximetry sensors for SpO2 measurements. Other oxygen
transducers (sensors) may cause improper performance.
• Tissue damage can be caused by incorrect application or use of an LNCS sensor for
example, by wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor Directions for Use to ensure skin integrity and correct positioning and adhesion of the sensor. • Do not damage LNCS sensors. Do not use an LNCS sensor with exposed optical components. Do not immerse the sensor in water, solvents, or cleaning solutions (The sensors and connectors are not waterproof). Do not sterilize by irradiation, steam, or ethylene oxide. See the cleaning instructions in the directions for reusable Masimo LNCS sensors. • Do not use damaged patient cables. Do not immerse the patient cables in water, solvents, or cleaning solutions (the patient cables are not waterproof). Do not sterilize by irradiation, steam, or ethylene oxide. See the cleaning instructions in the directions for reusable Masimo patient cables. • Do not use the pulse oximeter sensor during magnetic resonance imaging (MRI) scanning. Inducing current could potentially cause burns. The pulse oximeter may affect the MRI image and the MRI unit may affect the accuracy of the dosimetry measurements.
Batteries • Only use the power supply provided with the device. Use of any other power supply could
cause damage or create a fire and/or destroy the battery and device.
• If you witness a battery or the battery compartment starting to balloon, swell up, smoke, or
feel excessively hot, turn off the device, disconnect external power, and observe it in a safe place for approximately 15 minutes and send the device for service. Never puncture or disassemble the battery packs or cells.
User Safety • Electric shock hazard: Do not remove equipment covers. You may only perform
maintenance procedures specifically described in this manual. Refer all servicing to ZOLL or a ZOLL-authorized service center. • Possible explosion hazard if used in the presence of flammable anesthetics or other flammable substances in combination with air, oxygen-enriched environments, or nitrous oxide. • This device is not intended for use in explosive atmospheres. • Pins of connectors identified with the ESD warning symbol should not be touched. Always use precautionary procedures with ESD-sensitive connections.
Patient Safety • To ensure patient electrical isolation, connect only to other equipment with electronically
isolated circuits.
• Do not place the device or external power supply in any position that might cause it to fall
on the patient. Do not lift the device by the power cord, patient circuit, or pulse oximeter patient cable. • Never service the ventilator while in use with a patient.
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Warnings
MR Conditional Equipment • Failure to follow all instructions can result in MRI artifacts, injury to the patient or
user, or malfunction of the device.
• You must follow all safety procedures that are in effect for the MRI Environment. Do
not use the ventilator in an MRI Environment with greater than 3T magnetic force. • You must secure the device to a suitable MRI-compatible cart -- ZOLL MRI Roll Stand; Optional IV Arm Assembly. • You must place the ventilator behind the 2000 Gauss field line. • The ventilator must be attended by a person with no other responsibility than monitoring the device and patient while in the MRI Environment. • You must visually monitor the ventilator for alarms at all times -- during imaging, the alarms may not be audible beyond the area immediately adjacent to the MRI. • Danger! Possible Missile Projection. • DO NOT position any person between the bore entrance and an unsecured cart or device. • Lock the wheels when the rolling stand is in place. • We recommend that you tether the rolling stand in place when in the MRI Environment. • Place the ventilator and stand in its position before the patient is positioned on the scanner table and advanced into the bore. • Remove the patient from the MRI Environment before removing the ventilator and roll stand. • Unapproved device apparatus shall NOT be allowed in the MRI Environment, including: • Pulse Oximeters sensors and cabling. • External AC/DC Power Supply. • Rolling Cart Breathing Circuit Arm. • Active Humidification and associated support apparatus. • Ensure proper configuration of the ventilator. • DO NOT attach the pulse oximeter sensor to the patient and remove it from the device. • The ventilator should run only on battery power in the MRI Environment -- DO NOT use an external AC/DC power supply. • The ventilator’s battery should be fully charged before entering the MRI Environment. • Oxygen Supply -- an aluminum, non-magnetic cylinder and oxygen hose must provide the oxygen supply. • Ensure proper operation of the ventilator’s breathing system. • 12 ft patient circuits are available for use with the ventilator -- the additional length enables a suitable separation between the ventilator and the bore opening. (Adult/Pediatric Wye Patient Circuit; Pediatric/Infant Wye Patient Circuit). • The extended tubing length of a 12 ft patient circuit can result in loss of volume due to additional tubing compressibility. -- Set the Tubing Compliance (TC) to OFF and ensure that the patient is receiving correct tidal volume. -- Alternatively, calculate the TC as described by the patient circuit’s Instructions For Use (IFU) and adjust the TC value to ensure that the patient is receiving the correct tidal volume. • DO NOT use the 12 ft circuit with PEEP settings below 5 (5 cm H2O). • Ensure that the ventilator is able to maintain PEEP -- for patients with short expiratory times, the additional tubing length of the 12 ft circuit may affect system behavior.
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