Z Vent Ventilator Operator’s Guide
9650-002360-01 Rev. A
The issue date for the ZOLL Ventilator Operator’s Guide (REF 9650-002360-01 Rev. A) is September, 2018.
Copyright © 2018 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
Indicators ............................................................................................................. 2-4
Display Screen ............................................................................................................ 2-4
Message Area ...................................................................................................... 2-5
Parameter Windows ............................................................................................ 2-5
Shared Icon Area ................................................................................................. 2-5
9650-002360-01 Rev. A ZOLL Z Vent Ventilator Operator’s Guide i
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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
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
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
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Contents
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
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
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Using the Main 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
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
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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
Contents
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
9650-002360-01 Rev. A ZOLL Z Vent Ventilator Operator’s Guide v
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.
Chapter 1
General Information
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”.
9650-002360-01 Rev. A ZOLL Z Vent Ventilator Operator’s Guide 1-1
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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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.
General Information
Do Not Re-Use: This item should not be re-use
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.
d.
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.
9650-002360-01 Rev. A ZOLL Z Vent Ventilator Operator’s Guide 1-3
General Information
280 - 600 kPa
(40 - 87 PSIG)
O
2
NOT OCC
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.
High Pressure O
Connector (top faceplate icon).
2
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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General Information
+
LC
LC
_ _ _
_ _
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.
O
reservoir mode is in use.
2
Leak Compensation (LC) feature is ON.
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.
9650-002360-01 Rev. A ZOLL Z Vent Ventilator Operator’s Guide 1-5
General Information
EXT
BATT
off
on
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.
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.
Feature OFF -- feature or alarm not selected.
Feature ON -- feature or alarm has been selected.
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General Information
srch
stby
Symbol Description
Search (Pulse oximeter searching for a patient signal.)
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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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
ATL S - 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
ATP D - Ambient Temperature and Pressure Dry MRI - Magnetic Resonance Imaging
b/min - Beats Per Minute O
B/V - Bacterial/Viral Filter P
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
EMV - Emergency Medical Ventilator SPM - Smart Pneumatic Module
ESD - Electrostatic Discharge SpO
FIO
Fraction of Inspired Oxygen USP - United States Pharmacopoeia
2 -
HME - Heat and Moisture Exchanger VAC - Volts AC
- oxygen
2
- Airway Pressure
aw
Ventilation
- oxyhemoglobin saturation,%
2
HMEF - Heat and Moisture Exchanger/Bacterial Viral
filter combined
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
VDC - Volts DC
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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)
General Information
Features
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 (SpO
and pulse rate. The pulse SpO
oximeter and accessories are indicated for use with adult and
2
),
2
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.
• 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 < 10 lbs. (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 (-15 F to 131F).
• Altitude compensation from - 685.8 m to 7620 m (- 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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General Information
Warnings
General
• The Z Vent ventilator is intended for use by qualified personnel only. You should read this
• Before using the ventilator on a patient, you must test the device in its normal configuration
• Do not modify this equipment without authorization of the manufacturer.
• This operator’s guide is not meant to supersede any controlling operating procedure
• Follow all governing regulations regarding the disposal of any part of this medical device,
Ventilator
• The Z Vent ventilator can operate from its internal battery or from an external power source.
• The use of accessories and cables other than those sold by ZOLL may result in increased
• Portable and mobile RF communication equipment may affect the performance of this
• The ventilator may cause radio interference or may disrupt the operation of nearby
• 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
• Grounding:
• As with all medical equipment, carefully route the patient circuit, patient cabling, and
manual before using the device.
to ensure proper operation.
regarding the safe use of assisted ventilation.
the handling of materials contaminated by body fluids, and shipment of the Li-ION
batteries.
When using external power, position the power cord to avoid accidental disconnect.
emissions or decreased immunity of this device.
device. We describe the EMC performance for this device in Appendix A Specifications of
this guide.
equipment. It may be necessary to take mitigation measures, such as re-orienting or
relocating of the device or shielding the location.
Oximeter) that are specified by ZOLL.
• 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.
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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• 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:
• 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:
General Information
• 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.
• 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 SpO
2
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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General Information
• Sensors:
• Do not use the pulse oximeter sensor during magnetic resonance imaging (MRI) scanning.
Batteries
• Before use, carefully read the Masimo LNCS
• Use only Masimo oximetry sensors for SpO
®
sensor directions for use.
measurements. Other oxygen
2
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.
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.
• Only use the power supply provided with the device. Use of any other power supply could
• If you witness a battery or the battery compartment starting to balloon, swell up, smoke, or
User Safety
• Electric shock hazard: Do not remove equipment covers. You may only perform
• Possible explosion hazard if used in the presence of flammable anesthetics or other
• This device is not intended for use in explosive atmospheres.
• Pins of connectors identified with the ESD warning symbol should not be touched. Always
Patient Safety
• To ensure patient electrical isolation, connect only to other equipment with electronically
• Do not place the device or external power supply in any position that might cause it to fall
• Never service the ventilator while in use with a patient.
cause damage or create a fire and/or destroy the battery and device.
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.
maintenance procedures specifically described in this manual. Refer all servicing to
ZOLL or a ZOLL-authorized service center.
flammable substances in combination with air, oxygen-enriched environments, or nitrous
oxide.
use precautionary procedures with ESD-sensitive connections.
isolated circuits.
on the patient. Do not lift the device by the power cord, patient circuit, or pulse oximeter
patient cable.
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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 H
• 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.
General Information
O).
2
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General Information
Cautions
• Inspect the circuit every day to ensure that there is no damage or wear that could affect its
performance. Remove fluid or other biological material from the circuit or replace the
circuit following the local standard of care.
• Federal law restricts this device to sale by or on the order of a physician.
• Only qualified biomedical equipment technicians should service the device.
• Internal components are susceptible to damage from static discharge. Do not remove device
covers.
• Possession or purchase of this device does not convey any expressed or implied license to
use the device with unauthorized sensors or cables which would, alone, or in combination
with this device fall within the scope of one or more of the patients related to this device.
ZOLL cannot ensure the proper functioning of this device if it is used with unauthorized
sensors, cables, or patient circuits.
FDA Tracking Requirements
U.S. Federal Law (21 CFR 821) requires the tracking of ventilators. Under this law, owners
of this ventilator must notify ZOLL Medical Corporation if this product is
• Received
• Lost, stolen, or destroyed
• Donated, resold, or otherwise distributed to a different organization
If any such event occurs, contact ZOLL Medical Corporation in writing with the following
information:
• Originator's organization – Company name, address, contact name, and contact phone
number
• Model number, and serial number of the ventilator
• Disposition of the ventilator (for example, received, lost, stolen, destroyed, distributed to
another organization), new location and/or organization (if known and different from
originator’s organization) – company name, address, contact name, and contact phone
number
• Date when the change took effect
Please address the information to:
ZOLL Medical Corporation
Attn: Tracking Coordinator
269 Mill Road
Chelmsford, MA 01824-04105
Fax: (978) 421-0007
Telephone: (978) 421-9655
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Notification of Adverse Events
As a health care provider, you may have responsibilities under the Safe Medical Devices Act
(SMDA), for reporting to ZOLL Medical Corporation, and possibly to the FDA, the occurrence
of certain events.
These events, described in 21 CFR Part 803, include device-related death and serious injury or
illness. In addition, as part of our Quality Assurance Program, ZOLL Medical Corporation
requests to be notified of device failures or malfunctions. This information is required to ensure
that ZOLL Medical Corporation provides only the highest quality products.
Software License
Note: Read this Operator’s Guide and License agreement carefully before operating the
Z Vent ventilator product.
Software incorporated into the system is protected by copyright laws and international
copyright treaties as well as other intellectual property laws and treaties. This software is
licensed, not sold. By taking delivery of and using this system, the Purchaser signifies
agreement to and acceptance of the following terms and conditions:
1. Grant of License: In consideration of payment of the software license fee which is part of
the price paid for this product, ZOLL Medical Corporation grants the Purchaser a
nonexclusive license, without right to sublicense, to use the system software in object-code
form only.
2. Ownership of Software/Firmware: Title to, ownership of, and all rights and interests in the
system software and all copies thereof remain at all times vested in the manufacturer, and
Licensors to ZOLL Medical Corporation and they do not pass to purchaser.
3. Assignment: Purchaser agrees not to assign, sublicense, or otherwise transfer or share its
rights under the license without the express written permission of ZOLL Medical
Corporation.
4. Use Restrictions: As the Purchaser, you may physically transfer the products from one
location to another provided that the software/firmware is not copied. You may not disclose,
publish, translate, release, or distribute copies of the software/firmware to others. You may
not modify, adapt, translate, reverse engineer, decompile, crosscompile, disassemble, or
create derivative works based on the software/firmware.
General Information
NO IMPLIED LICENSE
Possession or purchase of this device does not convey any express or implied license to use the
device with replacement parts which would, alone, or in combination with this device, fall
within the scope of one or more of the patents relating to this device.
Limited Warranty
ZOLL warrants the device to be free from all defects in material and workmanship for a period
of one (1) year from the date of delivery to the original purchaser.
During the warranty period, ZOLL will repair or replace the device or any part which upon
examination is shown to be defective. At its sole discretion, ZOLL may choose to supply a new
or equivalent replacement product or refund the amount of the purchase price (on the date sold
by ZOLL). To qualify for such repair, replacement, or refund, the defective device must be
returned to the ZOLL Service Center within thirty (30) days from the date that the defect is
9650-002360-01 Rev. A ZOLL Z Vent Ventilator Operator’s Guide 1-15
General Information
discovered. This warranty does not apply if the device has been repaired or modified without
the authorization of ZOLL or if the damage was caused by incorrect (off-label) use, negligence,
or an accident.
Batteries, which by their nature are consumable and subjected to environmental extremes, will
be warranted only for a period of ninety (90) days. Accessories, also consumable in usage, such
as connecting hose and breathing circuits, are not warranted.
DISCLAIMER OF IMPLIED & OTHER WARRANTIES:
THE PRECEDING WARRANTY IS THE EXCLUSIVE WARRANTY AND ZOLL MAKES
NO OTHER WARRANTY OR REPRESENTATION OF ANY KIND WHATSOEVER,
EXPRESS OR IMPLIED, WITH RESPECT TO MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, OR ANY OTHER MATTER. THE REMEDIES STATED IN THIS
DOCUMENT WILL BE THE EXCLUSIVE REMEDIES AVAILABLE TO THE
CUSTOMER FOR ANY DEFECTS OR FOR DAMAGES RESULTING FROM ANY
CAUSE WHATSOEVER AND WITHOUT LIMITATION.
ZOLL WILL NOT IN ANY EVENT BE LIABLE TO THE CUSTOMER FOR
CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND, WHETHER FOR
DEFECTIVE OR NONCONFORMING PRODUCTS, BREACH OR REPUDIATION OF
ANY TERM OR CONDITION OF THIS DOCUMENT, NEGLIGENCE, OR ANY OTHER
REASON.
Technical Support
If the ventilator requires service, contact the ZOLL Technical Support Department.
For customers In the U.S.A. For customers outside the U.S.A.
Telephone
Email
When requesting support, please provide the following information to the support
representative:
• Ventilator serial number
• Description of the problem, and service code if available
• Department using the equipment and name of the person to contact
• Purchase order to allow tracking of loan equipment
• Purchase order for a device with an expired warranty
1-800-348-9011
1-978-421-9655
techsupport@zoll.com
Call the nearest authorized ZOLL Medical Corporation
representative.
To locate an authorized service center, contact:
ZOLL Medical Corporation
269 Mill Road
Chelmsford, MA 01824
Telephone: 1-978-421-9655
techsupport@zoll.com
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General Information
Returning a Ventilator for ZOLL Service
Before sending a ventilator to the ZOLL Technical Support Department for repair, obtain a
service request (SR) number from the service representative.
The Li-ion battery should remain inside the ventilator or aspirator. Follow directions provided
on the return authorization form.
Pack the ventilator with its power supply in the original shipping containers
(if available) or equivalent packaging. Be sure the assigned service request (SR) number
appears on each package and follow the Shipping Regulations as described in Chapter 7 of this
manual.
Return the device to:
.
For customers Return the device to
In the U.S.A. ZOLL Medical Corporation
269 Mill Road
Chelmsford, MA 01824
Attention: Technical Support Department (SR number
Telephone: 1-978-421-9655
)
In Canada ZOLL Medical Canada Inc.
1750 Sismet Road, Unit #1
Mississauga, ON L4W 1R6
Attention: Technical Support Department (SR number)
Telephone: 1-866-442-1011
In other locations The nearest authorized ZOLL Medical Corporation
representative.
To locate an authorized service center, contact the
International Sales Department at:
ZOLL Medical Corporation
269 Mill Road
Chelmsford, MA 01824-4105
Telephone: 1-978-421-9655
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Chapter 2
Product Overview
This chapter describes the Z Vent ventilator and provides more detailed descriptions of the
following:
• Main features
• Controls and indicators
• Display screen
• Fresh Gas/Emergency Air Intake and attachments
• Top Panel
• Pulse Oximeter compatibility
• Power sources
• Pneumatic design
• Oxygen Input
• Patient circuits
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Product Overview
Z Vent Ventilator Description
The sections that follow provide a detailed description of the Z Vent ventilator.
Main Features
Figure 2-1 shows the ventilator’s main features.
Figure 2-1 Main Features
Item Location Description
Oxygen Inlet Top Enables connection to an external high pressure oxygen
source.
Status Indicator LED Array Top Lights to indicate ventilator status and a visible alarm
indicator.
External Power Input
Connector
USB Connector Top Enables connection to a USB compatible device for
Pulse Oximeter Connector Top Enables connection to a pulse oximeter sensor
LCD Display Front Displays settings, ventilation data, and alarm information.
Alarm Message Center Front Displays active alarms and alarm mitigation information.
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Top Enables connection to an external power source.
servicing the ventilator.
Product Overview
Item Location Description
Control Panel Front Provides user access to the ventilator settings.
Battery Compartment Bottom Holds the ventilator’s rechargeable Li-ion battery.
Fresh Gas/Emergency Air
Intake
Handle Side
Controls and Indicators
The ventilator controls and indicators (shown in Figure 2-2) facilitate ease of use and visibility
in all operating environments.
Side Enables the ventilator internal compressor to use ambient
air and acts as an anti-asphyxia valve.
Figure 2-2 Controls and Indicators
Controls
The ventilator’s controls consist of the following:
Control Function
Power Switch Enables the user to turn the ventilator ON and OFF.
Parameter Buttons Enables the user to access primary parameters, secondary parameters
and context menus associated with a primary parameter (if applicable),
and then modify settings using the Selection Dial).
Menu Button Enables the user to access the Menu.
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Product Overview
Control Function
Selection Dial Enables the user to set values for a chosen (highlighted) Primary
Parameter, Secondary Parameter, Context Menu item, and Menu item.
Values accelerate with speed of turning.
Mute/Cancel button The Mute/Cancel button mutes the audible alarm allowing the user time
to change parameters. It can also be used to cancel parameter entries.
Accept/Select button The Accept/Select button allows the user to accept parameter value
settings, acknowledge popup messages, and accept a menu choices
Manual Breath Button/
Plateau Pressure
Indicators
The ventilator’s indicators consist of the following:
Indicator Description
LCD Display Displays settings, patient data, and alarm information.
LED Array Indicates operational status (Red, Yellow, or Green).
Display Screen
The ventilator’s display screen has four functional areas as shown in Figure 2-3:
• Alarm Message Center/Waveform Window
• Parameter Windows
• Shared Icon Area
• Auxiliary Parameter Boxes.
These functional areas are discussed in the following sections.
Enables the user to deliver a manual breath and measure Plateau
Pressure
Note: Plateau Pressure is an optional ventilator control.
Figure 2-3 Display Screen Functional Areas
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