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1000B
User Manual
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AirSep 1000B User Manual

Eclipse 5™ with autoSAT
®
Personal Ambulatory Oxygen System (PAOS)
Model 1000B
PROVIDER TECHNICAL MANUAL
™
TABLE OF CONTENTS
Warning and Caution Statements ........................................... 4
Introduction to the Eclipse 5 Oxygen System ................. 5
Pulse Dose Mode Specications .............................................. 7
Power Accessory Specications ............................................... 7
Provider Support Policy ................................................................. 8
Indications for Use...........................................................................26
Basic Concept Training .................................................................26
Safety Guidelines and Operational Safety
Locating the Eclipse 5 for Proper Use and
Showing Panel Buttons, Indicators, Alerts
ATF® Concentrator Module .........................................................13
Compressor and Compressor Enclosure ...........................14
Continuous Flow Mode ...............................................................17
Provider Mode Functions ............................................................18
Service Mode Functions ..............................................................19
“Power Cartridge (Battery) Conservation”
Active Lifestyle Training ...............................................................31
Eclipse 5 Maintenance ..................................................................35
TABLE OF CONTENTS CONTINUED
Clean the Cabinet and Control Panel
Patient Training Checklist ............................................................ 37
Annual Maintenance Procedures ..........................................39
Troubleshooting, Service, and
Repair Procedures ..............................................55
System Troubleshooting and Alarms ..................................56
Alarm Conditions and Alarm Codes ....................................59
System Schematics and Diagrams ........................................61
Remove and Replace the Product Tank
Remove and Replace the Control
Remove and Replace the Power Manager
Remove and Replace the Compressor
Purity and Flow Rate Test
Purity and Flow Rate Test Procedure-
Provider Service and Maintenance Record......................53
Chart-SeQual Customer Service Contact
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Personal Ambulatory Oxygen System Provider Technical Manual
GENERAL INFORMATION
This technical manual will familiarize you with Provider-specic information regarding the Eclipse 5 Oxygen System. Instructions in this manual are intended to help ensure that:
- Providers are familiar with Eclipse 5 system components and system principles of operation
- Providers are given proper guidance in the use of the Eclipse 5 and its accessories that can be conveyed to patients
- Providers are made aware of the care, diagnostics, maintenance, and repair of the Eclipse 5
Warning and Caution Statements
Safety instructions are dened as follows:
WARNING:
CAUTION
NOTE:
Important safety information for hazards that might cause serious injury.
Important information for preventing damage to the Eclipse 5.
Places emphasis on an operating characteristic or important consideration.
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INTRODUCTION TO THE ECLIPSE 5 OXYGEN SYSTEM
ECLIPSE 5
UNIVERSAL CART
AC POWER SUPPLY
WITH NEMA POWER CORD
PN: 5941-SEQ
DC POWER SUPPLY
PN: 5942-SEQ
POWER CARTRIDGE
BATTERY
PN: 5991-SEQ
Control Panel
Oxygen Outlet Port
FAA Approval Icon
Rating Label & Serial Number Location
FRONT
Handle
External Power Receptacle
Power Cord Retainer
Air Inlet Filter
FAA Approval Icon
Exhaust Vent
PN: 7082-SEQ
Power Cartridge Latch
BACK
EDAT Service Port
(Not for Patient Use)
Cart
Attachment
Location
Power
Cartridge
(Battery)
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Personal Ambulatory Oxygen System Provider Technical Manual
ECLIPSE 5 OXYGEN SYSTEM SPECIFICATIONS
Oxygen Concentrator
Dimensions (H x W X D)
Weight Eclipse 5 Power Cartridge
Flow Settings
Continuous Flow (measured in Liters Per Minute LPM) Pulse Dose (measured in mL)
Continuous Flow Accuracy +/- 10% or 200ml/min, whichever is greater Oxygen Concentration 87–95.6% for all ow settings Maximum System Pressure 15 psig (103.5 kPa) Oxygen Output Pressure 5.0 psig (34.5 kPa) nominal
Oxygen Concentration Status Indicator
Nominal Sound Level
3.0 LPM Continuous Flow
3.0 Pulse Dose Mode
Operating Environment
Temperature Humidity
Storage Environment
Temperature Humidity
Altitude 0 – 13,123 feet (0 - 4,000 meters)
Nominal Power
0.5 LPM Continuous ow 3 LPM Continuous Flow
1.0 Pulse Dose Setting
6.0 Pulse Dose Setting Battery Charging
Nominal Power Cartridge operating time
Continuous Flow
2.0 LPM
3.0 LPM
Pulse Dose (@ 12 BPM)
2.0
6.0
Continuous Flow Indication Expressed in liters per minute (LPM)
19.3 x 12.3 x 7.1 inches (49.0cm x 31.2cm x 18.0cm)
15.0 pounds
3.4 pounds
0.5 to 3.0 LPM (0.5 liter increments) 16-96 (8mL increments), 128mL, 160mL, 192mL
Green Light = Normal Operation Yellow Light = Warning or Caution, less than 85% ± 3% Red Light Flashing = Abnormal Operation, less than 70% ± 5%
48 dB(A) 40 dB(A)
50º F to 104º F (+10° to 40°C) 10% to 95%, Non-condensing, 82.4°F (28°C) Maximum Dew point
-4º F to 140º F (-20° to 60°C) Up to 95% Non-condensing
48 Watts 145 Watts 45 Watts 95 Watts 50 Watts
2.0 hours
1.3 hours
5.2 hours
3.5 hours
Note: Times will decrease with higher bolus size, breath rate, ambient temperature, power cartridge age and use over time.
• Loss of Power/Hot Power Cartridge
• Low Power Cartridge/Warm Power Cartridge
Audible Alarm Indicators
Back-Up Alarm Power 9V Internal Battery
Filters Air Inlet, HEPA, Compressor Intake
Device Classication IEC Class I, Type B Applied Part, IPX0
• Low Oxygen Output
• O
Flow Outside Normal Limits
2
• Unit Malfunction
• Low 9V battery
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Pulse Dose Mode Specications
Pulse Settings 1.0 to 6.0, in 8mL increments and 128mL, 160mL, 192mL Trigger Sensitivity Adjustable between settings of 1 (most sensitive) to 3 (least sensitive) Adjustable Bolus Rise Time Adjustable settings of Fast(factory setting), Medium, or Slow
• Cannula pressure has dropped below the trigger point (typically between 0.135—0.37
Trigger Criteria
Minimum time between breaths
Response to Missing Breaths
cm of H
• At least 1¼ seconds has passed since the last pulse began
1.25 seconds (max. 3 consecutive breaths)
While in Pulse Dose Mode, the Eclipse 5 is always monitoring for breath detection. After 15 seconds of no breath detected, the Eclipse 5 “delivers” Continuous Flow at the last Continuous Flow setting. After another 15 seconds, the Eclipse 5 stops delivering Continuous Flow and waits 15 seconds for a breath. The Eclipse 5 will stay in this modality until a breath is detected. (See Power Cartridge Conservation Feature, page 26.)
O of negative pressure)
2
Pulse Dose
BOLUS VOLUME +/ 15%
Setting
1.0 16 40 40
2.0 32 40 40
3.0 48 40 40
4.0 64 40 31
5.0 80 37 25
6.0 96 31 20
- 128 23 15
- 160 18 12
- 192 15 10
Bolus Size
(± 15%) mL
NOTE: Bolus volume decreases as breath rate exceeds published range.
Power Accessory Specications
AC Power Supply
Input Voltage 100-240VAC, 50-60 Hz
Input Power 245-260 VA
Output Voltage 28 VDC
Output Power 200W
AC Power Supply and
Power Cartridge (Battery)
Max Breath
Rate
DC Power Supply
Input Voltage 11.5-16VDC
Output Voltage 26 VDC
Output Power 150W Max
DC Power Supply
Max Breath
Rate
Power Cartridge (Battery)
Output voltage 14.8 VDC
Capacity
Nominal Power Cartridge Life 80% Capacity after 500 Charge/Discharge cycles
Power Cartridge Recharge Time
Quantity (2) 97.5 W-hrs batteries
(Each containing 7.92 grams equivalent Lithium content)
1.8 to 5.0 hours, dependent on ow setting, to achieve 80% capacity from a fully discharged Power Cartridge
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Independent Safety Testing
Eclipse System and Eclipse Concentrator, Model 1000B
Safety
Electromagnetic Compatibility
AC Power Supply, Model 5941
Safety IEC 60601-1:1988 + A1:1991 + A2:1995
Electromagnetic Compatibility
DC Power Supply, Model 5942
Safety
Electromagnetic
Compatibility
Power Cartridge 2400, PN 7082
Safety
Electromagnetic Compatibility
IEC 60601-1 :1988 + A1 :1991 + A2 :1995 + Corrigendum (6/95) EN 60601-1(1990) + A1(1993) + A2(1995) + A12(1993) + A13(1996) + Corrigenda (7/94)
FCC 15B (Sec. 107 & 109), EN55011, EN60601-1-2 :2001, EN6100-3-2, EN61000-3-3, IEC61000-4-2, IEC61000-4-3, IEC61000-4-4, IEC61000-4-5, IEC61000-4-6, IEC61000-4-8, IEC61000-4-11, IEC 60601-1­2 :2001, RTCA DO 160 Rev E
FCC 15B (Sec. 107 & 109), EN55011, EN60601-1-2 :2001, EN6100-3-2, EN61000-3-3, IEC61000-4-2, IEC61000-4-3, IEC61000-4-4, IEC61000-4-5, IEC61000-4-6, IEC61000-4-8, IEC61000-4-11, EN55014-1
Portions of IEC 60601-1:1988 + A1:1991 + A2:1995
FCC 15B (Sec. 109), EN55011, EN60601-1-2 :2001, IEC61000-4-2, IEC61000-4-3, IEC61000-4-4, IEC61000-4-6, IEC 60601-1-2 :2001
IEC 62133, UL60950-1, First Edition (UL File MH29443), IEC 60601-1:1988 + A1:1991 + A2:1995, UN Transportation Tests T1-T8
EN 61000-6-3 :2001 (EN55022 :1998+A1 :2001+A2 :2003), EN61000-6-1 :2001, EN61000-4­2 :1995+A1 :1998, EN61000-4-3 :2002
Any CSA-CUS mark for the Eclipse 5 system does not encompass operation with the DC Power Supply Model 5942.
PROVIDER SUPPORT POLICY
Objective: As a manufacturer our organizational goal is to provide customer support and assistance to
the highest level of excellence.
Customers are Providers (which include Dealers, Distributors and Agents). Support includes, but is not limited to, troubleshooting and Return Material Authorizations (RMA). Business Hours are Monday – Friday, 8:00am – 5:30pm EST.
Chart-SeQual can only support customers who are recognized as Providers, Dealers, Distributors and/or Agents. These partnerships are qualied as having an existing account or are in the process of credit application completion. All patient or end-user inquiries including but not limited to RMA, warranty or serial number questions must be handled by their Provider.
Provider Support Policy: Chart-SeQual Technologies is unable to provide direct assistance, clinical advice or recommenda­tions to a patient or end-user. Providers have sole responsibility in assisting their patients.
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ELECTROMAGNETIC COMPATIBILITY
This equipment has been tested and found to comply with the limits for medical devices to the IEC60601-1-2 Electromagnetic Compatibility standard. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed according to the instructions, may cause harmful interference to other devices in the vicinity. There is, however no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment o and on, the User is encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving device.
• Increase the separation distance between the equipment.
• Connect the equipment into an outlet on a circuit dierent from that which the other device(s) are connected.
• Consult with Chart SeQual’s Technical Support Department for help.
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual.
Portable and mobile RF communications equipment can aect Medical Electrical Equipment.
The use of Accessories, transducers, and cables other than those specied, with the exception of transducers and cables sold by the Manufacturer of this device as replacement parts for internal components, may result in increased Emissions or decreased Immunity of the Eclipse 5.
The Eclipse 5 should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the Eclipse 5 should be observed to verify normal operation in the conguration in which it will be used.
Guidance and Manufacturer’s Declaration ­electromagnetic emissions
The Eclipse 5 is intended for use in the electromagnetic environment specied below. The customer or the user of the Eclipse 5 should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic environment - guidance
RF emissions
EN 55011
RF emissions
EN 55011
Harmonic emissions IEC 61000-3-2
Voltage uctuations/ icker emissions IEC 61000-3-3
Group 1
Class B
Class A
Complies
The Eclipse 5 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
The Eclipse 5 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low - voltage power supply network that supplies buildings used for domestic purposes.
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Guidance and manufacturer’s declaration–electromagnetic immunity
The Eclipse 5 is intended for use in the electromagnetic environment specied below. The customer or the user of the Eclipse 5 should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Electromagnetic environment – guidance
IEC 61000-4-2
Electrical fast tran­sient/burst
±6 kV contact
±8 kV air
±2 kV for power supply lines
±6 kV contact
±8 kV air
±2 kV for power supply lines
Floors should be wood, concrete or ceramic tile. If oors are covered with synthetic mate­rial, the relative humidity should be at least 30 %.
Mains power quality should be that of a typi­cal commercial or hospital environment.
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
Power frequency (50/60 Hz) mag­netic eld IEC 61000-4-8
NOTE UT is the a.c. mains voltage prior to application of the test level.
±1 kV for input/output lines
±1 kV line(s) to line(s)
±2 kV line(s) to earth
<5 % UT (>95 % dip in UT ) for 0,5 cycle
40 % UT (60 % dip in UT ) for 5 cycles
70 % UT (30 % dip in UT ) for 25 cycles
<5 % UT (>95 % dip in UT ) for 5 sec
3 A / m 3 A / m Power frequency magnetic elds should be at
N/A
±1 kV line(s) to line(s)
±2 kV line(s) to earth
<5 % UT (>95 % dip in UT ) for 0,5 cycle
40 % UT (60 % dip in UT ) for 5 cycles
70 % UT (30 % dip in UT ) for 25 cycles
<5 % UT (>95 % dip in UT ) for 5 sec
Mains power quality should be that of a typi­cal commercial or hospital environment.
Mains power quality should be that of a typi­cal commercial or hospital environment. If the user of the Eclipse 5 requires continued operation during power mains interruptions, it is recommended that the Eclipse 5 be pow­ered from an uninterruptible power supply or a battery.
levels characteristic of a typical location in a typical commercial or hospital environment.
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Guidance and manufacturer’s declaration–electromagnetic immunity
The Eclipse 5 is intended for use in the electromagnetic environment specied below. The customer or the user of the Eclipse 5 should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Conducted RF IEC 61000-4-6
3 Vrms 150 kHz to 80 MHz
3 Vrms
Portable and mobile RF communications equipment should be used no closer to any part of the Eclipse 5, including cables, than
the recommended separation distance cal­Radiated RF IEC 61000-4-3
3 V/m 80 MHz to 2,5 GHz
3 V/m
culated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
d = 1.2 P
80 MHz to 800 MHz
d = 1.2 P
800 MHz to 2,5 GHz
d = 2.3 P
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in metres
(m).
Field strengths from xed RF transmitters, as
determined by an electromagnetic site sur-
vey, ashould be less than the compliance level
in each frequency range. b
Interference may occur in the vicinity of
equipment marked with the following sym-
bol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and people.
a
Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the Eclipse 5 is used exceeds the applicable RF compliance level above, the Eclipse 5 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Eclipse 5.
b
Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
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Pd 2.1
Pd 2.1
Pd 3.2
Recommended separation distances
between portable and mobile RF communications equipment and the Eclipse 5
The Eclipse 5 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The cus­tomer or the user of the Eclipse 5 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Eclipse 5 as recommended below, according to the maximum output power of the communications equipment.
Rated maximum out-
put power of transmit-
ter
W
0,01 0.12 0.12 0.23
0,1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
Separation distance according to frequency of transmitter
m
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reection from structures, objects and people.
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Personal Ambulatory Oxygen System Provider Technical Manual
How The Eclipse 5 Works
INTRODUCTION
The Eclipse 5, Personal Ambulatory Oxygen System with autoSAT Technology is a portable medical device used to extract oxygen from the atmosphere, concentrate it to 87–95.6% and present the oxygen to the patient. The device will operate in Continuous Flow Mode or Pulse Dose Mode. In Continuous Flow Mode the oxygen is provided at a constant ow rate between
0.5 and 3.0 LPM. In Pulse Dose Mode, oxygen is supplied in a bolus at the beginning of each inspiration, providing a selectable range setting of 16mL to 192mL.
The Eclipse 5 operates from either external power or from an internal rechargeable Power Cartridge. The system includes a “Smart” battery charger that recharges the internal Power Cartridge whenever the Eclipse 5 is connected to AC or DC power. The system monitors and controls both the power source and the Power Cartridge charger.
Figure 1: Eclipse 5 System Block Diagram
ATF® CONCENTRATOR MODULE
The Eclipse 5 uses a passive system to separate oxygen from air. Air ows into the Eclipse 5 where it is ltered and then enters the compressor. Pressurized air ows from the compressor into the ATF® Concentrator Module where it is separated into oxygen and nitrogen components. The air separation process uses a rotary valve system to force air through a series of pressurized sieve beds. Through a process known as “vacuum pressure swing adsorption,” nitrogen molecules are collected on an adsorbent material allowing the concentrated oxygen to be forced through a sieve bed into the product tank. The nitrogen molecules are then purged from the adsorbent material using a vacuum pressure cycle.
Oxygen ows from the product tank through a HEPA lter and past a sensor that measures ow and concentration. A ow control valve regulates the ow of concentrated oxygen presented to the patient. The process is continuously repeated during operation.
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COMPRESSOR AND COMPRESSOR ENCLOSURE
The Eclipse 5 Compressor is a two-cylinder, variable speed wobble piston compressor, driven by a highly ecient Brushless DC (BLDC) motor. When air ows into the Compressor enclosure, it passes through an air intake lter/muer that mues sound and lters out impurities. Using one cylinder, the compressor takes in ltered air and delivers it to the ATF Module under pressure. The second cylinder draws a vacuum on the ATF module and exhausts nitrogen rich gas to the exhaust vent.
Using a multifaceted approach, sound, heat, and vibration generated by the compressor are mitigated by the compressor enclosure. Vibration and structure-borne noise are addressed by the dual axis gimbal that supports the compressor and the tubing that connects the compressor to the ATF module. The rigid walls of the compressor enclosure and the sound adsorbing foam that lines it diminish the radiated noise. The centrifugal blower mounted within the compressor enclosure serves to eciently draw cooling air in over the compressor cylinders while simultaneously pushing exhaust gas out of the concentrator.
POWER DISTRIBUTION
The Power Manager takes external power that comes into the Eclipse 5 from the power supplies or Power Cartridge and monitors and controls power distribution to the rest of the Eclipse 5 system. The Power Manager drives the compressor, ATF module motor, blower, and provides power to the Control Board. In addition, when the unit is connected to an external power source, the power manager monitors and controls the recharging of the Power Cartridge.
CONTROL BOARD
The Control Board is at the center of nearly all Eclipse 5 functions. The board constantly monitors dynamics such as temperatures, pressures, product ow and concentration, and user input. It determines proper compressor and ATF motor speeds needed in order to provide optimum system performance. In addition, this system supports the operation of the Control Panel and its indicators.
The Control Board utilizes a proprietary ultrasonic ow and concentration sensor and a ow control valve to accurately control the ow of oxygen in Continuous Flow and Pulse Dose Modes.
Control BoardProduct Pressure
Figure 2: Flow Sensor Board Diagram
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CONTROL PANEL
The control panel provides a user interface consisting of a membrane panel keyboard, Liquid Crystal Display (LCD), external power present indicator, Power Cartridge capacity indicator, alarm status indicators, and an audio transducer. The user interface informs the user of the system status and allows the user to set the desired ow rate and ow mode.
Figure 3: User Control Panel
USER CONTROLS AND SYSTEM STATUS INDICATORS
The Eclipse 5 control panel displays important operating information. This section will help you understand this op­erating information.
ON/OFF Button (Green) Indicator: This button powers the device ON or OFF. The Green Indicator is
illuminated when the device is ON.
Increase or Decrease Setting Buttons:
Use these buttons to change prescribed settings.
Delivery Mode Button and Indicator: The button toggles between Continuous Flow and Pulse Dose
Mode. The Pulse Dose Mode activates autoSAT Technology—as the patient’s breath rate changes, the Eclipse 5 servo controls the unit to provide a consistent bolus size. The Pulse Dose Mode allows a signicant increase in the operating time while powered by the battery. When Pulse Dose Mode is activated, the green Delivery Mode Indicator illuminates and a pulse of oxygen is delivered with each inspiratory eort. When in Continuous Mode, the LED is o.
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USER CONTROLS AND SYSTEM STATUS INDICATORS, CONT.
Symbol Denition Symbol Denition
No Smoking Icon (button): Do not smoke near unit. Providers can access provider mode software functions using the Control Panel. All
provider mode information is displayed on the LCD. The software shall advance the following Eclipse 5 display mode when the “No Smoking” icon is pressed (see pg. 15).
ALERT (Yellow) Indicator—Low and Medium Priority Alerts:
When illuminated, this indicates a low priority awareness condition or Caution. Use of the unit may continue and refer to the Troubleshooting Table for the proper response. A ashing yellow indicates a medium priority alert. A prompt response is necessary.
ALARM (Red) Indicator —High Priority Alarms: Indicates a high priority alarm condition. An immediate response is necessary. Refer to the Troubleshooting Table.
Flow Setting Indicator: This is the main focus on your control panel. The home care provider will correctly set the prescribed ow for either the Continuous Flow Mode (LPM) and/or the Pulse Dose settings (mL). Each time you power the device ON, the previous mode and/or setting has been saved and will be used at start-up.
Power Cartridge (battery) Status Gauge: This indicator displays the charge remaining in the battery. Each of the ve horizontal gray bars represents approximately 20% of the total battery charge. When the battery is being charged, the charge indicator bars will blink in a waterfall-type fashion. If the battery is not installed, or if it is improperly installed, the Power Cartridge (battery) Status Gauge will not be illuminated.
External Power Indicator: When the Eclipse 5 is properly plugged in and is using the AC or DC Power Supply, this indicator will appear on the User Control Panel.
FAA approved for use aboard passenger aircraft.
Pulse Mode Operation
Device operating normally; power button
Do not get wet.
Type B Applied Part (degree of protection against electric shock)
Use no oil or grease.
DC Voltage No open or naked ames.
Drip Proof Equipment-IPX0: The Eclipse 5 enclosure does not provide protection against the harmful eects of the ingress of liquids. (IPX0, per IEC 60529)
Read user manual before operation. See user manual for instructions.
This symbol is to remind the equipment owners to return it to a recycling facility at the end of its life, per Waste Electrical and Electronic Equipment (WEEE) Directive.
Name and address of manufacturer Authorized representative in the European Community
Buzzer:
An audible alarm (or buzzer) is used to alert you to the operating condition of the device, either a warning or failure, and to conrm a valid key press by the user.
No serviceable parts insde. Do not open cover.
Certied for both the U.S. and Canadian markets, to the applicable U.S. and Canadian standards.
This device complies with the requirements of Directive 93/42/EEC concerning medical devices. It therefore bears the CE marking as shown.
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CONTINUOUS FLOW MODE
Continuous Flow Mode delivers a constant ow of oxygen to a patient by means of tubing and a nasal cannula at rates between 0.5 LPM and 3.0 LPM. Within the Eclipse 5, concentrated oxygen is stored in a 500ml product tank at pressures in the range of 5 to 9 psi. This pressure gives Continuous Flow Mode the capability to deliver the indicated ow rate to the patient even if extension tubing is used, up to 50 feet long. In addition, the Eclipse 5 Continuous Flow Mode is fully compatible with humidier use, with NC not exceeding 7 ft.
PULSE DOSE MODE
The Eclipse 5 Pulse Dose Mode delivers a measured bolus of oxygen at the very beginning of each inspiration. The approach is based on the manner in which gas is absorbed into a patient’s airway. Eclipse 5 users may select pulse dose volume delivery rates. Regardless of setting, the pulse prole is a simple square-wave pulse based on a 16 mL volume. (Refer to “Pulse Proles” table below). Pulse durations are no less than 100 milli-seconds at the beginning of the inspiration. There are three Rise Time settings (Slow, Medium, and Fast). The table below is for the FAST Rise Time setting (factory default is Fast).
Flow
Setting
1 8 120 16
2 9 213 32
3 10 288 48
4 11 349 64
5 12 400 80
6 13 443 96
128 15 512 128
160 17 565 160
192 19 606 192
The fundamental approach to triggering and controlling the oxygen bolus in Pulse Dose Mode is as follows:
The User may select a pulse trigger sensitivity in settings ranging from 1-3. Bolus volume should be prescribed by a physician and may range from 16mL up to 192mL. The pulse will be triggered when the system meets all of the following criteria:
• The cannula pressure has dropped below the trigger point (typically between 0.135 and 0.37 cm H20)
Pulse Peak Flow,
LPM (volumetric)
Pulse Proles
Pulse Duration
(milli-second)
Bolus
Volume (ml)
• At least 1¼ seconds has passed since the last pulse began
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PROVIDER MODE FUNCTIONS
Providers can access provider mode software functions using the Control Panel. All provider mode information is displayed on the LCD. The software shall advance the following Eclipse 5 display mode when the “No Smoking” icon is pressed:
• AlarmCode(ALRM)-Displaysmostrecentalarmcode.Additionalalarmcodes will also be displayed, if present, by continuing to press the + key.
• PulseSensitivity(PS)
• HoursofOperation(HRS)
• 9-voltBatteryStatus(9V)
• RiseTime(BOL)
• ControlBoardSoftwareRevision(CS)
• PowerManagerSoftwareRevision(PM)
ALARM CODE
While in Continuous Flow Mode, pressing the “No Smoking” icon displays the current Eclipse 5 alarm code on the LCD. This code may be used to help diagnose conditions indicated by the alert and alarm indicators. The LCD will show “ALRM=”. Refer to the “Level 1 Maintenance” section for further information.
PULSE MODE SENSITIVITY ADJUSTMENT
During patient setup, a qualied clinician may adjust the Pulse Mode sensitivity to best suit patient inspiratory eort. The LCD will show “PS=x”. PS=1 is the most sensitive setting, PS=3 is the least sensitive setting. Factory defaut is PS=2.
HOURS OF OPERATION
The Eclipse 5 hour meter provides valuable information on hours of operation. Providers may display the total number of hours of operation using the Control Panel. The display counts up to “99,999” hours, then rolls over to “00000.” The LCD will show “HRS xxxxx”. Refer to the “Level 1 Maintenance” section for further information.
9VOLT BATTERY STATUS
The status of the 9-Volt Battery is provided. This is the actual voltage of the 9-Volt battery. The LCD will show “9V=x.x”.
RISE TIME BOLUS DELIVERY
During patient set up, a qualied clinician may adjust the Rise Time (fast, medium or slow), i.e. how quickly the set bolus volume is delivered. The LCD will display “BOL=”. Factory default is BOL=FAST.
SOFTWARE VERSION
Providers may occasionally need to obtain the software version on the Eclipse 5 to perform maintenance. The provider may display software version numbers for both the Control Board and the Power Manager software using the Control Panel. Refer to the “Level 1 Maintenance” section for further information.
Example: CB394111: Control Board PCB: PN 3941 with Rev 1.1 software PM593211: Power Manager PCB: PN 5932 with Rev 1.1 software
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SERVICE MODE FUNCTIONS
Factory maintenance or service updates may sometimes be required on the Eclipse 5. Factory and qualied factory-trained technicians can access service mode software functions by using the Service Port located on the back of the unit. The Service Port is not for patient use.
Figure 4: Eclipse 5 Service Port
ECLIPSE 5 DATA ACQUISITION TOOL EDAT
EDAT is the world’s rst computer-based data retrieval service tool for oxygen concentrators. EDAT is proprietary to SeQual Technologies Inc., and is comprised of both hardware and software components. EDAT is SeQual’s global solution for your service and support needs.
EDAT software is capable of sensing and displaying historical event logs and values of components and sensors within the Eclipse 5 system. This can be used to determine system faults or user errors and communicate data for troubleshooting or documentation related to service and updates. EDAT hardware attaches or Plugs into the Eclipse 5 Service Port, and into a computer’s USB port.
The EDAT software set allows a provider to set-up a hub and spoke service center. Field service reps can travel to a patient’s home, troubleshoot and transmit the data to either in-house tech support personnel or SeQual. Support personnel can diagnose, provide solutions and print documentation for equipment records.
EDAT also makes Eclipse 5 software upgrades easy and accessible.
For more information on EDAT, contact Chart-SeQual Technologies Technical Service at 1-800-482-2473 and reference EDAT PN 5535-SEQ.
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POWER SUPPLIES
The Eclipse 5 may operate from either the AC or DC Power Supply or the Power Cartridge. When power is available from an external supply, the Eclipse 5 will draw from the external source rather than depleting the Power Cartridge. Connection to external power is indicated when the External Power Present Indicator located on the Control Panel is illuminated.
AC POWER SUPPLY
The AC Power Supply is a universal input type, capable of accepting 100-240VAC, 50/60 Hz. It is capable of delivering up to 200W of 28VDC output. The input cord requires a grounded receptacle. Country specic cords or universal power adapter PN 5591-SEQ may be used with the AC Power Supply, as the power supply is equipped with a universal input receptacle. When used in a medical care facility, international safety standards require the use of hospital grade AC power cord with the Eclipse 5.
Figure 5: Eclipse 5 AC Power Supply
The Eclipse 5 AC Power Supply does not contain a fan. When in use, the AC Power Supply should be located in a well-ventilated area.
Located near the output cord, there is a green LED that is illuminated when the AC Power Supply is supplying 28VDC power. If the LED is not illuminated, there is no input power available. In addition, the Power Supply contains protection circuits for output over-current, input over-voltage, and internal over-temperature conditions. If any of these conditions exist, output power will be interrupted and the LED turns o. However, these three conditions are self-resetting, such that output power will resume when protection circuits fall back into acceptable operating ranges.
DC POWER SUPPLY
The DC Power Supply is intended for use with DC accessory outlets, such as those found in motor vehicles. Input voltage to the DC Power Supply is 11.5-16 VDC. Sized to be compatible with most passenger vehicle electrical systems, it is capable of delivering up to 150W of 26VDC output to the Eclipse 5.
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Figure 6: Eclipse 5 DC Power Supply
Located near the output cord, there is a green LED that is illuminated when the DC Power Supply is supplying 26VDC power. If the LED is not illuminated, there is no input power available. The Power Supply contains protection circuits for output over­current, input over-voltage, and internal over-temperature conditions. If any of these conditions exist, output power will be interrupted and the LED will turn o. These three conditions are self-resetting, and output power will resume when protection circuits fall back into acceptable operating ranges.
The Eclipse 5 will run at all ow settings when being operated with the DC power supply in a vehicle including 3.0LPM on continuous ow and 192mL in pulse mode. The Eclipse 5 will charge the power cartridge while being operated with the DC power supply while running at 2.0LPM or below with continuous ow. The power cartridge can charge at all pulse ow rates, however charging functionality may stop depending on the breathing rate of the user. If the Eclipse 5 power cartridge is being charged, the battery symbol will display with a waterfall animation. However, if the power cartridge is not charging then the battery symbol will remain steady and display the current charge capacity.
DO NOT use the DC supply to power the Eclipse 5 once the vehicle’s engine is turned o as this may drain the car’s battery.
POWER CARTRIDGE BATTERY
The Power Cartridge allows operation away from AC or DC power. The Power Cartridge used with the Eclipse 5 contains Lithium ion battery cells, similar to those used in laptop computers and cell phones. The Eclipse 5 Power Cartridge contains a quantity of two 97.5 Watt hour battery packs. Each battery pack contains 7.92 grams of equivalent lithium content.
Figure 7: Eclipse 5 Power Cartridge
The Power Cartridge (Battery) may be charged in two ways: (a) place the Power Cartridge in the Eclipse 5 and connect the Eclipse 5 to AC or DC power, or (b) place the Power Cartridge in the optional Desktop Charger (PN 7112-SEQ).
Operating and servicing the Power Cartridge will ensure longer life and higher performance. It is important to follow the tips and recommendations when storing and operating the Eclipse 5 on the Power Cartridge.
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The Eclipse 5 Power Cartridge operation time may be aected by several factors such as bolus size, breathing rates, ambient temperature, age of power cartridge and use over time. The table below describes the typical operating time for a new Power Cartridge.
If the Eclipse 5 is used in Pulse Dose Mode, there will be longer operating time. The patient should consult their physician for a prescription for Pulse Dose Mode.
TYPICAL NEW POWER CARTRIDGE OPERATING TIMES
(At nominal
temperature
FLOW RATE
SETTING
Continuous
Flow (LPM)
mL
SETTING
Pulse Dose
Mode (12 BPM)
of 25ºC/77°F)
0.5 4.4 hours - -
1.0 3.7 hours 16mL 1.0 5.4 hours
2.0 2.0 hours 32mL 2.0 5.1 hours
3.0 1.3 hours 48mL 3.0 4.9 hours
64mL 4.0 4.0 hours
80mL 5.0 3.7 hours
96mL 6.0 3.5 hours
128mL 2.5 hours
160mL 2.0 hours
192mL 1.7 hours
Battery Consumption Chart
NOTE: Battery times will decrease with higher bolus size, breath rate, ambient temperature, Battery age and use over time.
The Power Cartridge packaged with the Eclipse 5 is not fully charged. Before using the Eclipse 5 Oxygen System for the rst time, the Power Cartridge must be fully charged.
Store the power cartridge in a cool, dry location. Do not leave the Eclipse 5 or Power Cartridge in a vehicle or trunk during a hot or cold day.
When checking the Eclipse 5 as baggage on a commercial airline ight for international travel, remove the Power Cartridge and properly package.
When shipping the Eclipse 5 for any reason, remove the Power Cartridge from the Eclipse 5.
If the Power Cartridge gets too warm, charging will not begin until the Power Cartridge suciently cools. Consider removing the Power Cartridge to allow for faster cooling.
The Power Cartridge operating time is longer if the Eclipse 5 is operated in Pulse Dose Mode. (Refer to Battery Consumption Chart above.)
The typical time to recharge the Power Cartridge to achieve 80% capacity from a fully discharged Power Cartridge is 1.8 hours to 5.0 hours, dependent upon the ow setting.
The capacity of the Eclipse 5 Power Cartridge is determined by electronics and the Eclipse 5 software.
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WARNING:
CAUTION
CAUTION
CAUTION
DO NOT tamper with, disassemble, crush or heat the Power Cartridge above 140° F (60° C). The Power Cartridge may present a risk of re or explosion and will void the warranty.
Store the Power Cartridge in a cool, dry place when not in use.
DO NOT leave the Eclipse 5 or the Power Cartridge in a vehicle or in the trunk during a hot or cold day.
The Eclipse 5 system can only work with a SeQual Power Cartridge. Use of another Power Cartridge or Battery may damage the unit, present a risk of re or explosion and will void the warranty.
Figure 8: Power Cartridge Status Gauge
While the Eclipse 5 Power Cartridge allows the concentrator to operate at its full range of capabilities, the primary purpose of the Power Cartridge is to allow a patient to ambulate while they are moving between stationary power sources. The Eclipse 5’s Power Cartridge, like all lithium ion batteries, is susceptible to permanent damage from excessive heat. Exposure to excessive heat may signicantly shorten the service life of the Power Cartridge.
Each Power Cartridge contains multiple temperature sensors to monitor battery cell temperature. The amount of heat the Power Cartridge can safely endure varies depending on how the Power Cartridge is being used. During discharge, the Eclipse 5 software will alarm when internal battery cell temperature exceeds 60°C, and will shut the system down if internal battery cell temperature exceeds 70°C. While the Power Cartridge is charging, software will interrupt charger operation when the internal battery temperature exceeds 45°C or temperature is less than 0°C . In both of these cases, when internal battery cell temperature falls within these limits, the Eclipse 5 will resume normal operation. Operation near these temperature limits will not damage the Power Cartridge, but are in place to ensure that the service life of the Power Cartridge is preserved.
Heat in the Power Cartridge is generated during discharge, and can also be the result of operating the Eclipse 5 in high ambient temperatures. The amount of internally generated heat varies with the ow setting – higher ows induce greater Power Cartridge heating. While high ambient temperatures are typically the result of operation on a hot day, running the Eclipse 5 with inadequate ventilation can also add additional heat. Always ensure that the Eclipse 5 is operated in a well­ventilated space, the air intake lter is clean, and intake and exhaust vents are unobstructed.
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CHARGING ALGORITHM
The charging algorithm is performed by the Power Manager software and involves three basic decisions:
1. When to start charging
2. How fast to charge
3. When to stop charging
Charging begins when Power Cartridge voltage falls below 16.0 volts.
The charging current is limited by the charger capability and the rated capacity of the Power Cartridge. Under certain conditions, the Eclipse 5 may not have enough external power available to charge the batteries at the full rate. In this case, the charging rate will be limited to the available power.
As the Power Cartridge accumulates charge, the charging current required will eventually fall. When the charging current for each Power Cartridge has fallen below 5% of the rated capacity, charging is complete and the Power Cartridge charger is shut o.
The software will only charge when the Power Cartridge temperature is at or below 45°C. The software will always run the cooling fan whenever the charger is enabled. The Power Cartridge charger is disabled and the cooling fan is set to maximum whenever the Power Cartridge temperature exceeds 45°C. The Power Cartridge charger is disabled when temperature is less than 0°C.
All lithium ion batteries self-discharge at very low rates when not in use. Eclipse 5 Power Cartridges are shipped from SeQual in a partially charged state (nominally 40%). When stored in a cool, dry location, the Power Cartridge can sit unused for up to 12 months without appreciable self-discharge occurring. Nevertheless, CAIRE recommends a rst in, rst out rotation of Power Cartridge inventory for maximum Power Cartridge service life.
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Training The Patient
INTRODUCTION
Welcome to the Eclipse 5, Personal Ambulatory Oxygen System with autoSAT Technology. Setting up and training your patient to use the Eclipse 5 has never been easier! You can expect your patients and care providers to easily learn how to use the device by following the directions in this section. While setting up and training a patient, be sure to point out the advantages of the Eclipse 5. For example:
Slim and sleek appearance Easy-to-use controls Quiet operation Lower electric bills Self-monitoring alarm system More consistent FiO2 at higher breath rates
After completing each training procedure, ask your patient if he or she has any questions. Proper training of your patients will result in fewer service calls, improved compliance and increased patient satisfaction.
PREDELIVERY CHECK LIST
Before delivering the device, check and log the status of the following:
Parts Inventory – Verify that each Eclipse 5 is provided to the patient with the following items:
aUsers Manual
aQuick Start Guide
aEclipse 5 Passport
aUniversal Cart
aCannula
Power Sources – Insert and check the following for proper operation:
aAC Power Supply with Power Cord aDC Power Supply aPower Cartridge (Battery)
Electrical System – Use the Control Panel to check and/or adjust the following:
 a Pulse Dose Setting aContinuous Flow Setting a Hour meter aPulse Dose Sensitivity
The Eclipse 5 is shipped from SeQual at default ow settings of 2 LPM Continuous Flow, 2.0 Pulse Dose, and 2 for Pulse Mode Sensitivity Adjustment and FAST Rise Time. You may adjust these settings to your patient’s prescription when you deliver and set up the device.
a 9V Battery Status a Rise Time a Software Revision a Power Cartridge Status Gauge
aAC Power Cord
aAC Power Supply
aDC Power Supply
aPower Cartridge (Battery)
aAir Inlet Filter and Spare
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INDICATIONS FOR USE
The Eclipse 5 is indicated for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
A physician must prescribe a specic oxygen ow rate setting to meet patients’ individual needs.
Recommended oxygen ow rates should be adjusted only under the advice of a physician.
WARNING:
Federal law restricts this device to sell by or on the order of a physician.
CONTRAINDICATIONS
WARNING:
The Eclipse 5 is not intended for life supporting or life sustaining applications, nor does it provide any patient monitoring capabilities.
WARNING:
WARNING:
WARNING:
In certain circumstances, the use of non-prescribed oxygen can be hazardous. This device should only be used when prescribed by a physician.
Not for use in the presence of ammable anesthetics.
As with any electrically powered device, the user may experience periods of non-operation as a result of electrical power interruption, or the need to have the Eclipse 5 serviced by a qualied technician. The Eclipse 5 is not appropriate for any patient who would experience adverse health consequences as a result of such temporary interruption.
BASIC CONCEPT TRAINING
The following section is intended to assist the provider to train the patient or caregiver to use the Eclipse 5. Topics in this section should be discussed with each patient prior to release for use of the Eclipse 5.
SAFETY GUIDELINES AND OPERATIONAL SAFETY WARNINGS & CAUTIONS
Provider should review all safety guidelines and operational safety Warnings/Cautions with each patient. In addition, provider should carry out a risk assessment prior to installation of the Eclipse 5 to assure proper connection and compatibility with other equipment the patient may be using.
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