C-Aire Eclipse 5 Manual de usuario

PROVIDER TECHNICAL MANUAL

Eclipse 5™with autoSAT®

Personal Ambulatory Oxygen System (PAOS)™

General Information..................................................4

Warning and Caution Statements........................................... 4

Introduction to the Eclipse 5 Oxygen System................. 5

Eclipse 5 Oxygen System Specications..................6

Pulse Dose Mode Specications .............................................. 7

Power Accessory Specications ............................................... 7

AC Power Supply ......................................................................... 7

DC Power Supply......................................................................... 7

Power Cartridge (Battery)....................................................... 7

Independent Safety Testing ........................................................ 8

Provider Support Policy ................................................................. 8

Electromagnetic Compatibility................................................. 9

Guidance and Manufacturer’s Declarations...................... 9

How The Eclipse 5 Works.........................................13

Introduction........................................................................................13

ATF®Concentrator Module.........................................................13

Compressor and Compressor Enclosure...........................14

Power Distribution..........................................................................14

Control Board.....................................................................................14

Control Panel ......................................................................................15

User Controls & System Status Indicators.........................15

Continuous Flow Mode...............................................................17

Pulse Dose Mode.............................................................................17

Provider Mode Functions............................................................18

Alarm Code....................................................................................18

Pulse Mode Sensitivity Adjustment ...............................18

Hours of Operation...................................................................18

9V Battery Status........................................................................18

Rise Time (Bolus Delivery).....................................................18

Software Version.........................................................................18

Service Mode Functions..............................................................19

Eclipse 5 Data Acquisition Tool (EDAT).........................19

Power Supplies..................................................................................20

AC Power Supply .......................................................................20

DC Power Supply.......................................................................20

TABLE OF CONTENTS

Power Cartridge................................................................................21

Typical New Power Cartridge Operation Time........21

Charging Algorithm.................................................................24

Training The Patient ................................................25

Introduction........................................................................................25

Pre-Delivery Check List...........................................................25

Indications for Use...........................................................................26

Contraindications ............................................................................26

Basic Concept Training.................................................................26

Safety Guidelines and Operational Safety

Warnings/Cautions.............................................................26

Locating the Eclipse 5 for Proper Use and

Ventilation ................................................................................27

The Users Manual......................................................................27

Showing Panel Buttons, Indicators, Alerts

and Alarms...............................................................................27

Showing Power Cartridge Power Level.......................28

Selecting the Proper Flow Mode and Setting .........28

Selecting Continuous Flow Mode ..................................28

Selecting Pulse Dose Mode ................................................28

“Power Cartridge (Battery) Conservation”

Feature.........................................................................................29

Adjusting the Pulse Mode Sensitivity Setting..........29

Adjusting Rise Time..................................................................30

Connecting the AC Power Supply..................................30

Connecting the DC Power Supply..................................31

Active Lifestyle Training ...............................................................31

Attach the Universal Cart......................................................32

Using Around the House......................................................32

Traveling by Vehicle..................................................................32

Traveling by Air............................................................................34

Traveling by Cruise Ship........................................................34

Traveling by Train.......................................................................34

Eclipse 5 Maintenance..................................................................35

Weekly Maintenance—Patient.........................................35

Clean the Air Inlet Filter .........................................................35

Clean and Care for the Tubing and Cannula ............35

Clean the Cabinet and Control Panel

and Power Supplies ...........................................................35

Monthly Maintenance—Patient ......................................36

Care for the Power Cartridge..............................................36

Calibrating the Power Cartridge ......................................36

Patient Training Checklist............................................................37

Annual Maintenance—Provider ............................38

Introduction........................................................................................38

Annual Maintenance Check List.......................................38

Checking and Replacing the Power Cartridge........38

Eclipse 5 Monthly Run-Time Cycle..................................38

Annual Maintenance Procedures ..........................................39

Removing the Unit Cover.....................................................39

Remove and Replace 9 Volt Battery...............................43

Remove and Replace HEPA Filter.....................................44

Internal Filters...............................................................................44

Remove and Replace the Compressor

Intake Filter..............................................................................46

Reinstalling or Replacing the Unit Cover....................48

Test Procedures.................................................................................49

Purity and Flow Rate Test

Procedure - Preferred Method ....................................49

Purity and Flow Rate Test Procedure-

Alternate Method................................................................49

Assembly and Alarm Verication Tests.........................50

Record Hours of Operation & Software Version......51

Electrical Safety Test.................................................................52

Cleaning the Eclipse 5 ............................................................52

Provider Service and Maintenance Record......................53

Shipping and Transporting the Eclipse 5....................54

Storing the Eclipse 5................................................................54

Discarding ......................................................................................54

Troubleshooting, Service, and

Repair Procedures ..............................................55

System Troubleshooting and Alarms ..................................56

Alarm Conditions and Alarm Codes ....................................59

Malfunction Codes..........................................................................60

System Schematics and Diagrams........................................61

Oxygen Circuit...................................................................................63

Remove and Replace the ATF Module.........................63

Remove and Replace the Product Tank

Assembly (PN 4378-SEQ) Eclipse 5...........................67

Electronics............................................................................................70

Remove and Replace the Control

Board Assembly ..................................................................70

Remove and Replace the Buzzer Wire Harness.......72

Control Board Connector Diagram ................................73

Remove and Replace the Power Manager

Printed Circuit Board .........................................................74

Compressor .........................................................................................78

Remove and Replace the Compressor Box...............78

Maintenance and Replacement Parts.................................82

Preventative Maintenance Parts.......................................82

Replacement Parts List...........................................................82

Optional Accessories...............................................................83

CAIRE Inc. Customer Service Contact

Information.........................................................84

TABLE OF CONTENTS CONTINUED

Personal Ambulatory Oxygen System Provider Technical Manual

PN 20631679 Rev D

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:

NOTE: Places emphasis on an operating characteristic or important

consideration.

CAUTION

Important safety information for hazards that might cause serious

injury.

WARNING:

Important information for preventing damage to the Eclipse 5.

Personal Ambulatory Oxygen System Provider Technical Manual

PN 20631679 Rev D

INTRODUCTION TO THE ECLIPSE 5 OXYGEN SYSTEM

FRONT

Control Panel Handle

External Power

Receptacle

Power Cord

Retainer

Oxygen

Outlet Port

FAA

Approval

Icon

BACK

Power Cartridge Latch

Exhaust Vent

Power

Cartridge

(Battery)

FAA Approval Icon

Cart

Attachment

Location

Air Inlet

Filter

EDAT Service Port

(Not for Patient Use)

Rating Label &

Serial Number

Location

ECLIPSE 5 AC POWER SUPPLY

WITH NEMA POWER CORD

DC POWER SUPPLY

UNIVERSAL CART

POWER CARTRIDGE

BATTERY

PN: 5941-SEQ

PN: 5942-SEQ

PN: 7082-SEQ

PN: 5991-SEQ

Personal Ambulatory Oxygen System Provider Technical Manual

PN 20631679 Rev D

Oxygen Concentrator

Dimensions (H x W X D) 19.3 x 12.3 x 7.1 inches

(49.0cm x 31.2cm x 18.0cm)

Weight

Eclipse 5

Power Cartridge

15.0 pounds

3.4 pounds

Flow Settings

Continuous Flow (measured in Liters Per Minute LPM)

Pulse Dose (measured in mL)

0.5 to 3.0 LPM (0.5 liter increments)

Settings 1.0-6.0: 16-96mL (8mL increments)

Settings 7-9: 128mL, 160mL, 192mL

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

Green Light = Normal Operation

Yellow Light = Warning or Caution, less than 85% ± 3%

Red Light Flashing = Abnormal Operation, less than 70% ± 5%

Nominal Sound Level

3.0 LPM Continuous Flow

3.0 Pulse Dose Mode

48 dB(A)

40 dB(A)

Operating Environment

Temperature

Humidity

50º F to 104º F (+10° to 40°C)

10% to 95%, Non-condensing, 82.4°F (28°C) Maximum Dew point

Storage Environment

Temperature

Humidity

-4º F to 140º F (-20° to 60°C)

Up to 95% Non-condensing

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

48 Watts

145 Watts

45 Watts

95 Watts

50 Watts

Nominal Power Cartridge operating time

Continuous Flow

2.0 LPM

3.0 LPM

Pulse Dose (@ 12 BPM)

Setting 2.0

Setting 6.0

Continuous Flow Indication Expressed in liters per minute (LPM)

Audible Alarm Indicators

• Loss of Power/Hot Power Cartridge

• Low Power Cartridge/Warm Power Cartridge

• Low Oxygen Output

• O2Flow Outside Normal Limits

• Unit Malfunction

• Low 9V battery

Back-Up Alarm Power 9V Internal Battery

Filters Air Inlet, HEPA, Compressor Intake

Device Classication IEC Class I, Type B Applied Part, IPX0

ECLIPSE 5 OXYGEN SYSTEM SPECIFICATIONS

Note: Times will decrease with higher bolus size,

breath rate, ambient temperature, power cartridge

age and use over time.

2.0 hours

1.3 hours

5.2 hours

3.5 hours

Personal Ambulatory Oxygen System Provider Technical Manual

PN 20631679 Rev D

Pulse Dose Mode Specications

Pulse Settings 1.0 to 6.0, in 8mL increments up to 96 mL; 7-9 in 32mL increments up to 192 mL

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

Trigger Criteria

• Cannula pressure has dropped below the trigger point (typically between 0.135—0.37

cm of H2O of negative pressure)

• At least 1¼ seconds has passed since the last pulse began

Minimum time between

breaths 1.25 seconds (max. 3 consecutive breaths)

Response to Missing 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.)

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

DC Power Supply

Input Voltage 11.5-16VDC

Output Voltage 26 VDC

Output Power 150W Max

Power Cartridge (Battery)

Output voltage 14.8 VDC

Capacity Quantity (2) 97.5 W-hrs batteries

(Each containing 7.92 grams equivalent Lithium content)

Nominal Power Cartridge Life 80% Capacity after 500 Charge/Discharge cycles

Power Cartridge Recharge Time 1.8 to 5.0 hours, dependent on ow setting, to achieve 80% capacity

from a fully discharged Power Cartridge

NOTE:Bolus volume decreases as breath rate exceeds published range.

BOLUS VOLUME +/ 15%

Pulse Dose

Setting

Bolus Size

(± 15%) mL

AC Power Supply and

Power Cartridge (Battery) DC Power Supply

Max Breath

Rate

Max Breath

Rate

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

7 128 23 15

8 160 18 12

9 192 15 10

Personal Ambulatory Oxygen System Provider Technical Manual

PN 20631679 Rev D

Independent Safety Testing

Eclipse System and Eclipse Concentrator

Safety 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)

Electromagnetic

Compatibility

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 60601-1-

2 :2001, RTCA DO 160 Rev E

AC Power Supply, Model 5941

Safety IEC 60601-1:1988 + A1:1991 + A2:1995

Electromagnetic

Compatibility

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

DC Power Supply, Model 5942

Safety Portions of IEC 60601-1:1988 + A1:1991 + A2:1995

Electromagnetic

Compatibility

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

Power Cartridge 2400, PN 7082

Safety IEC 62133, UL60950-1, First Edition (UL File MH29443), IEC 60601-1:1988 + A1:1991 + A2:1995, UN

Transportation Tests T1-T8

Electromagnetic

Compatibility

EN 61000-6-3 :2001 (EN55022 :1998+A1 :2001+A2 :2003), EN61000-6-1 :2001, EN61000-4-

2 :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.

CAIRE Inc. can only support customers who are recognized as Providers, Dealers, Distributors and/or Agents. These partner-

ships 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: CAIRE Inc. is unable to provide direct assistance, clinical advice or recommendations to a patient

or end-user. Providers have sole responsibility in assisting their patients.

Personal Ambulatory Oxygen System Provider Technical Manual

PN 20631679 Rev D

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 CAIRE’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 Group 1

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.

RF emissions

EN 55011 Class B

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.

Harmonic emissions IEC

61000-3-2 Class A

Voltage uctuations/

icker emissions IEC

61000-3-3

Complies

Personal Ambulatory Oxygen System Provider Technical Manual

PN 20631679 Rev D

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

±6 kV contact

±8 kV air

±6 kV contact

±8 kV air

Floors should be wood, concrete or ceramic

tile. If oors are covered with synthetic mate-

rial, the relative humidity should be at least

30 %.

Electrical fast tran-

sient/burst

IEC 61000-4-4

±2 kV for power supply

lines

±1 kV for input/output lines

±2 kV for power supply

lines

N/A

Mains power quality should be that of a typi-

cal commercial or hospital environment.

Surge

IEC 61000-4-5

±1 kV line(s) to line(s)

±2 kV line(s) to earth

±1 kV line(s) to line(s)

±2 kV line(s) to earth

Mains power quality should be that of a typi-

cal commercial or hospital environment.

Voltage dips, short

interruptions and

voltage variations

on power supply

input lines IEC

61000-4-11

<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

<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 typi-

cal 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 pow-

ered from an uninterruptible power supply or

a battery.

Power frequency

(50/60 Hz) mag-

netic eld IEC

61000-4-8

3 A / m 3 A / m Power frequency magnetic elds should be at

levels characteristic of a typical location in a

typical commercial or hospital environment.

NOTE UTis the a.c. mains voltage prior to application of the test level.

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