SeQual Technologies Eclipse 2 Manuale utente

SeQual®Technologies Inc.

Eclipse®2 Oxygen System

Model 1000A

Provider Technical Manual

Table of Contents

General Information.............................................................................................................................................6

WARNING AND CAUTION STATEMENTS.................................................................................................................6

INTRODUCTION TO THE ECLIPSE 2OXYGEN SYSTEM ............................................................................................7

Eclipse Oxygen System Specifications...............................................................................................................8

OXYGEN CONCENTRATOR...................................................................................................................................8

PULSE MODE SPECIFICATIONS............................................................................................................................9

POWER ACCESSORY SPECIFICATIONS.................................................................................................................9

AC Power Supply .........................................................................................................................................9

DC Power Supply.......................................................................................................................................10

Power Cartridge (Battery)...........................................................................................................................10

INDEPENDENT SAFETY TESTING........................................................................................................................10

How The Eclipse 2 Works .................................................................................................................................13

INTRODUCTION.................................................................................................................................................14

ATF® CONCENTRATOR MODULE ......................................................................................................................14

COMPRESSOR AND COMPRESSOR ENCLOSURE .................................................................................................15

POWER DISTRIBUTION ......................................................................................................................................15

CONTROL MODULE...........................................................................................................................................15

CONTROL PANEL..............................................................................................................................................16

CONTINUOUS FLOW MODE................................................................................................................................18

PULSE FLOW MODE..........................................................................................................................................18

PROVIDER MODE FUNCTIONS............................................................................................................................19

Alarm Code.................................................................................................................................................19

Display Total Hours of Operation...............................................................................................................19

Display Software Version ...........................................................................................................................19

Pulse Mode Sensitivity Adjustment............................................................................................................19

LCD Contrast..............................................................................................................................................19

SERVICE MODE FUNCTIONS..............................................................................................................................20

Data Logging..............................................................................................................................................20

Event History..............................................................................................................................................20

Usage Meters.............................................................................................................................................20

POWER SUPPLIES.............................................................................................................................................21

AC Power Supply .......................................................................................................................................21

DC Power Supply.......................................................................................................................................22

POWER CARTRIDGE..........................................................................................................................................23

Typical New Power Cartridge Operation Time...........................................................................................24

Training A New Patient......................................................................................................................................27

INTRODUCTION.................................................................................................................................................28

Pre-Delivery Check List..............................................................................................................................28

CONTRAINDICATIONS........................................................................................................................................29

BASIC CONCEPT TRAINING................................................................................................................................30

Safety Guidelines and Operational Safety Warnings/Cautions..................................................................30

Locating the Eclipse ...................................................................................................................................30

The Users Manual......................................................................................................................................31

Showing Panel Buttons, Indicators, Alerts and Alarms..............................................................................31

Showing Power Cartridge Power Level......................................................................................................31

Selecting the Proper Flow Mode and Setting.............................................................................................31

Selecting Continuous Flow Mode...............................................................................................................32

Selecting Pulse Flow Mode........................................................................................................................32

Adjusting the Pulse Mode Sensitivity Setting.............................................................................................33

Connecting the AC Power Supply..............................................................................................................33

Connecting the DC Power Supply..............................................................................................................34

ACTIVE LIFESTYLE TRAINING.............................................................................................................................36

Attach the Cart............................................................................................................................................36

Using Around the House ............................................................................................................................36

Traveling by Vehicle...................................................................................................................................36

Traveling by Air...........................................................................................................................................38

Traveling by Boat........................................................................................................................................39

Traveling by Train.......................................................................................................................................39

HOW TO MAINTAIN THE ECLIPSE........................................................................................................................40

Clean the Air Inlet Filter..............................................................................................................................40

Clean and Care for the Tubing and Cannula..............................................................................................40

Clean the Cabinet and Control Panel and Power Supplies........................................................................40

Care for the Power Cartridge .....................................................................................................................41

PATIENT TRAINING CHECKLIST..........................................................................................................................42

Provider Maintenance........................................................................................................................................43

INTRODUCTION.................................................................................................................................................44

Periodic Maintenance List ..........................................................................................................................44

Checking and Replacing the Power Cartridge ...........................................................................................44

Proper Care for the Power Cartridge..........................................................................................................44

MAINTENANCE PROCEDURES............................................................................................................................45

Remove and Replace the Unit Cover.........................................................................................................45

Remove and Replace 9 Volt Battery..........................................................................................................49

Remove and Replace HEPA Filter.............................................................................................................51

Remove and Replace the Compressor Intake Filter..................................................................................54

TEST PROCEDURES..........................................................................................................................................56

Eclipse Purity and Flow Rate Test Procedure - Preferred Method............................................................56

Purity and Flow Rate Test Procedure-Alternate Method............................................................................56

Assembly and Alarm Verification Tests......................................................................................................57

Electrical Safety Test..................................................................................................................................59

Cleaning the Eclipse...................................................................................................................................59

SERVICE AND MAINTENANCE RECORD...............................................................................................................60

Shipping and Transporting the Eclipse.......................................................................................................61

Storing the Eclipse......................................................................................................................................61

Discarding...................................................................................................................................................61

System Troubleshooting and Alarms ................................................................................................................62

TROUBLESHOOTING..........................................................................................................................................62

ALARM CONDITIONS AND ALARM CODES............................................................................................................63

Service and Repair Procedures ........................................................................................................................65

SYSTEM SCHEMATICS AND DIAGRAMS...............................................................................................................66

Simplified Block diagram............................................................................................................................66

OXYGEN CIRCUIT .............................................................................................................................................68

Remove and Replace the ATF Module......................................................................................................68

Remove and Replace the Product Tank Assembly....................................................................................72

Routing Diagram for Pneumatic Tubing.....................................................................................................74

ELECTRONICS ..................................................................................................................................................75

Remove and Replace the Control Module Assembly.................................................................................75

Remove and Replace the Buzzer Wire Harness........................................................................................77

Control Module Connector Diagram...........................................................................................................78

Remove and Replace the Power Manager Printed Circuit Board..............................................................79

Power Manager PC Board Connector Diagram.........................................................................................82

COMPRESSOR..................................................................................................................................................83

Remove and Replace the Compressor Box...............................................................................................83

PREVENTATIVE MAINTENANCE PARTS ...............................................................................................................87

REPLACEMENT PARTS LIST...............................................................................................................................87

SeQual Customer Service Contact Information ................................................................................................88

Table of Tables

TABLE 1: PULSE PROFILES...........................................................................................................................18

TABLE 2: FLOW MODES FOR DC POWER SUPPLY OPERATION. ............................................................38

TABLE 3: ECLIPSE STARTUP SEQUENCE INDICATIONS...........................................................................57

TABLE 4: SAMPLE ECLIPSE MAINTENANCE RECORD ..............................................................................60

Table of Illustrations

FIGURE 1: ECLIPSE SYSTEM BLOCK DIAGRAM.........................................................................................12

FIGURE 2: FLOW SENSOR BOARD DIAGRAM.............................................................................................15

FIGURE 3: CONTROL PANEL BUTTONS AND INDICATORS ......................................................................14

FIGURE 4: ECLIPSE SERVICE PORT............................................................................................................20

FIGURE 5: AC POWER SUPPLY....................................................................................................................21

FIGURE 6: DC POWER SUPPLY....................................................................................................................22

FIGURE 7: ECLIPSE POWER CARTRIDGE...................................................................................................23

FIGURE 8: POWER CARTRIDGE STATUS GAUGE......................................................................................25

FIGURE 9: DC POWER SUPPLY INPUT POWER SWITCH..........................................................................37

FIGURE 10: CLEANING THE AIR INLET FILTER...........................................................................................40

FIGURE 11: MAINTENANCE TOOLS..............................................................................................................45

FIGURE 12: REMOVING SCREWS TO OPEN THE FRONT COVER............................................................46

FIGURE 13: OPENING THE FRONT COVER.................................................................................................46

FIGURE 14: REMOVING THE CONTROL PANEL RIBBON CABLE..............................................................47

FIGURE 15: DISCONNECTING THE OXYGEN OUTLET TUBE....................................................................48

FIGURE 16: FRONT COVER REMOVAL........................................................................................................48

FIGURE 17: CONTROL PANEL RIBBON CABLE INSTALLATION................................................................49

FIGURE 18: REMOVING THE 9-VOLT BATTERY..........................................................................................50

FIGURE 19: DISCONNECTING THE 9-VOLT BATTERY...............................................................................50

FIGURE 20: REMOVING THE HEPA FILTER.................................................................................................51

FIGURE 21: DISCONNECTING THE HEPA FILTER. .....................................................................................52

FIGURE 22: INSTALLING THE HEPA FILTER................................................................................................52

FIGURE 23: REMOVING THE COMPRESSOR INTAKE FILTER...................................................................54

FIGURE 24: INSTALLING THE COMPRESSOR INTAKE FILTER.................................................................55

FIGURE 25: SEQUAL RECOMMENDED TEST SETUP TO VERIFY PERFORMANCE OF OXYGEN

CONCENTRATOR.......................................................................................................................56

FIGURE 26: DATA OUTPUT FORM................................................................................................................58

FIGURE 27: ECLIPSE OXYGEN SYSTEM SIMPLIFIED BLOCK DIAGRAM.................................................66

FIGURE 28: TOP CASE COMPONENTS........................................................................................................66

FIGURE 29: BOTTOM CASE COMPONENTS................................................................................................67

FIGURE 30: REMOVAL OF ATF MODULE PRODUCT HOSE.......................................................................68

FIGURE 31: REMOVAL OF ATF MODULE PRESSURE AND VACUUM TUBES..........................................68

FIGURE 32: REMOVE ATF MODULE FROM ECLIPSE CASE. .....................................................................69

FIGURE 33: ATF MODULE GROMMET INSTALLATION...............................................................................69

FIGURE 34: TUBE ROUTING UNDER ATF MODULE....................................................................................70

FIGURE 35: PRODUCT TANK INLET AND OUTLET CONNECTIONS..........................................................72

FIGURE 36: PRODUCT TANK REMOVAL......................................................................................................73

FIGURE 37: OXYGEN TUBING ROUTING .....................................................................................................74

FIGURE 38: CONTROL MODULE REMOVAL (ATF MODULE NOT SHOWN FOR CLARITY).....................75

FIGURE 39: CONTROL MODULE INSTALLATION. .......................................................................................76

FIGURE 40: BONDING THE BUZZER TO THE CASE. ..................................................................................77

FIGURE 41: BUZZER INSTALLATION............................................................................................................77

FIGURE 42: CONTROL MODULE CONNECTOR DIAGRAM.........................................................................78

FIGURE 43: BATTERY BRIDGE BOARD REMOVAL.....................................................................................79

FIGURE 44: POWER MANAGER PC BOARD REMOVAL..............................................................................80

FIGURE 45: EXHAUST TUBE REMOVAL.......................................................................................................80

FIGURE 46: ATF MOTOR, 9-VOLT BATTERY, AND CONTROL PC BOARD

COMMUNICATIONS WIRE HARNESS REMOVAL....................................................................81

FIGURE 47: POWER MANAGER PC BOARD CONNECTOR DIAGRAM......................................................82

FIGURE 48: CASE BOTTOM COVER REMOVAL..........................................................................................83

FIGURE 49: COMPRESSOR BOX ELECTRICAL CONNECTIONS. ..............................................................84

FIGURE 50: EXHAUST TUBE REMOVAL.......................................................................................................84

FIGURE 51: REMOVAL OF COMPRESSOR PRESSURE AND VACUUM HOSES FROM ATF MODULE. .85

FIGURE 52: REMOVE COMPRESSOR BOX SCREWS.................................................................................86

General Information

This technical manual will familiarize you with Provider-specific information regarding the Eclipse 2 Oxygen

System. Instructions in this manual are intended to help ensure that:

- Providers are familiar with Eclipse system components and system principles of operation

- Patients are given proper guidance in the use of the Eclipse and its accessories

- Providers are guided in the care, maintenance, and repair of the Eclipse Oxygen System

Warning and Caution Statements

Definitions of Warnings and Cautions as used on Eclipse

WARNING:

Important safety information for hazards that might cause serious

injury.

CAUTION:

Important information for preventing damage to the Eclipse Oxygen

System.

NOTE: Places emphasis on an operating characteristic or important

consideration.

Introduction to the Eclipse 2 Oxygen System

Eclipse Oxygen System Specifications

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

With Power Cartridge

Without Power Cartridge

17.9 pounds (8.1 kg)

14.5 pounds (6.6 kg)

Flow Settings

Continuous Flow

Pulse Flow

0.5 to 3.0 LPM, 0.5 LPM increments

Settings of 1.0 to 6.0, in 0.5 increments

Continuous Flow Accuracy +/- 10% or 200ml/min, whichever is greater

Oxygen concentration 90% +/- 3% for all flow settings

Maximum System Pressure 15 psig (103.5 kPa)

Oxygen Output Pressure 5.0 psig (34.5 kPa) nominal

Oxygen Concentration

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 LPM Continuous Flow

0.5LPM Continuous Flow

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

Nominal Power

0.5 LPM Continuous flow

3 LPM Continuous Flow

1.0 Pulse Flow Setting

6.0 Pulse Flow Setting

48 Watts

145 Watts

45 Watts

95 Watts

Nominal Power Cartridge

operating time

Continuous Flow

1.0 LPM

3.0 LPM

Pulse Flow

1.0

6.0

4.4 hours

1.3 hours

4.4 hours

2.1 hours

Continuous Flow Indication Expressed in liters per minute (LPM)

Note: Times will decrease with

higher bolus size, breath rate,

ambient temperature, power

cartridge age and use over time.

Audible Alarm Indicators Loss of Power/Hot Power Cartridge

Low Power Cartridge/Warm Power Cartridge

Low Oxygen Output

O2Flow Outside Normal Limits

Unit Malfunction

Back-Up Alarm Power 9V Internal Battery

Filters Air Inlet, HEPA, Compressor Intake

Device Classification IEC Class I, Type B Applied Part, IPX0

Pulse Mode Specifications

Pulse Settings 1.0 to 6.0, in increments of 0.5

Trigger Sensitivity Adjustable between settings of 1 (most sensitive) to 6 (least sensitive)

Trigger Criteria •Cannula pressure has dropped below the trigger point (typically

between 0.15 – 0.45 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 •Yellow LED is activated if no inspiration has been detected after 45

seconds.

•Switch to Continuous Mode if no inspiration has been detected for

60 seconds with an audible alarm.

Bolus Volume and Breath Rates

AC Power

Supply and

Power Cartridge

10 Amp

Switch Setting

DC Power Supply

15 Amp

Switch Setting

DC Power Supply

Pulse

Flow

Setting

Bolus Size

(± 15%)

Min

Breath

Rate Max Breath

Rate

1.0 16 6 40 40 40

2.0 32 6 40 40 40

3.0 48 6 40 40 40

4.0 64 6 39 31 39

5.0 80 6 31 25 31

6.0 96 6 26 20 26

Power Accessory Specifications

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 11.5-18VDC

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 1.4 to 5.0 hours, dependent on flow

setting, to achieve 80% capacity from a

fully discharged Power Cartridge

Independent Safety Testing

Eclipse System and Eclipse Concentrator, Model 1000A

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 4123

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 4124

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 1056

Safety UL2054, 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 system does not encompass operation with the DC Power Supply Model

4124.

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