Alaris Signature Edition GOLD Guardrails Models 71xx and 72xx Technical Service Manual

GENERAL CONTACT INFORMATION ALARIS Medical Systems, Inc. 10221 Wateridge Circle San Diego, California 92121

Customer Advocacy - North America Clinical and technical feedback. Phone: (800) 854-7128, Ext. 7812 E-Mail: [email protected]

Technical Support - North America Maintenance and service information support; troubleshooting. United States: Phone: (858) 458-6003 (800) 854-7128, Ext. 6003

Canada: Phone: Eastern: (800) 908-9918 Western: (800) 908-9919

Customer Care - North America Instrument return, service assistance, and order placement. United States: Phone: (800) 482-4822

Canada: Phone: (800) 387-8309

Technical Support and Customer Care - UK Maintenance and service information support. Instrument return, service assistance, and order placement. Customer Service: Freephone: 0800 917 8776 Fax: 01256 330 860

Technical Support: Freephone: 0800 389 6972

This Technical Service Manual is subject to change without notification.

Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

TABLE OF CONTENTS Chapter 1 - General Information 1.1

Introduction... 1-1

1.2

Precaution Definitions... 1-2

1.3

Specifications... 1-2

1.4

Accessories... 1-2

1.4.1

Nurse Call (7130/7230 only)... 1-2

1.4.2

Learn/Teach RS-232 Cable... 1-2

1.4.3

Flow Sensor... 1-7

1.5

Alarms, Errors, Messages... 1-7

1.5.1

Silencing Alarms... 1-7

1.6

Battery Management System... 1-7

1.6.1

Fan... 1-7

1.6.2

Battery and Charging Process... 1-7

1.6.3

Refresh Cycle... 1-8

1.6.4

Battery Gauge... 1-10

1.6.5

Power On/Off... 1-10

1.6.6

Lower LCD Display... 1-11

1.6.7

Clock... 1-11

1.6.8

Battery Maintenance... 1-11

1.7

NiCad Battery Capacity Information... 1-12

1.8

Dynamic Monitoring® System (DMS)... 1-14

1.9

Data Communications Function... 1-16

1.10

Trumpet and Start-Up Curves... 1-16

Chapter 2A - Checkout and Configuration (Software Versions 4.06 and 4.08) 2.1

Introduction... 2A-1

2.2

New Instrument Checkout... 2A-1

2.3

Configurable Options and Defaults... 2A-1

2.4

Configuration Procedure... 2A-2

2.4.1

Entering Configuration Mode... 2A-3

2.4.2

Setting to Defaults... 2A-3

2.4.3

Regional Settings... 2A-4

2.4.4

Setting Air-in-Line Threshold... 2A-4

2.4.5

Profiles... 2A-5

2.4.6

Setting Maximum Rate... 2A-6

2.4.7

Setting Computer Link... 2A-6

2.4.8

Setting Optional Modes... 2A-7

Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

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TABLE OF CONTENTS

Chapter 2A - Checkout and Configuration (Continued) 2.4.9

Setting Optional Features... 2A-8

2.4.10

Setting KVO Rate... 2A-9

2.4.11

Setting Dynamic Monitoring® System Features... 2A-10

2.4.12

Setting Audio Volume... 2A-12

2.4.13

Setting Configuration Name (Instrument ID Label)... 2A-13

2.4.14

Resistance Options... 2A-14

2.4.15

Pressure Options... 2A-15

2.4.16

Manual Baseline... 2A-16

2.5

Transferring Settings to Another Instrument... 2A-17

2.5.1

Learn/Teach Instrument Procedure... 2A-18

2.5.2

Pop-Up Displays... 2A-19

Chapter 2B - Checkout and Configuration (Software Version 2.78)

ii

2.1

Introduction... 2B-1

2.2

New Instrument Checkout... 2B-1

2.3

Configurable Options and Defaults... 2B-1

2.4

Configuration Procedure... 2B-2

2.4.1

Entering Configuration Mode... 2B-3

2.4.2

Setting to Defaults... 2B-3

2.4.3

Setting Language... 2B-4

2.4.4

Setting Air-in-Line Threshold... 2B-4

2.4.5

Setting Dose Rate Drugs... 2B-5

2.4.6

Setting Maximum Rate... 2B-7

2.4.7

Setting Computer Link... 2B-8

2.4.8

Setting Optional Modes... 2B-9

2.4.9

Setting Optional Features... 2B-10

2.4.10

Setting KVO Rate... 2B-10

2.4.11

Setting Dynamic Monitoring® System Features... 2B-11

2.4.12

Setting Audio Volume... 2B-14

2.4.13

Setting Configuration Name (Instrument ID Label)... 2B-14

2.5

Transferring Settings to Another Instrument... 2B-15

2.5.1

Learn/Teach Instrument Procedure... 2B-15

2.5.2

Pop-Up Displays... 2B-16

2.6

Resistance Options... 2B-17

2.7

Pressure Options... 2B-18

Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

TABLE OF CONTENTS

Chapter 3 - Preventive Maintenance 3.1

Introduction... 3-1

3.2

Preventive Maintenance Inspections... 3-1

3.2.1

Regular Inspection... 3-1

3.2.2

Functional Test... 3-2

3.2.3

Flow Stop Test... 3-3

3.2.4

Rate Calibration Procedure... 3-3

3.2.5

Post Calibration Rate Accuracy Verification... 3-5

3.2.6

Pressure Calibration... 3-7

3.2.7

Ground Current Leakage Test... 3-9

3.2.8

Ground Resistance Test... 3-9

3.2.9

Battery Refresh Cycle... 3-9

3.2.10

Reset Time... 3-10

3.2.11

Reset PM Due... 3-10

3.3

Storage and Cleaning... 3-10

3.3.1

Storage... 3-10

Chapter 4 - Principles of Operation 4.1

Introduction... 4-1

4.2

General Information... 4-1

4.3

Overview... 4-2

4.4

Main PCB... 4-3

4.4.1

CPU Kernel... 4-3

4.4.2

Combo IC... 4-4

4.4.3

EEPROM... 4-4

4.4.4

RAM... 4-4

4.4.5

Flash EEPROM... 4-5

4.4.6

RS-232 Interface... 4-5

4.5

Power System... 4-7

4.5.1

Battery Manager... 4-7

4.5.2

AC Off-Line Switcher... 4-8

4.5.3

Battery Charge Regulator... 4-8

4.5.4

Refresh Cycle Load... 4-9

4.5.5

VAO Shutdown... 4-9

4.5.6

AC Line Sense... 4-9

4.5.7

System Power Source Select... 4-9

4.5.8

Battery Voltage Monitor... 4-10

Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

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TABLE OF CONTENTS

Chapter 4 - Principles of Operation (Continued) 4.5.9

VMEAS... 4-10

4.5.10

Voltage Reference 4.1V... 4-10

4.5.11

System Current Monitor... 4-11

4.5.12

Always On Supply (+5VAO)... 4-11

4.5.13

System Switching Supplies... 4-11

4.5.14

VRAM Supply... 4-13

4.5.15

VPOS Supply... 4-13

4.5.16

Battery Temperature Sensor... 4-13

4.5.17

System Watchdog... 4-14

4.5.18

Power Switch... 4-15

4.5.19

System Reset/Power On... 4-16

4.5.20

Lower LCD Display Backlight Drive... 4-16

4.6

Motor Drive/Sensors... 4-17

4.6.1

Motor Drive... 4-17

4.6.2

Air-in-Line Sensor... 4-20

4.6.3

Transducer... 4-20

4.7

User Interface... 4-21

4.7.1

Main Speaker Driver... 4-22

4.7.2

Backup Audio Buzzer and Test Circuit... 4-22

4.8

LED Module

4.9

Lower LCD Display... 4-24

4.10

Main LCD Module... 4-24

4.10.1

Main LCD Backlight... 4-25

4.10.2

Graphic LCD Contrast... 4-25

4.11

Nurse Call Circuit (7130/7230 only)... 4-25

4.12

Panel Lock Switch... 4-25

4.13

ECD Board... 4-25

...

4-23

Chapter 5 - Corrective Maintenance

iv

5.1

Introduction... 5-1

5.2

Disassembly/Reassembly... 5-2

5.2.1

Removing Battery... 5-3

5.2.2

Separating Case Assemblies... 5-5

5.2.3

Removing Power Supply Board Assembly... 5-11

5.2.4

Removing ECD and RS-232 Board Assemblies... 5-13

Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

TABLE OF CONTENTS

Chapter 5 - Corrective Maintenance (Continued) 5.2.5

Removing Line Filter... 5-16

5.2.6

Removing Speaker Fan... 5-17

5.2.7

Removing Pole Clamp... 5-18

5.2.8

Disconnecting Cables

5.2.9 5.2.10 5.2.11 5.2.12 5.2.13 5.2.14 5.2.15

Removing Main Board... 5-24 Removing LED and LCD Modules... 5-26 Removing Mechanism... 5-27 Removing AIL Transmitter (Arm)... 5-28 Removing AIL Receiver (Button)... 5-30 Removing Seal Clip... 5-31 Removing Mechanism Seal... 5-32

5.2.16

Removing Keypad Assembly... 5-33

5.2.17

Routing and Connecting Cables... 5-34

5.3

Test and Calibration... 5-38

5.3.1

Power-On Self Test... 5-38

5.3.2

Mechanism Visual Check... 5-38

5.3.3

Mechanical Leak Test... 5-42

5.3.4

Pressure Verification and Calibration Test... 5-43

5.3.5

Set Sensor Check... 5-43

5.3.6

Test Run Mode... 5-44

5.3.7

Hard Pressure Cal Procedure... 5-45

5.3.8

Checking Pressure Calibration Set... 5-46

5.4

Level of Testing Guidelines... 5-47

...

5-21

Chapter 6 - Troubleshooting 6.1

Introduction... 6-1

6.2

Diagnostics Mode... 6-11

6.2.1

Entering Diagnostics Mode... 6-11

6.2.2

Setting Preventive Maintenance Interval... 6-12

6.2.3

Viewing Alarm or Event History (Event Log)... 6-13

6.2.4

Setting Time (and Date)... 6-16

6.2.5

Viewing Battery Status... 6-16

6.2.6

Changing Rated Capacity of Battery... 6-17

6.2.7

Viewing DC Voltages... 6-18

6.2.8

Setting ID Number... 6-18

6.2.9

Viewing Battery and Total Run Times... 6-19

6.2.10

Viewing Self-Check Timer... 6-19

Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

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TABLE OF CONTENTS

Chapter 6 - Troubleshooting (Continued) 6.2.11

Testing Channel Sensors... 6-20

6.2.12

Viewing/Changing Rate Calibration Information... 6-21

6.2.13

Testing Main LCD... 6-22

6.2.14

Testing Aux (Lower) LCD... 6-22

6.2.15

Testing Switches... 6-23

6.2.16

Changing Main LCD Contrast... 6-23

6.2.17

Calibrating Channel Pressure... 6-24

6.2.18

DAC Settings... 6-27

6.2.19

Configuring Pressure System Auto Zero... 6-28

Chapter 7 - Illustrated Part Breakdown 7.1

Introduction... 7-1

7.2

Illustrations... 7-1

7.3

Parts List... 7-1

7.4

Ordering Parts... 7-2

List of Figures

vi

1-1

Battery Refresh Cycle... 1-9

1-2

Lower LCD Display Layout... 1-11

1-3

Resistance Graph... 1-14

1-4

Pressure and Resistance Graph... 1-15

2-1

Map of Configuration Screens (Software versions 4.06 and higher)... 2-22A

2-2

Map of Configuration Screens (Software version 2.78)... 2-23B

3-1

Rate Accuracy Test Setup... 3-5

3-2

Pressure Test Setup... 3-8

4-1

Main Block Diagram... 4-2

4-2

COMBO IC Block Diagram... 4-5

4-3

Electrical Partitioning... 4-6

4-4

Battery Manager Block Diagram... 4-7

4-5

Battery Monitor... 4-12

4-6

Main Power Supply... 4-13

4-7

System Watchdog... 4-14

4-8

System Reset/Power On... 4-15

4-9

Motor Drive Circuit, Phase 1(A)... 4-19

4-10

Motor and Mechanism Sensors Block Diagram... 4-19

4-11

Air-in-Line Detector Block Diagram... 4-20

4-12

Pressure Sensor Interface Block Diagram... 4-20

Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

TABLE OF CONTENTS

List of Figures (Continued) 4-13

User Interface Block Diagram... 4-22

4-14

Main Speaker... 4-23

4-15

Backup Audio... 4-24

4-16

Lower LCD Display... 4-24

4-17

Flow Sensor Interface Block Diagram... 4-26

5-1

Instrument Assembly Organization... 5-2

5-2

View From Back of Instrument... 5-4

5-3

Alternate View From Back of Instrument... 5-4

5-4

Cap Handle Screws... 5-6

5-5

Hidden Case Screw in Battery Compartment... 5-6

5-6

Case Screw and Pole Clamp Position... 5-7

5-7

Separating Case Assemblies... 5-8

5-8

Locking Bar... 5-8

5-9a

Torque Sequence (Single)... 5-9

5-9b

Torque Sequence (Dual)

5-10a

Removing Power Supply Board Assembly... 5-11

5-10b

Disconnecting Cable... 5-12

5-11

Rear Case ECD Board... 5-13

5-12

RS-232 Cover... 5-14

5-13

RS-232 Board... 5-15

5-14

Line Filter Assembly... 5-16

5-15

Speaker and Fan Assembly... 5-17

5-16

Pole Clamp Assembly... 5-19

5-17

Retaining Ring Installation... 5-20

5-18a

Rear Case Cable Routing... 5-21

5-18b

Front Case Cable Routing... 5-22

5-18c

Front Case Cable Routing... 5-23

5-19

Removing Main Board... 5-25

5-20

LED / LCD Modules and Snap Fittings... 5-26

5-21

Mechanism Latch in Middle Position... 5-27

5-22

Remove Mechanism... 5-27

5-23

Unlocking AIL Gear Tab... 5-29

5-24

AIL Transmitter in Open Position... 5-29

5-25

AIL Transmitter in Closed Position... 5-29

5-26

Flat Edge of AIL Receiver... 5-30

5-27

Faceplate Hook... 5-30

5-28

Mechanism Latch in Middle Position... 5-31

...

Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

5-10

vii

TABLE OF CONTENTS

List of Figures (Continued) 5-29

Apply RTV Under Edges of Seal... 5-32

5-30a

Front Case Cable Routing... 5-35

5-30b

Front Case Cable Routing... 5-36

5-31

Rear Case Cable Routing... 5-37

5-32

Mechanism Assembly Spring Location: Between motor plate and clamp arm... 5-40

5-33

Mechanism Assembly Spring Location: Between back guide and clamp arm... 5-40

5-34

Detail of Proper Mechanism Spring Position... 5-41

5-35

Spring Installation Tool Position

5-36

Leak Test Setup... 5-42

5-37

Run-In Set... 5-44

5-38

Transducer Pot... 5-45

6-1

Map of Diagnostic Screens... 6-28

7-1

Power Cord Wrap Kit (Item 403)... 7-5

7-2a

Case Assembly, Single Channel... 7-6

7-2b

Case Assembly, Dual Channel... 7-7

7-3a

Front Case Assembly, Single Channel... 7-9

7-3b

Front Case Assembly, Dual Channel... 7-10

...

5-41

7-4

Mechanism Assembly... 7-11

7-5a

Rear Case Assembly, Single Channel... 7-13

7-5b

Rear Case Assembly, Dual Channel... 7-14

7-6

Pole Clamp Assembly... 7-16

7-7

Label / Literature Locations... 7-19

List of Tables

viii

1-1

Specifications... 1-3

1-2

Battery Trip Points... 1-9

1-3

Abbreviations, Acronyms, Symbols

2-1

Record of Configured Instruments... 2-20A

2-2

Drug List (7130/7230 only)... 2-6B

2-3

Record of Configured Instruments... 2-20B

2-4

Drug List Configuration... 2-22B

3-1

PM Inspections... 3-11

4-1

Motor Control Signals... 4-18

5-1

Test Equipment... 5-1

...

Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

1-17

TABLE OF CONTENTS

List of Tables (Continued) 5-2

Level of Testing Guidelines... 5-47

6-1

Technical Troubleshooting Guide... 6-1

6-2

Error Messages... 6-5

6-3

Battery Manager Error Codes (not in Alarm History)... 6-10

7-1

Other Parts... 7-3

7-2

Case Assembly... 7-4

7-3

Front Case Assembly... 7-8

7-4

Mechanism Assembly... 7-11

7-5

Rear Case Assembly... 7-12

7-6

Pole Clamp Assembly... 7-15

7-7

Label / Literature... 7-17

7-8

Packing Materials

...

Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

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ix

TABLE OF CONTENTS

T H I S PA G E I N T E N T I O N A L LY LEFT BLANK

x

Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

1 GENERAL INFORMATION

Chapter 1 - GENERAL INFORMATION 1.1

CAUTION Do not use sharp objects (pens, pencils, etc.) to activate switches, as this will damage the keypad.

INTRODUCTION This manual covers Signature Edition® GOLD Infusion Systems, with software versions 2.78, 4.06 and 4.08. It is used in conjunction with an applicable Signature Edition® GOLD Infusion System Directions for Use (DFU). This manual contains instructions for maintenance, repair, and configuration of the instrument. It is intended for personnel experienced in the analysis, troubleshooting, and repair of analog/digital microprocessor-based electronic equipment.

CAUTION Any attempt to service an ALARIS Medical Systems instrument by anyone other than an authorized ALARIS Medical Systems Service Representative while the instrument is under warranty may invalidate the warranty.

If the instrument requires service while under warranty, it is to be serviced only by ALARIS Medical Systems authorized service personnel. Refer to the “Service Information” and “Warranty” sections of the applicable Signature Edition® GOLD Infusion System DFU. The Signature Edition® GOLD Infusion System includes: • Single-Channel, Models 7130/7131 • Dual-Channel, Models 7230/7231 • AccuSlide® Flow Regulator administration sets The Signature Edition® GOLD Infusion System series includes the following configurations: • 7130B, 7130D, 7130E • 7131A, 7131B • 7230B, 7230D, 7230E • 7231A, 7231B

Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

1-1

GENERAL INFORMATION

1.1

INTRODUCTION (Continued)

1.2

A WARNING is an alert to a potential hazard which could result in serious personal injury and/or instrument damage if proper procedures are not followed.

7130/7131 and 7230/7231 Series: • is a 100-240 VAC, 50/60 Hz instruments family that supports both single and dual channel fluid delivery

A CAUTION is an alert to a potential hazard which could result in minor personal injury and/or instrument damage if proper procedures are not followed.

• features user-interactive software • displays prompts, alarms and alert messages, and troubleshooting information on main LCD display • can be configured to specific operational requirements • allows upgrades for future instrument enhancements

1.3

1.4

1.4.1

There is no Nurse Call option.

The 7131/7231 Series has a drug list only if the software version is 4.08 or higher and profiles are enabled. Some defaults are different in configuration mode and there are several languages to choose from in version 2.78. Refer to the applicable Signature Edition® GOLD Infusion System DFU for complete setup and operation information.

1-2

Nurse Call (7130/7230 only) All instruments are equipped with the nurse call feature. Alarms and some alerts from the instrument will be relayed to the facility’s existing nurse call system. No operating features of the instrument are changed and it will alarm with or without the nurse call. The only additional item needed is a cable with a 9-pin to mono phone jack (ALARIS P/N 136111).

The 7131/7231 Series is labeled for 220V with two power cord options and has isolated RS-232 Board, potential equalization (PE) connector, and drop sensor board installed.

• SOFTWARE

ACCESSORIES Accessory items are available for use with the instrument. These items are described in the following paragraphs.

• HARDWARE

Keypads, other than English, have symbols instead of words.

SPECIFICATIONS Refer to Table 1-1.

• has been designed to interface with accessory equipment. 7131/7231 Series key differences from 7130/7230 Series are:

PRECAUTION DEFINITIONS

1.4.2

Learn/Teach RS-232 Cable This is a standard commercially available 9-pin Null Modem RS-232 cable (ALARIS P/N 133450). The Learn/Teach RS-232 cable is used to connect two instruments for the purpose of transferring (downloading) configuration data from/to another instrument. NOTE: Guardrails® Safety Software data sets cannot be transferred via the Learn/Teach function. They must be downloaded directly from a PC.

Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

GENERAL INFORMATION

Table 1-1.

Specifications

Administration Sets:

Use only ALARIS Medical Systems® 72 Series administration sets. All disposable IV set and IV set accessory models are defined on a separate card. Configured Threshold 50µL 100µL 200µL 500µL

Air-in-Line Accuracy:

Alarms:

• • • • • •

Accumulated Air in Line Air in Line Battery Depleted Channel Malfunction Computer Link Failure Flow Sensor Unplugged

• • • • • •

Air Volume Detection Range 15µL - 85µL 35µL - 140µL 100µL - 235µL 275µL - 565µL

Hold Time Exceeded Instrument Malfunction Key Stuck Latch Open No Upstream Flow Detected Occlusion Downstream

• • • •

Occlusion Upstream Primary Flow Detection During Secondary Set Out Set Up Time Exceeded

Altitude:

Operating Altitude: -500 ft. (-150m) to 7,500 ft. (2285m)

Battery:

Rechargeable nickel-cadmium (NiCad). Use only NiCad 12V, 1.8 ampere-hour (Ah) (minimum) batteries. A single channel instrument will operate for 4 hours nominal and a dual channel instrument will operate for 3 hours nominal, under the following conditions: • • • •

new, fully-charged battery ambient room temperature 73 ± 7°F (23 ± 4°C) resistance monitoring modes rate: 100 mL/h on a single channel instrument and 50 mL/h on each channel of a dual channel instrument.

Battery run time is affected by operating mode, rate, monitoring options, and back pressure.

Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

1-3

GENERAL INFORMATION

Table 1-1.

Specifications (Continued)

Bolus Volume Limits:

Monitoring Options

Time Bolus Volume Released Upon Correcting Downstream Occlusion (mL)

25 mL/h

Resistance and High Resistance

25 mmHg

600 mmHg

Maximum

0.5

0.5

0.5

0.5

Typical

<0.1

0.3

<0.1

<0.1

Maximum

0.5

0.5

0.5

0.5

Typical

<0.1

0.3

<0.1

<0.1

Threshold Settings 1 mL/h

Pressure

100% 100% 25 mmHg 600 mmHg

NOTE: When the occlusion alarm pressure limit is set to the maximum threshold setting, the maximum infusion pressure generated into a hard occlusion at 25 mL/h is 11.6±3.9 psi. Testing performed using IV set Model 72003, at 68±4°F (20±2°C).

Case:

Impact and flame resistant plastic.

Critical Volume:

Maximum incremental volume in case of single point failure will not exceed 1.0 mL at 999.9 mL/h.

Dimensions (Nominal):

7130/7131

7230/7231

7.6 in/19.3 cm 8.6 in/21.8 cm 5.0 in/12.7 cm 6.6 lbs/3.0 kg 10 ft/3 m

10.7 in/26.7 cm 8.6 in/21.8 cm 5.0 in/12.7 cm 8.4 lbs/3.8 kg 10 ft/3 m

Operating

Storage/Transport

Temperature Range

5 to 40°C (41 to 104°F)

-40 to 60°C (-40 to 104°F)

Relative Humidity

20 to 90% Non-condensing

5 to 95% Non-condensing

Atmospheric Pressure

700 to 1060 hPa

500 to 1060 hPa

Width Height Depth § Weight §§ Power Cord § without pole clamp §§ without power cord

Environmental Conditions:

Fluid Ingress Rating:

1-4

Drip proof IPX1

Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

GENERAL INFORMATION

Table 1-1.

Specifications (Continued)

Ground Current Leakage:

Electrical leakage current, enclosure: <100 microamperes Electrical leakage current, patient: <10 microamperes

Log Capacity:

Software version 2.78: 2000 Event History Log Software version 4.06/4.08: 300 Continuous Quality Improvement (CQI) 1500 Event History Log

Maximum Infusion Pressure:

16 psi NOTE: Testing performed per proposed standard IEC 601-2-24 using IVAC® IV sets.

Maximum Time to Alarm:

Monitoring Options

Time to Detect Downstream Occlusion (minutes)

25 mmHg

600 mmHg

100% 25 mmHg

100% 25 mmHg

Maximum

2

75

2

7

Typical

0.6

30

0.6

4

Maximum

1

25

1

3

Typical

0.1

1

1.0

1

Threshold Settings

1 mL/h

25 mL/h

Resistance and High Resistance

Pressure

NOTE: When the occlusion alarm pressure limit is set to the maximum threshold setting, the maximum infusion pressure generated into a hard occlusion at 25 mL/h is 11.6±3.9 psi. Testing was performed using IV set Model 72003, at 68±4°F (20±2°C). Memory:

4.06 and higher: Maintains infusion perimeters indefinitely until the instrument is reprogrammed. 2.78: Interrupted secondary or advanced operating modes retain special program settings up to 6 hours. Resistance/pressure trending information is retained for 6 hours.

Mode of Operation:

Continuous

Number of Instruments per Pole:

3 (713X), 2 (723X), single pole, weighted base, 5 legs.

Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

1-5

GENERAL INFORMATION

Table 1-1.

Specifications (Continued)

Occlusion Alarm Pressure:

12 ± 4 psi maximum

Parts per mL:

Precision Flow 3600 steps to deliver 1 mL Pressure Mode (rate < 50 mL/h). All other occlusion monitoring options 1150 steps to deliver 1 mL (Cal # = 0.0) steps will vary with Cal #.

Power Requirements:

100-240 VAC, 50-60 Hz (40 W), 3-wire grounded system. Class 1 with internal power source.

Rate Accuracy:

For rates greater than 1 mL/h, up to 999.9 mL/h: ±5%, 95% of the time with 95% confidence, under the conditions listed below. For rates equal to or less than 1 mL/h: ±6.5%, 95% of the time with 95% confidence, under the conditions listed below. Infusion rate range: 0.1 to 999.9 mL/h Environment temperature: 68±8°F (20±4°C) Test solution: distilled water Needle: 18 gauge

Head height: 24 ± 1 in. (61 ± 2.5 cm) Back pressure: 0 psi. Set Model: 72003 Minimum collection volume: 6 mL

CAUTION Variations of head height, back pressure, time, monitoring mode option, instrument tilt, or any combination of these, may affect rate accuracy. Factors that can influence head height and back pressure are: IV set configuration, IV solution viscosity and IV solution temperature. Back pressure may also be affected by type of catheter.

Rate Range:

0.1 to 999.9 mL/h in 0.1 mL/h increments (primary) 0.1 to 270.0 mL/h in 0.1 mL/h increments (secondary)

RFI:

Tolerance < 10 V/m across frequency range.

Temperature:

Operating above 30°C, for extended periods will reduce battery life.

Volume to Be Infused Range:

0.1 to 9999.9 mL in 0.1 mL increments (primary and dose rate) 0.1 to 999.9 mL in 0.1 mL increments (secondary and loading dose) 0.1 to 999.9 mL per step in 0.1 mL increments (multi-step) 0.1 to 999.9 mL per dose in 0.1 mL increments (multi-dose)

WARNINGS (Alerts):

• Battery Low • Checking Line • Complete Entry • Computer Control Released • Dose Complete • Infusion in KVO

• Load Dose Complete • Multi-Step Complete • Resistance Alert • Secondary Complete • VTBI = 0

NOTE: The Signature Edition® GOLD Infusion System has been assessed and complies with the following Technical Standards: IEC 60601-1 / BS 5724, including amendments A1 and A2; IEC 60601-2-24; CISPR 11, Group 1, Class B Emissions; IEC 60601-1-2.

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Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

GENERAL INFORMATION

1.4

ACCESSORIES (Continued)

1.4.3

Flow Sensor

• Controls battery charger • Provides a battery status "battery gauge" • Monitors voltage and temperature of battery

Flow sensor capability is available with an upgrade kit for the 7130/7230 (refer to the “Illustrated Parts Breakdown” chapter). For 7131/7231, all that is needed is a flow sensor.

• Controls instrument power source (on/off function) • Drives Lower LCD Display (refer to Figure 1-2)

The flow sensor attaches to the administration set's drip chamber. It detects an empty solution container and verifies fluid flow. When installed, it will allow VTBI to be turned off. The flow sensor will not see drops falling if the drip chamber is tilted more than 24°. 1.5

The Battery Manager communicates with the main processor via a serial data channel. The main processor issues commands to the Battery Manager which then responds with status information and data using this channel.

ALARMS, ERRORS, MESSAGES Alarm messages are displayed on the Main Display. Refer to the applicable Signature Edition® GOLD Infusion System DFU for detailed information.

1.5.1

• Includes a relative-time clock

1.6.1

The internal fan is used for cooling, mainly to help prolong battery life. It is a ballbearing, brushless DC fan. The fan is always on when the battery is charging with "Fast" or "Top-up" charge. The fan will go on any time battery temperature is over 22°C.

Silencing Alarms All alarms can be temporarily silenced by pressing the Silence Key.

1.6

BATTERY MANAGEMENT SYSTEM This section contains general information on the battery management system. Included is information on how the Battery Manager monitors and maintains the battery, controls the power on/off for the rest of the instrument, and provides support functions for the main processor. Refer to the “Principles of Operation” chapter for more detailed functional descriptions. The battery management system consists of the Battery Manager IC and various sensors and signal processing circuits. The Battery Manager IC (Rev. 3.06) is a customprogrammed microcontroller that performs the following functions:

Fan

1.6.2

Battery and Charging Process The battery is a ten-cell (1.2V per cell), high capacity nickel-cadmium type rated at 12 volts and 1.8 amp-hours (with a minimum of 500 charge cycles). The battery pack (10 to 18V) has a built-in temperature sensor which allows the Battery Manager to monitor the temperature of the battery. The pack also includes a temperature-limiting thermostat which opens the circuit if the battery temperature gets too hot and closes again when the temperature returns to normal.

Signature Edition® GOLD Infusion System, Models 7130/7131 and 7230/7231 Technical Service Manual

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