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ICU Medical Plum 360 Service Manual

ICU Medical Plum 360
254 pages
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Technical Service Manual
IFU0000141 (02, 2021-08)
ICU Medical MedNet
â„¢
Compatible with:
Plum 360
â„¢
Infuser
For use with all configurations
of list number 30010

Table of Contents

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ICU Medical Plum 360 Specifications

General IconGeneral
Device TypeInfusion Pump
Battery LifeUp to 8 hours
Power SourceAC Power, Rechargeable Battery
Infusion Pressure MonitoringYes
Air DetectionYes
Infusion ModesIntermittent, TPN, PCA
ConnectivityEthernet, Wireless (optional)
Delivery Rate Range0.1 mL/hr to 999 mL/hr
VTBI Range1 to 9999 mL
Infusion Rate Range0.1 mL/hr to 999 mL/hr
Compatible Administration SetsPlumSet
AlarmsAir-in-line, Occlusion, Low battery
Drug LibraryYes
MemoryEvent logging

Summary

Section 1: Introduction

1.1 Reporting Serious Incidents

Procedure for reporting serious incidents related to the Plum 360 Infuser to ICU Medical.

1.2 Scope

Overview of the manual's organization and sections covering the Plum 360 Infuser.

1.3 Conventions

Explanation of conventions used in the manual, including text formatting and symbols.

1.4 Labeling Symbols Glossary

Defines symbols used on the Plum 360 Infuser labeling and their corresponding standards.

1.9 Electromagnetic Compatibility

Details compliance with electromagnetic compatibility standards for the Plum 360 Infuser.

1.13 Instrument Implementation Procedure

Steps for initial setup and preparation of the Plum 360 Infuser before use.

1.14 Self Test

Procedure for performing the Plum 360 Infuser's system self-test.

1.15 Connectivity Check

Instructions on how to verify wireless and Ethernet connectivity for the infuser.

1.16 Biomed Mode Operations

Covers accessing and performing various operations within the infuser's Biomed mode.

1.17 Taiwan NCC Warning Statement

Regulatory warning statement for Taiwan regarding low power radio waves.

1.18 Suspected Cybersecurity Event or Threat

Recommended procedures for detecting and reporting suspected cybersecurity events.

Section 2: Warranty

Section 3: System Operating Manual

Section 4: Service Support

4.1 Battery Charger

Description of the battery charger's function and charging scheme.

4.2 Battery

Details on the infuser's sealed lead-acid battery type, capacity, and operation.

Section 5: Maintenance and Service Tests

5.1 Cleaning and Disinfection

Procedures for cleaning and disinfecting the infuser between uses and monthly.

5.2 Cleaning Procedures

Detailed steps for cleaning various parts of the infuser.

5.3 Disinfection Procedures

Detailed steps for disinfecting the infuser and its components.

5.4 Preparation for Maintenance and Testing

Lists required equipment and test setup information for PM and PVT.

5.5 Preventive Maintenance

Routine maintenance schedule and inspections required for the Plum 360 Infuser.

5.6 Performance Verification Test (PVT)

Tests performed to ensure infuser operates properly after repair or maintenance.

Section 6: Troubleshooting

6.1 Technical Assistance

Contact information for customer service and technical support in the US and Canada.

6.2 Alarm Messages and Alarm Codes

Information on infuser alarms, including messages, codes, descriptions, and causes.

6.3 Troubleshooting Procedures

Procedures for resolving issues not related to technical service alarms.

Section 7: Replaceable Parts and Repairs

7.1 Replaceable Parts

Lists replaceable parts for the infuser and their identification in IPB and figures.

7.2 Replacement Procedures

Details safety precautions, tools, materials, and step-by-step procedures for part replacement.

7.2.4 Battery, Wire Harness, Door, and Door Pad Replacement

Procedure for replacing the battery, wire harness, door, or door pad.

7.2.6 CE Module Replacement

Step-by-step instructions for replacing the CE module.

7.2.8 Separating the Front Enclosure, Rear Enclosure, and Main Chassis

Procedure for disassembling the infuser's main housing components.

7.2.13 Main Chassis Assembly Component Replacement

Details component replacement procedures within the main chassis assembly.

7.2.13.1 Power Supply PWA Replacement

Procedure for replacing the power supply Printed Wiring Assembly (PWA).

7.2.13.4 CPU PWA Replacement

Procedure for replacing the Central Processing Unit (CPU) Printed Wiring Assembly (PWA).

7.2.13.6 Infusion Mechanism Assembly Replacement

Procedure for replacing the infuser's infusion mechanism assembly.

7.2.13.8 Cassette Door and Fluid Shield Replacement

Procedure for replacing the cassette door and fluid shield assembly.

Section 8: Specifications

Physical Specifications

Details dimensions, mass, casing material, and expected service life of the infuser.

Electrical Specifications

Information on power requirements, cord, fuses, leakage, battery type, and operation.

Nurse Call Interface

Configuration details for the nurse call interface, including default states.

Environmental Specifications

Operating and storage temperature, atmospheric pressure, and humidity ranges.

Section 9: Drawings

Use of the Infuser in Electromagnetic Environments

Electromagnetic Emissions (60601-1-2 Edition 3 Compliance)

Guidance on electromagnetic emissions compliance for Edition 3 standards.

Electromagnetic Immunity (60601-1-2 Edition 3 Compliance)

Guidance on electromagnetic immunity compliance for Edition 3 standards.

Electromagnetic Immunity for Life-Supporting Equipment and Systems (60601-1-2 Edition 4 Compliance)

Guidance for immunity near communications equipment under Edition 4 standards.

Recommended Separation Distances for Communications Equipment (60601-1-2 Edition 4 Compliance)

Recommended minimum distances for equipment to prevent EMI under Edition 4 standards.

Electromagnetic Emissions (60601-1-2 Edition 4 Compliance)

Guidance on electromagnetic emissions compliance for Edition 4 standards.

Electromagnetic Immunity (60601-1-2 Edition 4 Compliance)

Guidance on electromagnetic immunity compliance for Edition 4 standards.

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