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Precision Medical PM5200 - User Manual

Precision Medical PM5200
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U S E R M A N U A L
AIR-OXYGEN BLENDER
(DISS and NIST Connections)
Model No. PM5200 Series
PM5300 Series (shown)
SAVE THESE INSTRUCTIONS
CAUTION
Federal (USA) law restricts this device to sale
by or on the order of a physician.
300 Held Drive Tel: (+001) 610-262-6090
Northampton, PA 18067 USA Fax: (+001) 610-262-6080
www.precisionmedical.com

Questions and Answers

Summary

Safety Information and Warnings

DANGER Definition

Indicates an imminently hazardous situation that will result in death or serious injury if not avoided.

WARNING Definition

Indicates a potentially hazardous situation that could result in death or serious injury if not avoided.

CAUTION Definition (Injury)

Indicates a potentially hazardous situation that may result in minor or moderate injury if not avoided.

CAUTION Definition (Property Damage)

Indicates a potentially hazardous situation that may result in property damage if not avoided.

Consult Accompanying Documents Symbol

Symbol indicating that accompanying documents should be consulted.

Use No Oil Symbol

Symbol indicating that oil should not be used with the device.

CE Marking Compliance

Indicates the device complies with EU medical device directives.

Specifications

Model and Flow Ranges

Details primary and auxiliary outlet flow ranges for PM5200 and PM5300 models.

Alarm and Pressure Specifications

Covers bleed flow, bypass flow, bypass alarm activation, and alarm reset.

Operating and Gas Input Requirements

Specifies gas supply pressure, mixed gas stability, and connection types.

Dimensions and Weight

Provides physical dimensions (depth, width, height) and weight of the device.

Environmental and Gas Input Conditions

Details temperature, humidity, and gas quality requirements.

Component Description

Oxygen Concentration Dial

Dial for selecting oxygen concentrations between 21%-100%.

Primary Outlet Port

Male DISS fitting with check valve for flow delivery.

Auxiliary Outlet Port

Male DISS fitting with check valve and bleed valve.

Auxiliary Bleed Collar

Collar to engage/disengage bleed for accurate FiO2 concentration.

Oxygen Inlet Fitting

Female DISS or NIST fitting with one-way valve.

Air Inlet Fitting

Male DISS or NIST fitting with one-way valve for air supply.

Alarm

Audible alarm for excessive pressure drop or gas supply deletion.

Manifold Outlet (Optional)

Optional manifold with 3 primary outlets.

Rear Slide Mount

Mount with a dove tail for attachment.

Operating Instructions and Procedures

Alarm Test Procedure

Steps to test the audible alarm functionality.

Reverse Gas Flow Procedure

Procedure to check for leakage past inlet check valves (CE only).

Basic Operation

Turning on supplies and adjusting the oxygen concentration dial.

Bleed Activation and Deactivation

Instructions for using the auxiliary bleed collar.

Operational Verification

Required checks before placing the blender in service.

Cleaning Instructions

Guidelines for cleaning the device exterior surfaces.

Maintenance and Support

Maintenance Schedule

Describes monthly, annual, and bi-annual maintenance tasks by technicians.

Technical Description Reference

Points to the service manual for complete technical details and parts.

Returns Procedure

Information on returning products, including RGA requirements.

Disposal Instructions

Guidance on disposing of the device and its packaging.

Troubleshooting Guide

Oxygen Concentration Discrepancy

Addresses issues with oxygen concentration readings and their probable causes/remedies.

No Flow at Blender Outlets

Troubleshooting steps for when no flow is detected at the outlets.

Alarm Sounding

Explains causes and remedies for the alarm continuously sounding.

Limited Warranty and Liability

Warranty Period and Coverage

Details the two-year warranty for defects in workmanship and material.

Warranty Exclusions and Limitations

States that oral statements are not warranties and limits liability.

Limitation of Liability

Excludes liability for special, incidental, or consequential damages.

Declaration of Conformity

Manufacturer and Representative Information

Provides contact details for Precision Medical, Inc. and its EU representative.

Product and Compliance Details

Lists product models, MDD class, and classification criteria.

Conformity Documents

Lists standards and documents demonstrating conformity with MDD requirements.

Notified Body and Certificate

Identifies the Notified Body and EC Certificate Number.

Summary

Safety Information and Warnings

DANGER Definition

Indicates an imminently hazardous situation that will result in death or serious injury if not avoided.

WARNING Definition

Indicates a potentially hazardous situation that could result in death or serious injury if not avoided.

CAUTION Definition (Injury)

Indicates a potentially hazardous situation that may result in minor or moderate injury if not avoided.

CAUTION Definition (Property Damage)

Indicates a potentially hazardous situation that may result in property damage if not avoided.

Consult Accompanying Documents Symbol

Symbol indicating that accompanying documents should be consulted.

Use No Oil Symbol

Symbol indicating that oil should not be used with the device.

CE Marking Compliance

Indicates the device complies with EU medical device directives.

Specifications

Model and Flow Ranges

Details primary and auxiliary outlet flow ranges for PM5200 and PM5300 models.

Alarm and Pressure Specifications

Covers bleed flow, bypass flow, bypass alarm activation, and alarm reset.

Operating and Gas Input Requirements

Specifies gas supply pressure, mixed gas stability, and connection types.

Dimensions and Weight

Provides physical dimensions (depth, width, height) and weight of the device.

Environmental and Gas Input Conditions

Details temperature, humidity, and gas quality requirements.

Component Description

Oxygen Concentration Dial

Dial for selecting oxygen concentrations between 21%-100%.

Primary Outlet Port

Male DISS fitting with check valve for flow delivery.

Auxiliary Outlet Port

Male DISS fitting with check valve and bleed valve.

Auxiliary Bleed Collar

Collar to engage/disengage bleed for accurate FiO2 concentration.

Oxygen Inlet Fitting

Female DISS or NIST fitting with one-way valve.

Air Inlet Fitting

Male DISS or NIST fitting with one-way valve for air supply.

Alarm

Audible alarm for excessive pressure drop or gas supply deletion.

Manifold Outlet (Optional)

Optional manifold with 3 primary outlets.

Rear Slide Mount

Mount with a dove tail for attachment.

Operating Instructions and Procedures

Alarm Test Procedure

Steps to test the audible alarm functionality.

Reverse Gas Flow Procedure

Procedure to check for leakage past inlet check valves (CE only).

Basic Operation

Turning on supplies and adjusting the oxygen concentration dial.

Bleed Activation and Deactivation

Instructions for using the auxiliary bleed collar.

Operational Verification

Required checks before placing the blender in service.

Cleaning Instructions

Guidelines for cleaning the device exterior surfaces.

Maintenance and Support

Maintenance Schedule

Describes monthly, annual, and bi-annual maintenance tasks by technicians.

Technical Description Reference

Points to the service manual for complete technical details and parts.

Returns Procedure

Information on returning products, including RGA requirements.

Disposal Instructions

Guidance on disposing of the device and its packaging.

Troubleshooting Guide

Oxygen Concentration Discrepancy

Addresses issues with oxygen concentration readings and their probable causes/remedies.

No Flow at Blender Outlets

Troubleshooting steps for when no flow is detected at the outlets.

Alarm Sounding

Explains causes and remedies for the alarm continuously sounding.

Limited Warranty and Liability

Warranty Period and Coverage

Details the two-year warranty for defects in workmanship and material.

Warranty Exclusions and Limitations

States that oral statements are not warranties and limits liability.

Limitation of Liability

Excludes liability for special, incidental, or consequential damages.

Declaration of Conformity

Manufacturer and Representative Information

Provides contact details for Precision Medical, Inc. and its EU representative.

Product and Compliance Details

Lists product models, MDD class, and classification criteria.

Conformity Documents

Lists standards and documents demonstrating conformity with MDD requirements.

Notified Body and Certificate

Identifies the Notified Body and EC Certificate Number.

Precision Medical PM5200 Specifications

General IconGeneral
TypeOxygen Concentrator
Storage Temperature-4°F to 140°F (-20°C to 60°C)
Flow Rate0.5 - 5 LPM
AlarmsPower failure
Warranty3 years

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