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Spencer 170 NXT - User Manual

Spencer 170 NXT
25 pages
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User manual
Spencer 170 NXT
Electronic lung ventilator
0123 Class IIb Medical Device, compliant with the Medical device directive 93/42/CE
Warning
The information contained in this manual is subject to change without notice.
The Diagrams are inserted only for reference and may vary slightly from the actual device.
Spencer Italia S.r.l. assumes no responsibility for any errors contained herein or for damage, accidents or consequences connected with the supply,
performance or use of this manual
Prima emissione: 1998
Rev. 3: 21/05/2019
SPENCER ITALIA SRL Via Provinciale n° 12 43038 Sala Baganza (PR) - Italy
www.spencer.it | support.spencer.it - e-mail: info@spencer.it | service: service@spencer.it |Ph./Tel. +39.0521.541111
Quality System EN ISO 9001 EN ISO 13485

Questions and Answers

Summary

INTENDED USE

Warranty and support

WARNINGS

User training

Emphasizes the need for trained operators and the importance of continuous practice.

Product functionality

Lists essential guidelines for proper device operation and maintenance to ensure safety.

SPECIFIC WARNINGS

Environmental and Electromagnetic Compatibility

Warnings regarding device placement, RF interference, and EMC compliance.

Patient Suitability and Contraindications

Lists specific patient conditions and age groups for which the device is not suitable.

Device Handling and Maintenance Precautions

Covers warnings on device handling, cleaning, battery, and operational checks.

Operator and System Requirements

Emphasizes trained operator use, pneumatic supply, and device protection.

6.1 Requirements of operators

Outlines requirements for operators, including training and assessment of integrity.

Staffing and Operational Readiness

Stresses qualified staff assistance, readiness, battery replacement, and warranty seal integrity.

Storage, Handling, and Usage Environment

Covers proper storage, handling, ventilation, and avoiding lubrication.

Usage Restrictions and Patient Suitability

Details restrictions on substances, environment, NIV suitability, and complications.

RESIDUAL RISK

General Operational and Safety Risks

Covers risks from side effects, lack of doctor supervision, and infection from circuits.

INSTALLATION AND START-UP

9.1 Installation Procedures

Details critical installation steps, packaging checks, and environmental verification.

Immunity Tests and Separation Distances

Details immunity test levels, conformity, and recommended separation distances for RF equipment.

9.2 Start-Up and Functional Testing

Instructions for initial device start-up, including battery, functional tests, and alarm checks.

FUNCTIONAL CHARACTERISTICS

INSTRUCTION FOR USE

11.5 Usage and 11.6 Alarms

Covers patient assessment, alarm management, and information signals during device use.

CLEANING AND MAINTENANCE

Periodic maintenance

EXTRAORDINARY maintenance

TROUBLESHOOTING

Spencer 170 NXT Specifications

General IconGeneral
Power Supply220-240V / 50-60Hz
MaterialStainless Steel
Control SystemMicroprocessor-based
DisplayLCD
Cooling SystemAir Cooling
Safety FeaturesOver-temperature protection, Door lock

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