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Sunoptic Surgical SSL-4700 Operation Manual

Headlight system
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SSL-4700 HEADLIGHT SYSTEM
LIT-272_4700 LED Headlight System
Revision A
Effective Date: 07/21/2023
Operation Manual
Sunoptic Technologies
6018 Bowdendale Avenue
Jacksonville, FL32216 USA
AJW Technology Consulting GmbH
Breite Straße 3
40213 Düsseldorf, Germany
AJW Technology Consulting GmbH
Kreuzplatz 2
8032 Zürich
Switzerland
UK
AJW Technology Consulting Ltd 4/4a
Responsible
Bloomsbury Square London WC1A 2RP
Person
United Kingdom
®
Page 1 of 12
English

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Summary of Contents for Sunoptic Surgical SSL-4700

  • Page 1 SSL-4700 HEADLIGHT SYSTEM Operation Manual ® Sunoptic Technologies 6018 Bowdendale Avenue Jacksonville, FL32216 USA AJW Technology Consulting GmbH Breite Straße 3 40213 Düsseldorf, Germany AJW Technology Consulting GmbH Kreuzplatz 2 8032 Zürich Switzerland AJW Technology Consulting Ltd 4/4a Responsible Bloomsbury Square London WC1A 2RP...

  • Page 2: Table Of Contents

    Table of Contents SECTION HEADING PAGE Symbology Introduction Intended Use Contraindications Patient Target Group and Intended User(s) Adverse Events Clinical Benefits Adverse Effects Prior to Use Expected Life of Device Storage Conditions Function of Design Warnings / Cautions Warranty Assembly of 4700 LED Headlight 7, 8 Adjusting the Headband and Functional Check 8, 9...

  • Page 3: Symbology

    1. SYMBOLOGY Symbol Description Symbol Description Manufacture Date of Manufacture (YYYY-MM-DD) Manufacture w/Date of Manufacture NOTE: Date may also be placed on right side of factory symbol. YYYY-MM-DD “Authorized Representative”, European “Authorized Representative”, Switzerland Community Federal law restricts this device to sale by or on the order of a licensed European CE Mark healthcare practitioner...

  • Page 4: Introduction

    2. INTRODUCTION Congratulations on the purchase of your new LED Headlight 4700 system. The LED Headlight 4700 is a battery powered portable headlight with an adjustable spot and uses encrypted battery technology that requires the use of approved batteries obtained from the manufacturer or authorized distributors. Additionally, a low battery alarm is inc l u de d in this system and will beep when power is low.

  • Page 5: Clinical Benefits

    7. CLINICAL BENEFIT - DEFINITIONS Regulation (EU) 2017/745 Article 2(53) MDR defines clinical benefit as the positive impact of a device on the health of an individual, expressed in the terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health.

  • Page 6: Warnings / Cautions

    12. WARNINGS / CAUTIONS Use of this equipment may present hazards to the user and/or patient. Before operating this device, please read this operating manual thoroughly and follow all warnings, cautions, and instructions for use. WARNING symbol indicates conditions that may cause risk to the safety of the patient or user.

  • Page 7: Warranty

    Holster come with a 3-year warranty for all workmanship and defects of material. • Should your product prove to have such defects within the 3-year period, Sunoptic Surgical will repair or replace the product at its sole discretion without charge.

  • Page 8: Adjusting The Headband And Functional Check

    • To remove the LED Module from the Battery Holster, press the small, raised button on the quick disconnect device located between the LED Module and the Battery Holster and pull straight out without twisting. See Figure 2 below. Figure 2 16.

  • Page 9: Maintenance And Cleaning

    1. To avoid over-discharging of the battery pack, place the battery pack in the supplied charger once the holster beep notifying a LOW BATTERY condition CAUTION exists. DO NOT store batteries with low charge for extended periods of time, and DO NOT leave low charged batteries in the holster 17.

  • Page 10: Smart Charger And Calibrator

    • In the event of a battery leakage, do not allow the liquid to come in contact with skin or eyes. If contact has been made, wash the affected area with copious amounts of water and seek medical advice. • Do not use any charger other than a smart battery charger supplied by the manufacturer.

  • Page 11: Troubleshooting

    • Do not expose the charger to heat, fire, or mechanical shock. Place the charger in a cool spot, away from any heat sources. • Do not use this equipment in the presence of a mixture containing flammable anesthetic and/or air or oxygen or nitrous oxide. •...

  • Page 12: End Of Product Life

    1. The unit will become warm during normal operation. This does not indicate a malfunction. 2. Prevent metallic objects from coming into contact with the metal parts of the DC plug of the power supply. If this happens, a short may occur and the unit may be damaged. 3.

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