Sunoptic Surgical LED-400 User manual

LIT-216 Sunoptic Surgical®
Rev. E (English)
Page 1 of 114
LED-4000
(US PATENT 8,911,130)
LED Light Source
Operator Manual
Sunoptic Technologies®
6018 Bowdendale Avenue
Jacksonville, FL 32216 USA
Customer Service: 904 737 7611
Toll Free 877 677 2832
EC|REP AJW Technology Consulting GmbH
Breite Straße 3
40213 Düsseldorf, Germany
Telephone: [phone]

LIT-216 Sunoptic Surgical®
Rev. E (English)
Page 2 of 114
TABLE OF CONTENTS
1. INTRODUCTION
1.1. Indications for Use
1.2. Functions of Design
2. WARNINGS AND CAUTIONS
2.1. Warnings
2.2. Cautions
2.3. Notes
3. SPECIFICATIONS
4. CERTIFICATIONS
5. OVERVIEW
6. SETUP AND OPERATION
6.1. Device Setup
6.2. Operation
7. CLEANING AND DISINFECTION
7.1. Cleaning the Optic
8. MAINTENANCE, SERVICING, REPAIR & WARRANTY
8.1. Fuse Replacement
8.2. Warranty
8.3. Repair
8.4. Troubleshooting
9. END OF PRODUCT LIFE
10. SYMBOLOGY

LIT-216 Sunoptic Surgical®
Rev. E (English)
Page 3 of 114
1. INTRODUCTION
Congratulations on the purchase of your new LED-4000 Light Source!
This user-friendly, high efficiency LED light source utilizes state-of-the-art illumination technology. It
offers a variety of features such as:
•Quiet operation
•Long life, 30,000 hrs.
•Compact and light weight
•Turret which adapts to various types of light guides
•Pulse-width Modulation (PWM) Electrical Dimming
•Sensor automatically shuts off LED when light guide is removed
•Standard CRI option provides 75 CRI and 6500K color temperature (nominal)
•High CRI option provices 92 CRI and 5600K color temperature (nominal)
In short, you have chosen the best and we would like to make sure you receive the optimal results
with your new LED light source by using it correctly.
This Operator Manual will help you to install the device and optimally integrate it with other
components of your system. It will also instruct you how to operate the LED light source and how to
keep it clean. It will give you maintenance and service guidelines as well as recommendations for
best performance results.
1.1 Indications for Use
The LED illuminator is used to illuminate the site of surgery during minimally invasive procedures
including, but not limited to arthroscopy (orthopedic surgery), laparoscopy (general and
gynecological surgery), and endoscopy (general, gastroenterological, and ENT surgery). Light is
typically transmitted from the illuminator through a fiber optic cable and typically a scope or other
light guide.
The LED illuminator is intended to be used in a controlled operating room environment by qualified
medical personnel. The LED illuminator is provided non-sterile and is not intended to be sterilized.
The system has an expected, but not limited, three-year service life.
The illuminator is not intended to be used for monitoring, diagnostic, or other life support functions.
This device does not sustain nor support life. The device is not intended to compensate for injury,
handicap, replacement or modification of anatomy, or control of conception. No special intervention
is necessary in the event of device failure. As such, this device has no essential performance as
defined by IEC 60601-1, and should this device fail to operate, a suitable backup should be
available for any procedure where it may be used.
There are no contraindications.
1.2 Functions of Design
The LED-4000 comprises a standalone, mains-powered illuminator. The standard CRI model
produces 2200lm (typical) in the visible spectrum range, and the high CRI model produces 1200lm
(typical) in the visible spectrum range. The illuminator is typically used with a fiberoptic light guide
that connects to a light port located on the front panel. Light intensity is controlled via pushbuttons
located on the front panel of the console.

LIT-216 Sunoptic Surgical®
Rev. E (English)
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2. WARNINGS AND 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. The words warning, caution, and note carry special meaning and should be carefully reviewed:
WARNING: Indicates risks to the safety of the patient or user. Failure to follow warnings may result in
injury to the patient or user.
CAUTION: Indicates risks of improper use and/or damage to the equipment. Failure to follow cautions
may result in loss of function or product damage.
NOTE: Indicates special information to clarify instructions or present additional useful information.
The appropriate “WARNING”, “CAUTION” or “NOTE” symbol in this manual is intended to alert the user
to the presence of important operating and maintenance instructions in the manual.
2.1 Warnings
•Federal law restricts this device to sale by or on the on the order of a licensed practitioner.
•The illuminator produces highly concentrated light. Avoid shining light beam into eyes or looking
directly into the light beams at the ends of connected instruments and/or light guides. When not
using the device, it is advised to fully dim the illuminator or place unit into STANDBY mode.
•Qualified personnel must determine a safe working distance between the ends of connected
instruments and/or light guides and the patient for each application. There is a risk of patient injury
if a light guide or instrument connected to the light source comes to close to the patient.
•User is responsible for determining if interruption of light output will create an unacceptable risk.
Having a backup illuminator is advised.
•Not suitable for use in presence of flammable anesthetic mixture with air or with oxygen or nitrous
oxide.
•For endoscopic procedures: the illuminator should only be used with type BF endoscopic
instruments which have been certified to IEC 60601-1 and IEC 60101-2-18.
This symbol indicates type BF equipment.
•All devices and/or instruments connecting to the illuminator must be classified as medical
equipment. It is the user’s responsibility to ensure that all equipment used with this device meets
all applicable standards such as IEC 60601-1.
•To prevent fire and/or electric shock, do not open or expose the illuminator to liquids.
•The illuminator-side light guide connection may become hot during use. Allow adequate time to for
end tip to cool before removal from illuminator.
•Instruments and/or light guides connected to the illuminator must be NON-CONDUCTIVE. There
should be no conductive shielding or any conductive connection between the illuminator and the
patient. Such connections present a risk to patient safety.
•Instruments and/or light guides should be clean and dry before being connected to the illuminator.
•DO NOT modify the equipment without authorization from the manufacturer.
•The illuminator is provided non-sterile and is not intended to be sterilized.
•Use only the power cord supplied with illuminator or medically approved power cords with less than
200mΩ of ground impedance and less than 16ft (<5m) of length. If unauthorized cables are used,
the device may have increased electromagnetic emissions and/or decreased electromagnetic
immunity which may result in improper operation.
•This device meets CISPR 11 Class A limits and is suitable for use in a hospital and industrial
environments. If it is used in a residential environment (for which CISPR 11 class B is normally
required) this equipment might not offer adequate protection to radio-frequency communication
services. The user might need to take mitigation measures, such as relocating or re-orienting the
equipment.

LIT-216 Sunoptic Surgical®
Rev. E (English)
Page 5 of 114
•Performance of this device may be affected in proximity of another device and/or equipment
capable of producing high levels of RF emissions. The device should be used no closer than 12
inches (30 cm) to any part of RF equipment including cables. In the event performance of this
device is affected due to high levels of RF emissions, relocation of the suspected device and/or
equipment producing high levels of RF emissions, or the headlight system may reduce or eliminate
the problem.
2.2 Cautions
•Before each procedure, carefully check the illuminator for damage. DO NOT use a damaged
illuminator.
•The user should verify the light guide end tip and the active illumination port are of the same
type before insertion. DO NOT attempt to force an end tip into an incorrect port.
•All servicing and repair must be performed by the manufacturer or qualified service technicians.
•Ensure that the air vents located on the illuminator are not obstructed to allow the device to
receive the necessary cooling to prevent an overheating.
•The illuminator is designed to only be used with Sunoptic Technologies® fused light guides.
Other light guides may damage the unit due to the high levels of light intensity produced by the
unit.
•Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/or patient
is established.
2.3 Notes
•If there is a power interruption during use, the illuminator will shut down and automatically restart
if the power switch remains in the ON position. There may be a short delay as the unit reboots.