Integra Integra Duo Bedienungsanleitung
Instructions for Use
Integra®Duo
LED Surgical Headlight System
2
Table of Contents
10
Overview
30
Replacement Parts
24
Device Specifications
19
Baery Information
04
Indications &
Contraindications
12
Integra Duo Kit Options
31
Repair & Return
26
EMC User Information
22
Maintenance & Cleaning
05
Table of Symbols
14
Preparing the System
32
Product Information
Disclosure
29
Integra Duo Ordering
Information
23
Troubleshooting
06
Warnings & Cautions
3
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Indications for Use
The Integra®Duo LED Surgical Headlight System is designed to provide supplemental
illumination aiding visualization during surgical, diagnostic, or therapeutic procedures.
Contraindications
The Integra Duo LED Surgical Headlight System is contraindicated for use in neonatal
transillumination, ophthalmic procedures, photosensitive patients or patients who have
received photosensitizing agents (hematoporphyrin derivatives) within three months.
0oC
(-4oF)
500hPa
4
Table of Symbols
For Baery Purposes- No Naked
Flames
Product complies with the
requirements of directive 93/42/EEC
Class II Equipment, used on power
adapter
Listed by ETL
Eligible for Call2Recycle Program Recycle (Taiwan)
Catalog Number
Restriction of Hazardous Substances
(China) 5-Year Safe Use Period
Serial Number
Manufacturer Date of Manufacture
(YYYY-MM-DD)
Non-Sterile
MR Unsafe
Keep Dry
Caution
Degrees of protection provided by
enclosures (IP Code) for power
adapter
Authorized Representative in the
European Community
Caution: Federal (USA) law
restricts this device to sale by or on
the order of a physician
Storage Temperature Limitations
Storage Humidity Limitations
(Non-Condensing)
Storage Atmospheric Pressure
Limitations
Waste Electrical and Electronic
Equipment
Recycle
Consult Instructions for Use
www.integralife.com
0%
0oC
(-4oF)
49oC
(120oF)
1060hPa
500hPa
95%
5
• The user should carefully study the Instructions for Use (IFU) before using the Integra
Duo LED Surgical Headlight System in the clinical environment. Instructions should be
followed, with special aention given to warnings, controls, and user specifications.
The IFU should be made available to appropriate personnel.
• This IFU contains information about the proper procedures for preparing this product
for its use and care.
• Before every procedure, carefully inspect the Integra Duo LED Surgical Headlight
System to ensure it has been properly maintained, cleaned, and is fully functional.
DO NOT use if inspection reveals any damage or loose connectors.
• Follow the instructions of other manufacturers’ equipment when used in conjunction
with this product.
• To reduce the risk of fire and electric shock, do not expose electrical equipment to
moisture. When cleaning, do not immerse any electrical device in liquid.
• Do not use or store liquids on or above the Integra Duo LED Surgical Headlight System.
• Safety precautions must always be exercised when using electrical equipment to
prevent operator/patient shock, fire hazard or equipment damage.
• Electric shock hazard. If unit is not functioning properly, DO NOT OPEN. Please refer
to the Repair and Return section of this manual.
• The Integra Duo LED Surgical Headlight System must be used only with the
recommended Integra baery or with the AC power adapter supplied by Integra.
Using a different AC power adapter may not provide protection against electric shock.
• The Integra Duo LED Surgical Headlight System should never be used in ocular
surgery or in a surgical procedure requiring direct illumination of the eye.
General Warnings
6
• Use care not to point the Headlight directly at the eye while in use.
• Only use enough light to ensure good visualization and avoid prolonged close
stationary illumination of tissue to reduce the risk of thermal injury.
• When the Integra Duo LED Surgical Headlight System is not in use, turn off the power.
• Explosion hazard. Do not use the Integra Duo LED Surgical Headlight System in the
presence of flammable anesthetics, liquids, vapors, gases, or dusts.
• Keep cooling vents free of obstructions.
• To ensure patient / operator safety and optimal product performance, use only
recommended accessories and supplies with the system according to the instructions
for use. Use of accessories and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
• The Integra Duo LED Surgical Headlight System complies with applicable domestic
and international standards for electromagnetic interference and should not present
problems to other equipment or be affected by other devices. As a precaution, avoid
using the device in close proximity to other equipment.
• Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the Integra Duo LED Surgical Headlight System, including cables specified by Integra.
Otherwise, degradation of the performance of this equipment could result.
• Care should be taken if the equipment is used adjacent to or stacked with other
equipment; if adjacent or stacked use is inevitable, the equipment should be observed
to verify normal operation in the configuration in which it will be used.
General Warnings (Continued)
7
• When the Integra Duo LED Surgical Headlight System employs the direct power
option, the cord may present a tripping hazard.
• No modification of this equipment is allowed.
• This device is not indicated for use in the MR environment.
• Defective baeries can damage the Integra Duo LED Surgical Headlight System.
If the baery shows any signs of damage, leakage, or cracking, it must be replaced
immediately, and only with an Integra baery recommended for or supplied with the
system.
• Improper disposal of baeries may create an explosion or contamination hazard.
Never dispose of baeries in refuse containers. Do not dispose of the baery in fire.
Always recycle baeries according to local regulations.
• Improper handling of the baery can lead to heat generation, smoke, bursting, or fire.
• Do not remove the label from the baery.
• Do not immerse the baery in water or other liquids.
• Do not disassemble or modify the baery.
• Do not directly connect or short-circuit the positive (+) and negative baery terminals.
• To avoid short circuits, keep baery terminals away from metal objects.
• Do not expose the baery to temperatures higher than 49°C/120°F.
General Warnings (Continued)
Baery Warnings
8
• Do not expose the charger or power supply to water or liquids. The case is not sealed.
• Do not open the charger or power supply case. No user serviceable parts are inside.
• Do not cover the fan exhaust or obstruct the airflow; this will cause overheating.
• Use only the Integra supplied power supply, charger, baeries and power cords.
• Store the charger in a cool spot, away from external heat sources.
• During recharging, the charger may become warm.
• This device should be used in environments that meet the operating environmental
conditions in the Device Specifications section of this manual.
Baery Charger Warnings
Caution
9
Overview
Top Knob
Rear Knob
Headlight Cable
Comfort CodeTM
Alphanumeric Sizing
System
Figure 1
Headlight
Luminaire
Occipital Basket
Duct System
Iris Wheel
Suspension Linkage
The Integra Duo LED Surgical Headlight System is a self-contained headlight system that
can be operated using either baery or direct power supply. Using a baery pack gives the
surgeon complete mobility allowing unrestricted movement in and around the operating
suite. The direct power supply option is intended to be a back-up to the baery system but
could also be used as a primary power source for unlimited operating time.
The Integra Duo LED Surgical Headlight System provides supplemental illumination during a
surgical procedure. It does not have any essential performance that is not covered by basic safety.
The Integra Duo LED Surgical Headlight System utilizes an LED light source with an active
cooling system. A thermostatically-controlled cooling fan draws air through ports on the
luminaire, quietly cooling the LED. The air is drawn through a duct system and is gently
exhausted behind the surgeon and outside the surgical field. The major components of the
headlight itself are shown in Figure 1 and described on the adjacent page.
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