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OPELA III Instruction Manual
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OPELA III Instruction Manual - 1

Instruction Manual Wearable Surgical Lighting System TM Safety Precautions Part names Repair & Inspection Thank you for purchasing the Wearable Surgical Lighting System Please be sure to read this instruction manual before use. Please also keep this manual close at hand fo

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OPELA III Instruction Manual - 2

This product is a wearable surgical lighting system focused on the quality of light, while providing both moveableness (with installed batteries) and a comfortable feel. Introduction Safety Precautions [Purpose of Use] [Target Users] [Place of Use] [ Models ] To wear on your head and illuminate the field of vision during surgery, examinations, and treatment. Physicians, Medical staff Indoor -H (High Illumination Model) Achieves 145,000 Lux in pursuit of high illumination. [Basic Performance] Central Illumination: 6,000 to 145,000 Lux ±10% (For Mode-H, Illumination Distance 400 mm(16inch),...

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OPELA III Instruction Manual - 3

The following symbols indicate actions that you should not perform. The following symbol indicates an action that you must perform. Indicates that the description must be followed. ■General Precautions WARNING Safety Precautions

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OPELA III Instruction Manual - 4

■ Precautions for Usage, Charging, and Storage Locations

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OPELA III Instruction Manual - 8

Safety Precautions ■Symbols on Labels Symbol ■ Labels Attached to the Product SAMPLE VTiV.i (01)XXXXXXXXXXXXXXX (11)XXXXXX(21)XXXXXX IsN xxxxxx XXXX-XX-XX Wearable Surgical Lighting System OPELAIII Model - H (High illumination) . TAIYO CORPORATION IHl 3 0-9, Shiba 5 Chome, Minato-ku, TOKYO, JAPAN 9V- 7. 2 W MADE IN JAPAN (AD®© Rx Only Class 2 Battery Unit (for Wearable Surgical Lighting System OPELAIII only) 9V=0.8A 4 5 0 0 mAh TAIYO CORPORATION AC Adapter: MPU 3 2B-1 0 5 Mil 3 0-9, Shiba 5 Chome, (SINPRO ELECTRONICS CO., LTD) Minato-ku, TOKYO, JAPAN ^ SINPRO SWITCHING POWER SUPPLY MODEL...

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OPELA III Instruction Manual - 10

Part names Antibacterial urethane pad Main unit Heat sink Front face Front hub Light source unit Cord clip (Small) Cord clip (Large) Illumination range adjustment lever Part names Transparent cover Cord tie band Connection cord Battery Unit Size adjustment knob Illumination position adjustment lever Back face Power lamp Dimmer knob OUTPUT jack Charge lamp Power cord INPUT jack Power plug Belt clip Label Attached Belt Assistive belt Main belt Surface fastener of the main unit

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OPELA III Instruction Manual - 11

■Battery Unit: Safety Precautions WARNING

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OPELA III Instruction Manual - 12

Charging the Battery Unit 1. Turn the dimming knob clockwise to switch it on. If the charge lamp is illuminated orange, the battery needs to be charged. 2. Turn the dimming knob counter-clockwise to turn it off, and connect the dedicated AC adapter and battery unit (INPUT jack). 3. The charge lamp will turn orange when you insert the power plug into an outlet, and then the charging will start. 4. Immediately disconnect the dedicated AC adapter from the outlet and battery unit once charging is complete. Charge lamp Charge lamp

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OPELA III Instruction Manual - 13

Check that all 3 LED lights illuminate. Product safety may be affected if only 2 or fewer LEDs illuminate or if they flicker. Discontinue use and contact the distributor. <How to check> Move the Illumination Field Diameter adjustment lever all the way to the right, turn the dimming knob of the battery unit clockwise to turn it on, and place the palm of your hand near the light source to check for 3 light sources. Illumination range adjustment lever (right end)

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OPELA III Instruction Manual - 14

Wearing (Attached belt, battery unit) CAUTION 1. Remove the assistive belt and pull the main belt sideways from both directions.

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OPELA III Instruction Manual - 15

2. Place the attached belt on your pelvis. *Wear the attached belt underneath your surgery gown. *Wear the attached belt around your pelvis, not your waist. 3. Wrap the attached belt around your pelvis. Fasten the belt. 4. Hold the assistive belt at the back. 6. Fasten the assistive belt. 5. Pull the assistive belt. 5 cm (2 inch) below your pelvic bone 7. Insert the belt clip of the battery unit deeply and tightly on the backside of the main belt.

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OPELA III Instruction Manual - 16

Wearing (Main unit) CAUTION Put the product on yourself in front of a mirror before washing your hands. It may fall off if others put the product on for you as it tends to become loose or tilt. Be sure to put it on yourself in front of a mirror before washing your hands, to ensure it is worn in the correct position. 1. Replacing the antibacterial urethane pad Replace the antibacterial urethane pad with a new one if sweat or stains bother you. 4. Place your forehead against the front hub. 2. Turn the size adjustment knob 5. Lift your head with the front hub 3. Set the connection cord along...

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OPELA III Instruction Manual - 17

7. Tie the connection cord of the main unit with a tie band, and connect the main unit to the battery unit (OUTPUT jack) with the connection cord. 8. Put on your surgery gown. Flip your gown when controlling the battery unit. Check that it is worn in the correct position with no loose points. Wear the product in the correct position as shown below so that it does not move. A loose fit may result in the device falling. If the device cannot be worn in the correct position, discontinue use and contact the location of purchase, as it may have a distortion or defect. Correct Incorrect Nearly...

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OPELA III Instruction Manual - 18

1. Turn the dimming knob clockwise to turn it on and adjust the brightness. Power lamp Green: ON Off : OFF 【Continuous Lighting Hours】 ・Dimmer Knob MAX (Dimming Level 100%): Approx. 2.5 Hours ・Dimmer Knob # 7 (Dimming Level 70%): Approx. 3.5 Hours ・Dimmer Knob # 5 (Dimming Level 50%): Approx. 6 Hours Dimming knob *Adjust use in consideration of the required surgery time. If necessary, prepare spare batteries. Dark          Bright Adjust the light source position and range according to the operative field you want to illuminate. Illumination range adjustment lever Illumination range...

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OPELA III Instruction Manual - 19

The optimal illumination position depends on the operation. Adjust the light source position according to the operative field you want to illuminate. Major abdominal surgeries (heart, lung, kidney, liver, etc.) Surgeries in which the operative field is near the level of the eye of the operator (anus, vaginal opening, etc.) 【Case of illuminating in vertical direction】 The illumination position will no longer be aligned if your posture or operative field changes during surgery. Change the angle of your head according to the operative field or re-adjust the illumination position. 3. Turn the...

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