taiyo OPELA III Instruction Manual Download Page 8

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■

Standard Package

Main unit (Model - H)

Cord tie band

Cord clip (Small)

Cord clip (Large)

Antibacterial urethane pad (Front and back hub)

Battery unit

Dedicated AC adapter

Attached belt (M-L or LL)

Storage bag/Hard case (with calibration kit)

Instruction manual (This document)

Front hub: 2 sets, back hub: 2

1 copy

Description

Quantity

Part number

A standard package of this product includes the following items.
Please inquire the place of purchase regarding purchases of any additional accessories.

Composition

HTH

CBX

CCS

CCL

UPX

BAN

ACX

BLM / BLL

BGX / HCX

OP_P_02US(02)

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Labels Attached to the Product

Main unit

Dedicated AC adapter

Battery unit

(01)XXXXXXXXXXXXXXX

XXXXXX
XXXX-XX-XX

(11)XXXXXX(21)XXXXXX

SAMPLE

XXXX-XX-XX

XXXXXX-X

(01)XXXXXXXXXXXXXX

(11)XXXXXX(21)XXXXXX-X

SAMPLE

E300019

ANSI/AAMI ES60601-1

CSA-C22.2 No.60601-1

Wearable Surgical

Lighting System

OPELAIII Model

TAIYO CORPORATION

Symbol

Description

Symbol

Description

Caution

Class II equipment

For indoor use only

Temperature limit

Humidity limitation

Atmospheric pressure
limitation

Direct current

Manufacturer

Alternating current

Refer to instruction
manual/booklet

Caution: Federal law restricts

this product to sale by or on

the order of a physician

Polarity of d.c. power
connector

Serial number

Date of manufacture

■

Symbols on Labels

Consult instructions for

use or consult electronic

instructions for use

■

Accessories (sold separately)

Cord clip (Small)

Cord clip (Large)

Battery unit

Dedicated AC adapter

Antibacterial urethane pad (Front and back hub)

Attached belt (M-L)

Attached belt (LL)

Storage bag

Hard case

Calibration kit

10 set

Description

Order Unit

Part number

(Front hub: 10 sets, back hub: 10)

CCS

CCL

BAN

ACX

UPX

BLM

BLL

BGX

HCX

CKX

ompositio

Safety Pr

ecautions

Summary of Contents for OPELA III

Page 1: ...Part names 使用方法 How to use Storage Maintenance Repair Inspection Troubleshooting Specifications Warranty Wearable Surgical Lighting System Please be sure to read this instruction manual before use Please also keep this manual close at hand for future reference Instruction Manual E300019 ...

Page 2: ...mproperly handled Indicates expected failure damage malfunction or defects if this description is ignored and improperly handled Basic Performance Central Illumination 6 000 to 145 000 Lux 10 For Mode H Illumination Distance 400 mm 16inch Illumination Field Diameter φ75 mm 3inch Continuous Lighting Hours Dimmer Knob MAX Dimming Level 100 Approx 2 5 Hours Dimmer Knob 7 Dimming Level 70 Approx 3 5 H...

Page 3: ...luminate If only 2 or fewer LEDs illuminate or if they flicker discontinue use and contact the distributor Do not use damaged or failing products It may cause the product to drop heat generation or electric shock Request for repair at the distributor CAUTION Do not disassemble repair or modify the product It may cause battery leakage heat generation rupture ignition or damage and failure of the ma...

Page 4: ...trous oxide is used The product is not classified as AP or APG Using it may cause flammable gas to ignite and create a fire Charge or store in locations away from direct sunlight The temperature will increase due to direct sunlight and may cause battery leakage heat generation rupture or ignition Do not use in locations with much sand or dust It may cause failure Do not use in locations exposed to...

Page 5: ... touch the adapter or battery It may cause electric shock CAUTION WARNING NOTICE 5 Safety Precautions Handling the Battery Unit Do not drop in fire or heat up It may cause rupture or ignition Do not leave the battery unit under direct sunlight or in sun heated cars It may cause leakage heat generation rupture or ignition If fluid in the battery unit gets into your eyes immediately flush with water...

Page 6: ...aking from the battery unit before use Touching the fluid may cause burns Discontinue use put it in a plastic bag and contact the distributor Place the main unit on the calibration kit instead of directly on a platform or desk Otherwise the illumination position adjustment lever will touch the platform or desk and may cause it to bend or cause the protective cap to come off easily Broken parts can...

Page 7: ...torage bag hard case It may cause failure damage or injury CAUTION NOTICE NOTICE 7 Safety Precautions Maintenance Precautions Transport and Storage Precautions Do not wash it by exposing it to or submerging it in water It may cause electric shock or failure When cleaning use ethanol for disinfection Using detergent or disinfectants other than ethanol for disinfection may cause damage discoloration...

Page 8: ...IYO CORPORATION Symbol Description Symbol Description Caution Class II equipment For indoor use only Temperature limit Humidity limitation Atmospheric pressure limitation Direct current Manufacturer Alternating current Refer to instruction manual booklet Caution Federal law restricts this product to sale by or on the order of a physician Polarity of d c power connector Serial number Date of manufa...

Page 9: ... Unit Part number Front hub 10 sets back hub 10 CCS CCL BAN ACX UPX BLM BLL BGX HCX CKX 9 Composition Standard Package Main unit Model H Cord tie band Cord clip Small Cord clip Large Antibacterial urethane pad Front and back hub Battery unit Dedicated AC adapter Attached belt M L or LL Storage bag Hard case with calibration kit Instruction manual This document 1 1 2 2 Front hub 2 sets back hub 2 2...

Page 10: ...he main unit Assistive belt Dedicated AC adapter Attached Belt Main unit Power plug Power cord Plug Label Light source unit Cord tie band Heat sink Cord clip Small Connection cord Battery Unit Illumination range adjustment lever Mirror Transparent cover Illumination position adjustment lever OUTPUT jack Power lamp Dimmer knob Belt clip Charge lamp INPUT jack Label Label Label 10 Part names ...

Page 11: ... cases repeatedly charge and discharge several times before use CAUTION WARNING NOTICE 11 How to use How to use 5 Charging Wearing Lighting After Use Check 1 Check 2 Battery Unit Safety Precautions Charge in locations away from direct sunlight The temperature will increase due to direct sunlight and may cause leakage heat generation or ignition Charge in locations according to the Environmental Sp...

Page 12: ...k 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 Charging the Battery Unit 5 1 AC adapter cord Charge lamp Orange Charging Orange Insufficiently charged Off Charged Charge lamp Status When the charge lamp illuminates in oran...

Page 13: ...eck for 3 light sources All 3 illuminate Illumination range adjustment lever right end 13 How to use Charging Wearing Lighting After Use Check 1 Check 2 Check 1 5 2 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 ...

Page 14: ...ached belt of this product Wear the attached belt for a couple of hours before use Wear it for a couple of hours at first to check that there is no discomfort or itchiness You can use it all day once it fits comfortably Wrap the attached belt around your pelvis so that it does not loosen The battery unit may fall if the attached belt loosens or moves around Make sure to put on the attached belt by...

Page 15: ...Charging Wearing Lighting After Use Check 1 Check 2 5 cm 2 inch below your pelvic bone 15 How to use 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 4 Hold the assistive belt at the back 6 Fasten the assistive belt 5 Pull the assistive belt 7 Insert the ...

Page 16: ...t hub kept attached to your forehead 6 Turn the size adjustment knob to lock the main unit into position Charging Wearing Lighting After Use Check 1 Check 2 Wearing Main unit 5 4 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...

Page 17: ...may damage the heat sink Make sure to use the calibration kit NOTICE Correct Incorrect 17 How to use 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 OUTPUT jack Connection cord Charging Wearing Lighting After Use Check 1 Check 2 C...

Page 18: ...ange Illumination range adjustment Dimming knob Power lamp Green ON Off OFF Dark Bright Illumination position adjustment lever Slide up Light source position moves to the back Back side Front side Illumination position adjustment Adjust use in consideration of the required surgery time If necessary prepare spare batteries Dimmer Knob MAX Dimming Level 100 Approx 2 5 Hours Dimmer Knob 7 Dimming Lev...

Page 19: ...e of your head according to the operative field or re adjust the illumination position 19 How to use 3 Turn the dimming knob counter clockwise after use to turn it off then remove the connection cord of the main unit from the battery unit The optimal illumination position depends on the operation Adjust the light source position according to the operative field you want to illuminate Charging Wear...

Page 20: ...ing or carrying Leaving the product out or carrying it without putting it in the storage bag hard case may cause failure or damage Also if the heat sink is bent or warped you may be unable to wear the product or the light source unit may get hot and malfunction Do not store with the connection cord still connected to the battery unit It may cause failure Do not store in locations with corrosive ga...

Page 21: ... Latches Battery unit Dedicated AC adapter Attached belt Main unit on the calibration kit 21 Storage 1 Check that the calibration kit is firmly pushed to the bottom of the storage bag 3 Place the battery unit in the front pocket of the storage bag and firmly close the lid of the pocket 2 Place the main unit on the calibration kit and firmly close the lid of the storage bag Match the orientation of...

Page 22: ...id direct sunlight and hang dry in the shade Do not iron CAUTION NOTICE 3 Composition 22 Maintenance Have the manufacturer perform maintenance and inspection every 2 years with fee Manufacturer maintenance inspection Charging Wearing Lighting After Use Check 1 Check 2 Maintenance 5 8 Replace consumable parts at appropriate times Please see for the list of consumable parts available for purchase Re...

Page 23: ...b to rise from the pedestal when you let go The height of the heat sink is calibrated 23 Maintenance Please contact the distributor when disposing Disposal 5 9 Charging Wearing Lighting After Use Check 1 Check 2 1 Take out the calibration kit from the storage bag hard case and place it on a desk 4 Set the illumination position adjustment lever into the indentation front of the pedestal 5 Refer to ...

Page 24: ... fill in the required fields in the form below and immediately contact the distributor You will need to ship the product to the manufacturer for repair and or inspection Repair Inspection 6 Name of product Model Main unit Battery unit Name of institute affiliation Your name Phone number E mail address Date of purchase YY MM DD Distributor Customer information Description of problem Wearable Surgic...

Page 25: ...g Lighting does not completely turn off even when the dimming knob is turned to 1 25 Troubleshooting Troubleshooting 7 Main unit does not illuminate Illuminated period is shorter than 2 hours even when fully charged Bad connection cord contact Battery unit is deteriorated Battery unit life has been reached Repeat charging and discharging several times Replace with a new battery unit Lighting does ...

Page 26: ...0 Approx 2 5 Hours Dimmer Knob 7 Dimming Level 70 Approx 3 5 Hours Dimmer Knob 5 Dimming Level 50 Approx 6 Hours 12V 2 5A 9V 0 8A 4 500 mAh Approx 480 g 10 Excluding Dedicated AC Adapter Approx W140 x H100 x D50 mm 10 W5 5 x H3 9 x D2 inch 10 Manufacturer Model Number Rated Input Rated Output SINPRO ELECTRONICS CO LTD MPU32B 105 100 240V 47 63 Hz 0 6 0 4A 12V 2 5A max Main Body Battery Unit Dedica...

Page 27: ...er devices is necessary check that the product and other devices operate correctly WARNING Conformity information This product satisfies the requirements of CISPR11 2009 A1 2010 Group 1 Class B This product has been tested for immunity against level 4 electrostatic discharge contact discharge 8 kV air discharge 15 kV defined in IEC 61000 4 2 2008 This product meets the requirements of immunity to ...

Page 28: ...ibutable to anything other than this product h Any other defect and or damage caused by usage not specified in this instruction manual i Only the main unit and AC adapter are in scope Disclaimer It will not be covered by warranty if the failure or defect falls under any of the following items We assume no responsibility or liability for incidental damages loss of business profits or interruption o...

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