IRIS™ LED SURGICAL HEADLIGHTS96bda424cfcc34d9dd1a-0a7f10f87519dba22d2dbc6233a731e5.r41.cf2.… ·...

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| INSTRUCTIONS FOR USE & OPERATING MANUAL | IRIS™ LED SURGICAL HEADLIGHTS MODELS S-50, S-100, D-100 & D-200 AND B2X & B4X BATTERY PACKS 1839 Buerkle Road St. Paul, MN 55110 PH. 651.236.8857 FX. 651.344.0583 The leader in LED lighting solutions.

Transcript of IRIS™ LED SURGICAL HEADLIGHTS96bda424cfcc34d9dd1a-0a7f10f87519dba22d2dbc6233a731e5.r41.cf2.… ·...

Page 1: IRIS™ LED SURGICAL HEADLIGHTS96bda424cfcc34d9dd1a-0a7f10f87519dba22d2dbc6233a731e5.r41.cf2.… · to 50,000 lux (4,645 foot-candles ... To ensure long life of the headlight, ...

M D & QA Services

Timperley

Cheshire. UK.

WA15 7SN

Fax: +44 161 903 9787

Email: [email protected]

P Enova Illumination

1839 Buerkle Rd

St Paul, MN 55110 M

ITEM SPECIFICATIONS Iris S-50 LED Surgical Headlight (1)

Recommended for general dentistry, clinical exams, office use, EMT,

trauma units and veterinarians. Delivers a bright, white light output up

to 50,000 lux (4,645 foot-candles).

Iris S-100 LED Surgical Headlight (1)

Recommended for oral, maxillofacial, plastic, orthopedic and vascular

surgeons. Delivers a bright, white light output up to 100,000 lux

(9,290 foot-candles).

Iris D-100 LED Surgical Headlight (1)

Recommended for oral, plastic, orthopedic and vascular surgeons.

Delivers a bright, white light output up to 100,000 lux (9,290 foot-

candles).

Iris D-200 LED Surgical Headlight (1)

Recommended for “deep cavity” surgeons (cardiovascular, colorectal,

general, neurological, orthopedic), operating rooms and outpatient surgery

centers. Delivers a bright, white light output up to 200,000 lux (18,580 foot-

candles).

B2X Battery Pack (1) Lightweight –provides 2 – 4 hours per charge when used with the D-

Series lights and 4–8 hours when used with the S-Series headlights.

Clips onto scrubs, belt or fits in a pocket.

B4X Battery Pack (1) Lightweight –provides 4 – 8 hours per charge when used with the D-Series

lights and 8 – 16 hours when used with the S-Series headlights. Clip onto

scrubs, belt or fit inside pocket.

Smart Battery Charger (1) The Smart Charger will fully charge the B2X & B4X digital battery packs

within 4 hours.

Replacement Comfort Pads Front, top, rear replacement pads. (pack of 2)

Headlight Joysticks Autoclavable metal joysticks used to adjust the light angle on all D-Series

headlights. (pack of 2)

S-Series Lamp Protector (1) Autoclavable silicone lamp protector - used to adjust the light angle on S-

Series. Fits over the lamp assembly.

Orange Magnetic Filter - For dental use with S-Series. Magnetic, transparent orange acrylic filter

prevents composite cure.

Battery Cable Custom Cord used to attach the headlight to the B2X or B4X battery

pack

Headlight Hard Protective Carrying Case (1)

Hard-sided, shockproof, durable plastic case protects your headlight.

Includes foam insert to store headlight and accessories. Price is for case

and foam only.

Battery Belt Clip the B2X or B4X battery pack to this nylon belt and fasten around

your waist for a secure and comfortable fit

7. ACCESSORIES

PN 61776-001 Rev D

| INSTRUCTIONS FOR USE & OPERATING MANUAL |

IRIS™ LED SURGICAL HEADLIGHTS

MODELS S-50, S-100, D-100 & D-200

AND

B2X & B4X BATTERY PACKS

1839 Buerkle Road St. Paul, MN 55110 PH. 651.236.8857 FX. 651.344.0583

The leader in LED lighting solutions.

Page 2: IRIS™ LED SURGICAL HEADLIGHTS96bda424cfcc34d9dd1a-0a7f10f87519dba22d2dbc6233a731e5.r41.cf2.… · to 50,000 lux (4,645 foot-candles ... To ensure long life of the headlight, ...

SYMBOLS LEGEND

N Manufactured Date

PEC

Representative

CONTENTS

1. INTENDED USE

2. SPECIFICATIONS

2.1 ENVIRONMENT 2.2 CORDLESS LED SURGICAL HEADLIGHT

2.3 BATTERY PACKS

2.4 BATTERY CHARGER

3. OPERATION

3.1 HEADLIGHT ADJUSTMENT AND OPERATION WITH BATTERY PACK 3.2 CHARGER OPERATION

3.3 TROUBLESHOOTING

4. CLEANING, STORAGE AND MAINTENANCE

4.1 HEADLIGHT BODY, HEADBANDS, BATTERY PACK & CHARGER 4.2 HEADLIGHT LENS

4.3 HEADLIGHT (LAMP) PROTECTOR AND JOY STICKS

5. WARNINGS AND CAUTIONS

6. WARRANTY AND SERVICE

6.1 WARRANTY TERMS 6.2 SCOPE OF WARRANTY

6.3 LIMITATIONS OF WARRANTY 6.4 RETURNS AND SERVICE

7. ACCESSORIES

Serial Number

Manufactured by

Y

Follow instructions for use

Part Number

6. WARRANTY AND SERVICE

6.1 WARRANTY TERMS - All Enova products are warranted to be free of original defects in material

and workmanship and to perform in accordance with specifications articulated in this manual for the

following terms from the date of purchase:

LAMP AND LED - 5 year limited warranty

BATTERIES, BATTERY PACKS AND CHARGER - 1 year limited warranty

HEADBAND AND LAMP ATTACHMENT MECHANISM -1 year limited warranty

CORDS, CABLES, CONNECTORS AND ACCESSORIES - 180 day limited warranty

NOTE: All warranties are conditioned upon use of the products under normal conditions and when

used solely for the intended purpose (i.e. medical use in a medical setting). We reserve the right to

determine cause of breakage or failure of all items.

6.2 SCOPE OF WARRANTY- This limited warranty covers the replacement of parts, repairs and asso-

ciated labor. Except as otherwise set forth herein, Enova shall not be liable or responsible for any other

actions or damages (special, consequential or incidental) related to the products set forth herein. The

purchaser is responsible for the return of the product to Enova or to an authorized distributor and bears

the costs of shipping and insurance. (See section 6.4 below)

6.3 LIMITATIONS OF WARRANTY – THIS WARRANTY IS VOID AND DOES NOT APPLY IF:

The headlight is not used in accordance with Enova’s instructions, recommendations, or in a setting/manner outside of its intended use.

The headlight is repaired or serviced by persons other than Enova , Enova Distributors, or an Enova authorized representative.

The headlight is used with or powered by batteries or battery charger other than authentic and authorized Enova accessories or parts.

Damage is caused due to accidental damage, tampering, misuse, neglect, improper shipping or packaging, or excessive wear and tear.

6.4 RETURNS AND SERVICE - We accept all returns provided that they are shipped (insured) within

30 days of receiving the light and are returned in resalable condition. Damages incurred during return

shipment due to improper packaging are not covered by the warranty. Shipping costs are not covered

by any policies and are the responsibility of the purchaser.

For all returns, warranty, and service issues, please follow these steps:

STEP 1: For US customers, please contact Enova Customer Service (Email

[email protected] or call 1-651-236-8857) to discuss the problem you are experiencing,

receive an RMA (Return Material Authorization) tracking number and arrange payment for repairs

and service outside of the warranty parameters. You will need to provide the unit's serial number,

your return shipping address, email, and a daytime telephone number. Payment is charged once the

repair is complete using VISA, Mastercard, American Express, Purchase Order, or check.

STEP 2: Ship the unit (insured) to Enova. Please reference your RMA number on your shipping

statement. Securely package the unit and ship it (insured) to:

Enova Illumination

RMA # _________

1839 Buerkle Road

St. Paul, MN 55110

Page 3: IRIS™ LED SURGICAL HEADLIGHTS96bda424cfcc34d9dd1a-0a7f10f87519dba22d2dbc6233a731e5.r41.cf2.… · to 50,000 lux (4,645 foot-candles ... To ensure long life of the headlight, ...

4. CLEANING, STORAGE AND MAINTENANCE

WARNING: DO NOT AUTOCLAVE! DO NOT IMMERSE OR SUBMERGE IN LIQUID! DO

NOT LEAVE THE LIGHT “ON” WHEN INSIDE THE HARD SIDED CARRYING CASE AS IT

WILL CAUSE DAMAGE TO THE HEADLIGHT.

4.1 HEADLIGHT BODY, HEADBANDS, BATTERY PACKS AND CHARGERS, CABLES, CORDS

AND ELECTRICAL CONNECTORS

Exterior surfaces of headlight, headband, battery pack, and charger can be cleaned using a

gauze pad/cotton swab moistened with 70% isopropyl alcohol or mild soap.

It is important that the headlight body is not immersed into disinfecting liquids or sterilizers,

nor should any liquids be poured on the lens, lens housing or cable connections. Make sure no

liquid comes in contact with the battery packs. After cleaning, wipe area with a lint free soft

cloth moistened with water to remove any residue from cleaning products.

The comfort pads should be wiped down as indicated above and/or replaced periodically. Us-

ers may order additional comfort pads from Enova or your local distributor (See Section 7:

Accessories).

To ensure long life of the headlight, Enova recommends storing it in sealed soft-sided bag or

the optional hard sided Carrying Case. The battery pack may also be stored in the storage bag

or the optional hard sided Carrying Case. Users may order the Carrying Case from Enova or

your local distributor (See Section 7: Accessories).

Enova recommends recharging the battery pack with the supplied battery charger to prepare

for subsequent usage. The B2X and B4X battery packs may remain connected to the charger

indefinitely without harm to the battery packs.

4.2 HEADLIGHT LENS

Avoid scratching or striking the front lens as reduction in light transmission may occur.

Clean your lens periodically with a lens tissue or the Lens Cleaning Cloth, moistened with

either an optical lens cleaner or 70% isopropyl alcohol.

4.3 HEADLIGHT LAMP PROTECTOR AND JOY STICKS

The headlight lamp protector and joy sticks are autoclavable when detached (removed) from

the headlight. The lamp protectors and joy sticks provided are non-sterile.

5. WARNINGS AND CAUTIONS

Users of Enova’s LED Surgical Headlight Systems should read and understand the Operation Man-

ual for this headlight and all equipment used in conjunction with the headlight.

5.1 Do not look directly into headlight when illuminated. Eye injury may result.

5.2 After a few minutes of operation, the headlight housing becomes hot to the touch. This is

normal and functions to dissipate heat from the LEDs. Always use the lamp protector or

joysticks to adjust the angle of the lens when in use.

5.3 Do not use the headlight system including charger in explosive gas environments.

5.4 Please consult local regulations for the disposal of electronic products

Contact Enova Illumination or your local distributor for service and warranty information.

1. INTENDED USE

Enova Illumination LED Surgical Headlight Systems are intended to be used by surgeons, den-

tists, or other medical professionals as an adjunct light source during clinical or surgical procedures

in a medical setting.

2. SPECIFICATIONS

2.1 ENVIRONMENT

Recommended operating and storage temperature ranges:

2.2 ENOVA LED SURGICAL HEADLIGHTS

The Enova LED Surgical Headlights are powered using a B2X or B4X rechargeable lithium-ion

battery pack. Light emitting diodes (LEDs) illuminate the light source and the light angle is

adjusted by pivoting the headlamp assembly using the lamp protector or joy sticks. The head-

band is fully adjustable to fit various head sizes. All Enova LED Surgical Headlights are serial-

ized; the serial number is located on a label affixed under the comfort pad at the back of the head-

band.

2.3 BATTERY PACKS

The Headlight can be used with either the B2X or B4X battery pack.

The B2X battery pack will generally provide up to two hours of operating time at full intensity

and up to fourhours at minimum intensity when powering an IRIS D-Series Headlight. The B2X

will generally provide up to four hours of operating time at full intensity and up to eight hours at

minimum intensity when powering an IRIS S-Series Headlight.

The B4X battery pack will generally provide up to four hours of operating time at full intensity and

up to eight hours at minimum intensity when powering an IRIS D-Series Headlight. The B4X will

generally provide up to eight hours of operating time at full intensity and up to sixteen four hours at

minimum intensity when powering an IRIS S-Series Headlight.

Battery packs should be fully charged prior to first use or before any long non-use or storage peri-

ods. It is recommended to fully charge battery packs after each use and avoid partial charges. This

is not mandatory, but will help to keep the battery life gauge calibrated and the battery in peak oper-

ating condition. Users may order additional battery packs from Enova Illumination or your local

distributor.

LOW BATTERY WARNING CYCLE:

The low battery indicator goes through a sequence of 1 to 5 red

LEDs. One rent indicator light will appear approximately every two

minutes, with a beep every minuet. The battery pack will power off

approximately two minutes after fifth red indicator light is illumi-

nated. (See Figure 1). At this time you should recharge the battery to

full capacity. The battery pack is serialized; the serial number is lo-

cated on the back of the unit.

PRODUCT STORAGE OPERATING

HEADLIGHTS

40°F (5°C) to 122°F (50°C)

50°F (10°C) to 85°F (30°C)

BATTERY PACK

40°F (5°C) to 122°F (50°C)

50°F (10°C) to 85°F (30°C)

CHARGER -22°F (-30°C) to 185°F (85°C) 32°F (0°C) to 104°F (40°C)

Figure 1

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2.4 BATTERY CHARGER

SMART CHARGER

The Enova Smart Charger provides a full charge to the B2X and B4X battery packs within

four hours. Use only with Enova Surgical Headlight System B2X and B4X battery packs.

Input: 100-250 V alternating current, 50-60 Hz, 0.5A

Output: 8.4 V direct current, 1.7 A

Users may order additional chargers from Enova Illumination or your local distributor (See

Section 7: Accessories).

Enova Illumination will only warranty batteries and chargers supplied by Enova. Using non-

Enova supplied components will void the warranty.

3. OPERATION

WARNING: DO NOT LOOK DIRECTLY INTO LIGHT SOURCE OF HEADLIGHT WHEN ILLUMI-

NATED. EYE INJURY MAY RESULT. PATIENT’S EYES SHOULD BE APPROPRIATELY PRO-

TECTED IN SURGERIES INVOLVING THE FACE OR HEAD. AFTER A FEW MINUTES OF OPERA-TION, THE HEADLIGHT HOUSING BECOMES HOT TO THE TOUCH. THIS IS NORMAL AND

FUNCTIONS TO DISSIPATE HEAT FROM THE LEDS. ALWAYS USE THE HEADLIGHT JOY-

STICKS TO ADJUST THE ANGLE OF THE HEADLIGHT HOUSING.

3.1 HEADLIGHT ADJUSTMENT & OPERATION WITH BATTERY PACK

Place headlight on head and adjust the circumference by turning the back knob to comfortably

secure the headlight onto the head. The top velcro strap can be secured by pulling and firmly

pressing ends of strap together. The headband should fit firmly but not too tight.

To operate the light, follow these instructions:

Connect the Ultra-Lite Battery Cable with the headlight by firmly

inserting the black end of the cable directly (absolutely straight)

into the receptor on the headlight. DO NOT TWIST OR BEND WHEN CONNECTING OR DIS-

CONNECTING. Twisting or bending the cables will cause

damage resulting in headlight failure. (See Figure 2) Next, connect the cable into the battery pack by inserting the gray

plug into the top of the connector located on the battery pack.

NOTE: To connect or release the Ultra-Lite cable with the

battery pack, pull up on the gray plug (sleeve) and release. DO

NOT TWIST OR BEND. Twisting or bending will cause

damage resulting in headlight failure. (see Figure 3.) Press the On/Off button until the light illuminates (you will hear a

beep, a 1-2 second lag is normal)

The battery life will then be shown on the battery life indicator.

To increase the light intensity, press the up arrow.

To decrease the light intensity, press the down arrow.

To turn the battery pack “Off” press the On/Off button.

NOTE: WHEN THE BATTERY PACK IS POWERED

“ON” THE BATTERY LIFE INDICTOR WILL SHOW

THE CURRENT CHARGE STATUS.

Figure 3

Caution:

Pull the

sleeve,

Do Not

Twist!

REMOVE STRAIGHT

Figure 2

Caution: Do not twist or

INSERT STRAIGHT

BATTERY STATUS:

To check the battery status during use glance at the battery life gauge. The battery life gauge will

give an approximate indication of the state of charge remaining in the lithium-ion battery (See

Table Below).

3.2 BATTERY CHARGER OPERATION

WARNING: USE ONLY SMART CHARGER PART NUMBER 80058-001 PURCHASED THROUGH

ENOVA TO CHARGE THE BATTERY PACKS. USE OF OTHER CHARGERS MAY RESULT IN FIRE

OR EXPLOSION. DO NOT HAVE HEADLIGHT PLUGGED IN TO BATTERY PACK WHEN CHARG-ING. BATTERY PACK MUST BE POWERED OFF WHEN CHARGING. DO NOT USE OR STORE

CHARGER IN OPERATING ROOM OR PATIENT AREA.

SMART CHARGER

The Enova Illumination standard battery charger provides a full charge to the B2X and B4X bat-

tery packs within four hours.

Follow these steps to charge the B2X or B4X battery pack

Turn off battery pack prior to charging.

Plug the power cord from the charging unit into the wall outlet.

Plug the small charging cord into the battery pack.

The orange light on the Smart Charger will go on when battery pack is plugged in.

When battery pack is charged to 80% capacity the green light on the Smart Charger will appear

along with the orange light.

When the battery pack is fully charged the green light on the Smart Charger will stay on and the

orange light on the Smart Charger will go off.

Wait approximately 5 seconds before turning on battery pack.

3.3 TROUBLESHOOTING

1. If the headlight does not turn on check to see if: (1) the battery is charged. (2) all cables are

fully connected. 2. If the headlight flickers or goes out during use, check the Ultra-Lite Battery Cable connections

to both the headlight and the battery pack to confirm that they are firmly connected. If the light does

not return, gently wiggle the cable at both connections. If the light flickers or returns, the cable may

need to be replaced. If the light does not return and the connections are fully secure, please contact

Customer Service.

3. If the battery pack will not turn on, plug the battery pack into the charger for a few minutes. If

the battery pack has a charge, continue to charge until it reaches a full charge. If the battery pack is still

not working contact Customer Service.

IF PREDICTED BATTERY LIFE

IS GREEN BARS RED BARS BEEP

100% 5 x x

~ 60% 4 x x

~ 40% 3 x x

~ 20% 2 x x

~ 10% 1 x x

~ 10 minutes x 1 1 per minute

~ 8 minutes x 2 1 per minute

~ 6 minutes x 3 1 per minute

~ 4 minutes x 4 1 per minute

~ 2 minutes x 5 1 per minute

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2.4 BATTERY CHARGER

SMART CHARGER

The Enova Smart Charger provides a full charge to the B2X and B4X battery packs within

four hours. Use only with Enova Surgical Headlight System B2X and B4X battery packs.

Input: 100-250 V alternating current, 50-60 Hz, 0.5A

Output: 8.4 V direct current, 1.7 A

Users may order additional chargers from Enova Illumination or your local distributor (See

Section 7: Accessories).

Enova Illumination will only warranty batteries and chargers supplied by Enova. Using non-

Enova supplied components will void the warranty.

3. OPERATION

WARNING: DO NOT LOOK DIRECTLY INTO LIGHT SOURCE OF HEADLIGHT WHEN ILLUMI-

NATED. EYE INJURY MAY RESULT. PATIENT’S EYES SHOULD BE APPROPRIATELY PRO-

TECTED IN SURGERIES INVOLVING THE FACE OR HEAD. AFTER A FEW MINUTES OF OPERA-TION, THE HEADLIGHT HOUSING BECOMES HOT TO THE TOUCH. THIS IS NORMAL AND

FUNCTIONS TO DISSIPATE HEAT FROM THE LEDS. ALWAYS USE THE HEADLIGHT JOY-

STICKS TO ADJUST THE ANGLE OF THE HEADLIGHT HOUSING.

3.1 HEADLIGHT ADJUSTMENT & OPERATION WITH BATTERY PACK

Place headlight on head and adjust the circumference by turning the back knob to comfortably

secure the headlight onto the head. The top velcro strap can be secured by pulling and firmly

pressing ends of strap together. The headband should fit firmly but not too tight.

To operate the light, follow these instructions:

Connect the Ultra-Lite Battery Cable with the headlight by firmly

inserting the black end of the cable directly (absolutely straight)

into the receptor on the headlight. DO NOT TWIST OR BEND WHEN CONNECTING OR DIS-

CONNECTING. Twisting or bending the cables will cause

damage resulting in headlight failure. (See Figure 2) Next, connect the cable into the battery pack by inserting the gray

plug into the top of the connector located on the battery pack.

NOTE: To connect or release the Ultra-Lite cable with the

battery pack, pull up on the gray plug (sleeve) and release. DO

NOT TWIST OR BEND. Twisting or bending will cause

damage resulting in headlight failure. (see Figure 3.) Press the On/Off button until the light illuminates (you will hear a

beep, a 1-2 second lag is normal)

The battery life will then be shown on the battery life indicator.

To increase the light intensity, press the up arrow.

To decrease the light intensity, press the down arrow.

To turn the battery pack “Off” press the On/Off button.

NOTE: WHEN THE BATTERY PACK IS POWERED

“ON” THE BATTERY LIFE INDICTOR WILL SHOW

THE CURRENT CHARGE STATUS.

Figure 3

Caution:

Pull the

sleeve,

Do Not

Twist!

REMOVE STRAIGHT

Figure 2

Caution: Do not twist or

INSERT STRAIGHT

BATTERY STATUS:

To check the battery status during use glance at the battery life gauge. The battery life gauge will

give an approximate indication of the state of charge remaining in the lithium-ion battery (See

Table Below).

3.2 BATTERY CHARGER OPERATION

WARNING: USE ONLY SMART CHARGER PART NUMBER 80058-001 PURCHASED THROUGH

ENOVA TO CHARGE THE BATTERY PACKS. USE OF OTHER CHARGERS MAY RESULT IN FIRE

OR EXPLOSION. DO NOT HAVE HEADLIGHT PLUGGED IN TO BATTERY PACK WHEN CHARG-ING. BATTERY PACK MUST BE POWERED OFF WHEN CHARGING. DO NOT USE OR STORE

CHARGER IN OPERATING ROOM OR PATIENT AREA.

SMART CHARGER

The Enova Illumination standard battery charger provides a full charge to the B2X and B4X bat-

tery packs within four hours.

Follow these steps to charge the B2X or B4X battery pack

Turn off battery pack prior to charging.

Plug the power cord from the charging unit into the wall outlet.

Plug the small charging cord into the battery pack.

The orange light on the Smart Charger will go on when battery pack is plugged in.

When battery pack is charged to 80% capacity the green light on the Smart Charger will appear

along with the orange light.

When the battery pack is fully charged the green light on the Smart Charger will stay on and the

orange light on the Smart Charger will go off.

Wait approximately 5 seconds before turning on battery pack.

3.3 TROUBLESHOOTING

1. If the headlight does not turn on check to see if: (1) the battery is charged. (2) all cables are

fully connected. 2. If the headlight flickers or goes out during use, check the Ultra-Lite Battery Cable connections

to both the headlight and the battery pack to confirm that they are firmly connected. If the light does

not return, gently wiggle the cable at both connections. If the light flickers or returns, the cable may

need to be replaced. If the light does not return and the connections are fully secure, please contact

Customer Service.

3. If the battery pack will not turn on, plug the battery pack into the charger for a few minutes. If

the battery pack has a charge, continue to charge until it reaches a full charge. If the battery pack is still

not working contact Customer Service.

IF PREDICTED BATTERY LIFE

IS GREEN BARS RED BARS BEEP

100% 5 x x

~ 60% 4 x x

~ 40% 3 x x

~ 20% 2 x x

~ 10% 1 x x

~ 10 minutes x 1 1 per minute

~ 8 minutes x 2 1 per minute

~ 6 minutes x 3 1 per minute

~ 4 minutes x 4 1 per minute

~ 2 minutes x 5 1 per minute

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4. CLEANING, STORAGE AND MAINTENANCE

WARNING: DO NOT AUTOCLAVE! DO NOT IMMERSE OR SUBMERGE IN LIQUID! DO

NOT LEAVE THE LIGHT “ON” WHEN INSIDE THE HARD SIDED CARRYING CASE AS IT

WILL CAUSE DAMAGE TO THE HEADLIGHT.

4.1 HEADLIGHT BODY, HEADBANDS, BATTERY PACKS AND CHARGERS, CABLES, CORDS

AND ELECTRICAL CONNECTORS

Exterior surfaces of headlight, headband, battery pack, and charger can be cleaned using a

gauze pad/cotton swab moistened with 70% isopropyl alcohol or mild soap.

It is important that the headlight body is not immersed into disinfecting liquids or sterilizers,

nor should any liquids be poured on the lens, lens housing or cable connections. Make sure no

liquid comes in contact with the battery packs. After cleaning, wipe area with a lint free soft

cloth moistened with water to remove any residue from cleaning products.

The comfort pads should be wiped down as indicated above and/or replaced periodically. Us-

ers may order additional comfort pads from Enova or your local distributor (See Section 7:

Accessories).

To ensure long life of the headlight, Enova recommends storing it in sealed soft-sided bag or

the optional hard sided Carrying Case. The battery pack may also be stored in the storage bag

or the optional hard sided Carrying Case. Users may order the Carrying Case from Enova or

your local distributor (See Section 7: Accessories).

Enova recommends recharging the battery pack with the supplied battery charger to prepare

for subsequent usage. The B2X and B4X battery packs may remain connected to the charger

indefinitely without harm to the battery packs.

4.2 HEADLIGHT LENS

Avoid scratching or striking the front lens as reduction in light transmission may occur.

Clean your lens periodically with a lens tissue or the Lens Cleaning Cloth, moistened with

either an optical lens cleaner or 70% isopropyl alcohol.

4.3 HEADLIGHT LAMP PROTECTOR AND JOY STICKS

The headlight lamp protector and joy sticks are autoclavable when detached (removed) from

the headlight. The lamp protectors and joy sticks provided are non-sterile.

5. WARNINGS AND CAUTIONS

Users of Enova’s LED Surgical Headlight Systems should read and understand the Operation Man-

ual for this headlight and all equipment used in conjunction with the headlight.

5.1 Do not look directly into headlight when illuminated. Eye injury may result.

5.2 After a few minutes of operation, the headlight housing becomes hot to the touch. This is

normal and functions to dissipate heat from the LEDs. Always use the lamp protector or

joysticks to adjust the angle of the lens when in use.

5.3 Do not use the headlight system including charger in explosive gas environments.

5.4 Please consult local regulations for the disposal of electronic products

Contact Enova Illumination or your local distributor for service and warranty information.

1. INTENDED USE

Enova Illumination LED Surgical Headlight Systems are intended to be used by surgeons, den-

tists, or other medical professionals as an adjunct light source during clinical or surgical procedures

in a medical setting.

2. SPECIFICATIONS

2.1 ENVIRONMENT

Recommended operating and storage temperature ranges:

2.2 ENOVA LED SURGICAL HEADLIGHTS

The Enova LED Surgical Headlights are powered using a B2X or B4X rechargeable lithium-ion

battery pack. Light emitting diodes (LEDs) illuminate the light source and the light angle is

adjusted by pivoting the headlamp assembly using the lamp protector or joy sticks. The head-

band is fully adjustable to fit various head sizes. All Enova LED Surgical Headlights are serial-

ized; the serial number is located on a label affixed under the comfort pad at the back of the head-

band.

2.3 BATTERY PACKS

The Headlight can be used with either the B2X or B4X battery pack.

The B2X battery pack will generally provide up to two hours of operating time at full intensity

and up to fourhours at minimum intensity when powering an IRIS D-Series Headlight. The B2X

will generally provide up to four hours of operating time at full intensity and up to eight hours at

minimum intensity when powering an IRIS S-Series Headlight.

The B4X battery pack will generally provide up to four hours of operating time at full intensity and

up to eight hours at minimum intensity when powering an IRIS D-Series Headlight. The B4X will

generally provide up to eight hours of operating time at full intensity and up to sixteen four hours at

minimum intensity when powering an IRIS S-Series Headlight.

Battery packs should be fully charged prior to first use or before any long non-use or storage peri-

ods. It is recommended to fully charge battery packs after each use and avoid partial charges. This

is not mandatory, but will help to keep the battery life gauge calibrated and the battery in peak oper-

ating condition. Users may order additional battery packs from Enova Illumination or your local

distributor.

LOW BATTERY WARNING CYCLE:

The low battery indicator goes through a sequence of 1 to 5 red

LEDs. One rent indicator light will appear approximately every two

minutes, with a beep every minuet. The battery pack will power off

approximately two minutes after fifth red indicator light is illumi-

nated. (See Figure 1). At this time you should recharge the battery to

full capacity. The battery pack is serialized; the serial number is lo-

cated on the back of the unit.

PRODUCT STORAGE OPERATING

HEADLIGHTS

40°F (5°C) to 122°F (50°C)

50°F (10°C) to 85°F (30°C)

BATTERY PACK

40°F (5°C) to 122°F (50°C)

50°F (10°C) to 85°F (30°C)

CHARGER -22°F (-30°C) to 185°F (85°C) 32°F (0°C) to 104°F (40°C)

Figure 1

Page 7: IRIS™ LED SURGICAL HEADLIGHTS96bda424cfcc34d9dd1a-0a7f10f87519dba22d2dbc6233a731e5.r41.cf2.… · to 50,000 lux (4,645 foot-candles ... To ensure long life of the headlight, ...

SYMBOLS LEGEND

N Manufactured Date

PEC

Representative

CONTENTS

1. INTENDED USE

2. SPECIFICATIONS

2.1 ENVIRONMENT 2.2 CORDLESS LED SURGICAL HEADLIGHT

2.3 BATTERY PACKS

2.4 BATTERY CHARGER

3. OPERATION

3.1 HEADLIGHT ADJUSTMENT AND OPERATION WITH BATTERY PACK 3.2 CHARGER OPERATION

3.3 TROUBLESHOOTING

4. CLEANING, STORAGE AND MAINTENANCE

4.1 HEADLIGHT BODY, HEADBANDS, BATTERY PACK & CHARGER 4.2 HEADLIGHT LENS

4.3 HEADLIGHT (LAMP) PROTECTOR AND JOY STICKS

5. WARNINGS AND CAUTIONS

6. WARRANTY AND SERVICE

6.1 WARRANTY TERMS 6.2 SCOPE OF WARRANTY

6.3 LIMITATIONS OF WARRANTY 6.4 RETURNS AND SERVICE

7. ACCESSORIES

Serial Number

Manufactured by

Y

Follow instructions for use

Part Number

6. WARRANTY AND SERVICE

6.1 WARRANTY TERMS - All Enova products are warranted to be free of original defects in material

and workmanship and to perform in accordance with specifications articulated in this manual for the

following terms from the date of purchase:

LAMP AND LED - 5 year limited warranty

BATTERIES, BATTERY PACKS AND CHARGER - 1 year limited warranty

HEADBAND AND LAMP ATTACHMENT MECHANISM -1 year limited warranty

CORDS, CABLES, CONNECTORS AND ACCESSORIES - 180 day limited warranty

NOTE: All warranties are conditioned upon use of the products under normal conditions and when

used solely for the intended purpose (i.e. medical use in a medical setting). We reserve the right to

determine cause of breakage or failure of all items.

6.2 SCOPE OF WARRANTY- This limited warranty covers the replacement of parts, repairs and asso-

ciated labor. Except as otherwise set forth herein, Enova shall not be liable or responsible for any other

actions or damages (special, consequential or incidental) related to the products set forth herein. The

purchaser is responsible for the return of the product to Enova or to an authorized distributor and bears

the costs of shipping and insurance. (See section 6.4 below)

6.3 LIMITATIONS OF WARRANTY – THIS WARRANTY IS VOID AND DOES NOT APPLY IF:

The headlight is not used in accordance with Enova’s instructions, recommendations, or in a setting/manner outside of its intended use.

The headlight is repaired or serviced by persons other than Enova , Enova Distributors, or an Enova authorized representative.

The headlight is used with or powered by batteries or battery charger other than authentic and authorized Enova accessories or parts.

Damage is caused due to accidental damage, tampering, misuse, neglect, improper shipping or packaging, or excessive wear and tear.

6.4 RETURNS AND SERVICE - We accept all returns provided that they are shipped (insured) within

30 days of receiving the light and are returned in resalable condition. Damages incurred during return

shipment due to improper packaging are not covered by the warranty. Shipping costs are not covered

by any policies and are the responsibility of the purchaser.

For all returns, warranty, and service issues, please follow these steps:

STEP 1: For US customers, please contact Enova Customer Service (Email

[email protected] or call 1-651-236-8857) to discuss the problem you are experiencing,

receive an RMA (Return Material Authorization) tracking number and arrange payment for repairs

and service outside of the warranty parameters. You will need to provide the unit's serial number,

your return shipping address, email, and a daytime telephone number. Payment is charged once the

repair is complete using VISA, Mastercard, American Express, Purchase Order, or check.

STEP 2: Ship the unit (insured) to Enova. Please reference your RMA number on your shipping

statement. Securely package the unit and ship it (insured) to:

Enova Illumination

RMA # _________

1839 Buerkle Road

St. Paul, MN 55110

Page 8: IRIS™ LED SURGICAL HEADLIGHTS96bda424cfcc34d9dd1a-0a7f10f87519dba22d2dbc6233a731e5.r41.cf2.… · to 50,000 lux (4,645 foot-candles ... To ensure long life of the headlight, ...

M D & QA Services

Timperley

Cheshire. UK.

WA15 7SN

Fax: +44 161 903 9787

Email: [email protected]

P Enova Illumination

1839 Buerkle Rd

St Paul, MN 55110 M

ITEM SPECIFICATIONS Iris S-50 LED Surgical Headlight (1)

Recommended for general dentistry, clinical exams, office use, EMT,

trauma units and veterinarians. Delivers a bright, white light output up

to 50,000 lux (4,645 foot-candles).

Iris S-100 LED Surgical Headlight (1)

Recommended for oral, maxillofacial, plastic, orthopedic and vascular

surgeons. Delivers a bright, white light output up to 100,000 lux

(9,290 foot-candles).

Iris D-100 LED Surgical Headlight (1)

Recommended for oral, plastic, orthopedic and vascular surgeons.

Delivers a bright, white light output up to 100,000 lux (9,290 foot-

candles).

Iris D-200 LED Surgical Headlight (1)

Recommended for “deep cavity” surgeons (cardiovascular, colorectal,

general, neurological, orthopedic), operating rooms and outpatient surgery

centers. Delivers a bright, white light output up to 200,000 lux (18,580 foot-

candles).

B2X Battery Pack (1) Lightweight –provides 2 – 4 hours per charge when used with the D-

Series lights and 4–8 hours when used with the S-Series headlights.

Clips onto scrubs, belt or fits in a pocket.

B4X Battery Pack (1) Lightweight –provides 4 – 8 hours per charge when used with the D-Series

lights and 8 – 16 hours when used with the S-Series headlights. Clip onto

scrubs, belt or fit inside pocket.

Smart Battery Charger (1) The Smart Charger will fully charge the B2X & B4X digital battery packs

within 4 hours.

Replacement Comfort Pads Front, top, rear replacement pads. (pack of 2)

Headlight Joysticks Autoclavable metal joysticks used to adjust the light angle on all D-Series

headlights. (pack of 2)

S-Series Lamp Protector (1) Autoclavable silicone lamp protector - used to adjust the light angle on S-

Series. Fits over the lamp assembly.

Orange Magnetic Filter - For dental use with S-Series. Magnetic, transparent orange acrylic filter

prevents composite cure.

Battery Cable Custom Cord used to attach the headlight to the B2X or B4X battery

pack

Headlight Hard Protective Carrying Case (1)

Hard-sided, shockproof, durable plastic case protects your headlight.

Includes foam insert to store headlight and accessories. Price is for case

and foam only.

Battery Belt Clip the B2X or B4X battery pack to this nylon belt and fasten around

your waist for a secure and comfortable fit

7. ACCESSORIES

PN 61776-001 Rev D

| INSTRUCTIONS FOR USE & OPERATING MANUAL |

IRIS™ LED SURGICAL HEADLIGHTS

MODELS S-50, S-100, D-100 & D-200

AND

B2X & B4X BATTERY PACKS

1839 Buerkle Road St. Paul, MN 55110 PH. 651.236.8857 FX. 651.344.0583

The leader in LED lighting solutions.