Stryker Quantum LED Surgical Headlights User manual

Quantum™ LED Surgical Headlights
Instructions For Use
2021-07
Quantum™ Cool LED Surgical Headlight
Quantum™ Warm LED Surgical Headlight
ENGLISH (EN)

EN
2www.goenova.com
F20006 Rev E
Introduction User / Patient Safety
Accessories
This Instructions For Use manual is the most comprehensive source of
information for the safe and effective use of your product. This manual may be
used by surgeons, dentists, veterinarians, or other healthcare professionals.
Keep and consult this reference manual during the life of the product.
The following conventions are used in this manual:
A WARNING highlights a safety-related issue. ALWAYS comply with this
information to prevent patient and/or healthcare staff injury.
A CAUTION highlights a product reliability issue. ALWAYS comply with this
information to prevent product damage.
A NOTE supplements and/or clarifies procedural information.
If additional information, especially safety information, or in-service training is
required, contact your Enova sales representative or call Enova customer
service.
Indications for Use
LED Surgical Headlight Systems are adjunct light sources used for illumination
during clinical or surgical procedures in a medical setting.
Contraindications
None known.
Limitations of Use
None known.
For Use With
Rechargeable PP4 Power Pack and the Quantum Twist Cable.
See Accessories section.
This section describes components that may be ordered to replace original
equipment that is damaged, worn, or must be replaced.
WARNINGS:
Use only Enova-approved components and accessories, including power
packs, unless otherwise specified.
DO NOT modify any component or accessory, unless otherwise specified.
The following Enova-approved accessories are sold separately:
NOTE: For a complete list of accessories, contact your Enova's
sales representative or call Enova's customer service.
WWARNINGS:
ARNINGS:
Prior to operation, users of Enova LED Surgical Headlight Systems should
read and understand the operation manual for all equipment used in
conjunction with the LED surgical headlight. Contact or your local distributor
for service and warranty information.
DO NOT look directly into the LED surgical headlight when illuminated. DO
NOT shine the light directly into the patient eyes or face. Due to the intensity
of light, eye injury may result. Patient's eyes should be appropriately
protected in surgeries involving the face or head.
After a few minutes of operation, the headlamp housing may become warm to
the touch. This is normal and functions to dissipate heat from the LED. Always
use a surgical glove, or sterile cloth to adjust the angle of the lens when in use.
Use only Enova's SUPPLIED BASE STATION AND POWER PACKS. The
use of other base stations or power packs may result in fire, explosion, or
damage to the power packs or LED surgical headlight and will void warranty.
The power pack must be powered off when charging. DO NOT USE OR
STORE BASE STATION IN OPERATING ROOM OR SURGERY SUITE.
All Enova's LED surgical headlights are designed to be wireless. DO NOT USE
THE LED SURGICAL HEADLIGHT WHILE POWER PACKS ARE CHARGING.
DO NOT use the LED surgical headlight, power packs or base station in
explosive gas environments.
DO NOT autoclave, immerse or submerge in liquid, spray with liquids or leave
the LED surgical headlight "on" when inside the composite carrying case as it
will cause damage to the LED surgical headlight or may cause a fire.
Please consult local regulations for the disposal of electronic products.
DO NOT INTERCHANGE TWIST CABLES. Use specified twist cable for
correct LED surgical headlight otherwise, the LED surgical headlight will
function abnormally and may damage the circuitry causing the light to fail.
Trademarks not the property of Enova's Corporation are the property of
their respective owners.
NOTE: The user and/or patient should report any serious product-related
incident to both the manufacturer and the Competent Authority of the European
Member State where the user and/or patient is established.
NOTE: The expected service life of the headlight is 5 years.
PP4 Power Pack
Deluxe Comfort Pad Set
PP4 Power Pack Charging Base Station
Gray Twist Cable
NA C-13 Power Cord
Battery Belt
Composite Carrying Case
DESCRIPTION REF
80201-001
80403-001
80100-001
80302-001
80150-001
80500-001
80034-001

EN
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F20006 Rev E
Features
A
B
C
D
E
Spot Size Adjustment Ring:
This ring is used to make the spot size smaller (2”) and bigger (5”).
Headlight Adjustment Bracket:
This bracket is used to adjust the light beam to fit coaxially to the line of sight.
Headband Adjustment Knobs:
Customize the fit by turning the knob clockwise to tighten and counterclockwise
to loosen the headband.
Quantum Twist Cable:
This cable routes light from the power pack to the LED surgical headlight.
Comfort Pads:
These removable pads providea comfortable fit.
C
A
B
D
E

EN F20006 Rev E
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INTERVAL INSPECTION CRITERIA ACTION
Before
Use
Inspect equipment for damage, wear, or
missing components.
Inspect power cord and twist cable for
cuts or punctures.
Inspect headlight lens for scratches.
Inspect the power pack housing for cracks.
If damage is
apparent, replace
the equipment.
Loremipsum
Instructions Inspection and Testing
Only individuals trained and experienced in the maintenance of reusable
medical devices should inspect and test this equipment.
DO NOT use any equipment if damage is apparent or the inspection criteria
are not met.
DO NOT disassemble or service this equipment, unless otherwise specified.
Perform recommended inspection and testing as indicated in the Inspection
and Testing section.
ALWAYS operate the equipment within the specified environmental condition
values. See the Specifications section.
This equipment is suitable to use in a professional healthcare facility environment.
DO NOT cut or puncture the twist cable.
ALWAYS turn the light source power off before connecting or disconnecting
the twist cable to or from the LED surgical headlight.
ALWAYS hold the strain relief near the end of the twist cable when connecting
or disconnecting the twist cable from the light source.
DO NOT scratch the LED surgical headlight lens.
DO NOT stretch or kink the twist cable. Failure to comply will damage the
twist cable and reduce the light output permanently.
NOTE: Headband position will vary from person to person depending on head
size and personal comfort preferences.
CAUTIONS:
To Don a LED Surgical Headlight
Connect the LED surgical headlight power cable to the appropriate twist cable
(figure 2). See the Accessories section.
NOTE: To disconnect the power cable, twist the connector sleeve back before
separating the connector plug and receptacle (figure 2).
DO NOT connect the twist cable to the power pack before donning the LED
surgical headlight.
1.
Loosen the headband adjustment knob on the top and back of the LED
surgical headlight (figure 3).
2.
Put the LED surgical headlight on your head and turn the headband knob on
the top and back to secure the LED surgical headlight (figure 4). When using
loupes, put them on after this step.
NOTE: Make sure the LED surgical headlight fits securely on top of your head
and that the light is coaxial to your line of sight (figure 5).
3.
To Use a LED Surgical Headlight
Plug the twist cable connector into the jack on the power pack (figure 6).
Press the power button on top of the power pack (figure 7).
Press the variable control buttons (”+” and “-”) to adjust the light intensity.
See the Troubleshooting section if required (figure 8).
1.
2.
3.
To Doff a LED Surgical Headlight
Turn the power pack off.
Loosen the headband knobs on the top and back of the LED surgical headlight
and remove the LED surgical headlight from your head.
Clean the LED surgical headlight and cord. See the Cleaning section. To clean
the PP4 Power Pack, see the instructions for use supplied with the PP4
Charging Base Station.
1.
2.
3.
NOTE: For service, contact your Enova's sales representative or call
Enova's customer service.
NOTE: If any component must be discarded, see the Disposal / Recycle
section.
WARNINGS: WARNINGS:

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F20006 Rev E EN
*NOTE: It is recommended the operator wears gloves while performing these steps.
Instructions
1*
5 6*
3*
7*
4*
8*
2*

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EN F20006 Rev E
Cleaning Troubleshooting
WARNINGS:
NOTE: If any component must be discarded, see the Disposal/Recycle section.
Exterior surfaces of LED surgical headlight, headband, and comfort pads
can be cleaned using a gauze pad or cotton swab moistened with 70%
isopropyl alcohol or mild soap. After cleaning, wipe the area with a lint-free oft
cloth moistened with water to remove any residue from cleaning products.
DO NOT immerse or spray the LED surgical headlight, power pack or base
station with 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 LED surgical headlight, electrical connectors, base station or
power packs.
To ensure a long life of the LED surgical headlight, power packs, and base
station, Enova recommends storing them in the Carrying Case
For proper hygiene, it is recommended to replace the comfort pads every 3-6
months. Users may order additional comfort pads from Enova or your local
distributor.
Lens - Avoid scratching or striking the front lens as a reduction in light
transmission may occur.
1.
2.
3.
4.
5.
CAUTION: DO NOT use solvents, lubricants, or other chemicals, unless
otherwise specified.
To Clean the Surgical Headlight
Storage and Handling
CAUTION: ALWAYS store the equipment within the specified environmental
condition values throughout its useful life. See the Specifications section.
To ensure the longevity, performance and safety of this equipment, use of the
original packaging material is recommended when storing or transporting this
equipment.
Disposal / Recycle
WARNINGS: ALWAYS follow the current local recommendations and/or
regulations governing environmental protection and risks associated with
recycling or disposing of the equipment at the end of its useful life.
WARNINGS:DO NOT service this equipment, unless otherwise
specified. If you require service, contact your Enova's sales
representative or call Enova's customer service.
ACTION
PROBLEM CAUSE
The LED surgical
headlight is flickering
Try another twist cable. If it
works, then replace the
other twist cable.
Twist cable may be
damaged.
If the other twist cable does
not work. Send the LED
surgical headlight in for repair.
Cable attached to LED
surgical headlight is
damaged.
Replace the power pack with a
fully charged one. Put the
power pack on the base station.
The LED surgical
headlight does not
turn on.
The power pack is
not charged.
Replace the LED surgical
headlight.
The LED surgical
headlight is damaged
Try another twist cable. If it
works, then replace the other
twist cable.
The LED surgical
headlight is shorting
out.
The twist cable is
damaged.
If the other power pack does
not work, try another twist
cable. If it works, then replace
the twist cable.
The twist cable is
damaged.
Replace the LED surgical
headlight.
The LED surgical
headlight is damaged.
Replace the LED surgical
headlight.
The LED surgical
headlight is damaged.

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Specifications
F20006 Rev E
Model:
Description:
Light Source:
Lamp Illumination:
Color Temperature:
Illumination Spot Size:
Headlight Weight:
Headlight Construction:
Quantum Cool XLT-250A
Quantum Cool LED Surgical Headlight Quantum Warm LED Surgical Headlight
LED Refractive Technology
250,000 - 500,000 Lux 175,000 - 480,000 Lux
6100K 4500K
2” to 5” adjustable (5.08 cm to 12.7 cm)
12 oz (340 g)
Aluminum
Environmental Conditions:
Temperature Limitation:
Humidity Limitation:
Atmospheric Pressure Limitation:
Operation
10oC
30oC
30%
75%
70 kPa
106 kPa
Storage and Transportation
5oC
50oC
10%
75%
50 kPa
106 kPa
Symbol Definition
Definition (Indication Color)
General Warning Sign (Yellow)
Refer to Instruction Manual / Booklet (Blue)
Catalog number
Quantity
Lot number
Storage: Temperature Limitation
Transportation: Temperature Limitation
Operation: Temperature Limitation
Storage, Transportation, and Operation: Humidity Limitation
Medical Device
Storage, Transportation,and Operation: Atmospheric Pressure Limitation
Recycle (in Accordance with Local Laws) of Li-Ion Battery
Power On/Off
Light Intensity Adjustment and Indicator
QTY
MD
LOT
REF
Symbol
Quantum Warm PLT-175A

2021-07 www.goenova.comF20006 Rev E