Ronin X Series User manual

Ronin X Series Surgical Headlights &
Ronin X Series Chargers
Instructions for Use
(IFU)
Caution: Thoroughly read all instructions prior to operating the devices.
Ronin is a Registered Trademark of RONIN SURGICAL CORP.
RONIN SURGICAL CORP
[phone]
www.RoninSurgical.com
1
RK0350 - Rev A - Ronin X Series Instructions for Use (IFU)

Table of Contents
1. DESCRIPTION (page 3)
2. INDICATION FOR USE (page 3)
3. CONTRAINDICATIONS (page 3)
4. INSTALLATION (For Charger Only) (page 4)
5. NORMAL USE (page 5)
6. UNPACKING THE UNIT (page 6)
7. WARNINGS AND PRECAUTIONS (page 6)
8. IMPORTANT SAFETY INFORMATION (page 11)
9. EXPLANATION OF SYMBOLS (page 12)
10. OPERATING INSTRUCTIONS (NORMAL MODE OPERATION) (page 13)
11. INDICATOR LEDS, BATTERY CHARGING, AND BATTERYFUEL GAUGE (page 15)
12. BATTERY REPLACEMENT (page 16)
13. BATTERY DISPOSAL (page 16)
14. BATTERY STORAGE, TRANSIT, AIR TRAVEL AND SHIPPING (page 16)
15. TROUBLESHOOTING AND FAQ (page 17)
16. CLEANING (page 18)
17. MAINTENANCE (page 19)
18. DECLARATION OF CONFORMITY (page 19)
19. WARRANTY (page 20)
2
RK0350 - Rev A - Ronin X Series Instructions for Use (IFU)

Ronin X Series Diagram
1. DESCRIPTION
The Ronin X Series Surgical Headlight provides supplemental high intensity illumination to aid
visualization in a surgical and clinical setting. The headlight consists of a head mounted luminaire,
a hip mounted battery holster, and Ronin approved battery packs. Available battery packs vary in
energy capacity and physical dimensions. The luminaire is connected to the battery holster via a
cable, and the battery holster can be loaded with a desired battery variant. The diameter of the
illuminated spot can be adjusted at the luminaire using the spot diameter adjustment knob.
Power and LED intensity can be adjusted at the battery holster using the ON/OFF switch and
dimming knob respectively. A Ronin approved power supply is provided. Use only Ronin approved
batteries and power supplies.
Additional information and replacement parts can be found at www.RoninSurgical.com
2. INDICATION FOR USE
Ronin X Series Surgical Headlights are intended to supply supplemental high intensity
illumination to aid visualization in a surgical or clinical setting.
3. CONTRAINDICATIONS
The Ronin X Series Surgical Headlight is contraindicated for use in neonatal transillumination,
ophthalmic procedures, or with heat or photosensitive surfaces/patients, including but not
limited to those who have received photosensitizing agents such as hematoporphyrin derivatives.
3
RK0350 - Rev A - Ronin X Series Instructions for Use (IFU)

CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A
PHYSICIAN
4. INSTALLATION (For Charger Only)
Installation should ONLY be done by persons with proper authorization, professional licensing,
and liability protection.
The X Series Supercharger, or an array of X Series Superchargers, must not be installed in direct
sunlight or on insulative or heat sensitive surfaces as excess heat may accumulate and cause a risk
of burn or fire.
The charger may be positioned on a desk or flat surface. Some charger models are equipped with
a mounting plate with pre-drilled holes, which permits fastening via screws to any suitable wall or
flat surface. FOR MOUNTING USING SCREWS OR OTHER WALL PIERCING FASTENERSinstallation
MUST ONLY be done by a person with proper authorization, professional licensing, and liability
protection. The installation professional must ensure avoidance of, and damage to, potentially
hidden components behind the wall of other surface including but not limited to: liquid or gas
pipes, electrical tubing or wiring, HVAC piping or ducting, water and sewer piping, fire alarm or
fire suppression components, electronics, and any equipment that may be in direct or indirect
connection to any of the above. It is the responsibility of the professional to ensure the device is
properly secured to avoid the device detaching during normal use, which may cause damage to
the device or harm to any persons nearby.
RONIN IS NOT LIABLE for either anticipated or unanticipated effects on any surfaces, buildings,
equipment, property or people resulting directly or indirectly from the installation of any Ronin
product.
During installation:
Be sure the device is disconnected from wall power during installation.
For power supplies with housing bodies that plug directly into a wall outlet (not via an AC cable)
ensure that the power supply is accessible. This is CRITICAL if the chosen array or installation
limits access to the DC electrical plug connected to the device. In case of emergency, staff must be
able to terminate power to the device by disconnecting the unit from wall power.
For power supplies with both an AC Cable side and DC Cable side ensure that at least one end of
the AC power cable (the cable running from the power supply body to the wall outlet) is
accessible. This is CRITICAL if the chosen array or installation limits access to the DC electrical plug
connected to the device. In case of emergency, staff must be able to terminate power to the
device by disconnecting the unit from wall power.
For installation using screws or other wall piercing fasteners, select an appropriate fastener and
anchor for the given surface. Use as many of the predrilled fastener holes in the metal backing
plate as is required to securely hold the device. Be sure to account for the weight of the batteries,
4
RK0350 - Rev A - Ronin X Series Instructions for Use (IFU)

power supply, and maximum mechanical force applied by users during use or that the device may
endure during unanticipated forces such as earthquakes.
DO NOT drill any additional holes in the charger mounting plate or device.
DO NOT drive any screws through any part of the charger other than the holes of the provided
mounting plate.
5. NORMAL USE
The user should carefully study the Instructions for Use (IFU) before using the X Series Surgical
Headlight. Instructions should be followed, with special attention given to warnings,
precautions, 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.
WARNING: DO NOT use the Ronin X Series Headlight ata distance of less than 12 inches (30 cm)
measured from the end of the luminaire to any illuminated surface. It is the responsibility of
the user to ensure proper use of the headlight and monitor whether use of the emitted light is
causing any desiccation, singe, burn, fire or other harmful effects at the surface.
WARNING: Before every use the X Series Surgical Headlight System MUST be carefully inspected
to ensure it has been properly maintained, cleaned, and is fully functional. DO NOTuse if
inspection reveals any debris, or damaged or loose parts or pieces. Failure to do so could result
in hazards including burn, fire, shock, or contamination. Contact Ronin at [phone] or
email Ronin at [e-mail] for repair and replacement.
WARNING: Risk of burn or fire if device is not turned OFF at the end of use. The Operator MUST
turn the holster switch to OFF, and/or remove the battery, and/or disconnect the Luminaire
from the holster, even if it appears that the battery is fully depleted. A depleted Lithium Ion
battery, like most chemical batteries, has the ability to partially recharge without the addition
of external power. This may cause the device to illuminate without notice and remain
illuminated until the battery is again depleted.
See IFU section WARNINGS AND PRECAUTIONS for further detail on the above points in
addition to other important information.
Ronin X Series Surgical Headlights are intended to supply supplemental high intensity illumination
to aid visualization in a surgical or clinical setting.
Suggested use is to first don the battery holster, then the luminaire with the links in a compressed
upside down “U” configuration. Load a Ronin approved battery logo-side out. After the luminaire
and battery holster are comfortably adjusted, bring the luminare down between the eyes,
positioning it as close to the bridge nose as possible to create light coaxial to the eyes.
5
RK0350 - Rev A - Ronin X Series Instructions for Use (IFU)

The supplied links support compatibility with variable surgical needs including face shields and
loupes. Do not operate with the links fully extended to avoid bumping heads with another
surgeon, to reduce mechanical shaking, and to achieve the greatest safe working distance to the
surface.
Turn the power switch from OFF to ON, then adjust the position of the luminaire, illumination
angle, distance from desired surface, spot size, and LED intensity to produce the desired
illumination. For more detailed instructions see the Instructions for Use (IFU) section OPERATING
INSTRUCTIONS (NORMAL MODE OPERATION)
Headlight must be properly turned off and/or disconnected from power following use. See IFU
section WARNINGS AND PRECAUTIONS for further detail.
WARNING: Once a battery has been fully charged remove it from the charger. Failure to do so
could result in hazards including burn, fire, shock, or contamination.
To charge a battery, insert the battery with with the logo side facing the front of the charger and
make sure the battery connectors on both the charger and battery are aligned. It can take up to
30 seconds for the indicator lights on the charger to illuminate. Orange indicates charging. Green
indicated fully charged. Remove the battery from the charger once it has been fully charged.
See IFU section WARNINGS AND PRECAUTIONS for further detail.
6. UNPACKING THE UNIT
Remove the unit from its container and properly dispose of any packaging material. Batteries may
be shipped separate from the unit to comply with shipping regulations.
7. WARNINGS AND PRECAUTIONS
WARNINGS are used to signal potential hazards which could lead to death or serious injury.
PRECAUTIONS are used to warn of a potentially hazardous situation which, if not avoided, may
result in minor or moderate injury to the user or patient, or damage to the equipment or other
property.
Warnings
●The user should carefully study the Instructions for Use (IFU) before using the X Series
Surgical Headlight. Instructions should be followed, with special attention given to
warnings, precautions, 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.
●WARNING: Before every use the X Series Surgical Headlight System MUST be carefully
inspected to ensure it has been properly maintained, cleaned, and is fully functional. DO
NOTuse if inspection reveals any debris, or damaged or loose parts or pieces.Failure to
do so could result in hazards including burn, fire, shock, or contamination. Contact Ronin
6
RK0350 - Rev A - Ronin X Series Instructions for Use (IFU)

at [phone] or email Ronin at [e-mail] for repair and
replacement.
●WARNING: Risk of burn or fire if device is not turned OFF at the end of use. The Operator
MUST turn the holster switch to OFF, and/or remove the battery, and/or disconnect the
Luminaire from the holster, even if it appears that the battery is fully depleted. A depleted
Lithium Ion battery, like most chemical batteries, has the ability to partially recharge
without the addition of external power. This may cause the device to illuminate without
notice and remain illuminated until the battery is again depleted.
●WARNING: DO NOT use the Ronin X Series Headlight at a distance of less than 12 inches
(30 cm) measured from the end of the luminaire to any illuminated surface. It is the
responsibility of the user to ensure proper use of the headlight and monitor whether use
of the emitted light is causing any desiccation, singe, burn, fire or other harmful effects at
the surface.
●WARNING: RISK OF BURN OR FIRE FROM EMITTED PHOTONIC ENERGY. The Operator, in
their professional judgment, MUST determine and observe a safe brightness setting,
distance to the illuminated surface, and duration of time illuminating the surface, for the
given circumstances, variables, conditions and unique surface/patient sensitivities.
●WARNING: Operator MUST take into account variation in surface temperature rise from
factors including but not limited to: additional sources of energy, starting surface
temperature, surface light absorbance/reflectance, surface thermal
conductivity/capacitance, and surface conditions/preparations such as chemicals or
moisture.
●WARNING: Operator MUST take into account usage circumstances, conditions, variables,
and unique surface/patient sensitivities that cannot be anticipated here, including but not
limited to chemical, genetic, pharmacological, photosensitivity, thermal sensitivity, and
preexisting conditions, each of which may make even typical safe working distances
unsuitable and potentially unsafe.
●WARNING: Use only enough light for good visualization. Avoid prolonged close stationary
illumination of tissue to reduce the risk of burn or thermal injury.
●DO NOTuse previous experience with other headlight models or illumination technologies
when determining the safe usage of the Ronin X Series Headlight with regard to working
distance, light intensity, and surface illumination duration. Please read these instructions,
as each light source has different operating and use instructions.
●WARNING: ULTIMATELY IT IS SOLELY THE OPERATOR’S RESPONSIBILITY TO ENSURE SAFE
USAGE OF THE DEVICE.
●WARNING: During peak charging, the enclosure of the power supply may get very hot to
the touch. If the outside of the power supply is uncomfortable to touch, (a) allow it to cool
by waiting for the batteries to fully charge, or (b) disconnect the batteries and allow the
charger to cool before touching or holding the power supply.
●WARNING: During normal use, the luminaire, holster,battery, and charger may be very
warm to the touch, but never uncomfortable. Any level of significant discomfort is NOT
normal. If unit is uncomfortably warm, immediately stop using the Ronin X Series Surgical
Headlight System and report the issue to Ronin customer service at [phone] or
email [e-mail]
●WARNING: DO NOTcharge a lithium ion battery that has been in a fully depleted,
uncharged, or “dead” state for a period of 6 months or more. Dispose of the battery safely
7
RK0350 - Rev A - Ronin X Series Instructions for Use (IFU)

per local regulations and contact Ronin for replacement. Failure to do so could result in
hazards including burn, fire, shock, or contamination.
●WARNING: Once a battery has been fully charged remove it from the charger. Failure to do
so could result in hazards including burn, fire, shock, or contamination.
●WARNING: Safely dispose of all Ronin lithium ion batteries 5 (five) years from date of
receipt. Failure to do so could result in hazards including burn, fire, shock, or
contamination.
●In a single fault condition, the temperature of the luminaire, holster, charger and batteries
can get hot, creating a possible risk of a burn if touched.
●The luminaire inlet and outlet air vents MUST be adequately ventilated in open air and
free of obstructions to allow proper cooling of the device.
●While powered, the luminaire, holster, and charger MUST NOTbe placed or installed on a
thermally insulative surface and MUST be in a well ventilated open air environment away
from external heat sources to allow for proper cooling. Otherwise, excessive heat may
accumulate and could result in permanent damage to the equipment, excessive
temperatures, or fire.
●No modification of this equipment is permitted, unless as specifically instructed by Ronin.
●DO NOTopen the enclosure. The X Series Surgical Headlight System has no serviceable
parts. Opening the device enclosure voids the warranty and creates a risk of shock, burn,
or fire. Please contact Ronin at [phone] or email Ronin at
[e-mail] for repair and replacement.
●DO NOTinsert anything into, tamper with, or open any sealed or assembled components
of the Ronin X Series Surgical Headlight. There are precisely installed safety components
and electrically live circuits. Slight alterations or interference can result in permanent
damage to the equipment, excessive temperatures, burn, fire or electrical shock.
Maintenance should be limited to following cleaning instructions as indicated by Ronin.
Please contact Ronin at [phone] or email Ronin at [e-mail]
for repair and replacement.
●DO NOTuse the X Series Surgical Headlight System in wet environments or expose it to
water or liquids. It IS NOTsealed or designed for water resistance or fluid ingress.
●To reduce the risk of fire and electric shock, DO NOTexpose electrical equipment to
moisture. When cleaning, do not immerse any electrical device in liquid.
●DO NOTstore or use liquids of any type on or above the X Series Surgical Headlight
System.
●DO NOTpress on the fan blades to avoid damaging or cracking them.
●In a fault condition the light may suddenly and without notice cease to produce light. The
user is responsible for ensuring that interruption of light output does not create an
unacceptable risk. If such a determination is made, alternate arrangements (such as a
standby headlight) should be made by the user to reduce the risk.
●When moving while wearing the X Series Surgical Headlight System use precaution to
avoid catching headlight components on anything that could suddenly pull the device
away from the user’s body resulting in either harm to the device or user.
●Care should be taken if the equipment is used simultaneously or adjacent to other
equipment; if simultaneous or adjacent use is inevitable, the equipment should be
observed to verify normal operation prior to use.
●Follow the instructions of other manufacturers’ equipment when used in conjunction with
this product.
8
RK0350 - Rev A - Ronin X Series Instructions for Use (IFU)

●Explosion: DO NOTuse the Ronin X Series Surgical Headlight in oxygen-enriched
environments or environments with flammable anesthetics, liquids, vapors,
gases or dusts.
●DO NOTallow the emitted high intensity light to shine directly into eyes as it may cause
permanent damage.
●DO NOTuse the X Series Surgical Headlight System in ocular surgery or in a surgical
procedure requiring direct illumination of the eye.
●Unattended use of the X Series Surgical Headlight System by children or persons not
familiar high intensity surgical headlights may be dangerous.
●DO NOTuse this device in a magnetic resonance (MR) environment or in any environment
where MRIs are used.
●DO NOTsterilize the X Series Surgical Headlight System by placing the device in an
autoclave or other sterilizer. This device should only be cleaned as instructed in IFU
section CLEANING.
●Safety precautions MUST always be exercised when using electrical equipment to prevent
operator/patient shock, fire hazard or equipment damage.
●DO NOTallow persons, devices, or sensitive surfaces beneath the charger installation to
avoid physical harm or contamination. When charger is installed on a wall or elevated
surface, due to improper installation, improper use, or material failure, the charger or
batteries may unexpectedly detach and/or fall. See IFU section INSTALLATION for further
detail.
●DO NOTdrill any additional holes in the charger mounting plate.
●DO NOTdrive any screws through any part of the charger other than the holes of the
provided mounting plate.
●During charger installation, ensure that the power supply body or at least one end of the
AC power cord (if equipped) is accessible. This is CRITICAL if the chosen array or
installation blocks access to the DC barrel jack. In the case of emergency, staff must be
able to terminate power to the device by unplugging the unit from the wall.
●Use ONLYRonin approved power supplies and batteries (U80507, U80510, RK0320-M,
RK0321-M as of this IFU revision) with this device. Contact Ronin for the most up to date
list of approved batteries and power supplies.
●DO NOTuse defective, damaged, or unauthorized batteries or power supplies. They can
pose a risk of electric shock, burn, fire, and explosion. If the battery or power supply
shows any signs of damage, leakage, or cracking, it must be replaced immediately, and
only with a Ronin approved battery or power supply.
●BatteryMUST be inserted so that that the 5-pin connector in the holster or charger mates
with the 5 slots on the battery. DO NOTforce batteryduring mating as misaligned pins
may damage the battery or the device and may result in risk of electrical shock, burn, or
fire.
●Improper handling of the battery can lead to heat generation, smoke, bursting, or fire.
●DO NOTdrop the device or any of its components as it may damage or break the device.
This may cause unexpected behavior and potential for fire, burn, shock, or contamination.
●DO NOTremove the label from the battery.
●DO NOTimmerse the battery in water or other liquids.
●DO NOTcharge or use batteries with non approved Ronin devices.
●DO NOTdisassemble or modify the battery.
●DO NOTdirectly connect or short-circuit the positive (+) and negative (-) battery terminals.
9
RK0350 - Rev A - Ronin X Series Instructions for Use (IFU)

●To avoid short circuits, keep battery terminals away from metal objects.
●DO NOTexpose the battery to temperatures higher than 49°C/120°F.
●While not in use, during storage, and during shipping, the batteryMUST be removed from
the battery holster to ensure that the LED is not accidentally powered on, which could
result in permanent damage to the equipment, excessive temperatures, or fire.
●For Shipping and Transport of Lithium Ion batteries (most critically for Air Shipping and Air
Transport), the most up to date regulations of the Common Carrier (UPS, FedEx, USPS,
etc.) and local and federal authorities MUST be strictly adhered to. Violation of these
regulations, either knowingly or unknowingly, may constitute a felony. See the IFU section
BATTERY STORAGE, TRANSIT, AIR TRAVEL AND SHIPPING for more information on proper
shipping and transport. IF A CUSTOMER BREAKS TRANSPORT LAWS RONIN ASSUMES
ZERO LIABILITY. Improper disposal of batteries maycreate an explosion or contamination
hazard. Never dispose of batteries in refuse containers. Do not dispose of the battery in
fire. Always recycle batteries according to local regulations.
●For shipping and transport ensure the battery terminal is securely taped or access is
otherwise blocked to prevent accidental short circuit of the positive (+) and negative (-)
battery terminals.
●To ensure patient and operator safety and optimal product performance, use only
recommended accessories and supplies with the system according to the IFU. Use of
accessories 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 X Series 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 X
Series Surgical Headlight System, including cables specified by Ronin. Otherwise,
degradation of the performance of this equipment could result.
Precautions
●CAUTION: Use only cleaning agents and chemicals identified by Ronin as suitable for use
on the Ronin X Series Headlight system and related accessories. Use of alternative
cleaning agents may cause harm to the product. See IFU section CLEANING for appropriate
cleaning agents.
●CAUTION: To prevent damage to the cable or connector components, DO NOThold, carry,
plug or unplug the unit by any of its cables.
●CAUTION Immediately stop using the Ronin X Series Surgical Headlight and report any
significant user discomfort or issues with the unit to Ronin customer support at
[phone] or email Ronin [e-mail]
●CAUTION: Do not operate with the links fully extended to avoid bumping heads with
another surgeon, reduce mechanical shaking, and to achieve the greatest safe working
distance to the surface.
●CAUTION: When moving while wearing the X Series Surgical Headlight System use
precaution to avoid inadvertently contaminating sterile or sensitive surfaces.
10
RK0350 - Rev A - Ronin X Series Instructions for Use (IFU)