HAWKEYE SURGICAL V1 Compact Headlight Owner’s Manual

HAWKEYE SURGICAL V1 Compact Headlight

Product Information

• Product Name: V1 LED Lamp
• Intended Use: Medical, dental, and veterinary procedures requiring focused illumination
• Usage: Professionals trained in the specific medical procedure
• Compliance: FCC Part 15
• Warranty: Headlight – 10,000 usage hours; Power bank, charger, cables – 2 years

Product Usage Instructions

• Intended Use:
  The V1 LED lamp is designed for use in medical, dental, and veterinary procedures where focused illumination is needed. It is meant to provide lighting directed at the point of interest or area of operation. Only professionals trained in the specific medical procedure should use the V1 headlight.

• Warnings and Precautions:
  Ensure compliance with FCC Part 15 regulations to avoid interference issues. Any modifications not approved may void the user’s authority to operate the equipment.

• Instructions for Use:
  If voice commands are enabled, using the brighter command after the light has dimmed will return it to the original brightness when the user’s head remains within the same quadrant of head position control.

• Battery Changeouts and Charging:
  Only use Voxel Surgical-approved cable and wall transformer for battery changeouts and charging.

• Maintenance:
  The V1 does not require ongoing maintenance. Before each use, inspect the device and accessories for damage or wear. Do not use it if any components are damaged. Store the V1 in the provided case after use for proper protection.

• Warranty:
  The V1 headlight is warranted against defects for 10,000 usage hours. A power bank, charger, and cables are warranted for two years. Improper maintenance or usage may not be covered by the warranty.

FAQ

Are there any contraindications for using the V1 LED lamp?
No, there are no contraindications listed for using the V1 LED lamp.

Description

The V1 is a compact headlight that provides focused lighting directed at a point of interest and/or area of operation. The device consists of the V1 headlight, V1 cable, and approved power banks. The device includes voice control firmware which allows the brightness to be adjusted incrementally using voice commands “brighter” and “dimmer”. Heads-up detection decreases the brightness to its lowest setting when the light is raised above a pre- specified angle. Adaptive brightness can be enabled which allows the V1 to automatically adjust light output based on ambient lighting. These settings can be enabled/disabled with the associated mobile application.

Specifications

• Weight: 15g
• Device dimensions: 25.5mm x 25.5mm x 45mm
• Maximum illuminance: 200,000 lux @13” working distance
• Minimum illuminance: 10,000 lux @13” working distance
• Light source: Light Emitting Diode
• Light color: 5700K
• Battery life: 6 hrs nominal
• Battery charge time: 60 minutes

Intended Use
The V1 LED lamp is indicated for use in medical, dental, and veterinary procedures where focused illumination is required. It is intended to provide lighting directed at the point of interest and/or area of operation. The V1 headlight is intended only to be used by professionals trained to perform the medical procedure being conducted.

Contraindications
None

Warnings and Precautions

Warnings

• Operator must consider usage circumstances, conditions, variables, and unique surface/patient sensitivities, including but not limited to chemical, genetic, pharmacological, photosensitivity, thermal sensitivity, and preexisting conditions, which may make even typical safe working distances unsuitable and potentially unsafe.
• Always dispose of power banks according to local, state, and federal laws and regulations. Improper disposal can lead to environmental harm.
• Only use approved accessories. Use of accessories other than those specified or provided by Voxel Surgical could result in improper operation.
• Do not force any screws or adjustable components on the device. This can lead to damage to the device or components and improper securement of the device.
• During normal use, the headlight, power bank, and charger may be warm to the touch but should not be uncomfortable. If the unit becomes uncomfortably warm, immediately stop using the device and report the issue to Voxel customer service.

Precautions

• Handle devices and accessories with care. Do not drop the device, accessories, or packaging as it may damage or break the device.
• Store the case in a secure, clean, and dry location. Failure to do so may result in damage or malfunction of the device.
• Always examine the device and components for damage and to ensure the proper function before use.
• Do not use damaged accessories and contact Voxel Surgical for replacements if components are damaged or not functional.
• Do not sterilize devices or components.
• Do not use this equipment adjacent to or stacked with other equipment. If this use is necessary, confirm the proper operation of both this device and nearby equipment before use.
• Power down the device after the end of each use by removing the cable from the power bank.
• Disinfect all exposed surfaces of the headlight, cables, power bank, and accessories with only Lysol IC surface disinfectant/cleaner.
• Do not use alcohol, phenol, ammonia, or iodine complex solutions to disinfect the device and/or components.
• Do not allow liquids to enter into openings or ports.
• Do not immerse parts in solutions.
• Ensure the headlight is accurately adjusted to the correct field of view before clinical use. This can be achieved by manually moving the headlight laterally and using the hex driver to adjust the angle adjustment screw.
• The Voxel V1 may be adversely affected by electromagnetic disturbances.

FCC Compliance Statement

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

1. This device may not cause harmful interference, and
2. This device must accept any interference received, including interference that may cause undesired operation.

CAUTION:
The grantee is not responsible for any changes or modifications not expressly approved by the party responsible for compliance. Such modifications could void the user’s authority to operate the equipment.

NOTE:
This equipment has been tested and found to comply with the limits for a Class B digital device, under part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy, and if not installed and used per the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and the receiver.
• Connect the equipment to an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

Instructions for Use/Directions for use

Unpacking + Setup

• Remove the case from the box and properly dispose of any packaging material.
• Carefully remove the headlight, power cable, charging cable, power banks, and transformer from the case.
• Loosen the set screw on the top of the headlight with the associated hex driver.
• Place light onto the bridge of glasses/loupes.
  • Note: Voxel V1 is only compatible with Design for Visions and Orascoptic loupes.
• Perform lateral angle adjustments to align the field of view with the focus of light.
• Tighten the set screw until the headlight is securely attached, but do not force the screw in either direction.
• Perform superior and inferior angle adjustments using the angle adjustment screw to align the field of view with the focus of light. Do not force the screw in either direction.
• Plug a Voxel-approved 90-degree USB-C cable into the USB-C port on top of the headlight.
• Attach associated eyewear retainers to glasses/loupes.
• Route cable along temporal armband of glasses/loupes.
• Secure cable on glasses using an included rubber band.
• Secure cable at the back of the head using the loom on the eyewear retainers.
• Place the power bank in the provided clip and secure it on the waist.
• Plug the USB-C cable into the USB-C port on the power bank.
• The device is ready for use.

Mobile Application Setup + Use

• Download the Voxel App from either the App Store or Google Play.
• Open app.
• Follow the instructions on the screen to pair the headlight to the mobile application.
• Turn on desired settings (voice control, head-position control, adaptive-brightness).
• Use the slider to control brightness as desired.

Device Control During Use

• Voice Control
  • Voice control option can be enabled or disabled using the associated mobile application.
  • If enabled, use phrases “brighter” or ”dimmer” to increase or decrease the brightness respectively. When the headlight reaches maximum or minimum brightness, it will flash once to signal it has reached the limit.
• Heads-up detection
  • Heads-up detection can be enabled or disabled using the associated mobile application.
  • If enabled, when the headlight is raised above the prespecified angle in the application the light will decrease to minimum brightness.
  • When the headlight is lowered below the same angle it will increase to the previous brightness level.
  • If voice commands are enabled, invoking the “brighter” command after the light has dimmed upon reaching a prescribed head position will return the light to the original brightness for the duration that the user’s head remains within the same quadrant of head position control.

Battery changeouts and charging

• Remove the power bank from the pocket or waist clip.
• Remove the cable from the power bank.
• Place the discharged power bank on the charger with the associated cable and wall transformer.
  • Note: only use Voxel Surgical-approved cable and wall transformer
• Retrieve the replacement power bank.
• Connect the cable to the replacement power bank.
• Place the power bank in a pocket or on the waist clip.

Routine Shutdown and Storage

• Remove glasses from the head.
• Remove the cable from the power bank, the light will power off automatically.
• Disinfect all exposed surfaces of the headlight, cables, power bank, and accessories with Lysol IC surface disinfectant/cleaner.
• Do not use alcohol, phenol, ammonia, or iodine complex solutions.
• Do not allow liquids to enter into openings or ports.
• Do not immerse parts in solutions.
• Remove the cable from the power bank.
• Retrieve the case and place the power bank into its designated slot.
• Place glasses and headlight in a large open cavity.
• Loop the cable and place it on top of the glasses.
• Close the zipper on the case and store it in a secure, clean, and dry location until the next use.

Removing headlight from glasses

• Remove the cable from the headlight.
• Use the hex driver to turn the set screw counterclockwise to loosen the frame clamp.
• Remove the headlight from the bridge of the glasses.
• Remove cable from loom on eyewear retainers.
• Remove the rubber band retainer from the arm of the glasses.
• Unplug the cable from the power bank.
• Coil cable and place cable, headlight, power bank, and accessories in the case.

Disposal
Dispose of the device, V1 power bank, and accessories according to hospital procedures and applicable local, state, and federal laws and regulations

Maintenance

The V1 does not require any ongoing maintenance. However, inspect the device and all accessories for damage and/or wear before each use. Ensure the device is fully functional before each use. Do not use if inspection reveals any damaged or broken components or accessories. Keep the V1 in the provided storage case after use, in a safe and secure location for proper protection.

Warranty

The V1 headlight is warranted against imperfections and defects in materials and workmanship for 10,000 usage hours. The power bank, charger, and cables are warranted for two years. Any damage caused by improper maintenance or usage as described in the manual may not be covered by the warranty.

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