VERABAND INSTRUCTIONS FOR USE

VERABAND™ Non-Sterile, Single-Use Only Rev. D

REF VB4001-01	VB Small/Medium
REF VB4003-01	VB Medium/Large

INTENDED USE
The VERABAND™ is an FDA-cleared, compact, lightweight, body-worn activity monitoring device designed to document physical movement associated with applications in physiological monitoring. The device is intended to monitor limb or body movements during daily living and sleep for a limited time interval (up to 28-days). The VERABAND™ can be used to assess activity in any instance where quantifiable analysis of physical motion is desired. VERABAND™ is not intended for diagnostic purposes.

ENVIRONMENT OF USE
It is intended that the VERABAND™ device be administered only by a qualified prescribing physician. The VERABAND™ device is suitable for patient use within a home healthcare environment.

VERABAND™ OVERVIEW

VERABAND™

The VERABAND™ is a physician prescribed, wrist-worn wearable device intended for collecting a patient's motion data for assessing patient activity.

The VERABAND™ is suitable for use in the Home Healthcare environment.

VERABAND™ Specifications
Dimension	Approx. 2.75" x 2.25" x 0.375"	Dynamic Range	± 2g
Weight	Approx. 4.5 grams	Wear Location	Wrist of non-dominant hand
Memory	28 days/4MB	Water Resistance	IP57

WARNINGS

	The VERABAND™ must be dispensed to an individual patient for wear by the prescribing physician. The patient is an intended operator of the VERABAND™.
	Choking Hazard: Do not place device in or around mouth. Keep out of reach of children and pets.
	Do not expose the VERABAND™ to temperatures greater than 60°C (140°F) or lower than -20°C (-4°F).
	Do not wear the VERABAND™ device during exposure to medical imaging equipment, including MRI, CT Scans, X-rays and Ultrasound.
	Do not attempt to open or modify the VERABAND™. Your VERABAND™ device is waterproof and modifying the device may destroy the waterproof seal.
	MR Unsafe - Projectile Hazard Keep Outside of MRI Scanner Room.
	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 VERABAND™ device, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
	Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
	In the unlikely event of a battery short, the VERABAND™ device may temporarily reach a temperature of 45°C (113°F). If you notice heat or mild discomfort at the point of contact, immediately remove the device and contact VERACRON™ via our online feedback form.

CAUTIONS

	Federal law restricts this device for use by order of a physician.
	Read all instructions carefully before removing the VERABAND™ from its package, before wearing the VERABAND™ device, and before returning it to VERACRON™ in the pre-addressed, pre-paid mailer.
	Prior to activation, do not expose the VERABAND™ device to temperatures greater than 60°C (140°F) or lower than -20°C (-4°F).
	Once it is activated, do not expose the VERABAND™ device to temperatures to greater than 40°C (104°F) or lower than -20°C (-4°F).
	Transport, storage, and operational use of the VERABAND™ is limited to atmospheric pressures between 0.59 ATM to 1.0 ATM, and a relative humidity between 0 to 93%.
	The VERABAND™ device must not be worn longer than 28 days. At the end of the wear period (28 days or less) immediately return the VERABAND™ to VERACRON™, using the postage-paid return envelope.
	If the VERABAND™ device has been exposed to temperatures outside of the allowable transport and storage temperatures (-20°C – 60°C), allow it to acclimate to room temperature for a minimum of 2 hours before activating it.
	The VERABAND™ device continuously records data for 28 days once activated. The device must be activated prior to its Expiration Date (found on the device package label).

CONTRAINDICATIONS

The VERABAND™ is contraindicated for use by patients under the age of 21.

PRESCRIBING VERABAND™ FOR PATIENT USE

When prescribing the VERABAND™ device for patient use, the physician should consider the patient’s willingness to comply with the prescribed wear period. The ideal candidate will wear the VERABAND™ device for 16-24 hours per day, for the prescribed number of days (up to 28).

DISPENSING VERABAND™ TO THE PATIENT

When dispensing a VERABAND™ device to a patient for the first time, the prescribing physician or clinic shall instruct the patient on how to unpack the device, and return it after the prescribed wear time. The first device shall be unpacked and activated under the supervision of the prescribing physician/clinic.

Additional devices may be sent home with the patient, as long as their packaging remains closed until ready for use.

The prescribing physician/clinic shall record the Serial Number of each VERABAND™ device distributed to a patient within the patient's medical chart. The serial number is located on the outer label of the mailer and on the skin-facing (inner) side of the VERABAND™ device.

The VERABAND™ is available in two sizes, VB4001-01 (S/M) and VB4003-01 (M/L). To determine the appropriate size to dispense, measure the circumference of the intended patient/user's wrist at the base of the wrist. If the wrist measures 171 mm (approximately 6.73 in.) or less select VB4001-01 (S/M). If the wrist measure 172 mm to 198 mm (approximately 7.80 in) select VB-4003-01 (M/L). The VERABAND™ should not be worn if an appropriate fit cannot be achieved.

UNPACKING AND USING THE VERABAND™ AT HOME
For any assistance in setting up or using the VERABAND™ device, or to report an issue with your device, please contact VERACRON™ Wellness Systems using the online feedback form (www.veraband.com).
1. The VERABAND™ is packaged in a white light-blocking envelope. DO NOT remove it from the white envelope until ready to wear.
2. When ready to use, tear the label on the flap of the white envelope to open it, and pull the VERABAND™ out of the surrounding foam pocket. The VERABAND™ device itself is further protected by a smooth black plastic sleeve. DO NOT DISCARD ENVELOPE. IT WILL BE USED TO RETURN THE DEVICE ONCE YOUR WEAR PERIOD IS COMPLETE.
3. Remove the VERABAND™ device from the black protective sleeve. Upon removal it will automatically activate. You may discard this black sleeve. Once removed from the black protective sleeve, the VERABAND™ device will self-activate.
4. Place the VERABAND™ device onto your wrist by gently expanding the band over your non-dominant hand. The device is intended to be worn at the base of the wrist and should not be positioned higher on the arm. The VERABAND™ may be worn continuously for up to 28 days, and is waterproof. DO NOT continuously submerse the band in water for more than 30 minutes. NOTE: REMOVE the device immediately if any of the following are experienced during wear and notify your prescribing physician/clinic: Tightness Pain Numbness of tingling Swelling Skin discoloration Skin ittitation or sores A loose fit that allows the device to slip off the band Any other discomfort associated with wear

CLEANING THE VERABAND™
At home: While not intended to be sterile, the VERABAND™ device may be cleaned to remove general dirt, debris, spills, etc. VERACRON™ recommends cleaning all external surfaces of the VERABAND™ device with a 70% isopropyl alcohol (IPA) solution for a minimum of 60 seconds. Wipe with a soft, dry towel after cleaning.
Before returning your VERABAND™ device: Please clean the device as instructed above, before placing it in the mailer and returning.

RETURNING THE VERABAND™ TO VERACRON™
1. Once your wear period is complete, clean the VERABAND™ device (instructions above), and place it back into its original white envelope. Peel back the paper from the adhesive strip on the original white envelope and fold the panel to seal the envelope.
2. The envelope for the VERABAND™ device is pre-addressed and postage-paid. It may be mailed anywhere U.S. mail is accepted. Please ensure the VERABAND™ is placed in the U.S. mail as soon as you have completed your wear period.

RECEIVING THE VERABAND™ REPORT FROM VERACRON™
1. The VERABAND™ report will be prepared at VERACRON™ and then delivered to the prescribing physician via a secured digital delivery or facsimile (fax) method (i.e as a PDF via a secure web portal). The 2-page report includes VERABAND™ Report Interpretation Notes for the Prescribing Physician. A sample VERABAND™ Report is available on the VERACRON™ webpage (www.veraband.com) for reference.
2. The second page of the VERABAND™ Report provides interpretation notes for the prescribing physician.

The Expected Service Life of the VERABAND™ is 395 days. If the device is not activated by the expiration date on the package, please return to the manufacturer per the instructions above, or contact VERACRON™ using the online feedback form (www.veraband.com) to arrange for return of any devices.

EM DISTURBANCES

The VERABAND™ is designed and manufactured to minimize the effects of external EMI upon the device and to minimize the effect upon the environment from the device. The system conforms to the appropriate standards with respect to EMI performance. In the event of partial or complete loss of device function due to external or environmental factors, VERACRON™ will make reasonable efforts to generate and provide a VERABAND™ report using the available data. If a report cannot be generated, or if the available data is insufficient, the clinician may determine whether a replacement VERABAND™ device is appropriate.

VERABAND™ EMC Compliance

Guidance and Manufacturer's Declaration - Electromagnetic Emissions
The VERABAND™ is intended for use in the electromagnetic environment specified below. The customer or the user of the VERABAND™ should assure that it is used in such an environment.
Emissions test	Compliance	Electromagnetic environment - guidance
RF emissions CISPR 11	Group 1	The VERABAND™ uses RF energy only for its internal function. Its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11	Class B
Radiation Disturbance IEC 60601-1-2	Complies	The VERABAND™ is suitable for use in home healthcare environments. The VERABAND™ has not been tested for use in the following environments: -Military applications/areas -Industrial applications/areas -Hospitals and medical treatment areas with imaging equipment including MRI’s, CT Scans, X-rays and Ultrasound.
Harmonic emissions IEC 60601-3-2	Not applicable
Voltage fluctuations/flicker emissions IEC 60601-3-3	Not applicable

Guidance and manufacturer’s declaration – electromagnetic immunity
The VERABAND™ is intended for use in the electromagnetic environment specified below. The customer or the user of the VERABAND™ should assure that it is used in such an environment.
Immunity test	Test Level	Compliance	Electromagnetic environment - guidance
ESD IEC 61000-4-2	±8 kV Contact ±2,4,8,15 kV Air	Passed	The VERABAND™ is suitable for use in home healthcare environments.
ESD Rated power frequency magnetic fields IEC 61000-4-8	30 A/m	Passed	Power frequency magnetic fields should be at levels characteristic to those in typical home healthcare environments.
ESD Radiated RF EM fields IEC 61000-4-3	10 V/m 80 MHz to 2.7 GHz	Passed	The VERABAND™ is suitable for use in home healthcare environments. The VERABAND™ has not been tested for use in the following environments: -Military applications/areas -Industrial applications/areas -Hospitals and medical treatment areas with imaging equipment including MRI’s, CT Scans, X-rays and Ultrasound.
Immunity to proximity fields from RF wireless communications IEC 60601-1-2	27 V/m @ 385 MHz 28 V/m @ 450,810-2450 MHz 9 V/m @ 710-780, 5240-5785 MHz	Passed
Immunity to proximity magnetic fields IEC 61000-4-39	8 A/m @ 30 kHz 65 A/m @ 134.2 kHz 7.5 @ 13.56 kHz	Passed

SYMBOLS GLOSSARY

	Prescription use only
	Warning
	Caution
	Catalog Number
	Lot Number
	Serial Number
	Quantity
	Consult Instructions for Use
	Use By Date
	Temperature Range
	Single-use Only - Do Not Reuse
	Non-Sterile
	Product Is Not Made with Natural Rubber Latex
	MR Unsafe - Projectile Hazard Keep Outside of MRI Scanner Room
	Manufacturer
	Ingress Protection – Protected Against Solid Particle Such as Dust/Debris (5) and Temporary Immersion in Liquids to a Depth of up to 1 Meter (7)
	The VERABAND™ Device, in its Entirety, is an Applied Part (Type BF)
	Sunlight Away
	Humidity Range
	Atmospheric Pressure Range
	Do not remove the device from packaging until ready to wear

VERABAND™ IFU P/N 55-015 Rev D