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Zida Control Sock Clinician Brochure

Zida Control Sock Prescription Form

Randomized Controlled Trial

USE INSTRUCTIONS

Use only once weekly for the recommended 30 minutes treatment session. More frequent use of ZIDA or longer treatment times have not been clinically evaluated. Overuse may result in medical complications.For more use instructions see User Guide.

INDICATIONS

ZIDA is a nueromodulation System that is intended to treat patients with an Overactive Bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.

DESCRIPTION

ZIDA is a home-care Neuromodulation System that is minimally invasive. The system is designed to deliver non-invasive access to the sacral nerve plexus through transcutaneous electrical stimulation of the posterior tibial nerve. This method of treatment is referred to as Transcutaneous Tibial Nerve Stimulation (TTNS). The ZIDA Neuromodulation System consists of the ZIDA CONTROL UNIT and the ZIDA Embedded Garment (Sock, Tights). The CONTROL UNIT is a battery powered, external pulse generator, which is designed, constructed, and manufactured for multiple use. The CONTROL UNIT should only be used in conjunction with a ZIDA Embedded Garment (Sock/ Tights). The ZIDA Embedded Garment (Sock/Tights) transfer(s) the electrical pulses from the CONTROL UNIT to the tibial nerve via the embedded silver knit electrodes.

ZIDA CONTROL UNIT

1.Design Features:
» Lightweight, ergonomic, wearable design.
» Intuitive power and pulse intensity controls.
» Raised and embossed buttons to provide physical feedback.
» Indicator lights provide operational status.
» One-way fit connection site for the CONTROL UNIT and Embedded Garment.

2.Electrical Current Settings:
» Pulse characteristics:
– Fixed pulse frequency of 20 Hz.
– Pulse width of 200 microseconds.
– Square waveform.
» Resistance of 500-4000 Ohms.
» Ten incremental presses on the current adjustment buttons increases/ decreases the stimulation level by 1 mA (R.M.S).
» Continuously pressing on the current adjustment buttons increases/ decreases the stimulation level by 1 mA/Sec (R.M.S)

CONTRAINDICATIONS

1.Use of the device is contraindicated for use on patients with
   the following medical history or conditions:
» Patients with pacemakers or implanted defibrillators
» Patients prone to excessive bleeding
» Patients with nerve damage that could impact the percutaneous tibial nerve or pelvic floor function
» Patients who are pregnant or planning to become pregnant while using this product.
2.The CONTROL UNIT is not intended for intra-cardiac or trans-thoracic use.
3.Concurrent use of medical monitoring equipment during stimulation is not recommended.
4.This device is not suitable for use around flammable compressed mixtures including but not limited to oxygen or nitrous     oxide.

WARNINGS
  1. The Instructions for Use is NOT a comprehensive reference to therapeutic techniques for the treatment indications noted for the ZIDA device.
  2. Users should be familiar with appropriate application and techniques involved in the use of the CONTROL UNIT and the Embedded Garment (Sock/Tights).
  3. Do not use the ZIDA device in or around water.
  4. Do not use ZIDA on skin that is inflamed, infected, or otherwise compromised.
  5. Do not open the battery cover while the CONTROL UNIT is powered on or connected to the patient.
  6. Patients should not spend more than 30 minutes in Therapy mode during a single treatment session.
  7. The patient should remain comfortably seated or while laying down during treatment. The patient should not stand or walk until treatment is complete as mobility during treatment has not yet been assessed.
  8. Do not use the CONTROL UNIT or Embedded Garment if they are damaged.
  9. Remove the battery if the ZIDA system is not likely to be used for some time.
  10. Simultaneous connection of a patient to high frequency surgical equipment may result in burns at the site of the CONTROL UNIT electrodes and possible damage to the CONTROL UNIT.
  11. Device operation in close proximity (e.g. 1 meter) to short wave or microwave therapy equipment may produce instability in the CONTROL UNIT output.
  12. The application of the electrodes near the thorax may increase the risk of cardiac fibrillation.
  13. Do not apply stimulation across or through the head, directly on the eyes, covering the mouth, on the front of the neck (especially the carotid sinus), chest, upper back, or traversing the heart.
  14. The CONTROL UNIT has electric shock protection, Type “Internally Powered Equipment.”
  15. The CONTROL UNIT enclosure is Type IPX0 and does not protect against the ingress of water.
  16. Unauthorized modification of this equipment may cause injury to either the patient or the device operator.
  17. Use only once weekly for the recommended 30 minutes treatment session. More frequent use of ZIDA or longer treatment times have not been clinically evaluated. Overuse may result in medical complications.
PRECAUTIONS
  1. Prior to using the ZIDA® Neuromodulation System, read and understand all instructions in the ZIDA NEUROMOUDULATION UNIT’S Instructions for Use.
  2. Take caution treating patients with suspected or diagnosed heart problems, especially relating to the pacing or electrical functioning of the heart.
  3. The following are potential health risks associated with this type of device and therapy: » Discomfort and pain (including throbbing pain) at, or near the stimulation site, including the patient’s lower leg and foot. » Redness/inflammation at, or near, the stimulation site. » Numbness of toes
  4. Medical electrical equipment require special precautions regarding electromagnetic compatibility (EMC) and should be installed and placed into service according to EMC guidelines provided.
a. Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment.
b. The end user of this product should ensure it is used in an appropriate environment.
i. Portable and mobile RF Communications equipment (i.e. cell phones) should not be used in close proximity.
ii.Power frequency magnetic fields should be at levels characteristic of a typical home use device.
MRI WARNING
  1. Keep ZIDA Control Unit and garment outside the MRI scanner room.
TREATMENT FREQUENCY
  • Conduct 12 treatments, typically once per week.
  • After the initial 12 treatments, slowly increase the time between treatments, with the patient closely monitored for the return of symptoms.
  • If symptoms reappear or increase in severity, the patient’s treatment schedule should revert to the last previously effective treatment schedule.
MAINTENANCE
  • After each treatment the surface of the Control Unit should be wiped down with a soft cloth. The cloth may be slightly dampened, but not saturated, with water or with a mix of isopropyl alcohol (70%) and water (30%).
  • Use only a AAA alkaline battery to power the CONTROL UNIT.
  • Never operate the CONTROL UNIT with any type of line-powered battery eliminator or other external power source.
  • Battery life is dependent on the intensity of treatment; a new AAA battery will perform approximately 12 treatments for the average patient.
  • Recycle or dispose of batteries in compliance with applicable local and/or national regulations.
  • Do not store CONTROL UNIT for long periods with battery in the device.
  • If the CONTROL UNIT is not working properly, contact ZID
WARRANTY

ZIDA warrants that reasonable care has been used to design and manufacture this product. The product will be replaced for up to one year from date of purchase, if ZIDA Medical determines its’ material or workmanship is defective. This is ZIDA Medical’s only warranty and it excludes all other warranties (including those implied by operation of law).
ZIDA Medical is not responsible for matters within the control of the user or others, such as product handling, storage, patient selection and diagnosis, and treatment procedures.

CHANGING BATTERY

1. Slide open the battery cover located on the front face of the ZIDA CONTROL UNIT.
2. Push down on the cover while sliding the cover down.
3. Remove Used battery.
4. Insert New AAA Battery
5. Slide cover back into place.


Battery life is dependent on the intensity of treatment;
a new AAA battery can sustain approximately 12 treatments for the average patient.

Guidance and Manufacturer’s Declaration– Electromagnetic Emissions

The ZIDA CONTROL UNIT is intended for use in the electromagnetic environment specified below. The customer or user of the ZIDA CONTROL UNIT should ensure it is operated in this environment.

LED behavior

ModeBehavior
Power On3 rapid blinks (1sec-ON/1sec-OFF), LED color changes according to battery fulness
Color: Low = RED Half Empty = Blue Full = Green
Test modeBlue led blinks constantly for the duration of test mode.
The blink rate starts "slowly" and increases gradually, creating a "countdown effect".
TherapyGreen led blinks constantly for the duration of test mode.
Rate: (0.5sec-ON/3sec-OFF)
Power OffColor: Orange
3 rapid blinks (1sec-ON/1sec-OFF).
Low battery ErrorRed led blinks until power OFF
Rate: (1 sec-ON/1sec-OFF)
Increase IntensitySingle button press: Green led blink once Constant button press: Green led is on constantly
Decrease IntensityYellow
Recommended Separation Distances Between Portable and Mobile RF
Communications Equipment and ZIDA CONTROL UNIT
The ZIDA is intended for use in an electromagnetic environment where radiated R disturbances are controlled. The customer or use of the ZIDA CONTROL UNIT can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters) and the ZIDA CONTROL UNIT as recommended below. according to the maximum output power of the communication equipment
Rated Maximum
Output Power of
Transmitter
W
Separation Distance According to Frequency of
Transmitter M
150 kHz to 80
MHz
d = 1,2✓P
80 MHz to 800 MHz
d = 1,2 ✓P
80 MHz to 2,5 GHz
d = 2,3✓P
0,010,120,120,23
0,10,380,380,73
11,21,22,3
103,83,87,3
100121223
For transmitters rated at a maximum output power not listed above, the recommended separation distance din meters (m) can be estimated using the equation applicable to the frequency of the transmitter where is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer
NOTE 1 At B0 MHz and 800 MH2, the separation distance for the higher frequency range applies
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propegation is affectesorption and reflection from structure objects, and people.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The ZIDA CONTROL UNIT is intended for use in the electromagnetic environment specified below. The customer or user
of the ZIDA CONTROL UNIT should ensure it is operated in this environment.
Immunity TestIEC 60601 Test Level Compliance
Level
Electromagnetic
Environment - Guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
± 6kV contact
± 8kV air
± 6kV contact
± 8kV air
Floors should be wood, concrete or
contact ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30%
Electrical fast transient/burst
IEC 61000-4-4
± 2kV for power supply lines
± 1kV for input/output lines
Not
applicable
Not applicable
Surge
IEC 61000-4-5
± 1kV differential mode
± 2 kV common mode
Not
applicable
Not applicable
Voltage dips, short interruptions
and voltage variations on
power supply input lines IEC
61000-4-11
<5% UT
(>95% dip in UT) for 0,5 cycle
40 % UT
(>95% dip in UT) for 0,5 cycle
70 % UT
(>95% dip in UT) for 25 cycle
<5% UT
(>95% dip in UT) for 5 sec
Not
applicable
Not applicable
Power frequency (50/60 Hz)
magnetic field IEC 61000-4-8
3 A/m Not
applicable
Not applicable
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The ZIDA CONTROL UNIT is intended forse in the electromagnetic enekonment apecfied below. The customer ruse of te ZIDA CONTROL UNIT
should ensure it used in ths environment.
Immunity TestIEC 60601 Test Level Compliance
Level
Electromagnetic
Environment - Guidance
Conductea
RFIEC
61000-4-6
61000-4-8
3 Vrms
150 kHz
to
80 MHz
3 VrmsPortable and mobile RF communications equipment should not be used near any part of the ZIDA CONTROL DEVICE, including cables. Do not exceed the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance
d = 1,2✓P
d = 1,2✓P 80 MHz to 800 MHz
d = 1,3✓P 800 MHz to 2,5 GHz
Radiated
RFIEC
61000-4-3
3 V/m
80 MHz to
2,5 GHz
3 V/m where P is the maximum output power rating of the transmitter n Watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Recommended separation distance
Field strength from fixed RF transmitters, es determined by an electromagnetic site survey.s should be less than the compliance level in each frequency range.b Interference may occur In the vicinity of payment marked with the following symbol
NOTE 1 A 80 MHz and 800 MHz. the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. electromagnetic propagation is affected by absorption and reflection from structures. objects, and people.
NOTE 1 A 80 MHz and 800 MHz. the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. electromagnetic propagation is affected by absorption and reflection from structures. objects, and people.
a Field strength from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio. AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters. on electromagnetic site survey should be considered. If the measured field strength in the location in which the ZIDA CONTROL DEVICE is used. exceeds the applicable RF compliance level above, the ZIDA CONTROL DEVICE should be observed to verify normal operation. If abnormal performance Is detected. additional measures may be weeny. such as re-orienting or relocating the MIA CONTROL DEVICE. b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V/m
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SizeEuroUS WomensUS MensNAHM Small SizeNAHM Large Size
Small34-374-6.53-5.599.5
Medium38-417-9.56-8.51011
Large42-4510-12.59-11.511.512.5
X-Large46-4912-14.51315