Resources
Zida Control Sock Trifold Brochure
Zida Control Sock Prescription Form
Randomized Controlled Trial
User Instructions
Use once weekly for a 30-minute treatment session. More frequent or longer treatments have not been clinically evaluated. Overuse may result in medical complications. Refer to the full User Guide for complete instructions.
Indications
ZIDA is a neuromodulation system intended to treat patients with overactive bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.
Description
ZIDA is a home-care neuromodulation system that delivers non-invasive access to the sacral nerve plexus through transcutaneous electrical stimulation of the posterior tibial nerve (Transcutaneous Tibial Nerve Stimulation, TTNS).
The system consists of the ZIDA CONTROL UNIT and the ZIDA Embedded Garment (Sock/Tights). The CONTROL UNIT is a battery-powered, external pulse generator for multiple use and should only be used with a ZIDA Embedded Garment. Embedded silver knit electrodes in the garment transfer electrical pulses from the CONTROL UNIT to the tibial nerve.
Zida Control Unit - Design Features
- Lightweight, ergonomic, wearable design.
- Intuitive power and pulse-intensity controls with raised, embossed buttons.
- Indicator lights provide operational status.
- One-way fit connection site for the CONTROL UNIT and Embedded Garment.
Electrical Current Settings
- Pulse frequency: 20 Hz (fixed)
- Pulse width: 200 microseconds
- Waveform: square
- Resistance: 500–4,000 Ohms
- Ten incremental presses on the adjustment buttons change stimulation level by 1 mA (RMS).
- Holding the adjustment buttons changes stimulation level continuously at 1 mA/sec (RMS).
Contraindications
Use of the device is contraindicated in 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 affect the percutaneous tibial nerve or pelvic floor function
- Patients who are pregnant or planning to become pregnant while using this product
The CONTROL UNIT is not intended for use on the heart or chest. Concurrent use of the device with medical monitoring equipment is not recommended. This device is not suitable for use around flammable compressed mixtures, including but not limited to oxygen or nitrous oxide.
Warnings
- The Instructions for Use are not a comprehensive reference to therapeutic techniques. Users should be familiar with proper use of the CONTROL UNIT and the Embedded Garment.
- Do not use the ZIDA device in or around water.
- Do not use the ZIDA device on skin that is inflamed, infected, or otherwise compromised.
- Do not open the battery cover while the CONTROL UNIT is powered on or connected to the patient.
- Each treatment should last 30 minutes or less.
- Remain comfortably seated or lying down during treatment. Standing or walking during treatment has not been assessed.
- Do not use the CONTROL UNIT or Embedded Garment if damaged.
- Remove the battery if the ZIDA system will not be used for an extended period.
- Simultaneous connection to high-frequency surgical equipment may result in burns at electrode sites and possible device damage.
- Operation near short-wave or microwave therapy equipment (≈1 meter) may produce output instability.
- Electrode application near the thorax may increase the risk of cardiac fibrillation.
- Do not apply stimulation across or through the head, on the eyes, over the mouth, on the front of the neck (especially the carotid sinus), chest, upper back, or traversing the heart.
- The CONTROL UNIT has electric shock protection: Type “Internally Powered Equipment.”
- The CONTROL UNIT enclosure is Type IPX0 and does not protect against the ingress of water.
- Do not attempt to modify the device, as this could result in injury.
- Use the device once per week for 30 minutes. Using it more often has not been studied and may not be safe.
Precautions
- Before use, read and understand all instructions in the ZIDA NEUROMODULATION UNIT Instructions for Use.
- Use caution in patients with suspected or diagnosed heart problems, especially relating to pacing or electrical function.
- Potential risks include discomfort or pain at or near the stimulation site (lower leg/foot), redness or inflammation at or near the site, and numbness of toes.
- The device should be used away from strong electrical equipment that could cause interference.
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.
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
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 ZIDA.
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 the date of purchase if Zida determines its material or workmanship is defective. This is Zida’s only warranty. Zida 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 the Battery
- Slide open the battery cover located on the front face of the ZIDA CONTROL UNIT.
- Push down on the cover while sliding the cover down.
- Remove the used battery.
- Insert a new AAA battery.
- Slide cover back into place.
Battery life depends on the intensity of treatment. A new AAA battery can provide 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.
| Mode | Behavior |
|---|---|
| Power On | 3 rapid blinks (1 sec ON / 1 sec OFF). LED color changes according to battery level. Color: Low = Red, Half = Blue, Full = Green |
| Test mode | Blue LED blinks constantly for the duration of test mode. Blink rate increases gradually to create a countdown effect. |
| Therapy | Green LED blinks throughout therapy. Rate: 0.5 sec ON / 3 sec OFF. |
| Power Off | Orange LED: 3 rapid blinks (1 sec ON / 1 sec OFF). |
| Low battery Error | Red LED blinks until power is OFF (1 sec ON / 1 sec OFF). |
| Increase Intensity | Single button press: Green LED blinks once. Constant button press: Green LED is on continuously. |
| Decrease Intensity | Yellow LED indicates decreasing intensity. |
| Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and ZIDA CONTROL UNIT |
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| 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 |
|
| 0,01 | 0,12 | 0,12 | 0,23 |
| 0,1 | 0,38 | 0,38 | 0,73 |
| 1 | 1,2 | 1,2 | 2,3 |
| 10 | 3,8 | 3,8 | 7,3 |
| 100 | 12 | 12 | 23 |
|
For transmitters rated at a maximum output power not listed above, the recommended
separation distance, in meters (m), can be estimated using the equation applicable to the frequency of the transmitter, where the maximum output power rating of the transmitter is in Watts (W), according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the separation distance for 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. |
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| 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. |
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| Immunity Test | IEC 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 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 for use in the electromagnetic environment specified below. The customer or user of the ZIDA CONTROL UNIT should ensure that it is used in this environment. | |||||
| Immunity Test | IEC 60601 Test Level | Compliance Level |
Electromagnetic Environment - Guidance |
||
|---|---|---|---|---|---|
| Conductea RFIEC 61000-4-6 61000-4-8 |
3 Vrms 150 kHz to 80 MHz |
3 Vrms | Portable 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 |
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| 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 in 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, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol. |
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| 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. |
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| NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Signals can be affected by walls, objects, and people nearby. NOTE 3: Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones, land mobile radios, amateur radios, AM and FM radio broadcast, and TV broadcast, cannot be predicted with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength where the ZIDA CONTROL UNIT is used exceeds the applicable RF compliance level, verify normal operation. If abnormal performance is detected, reorient or relocate the device. NOTE 4: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. |
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