Device Description; Intended Use - Halyard INDISCAL Instrucciones De Uso

HALYARD*
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INDISCAL* Analog Manometer
Federal Law (USA) restricts this device to sale by or on the order of a physician.

Device Description

The HALYARD* INDISCAL* Analog Manometer is a one-piece, plastic, disposable syringe with a
lock lever design that controls the piston, a manometer and a connecting tube with a male rotating
adapter. An optional 3-way stopcock may also be enclosed for use during the preparation of the device.
The manometer measures pressures ranging from vacuum to gauge capacity. The accuracy of the
manometer has been determined to be within 5 psi over the range.
Indications For Use
The HALYARD* INDISCAL* Analog Manometer is a sterile, single-use, disposable, piston syringe
equipped with an analog manometer. It allows a physician to inject fluid into a patient and measure
the pressure of the fluid using the manometer.

Intended Use

The HALYARD* INDISCAL* Analog Manometer is intended to be used for dispensing fluids into the
intervertebral disc and monitoring the pressure of those fluids. The fluid is dispensed by a physician
through mechanical actuation of the device and the pressure of the fluid is displayed on the pressure
gauge. Pressure readings from the manometer and patient feedback are used to establish a diagnosis
for discogenic pain.
Warnings and Precautions
The INDISCAL* Analog Manometer is a single-use device. Do not reuse, reprocess, or
resterilize this medical device. Reuse, reprocessing, or resterilization may 1) adversely
affect the known biocompatibility of the device, 2) compromise the structural integrity
of the device, 3) lead to the device not performing as intended, or 4) create a risk of
contamination and cause the transmission of infectious diseases resulting in a patient
injury, illness, or death.
Do not modify the INDISCAL* Analog Manometer. Modifications can result in device
malfunction, failure or patient injury.
Do not immerse in liquids.
Use only liquid media. Do not inflate with air.
Do not exceed 100 psi.
Do not attempt to use the INDISCAL* Analog Manometer before reading these Instructions
for Use.
Always follow the manufacturer's directions accompanying the other instruments needed
for the relevant procedure in which fluids will be dispensed into the body and the pressure
of those fluids monitored.
Adverse Events
Potential complications associated with the use of this device include but are not limited to: infection,
nerve damage, increased pain, visceral injury, failure of technique, paralysis, and death.
Inspection Prior To Use
Prior to use, inspect the packaging and device to ensure there is no damage. Discard equipment if
damage is found.
Prior to use, ensure the connector tubing is completely free of air.
Instructions For Use
Preparation
Make all aspiration and injection maneuvers with the lock lever pushed left, i.e., unlocked.
Unlock the piston by pushing the lock lever left. In this position, you can freely pull the piston back
for aspiration, or push it forward for injection. To lock the piston in position, slide the lever right to
the straight up position.
1. Prepare a solution in a small sterile bowl.
2. Attach an open stopcock to the end of the tubing and immerse downward into the solution.
3. Push the release lever left and aspirate enough solution to fill the syringe one-half to two-thirds
full, and then close the stopcock.
4. While holding the device with the distal end facing down, pull back plunger knob to create a
vacuum and purge air from the gauge, syringe and connecting tube. Tap the syringe lightly, if
necessary, to loosen all the air bubbles, then position device upright, open stopcock and push
plunger forward to expel air and fill the connecting tube completely with fluid.
5. Inspect the syringe, tubing and stopcock to ensure that the device has been completely purged
of air bubbles.
6. Adjust the syringe volume to the desired amount. If more solution is needed, submerge the
tubing tip into the basin of solution and aspirate. Close stopcock.
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