Twin-Star International PMFC Instructions For Use Manual

Brand: Twin-Star International

Model: PMFC

Category: Measuring, testing & control

Type: Instructions For Use Manual

This manual is also suitable for

Twin-Star International PMFC

The Twin-Star International PMFC (Pressure Monitoring and Fluid Collection Catheter) is a sterile, disposable device intended for the immediate or continuous measurement of intracompartmental pressures and/or the withdrawal of fluid for subsequent analysis. The measured compartmental pressures can be used as an aid in the diagnosis of compartment syndrome.

The PMFC Catheter consists of a catheter body, a porous membrane, a pressure sensor, a vacuum connector and pressure sensor connectors, a catheter connection manifold, and a fluid sample chamber with collection port. The only section of the catheter that is inserted into the patient is the distal 10 cm, which contains the pressure sensor, porous membrane, and catheter body.

Twin-Star International PMFC

13-10006, Rev C Released 3/29/13 Page 1 of 36

Instructions for Use

ECS Monitoring System – PACS Study

Pressure Monitoring Module

Pressure Measurement Fluid Collection (PMFC) Catheter

Pressure Monitor Pressure Measurement Fluid

Collection (PMFC) Catheter

WARNING:

The personal safety of the patient may be involved. Disregarding

this information could result in injury to the patient.

CAUTION:

These instructions point out special service procedures or

precautions that must be followed to avoid damaging the device.

CAUTION:

Investigational device. Limited by Federal (or United States) Law to

Investigational Use

CAUTION - Investigational Device. Limited by Federal (or United States) Law to Investigational Use

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Classification

Type of protection against electric shock: Class 1.

Degree of protection against electric shock: Type BF applied part.

Equipment not suitable for use in the presence of flammable mixtures.

Mode of operation: Continuous:

Electromagnetic Interface

This equipment has been tested and found to comply with the limits for a Group 1

Class B device, pursuant to IEC/EN 60601-1-2. These limits are designed to

provide reasonable protection against harmful interference. This equipment, if

not installed and used in accordance with the instructions, may cause harmful

interference to other equipment. However, there is no guarantee that

interference will not occur in a particular installation. If this equipment does

cause harmful interference to other devices, 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 other equipment.

 Increase the separation between the Twin Star Compartment

Monitoring System and the other equipment.

 Connect the other equipment into an outlet on a circuit different

from that to which the Twin Star Compartment Monitoring System is

connected.

 Consult Twin Star ECS Inc. for help.

Maintenance

Routine maintenance and operation to be performed by trained qualified

personnel only. Consult Twin Star ECS, Inc. for information on maintenance and

operation.

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Description

The Twin Star ECS Monitoring System consists of four major components, i.e.,

an Introducer, a Pressure Monitoring and Fluid Collection (PMFC) Catheter, and

a Pressure Monitor.

Indications

The Twin Star ECS Monitoring System is intended for the immediate or

continuous measurement of intracompartmental pressures and/or the withdrawal

of fluid for subsequent analysis. The measured compartmental pressures can be

used as an aid in the diagnosis of compartment syndrome.

CAUTION

As an interpretive tool, the Twin Star ECS Monitoring System should be

used along with other clinical indicators to aid the physician in the

diagnosis of compartment syndrome.

Patient Education

It is the responsibility of the physician to educate the patient and/or

representative(s) regarding compartment syndrome and the Twin Star ECS

Monitoring System. This should include a description of the complications

associated with the Twin Star ECS Monitoring System, and an explanation of

alternative treatments.

Warnings and Precautions

DANGER: Explosive Hazard. Do not use in the presence of flammable gas.

DANGER: Electrical Shock Hazard. Do not remove cover. Refer servicing to

qualified personnel.

WARNING: The Twin Star ECS Monitor measures a reference Blood Pressure

for the calculation of perfusion pressure in the muscle compartment. This blood

pressure measurement is for reference only, and should not be used for patient

monitoring.

CAUTION: Catheters are for SINGLE USE ONLY.

CAUTION: Twin Star catheters are supplied sterile. Inspect package and

contents for damage. If inner package seal is broken or the package has been

opened or is damaged, do not use product.

CAUTION: Only use accessories provided or recommended by Twin Star ECS.

Attention: RS-232 (DB9) port is for service use only.

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Attention: Use the Twin Star unit on battery if the grounding integrity is in doubt.

CAUTION: During monitoring period, the monitor must be located in close

proximity to the patient to avoid any accidental “pulling” on catheter. If patient

must be moved during monitoring period, secure monitor to patient bed during

transport. DO NOT leave monitor on IV pole while transporting patient. If unable

to secure the monitor to the patient bed, disconnect the catheter(s) from the

monitor while moving patient. DO NOT STOP ACQUISITION AT THIS TIME.

Reconnect catheter(s) to monitor after patient has been moved.

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Battery

The Twin Star ECS Monitor should be plugged into a wall socket during normal

use. The battery power is only to be used while transporting the system when

the patient is connected to from one location to another. The ECS Monitor can

be run on batteries for up to 2 hours without recharging. If the battery is

discharged completely or nearly completely, allow the unit to charge for 24 hours

to ensure the battery is fully charged. If the battery is only partially discharged,

the battery may take approximately 1-24 hours to charge depending on how

discharged the battery is at the time the system is plugged back into the wall.

The battery is charging anytime the system is plugged into a wall socket

regardless if the system is on or off.

The battery should be replaced or serviced annually to ensure proper

performance and reliability. This should only be done by a qualified technician

approved by Twin Star ECS Inc.

Warning: Remove the batteries from the equipment if it is not likely to be used

for a long period of time. Removal of the battery should only be done by a

qualified technician.

Battery Pack Specifications:

Type: Li-ion Rechargeable Battery

Voltage: 7.4V

Amp Hour Rating: 9600mAh

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Introducer

The Introducer consists of a “tear-away” plastic Sheath placed over a stainless

steel Trocar as shown in Figure 1. The introducer size is 5 French (.070 inches

in diameter) by 11 cm in length. The sterile disposable Introducer provides an

access to the targeted muscle compartment to facilitate the placement of the

Pressure Monitoring and Fluid Collection (PMFC) Catheters. First, the sharp-

tipped Trocar and Sheath are inserted through the skin and into the targeted

muscle compartment. Once properly positioned, the Trocar is removed leaving

the hollow tear-away Sheath in place. The catheters can then be placed through

the hollow Sheath and into the muscle compartment. Once the catheters are

placed, the Sheath is designed to easily tear-away for removal.

Trocar

Tear-Away Sheath

Trocar Hub

Sheath Hub

Figure 1: Twin Star Introducer

The Introducer’s Trocar and tear-away Sheath design and materials are the

same as those used for standard cardiovascular or percutaneous access

devices. The tear-away Sheath is constructed of thin walled polyethylene tubing.

The Trocar is composed of stainless steel needle with a three-facet sharp tip

point.

Pressure Monitoring and Fluid Collection (PMFC)

Catheter

The PMFC Catheter is designed to monitor muscle compartment pressure as

well as remove interstitial fluid. The indwelling PMFC Catheter is provided as a

sterile disposable. The Catheter consists of a catheter body, a porous

membrane, a pressure sensor, a vacuum connector and pressure sensor

connectors, a catheter connection manifold, and a fluid sample chamber with

collection port as shown in Figure 2. The only section of the catheter that is

inserted into the patient is the distal 10 cm, which contains the pressure sensor,

porous membrane, and catheter body. The maximum diameter if the inserted

section of the catheter is .065 inches. The insertion depth will range from 5-10

centimeters, depending on which muscle compartment is being monitored.

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Figure 2: Pressure Monitoring and Fluid Collection (PMFC) Catheter

The PMFC Catheter (Figure 2) provides the following functions:

 Measure compartment pressure

 Remove interstitial fluid

 Provide fluid analysis sample

 Provide connections for additional fluid collection catheters

The catheter contains a pressure sensor at the distal tip that measures

compartment pressure throughout the treatment period. The sensor is

connected to the Pressure Monitor by fiber optic cable that extends through the

entire length of the catheter. A fiber optic connector is located at the proximal

end of the catheter that connects to the ECS Monitor.

Interstitial fluid is removed through the porous membranes located at the distal

section of the catheter. When vacuum is applied, fluid passes through the walls

of the micro-porous membranes, through the catheter body and into the 1 cc

Fluid Collection Chamber. The Pressure Monitor provides a low vacuum to the

catheter to draw fluid through the porous membranes. Fluid that is contained in

the Fluid Collection Chamber can be aspirated using a standard syringe through

the Fluid Sample Collection Port. The fluid can be transferred to a sterile vial and

saved for analysis.

Vacuum

Connector

Pressure Connector

Maximum

Insertion Length

Pressure

Sensor

Porous

Membrane

Catheter

Body

Fluid Sample

Collection Port

Fluid Collection

Chamber

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The length of catheter from the patient to the monitor is approximately 2 meters

to allow the Pressure Monitor to be placed near the patient’s bed.

Pressure Monitor

NOTE – For the purposes of the PACS study, the ECS monitor has modified

as described below:

The vacuum source has been disabled to prevent fluid

removal. Catheters should still be connected to the monitor

as described in the following instructions.

The display has been modified to prevent users from seeing

real time pressures and the historical chart. Users will be

allowed two pressure readings during the monitoring

session.

The PMFC is designed to be used with the Twin Star ECS Monitor (Figure 3).

The ECS Monitor senses, displays and records compartment pressure as

measured by up to two PMFC catheters. In addition, the ECS Monitor measures

patient blood pressure, which is used for calculating the perfusion pressure of the

muscle compartment (Perfusion Pressure = Diastolic Pressure – Compartment

Pressure). The Twin Star ECS Monitor has been successfully tested to ensure

the delivery of the specified functional performance needed to reliably operate

the Twin Star Catheters. The Twin Star ECS Monitor has been tested and has

met current electrical safety standards established for clinical use.

The Twin Star ECS Monitor consists of a single housing that incorporates a

vacuum source, a muscle compartment pressure monitor, a blood pressure

monitor, and a user interface. The unit will be AC powered with battery back-up,

and sized to be fitted on a bedside pole and/or table top. The monitor measures

12 inches tall by 8 inches wide by 8 inches deep. An illustration of the ECS

Monitor is shown in Figure 3.

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Figure 3: Twin Star ECS Monitor

The vacuum source draws a constant vacuum of -150 mmHg to the interstitial

fluid collection line of the PMFC catheter. The pressure monitor works with

pressure sensors located in the PMFC catheter, to monitor the fluid pressure

within the muscle compartment.

The User Interface consists of a Touch Screen Display input to allow the user to

add a patient ID, start/stop the procedure and to save the data to a data storage

device. The Monitor will display the current compartment pressure and perfusion

pressure for each catheter, along with a historical chart of the pressure from the

start of the procedure.

How the

System

Works

Connect Catheters to Pressure Monitor

Before inserting the PMFC Catheter, connect the catheter to the ECS

Monitor

Insert Catheter into Muscle Compartment

To place the PMFC Catheter, an Introducer, consisting of a Polyethylene

Sheath placed over a stainless steel Trocar, is initially inserted into the

targeted muscle compartment. After the Introducer is positioned, the

Trocar is removed leaving the Sheath in place. The PMFC Catheter is

then inserted through the Sheath’s lumen. The tear-away Sheath is then

LCD Display

with

Touchscreen

Catheter

Pressure

Connection Port

Fluid Overflow

Reservoir

Blood Pressure

Cuff Connection

Catheter

Vacuum

Connection Port

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longitudinally split and separated for removal, allowing the PMFC

Catheter to remain in the muscle compartment. The PMFC Catheter is

designed to be indwelling for up to 24 hours. (refer to Figure 4 for Clinical

set-up).

Figure 4: Clinical Set-Up of the Twin Star ECS Catheter and Monitor

Monitor Compartment Pressure

The PMFC Catheter’s distal tip employs an integrated pressure sensor to

measure intra-muscular pressure. Both real time pressure and a

historical chart are displayed on the equipment module. Up to 2 catheters

can be accommodated by the ECS Monitor.

Integrated

Pressure

Sensor

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Obtaining an Interstitial Fluid Sample

NOTE: For purposes of the PACS study, the ECS monitor has

modified as described below:

1. The vacuum source has been disabled to prevent fluid removal.

Catheters should still be connected to the monitor as described in

the following instructions.

In addition to measuring pressure, the PMFC Catheter has a filtration fiber

located near its distal tip. A vacuum pressure of negative 150 mm Hg is

applied to remove interstitial fluid in the vicinity of the Catheter’s distal tip.

During the removal process, the fluid is collected into a 1cc Fluid

Collection Chamber located proximal to the catheter.

The Figure 5 illustrates the proper equipment set-up configuration for

intracompartment pressure monitoring using the Twin Star ECS Monitoring

System.

2 Catheters

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Figure 5: Proper Equipment Set-up Configuration

The anterior compartment is considered to be the “sentinel compartment” by

most physicians and is typically the primary compartment measured however,

multiple compartments can be measured using the Twin Star ECS Monitoring

System. If multiple compartments are measured in the same patient, each

pressure measurement should be considered individually. Individual pressure

measurements from multiple compartments should not be added together to form

a single measurement number. Importantly, it is imperative to never use

pressure measurements alone to make a compartment syndrome diagnosis.

Only in conjunction with other clinical signs and symptoms should pressure

measurements be used to make a diagnosis.

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Procedure Instructions

LCD Display

with

Touchscreen

Catheter

Pressure

Connection Port

Fluid Overflow

Reservoir

Blood Pressure

Cuff Connection

Catheter

Vacuum

Connection Port

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Equipment Set-Up

Attach

Fluid

Overflow

Container

Open package containing Fluid Overflow Container. Attach vacuum

hose to ECS Monitor and place container in ECS Monitor.

Power Up

Monitor

Plug ECS Monitor into AC outlet and power up ECS Monitor.

NOTE: Make sure monitor location is in close proximity to patient.

Enter

Patient ID

From the touch screen display, select “New Case”, and enter patient ID.

NOTE: The facility name will be displayed (i.e. “PACS-“), therefore it is

only necessary to enter the subject number (001, 002, etc.)

Selecting “Back Space” will move the cursor one space at a time.

Hitting “Clear Value” will clear the entire entry, requiring the user to

enter the complete patient ID.

When finished select “Done”. Place monitor near sterile tray for catheter

connections.

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Operating Instructions

Connect Catheter To Monitor

NOTE: The vacuum source has been disabled to prevent fluid removal.

Catheters should be connected to the monitor as described in the following

instruction.

Connect

Catheter to

Monitor

Remove protective cap from Fiber Optic Pressure Connector and

connect to the ECS Monitor’s Catheter Connection Port.

Connect

Vacuum

Line

(Pressure

Monitoring)

Pressure Monitoring and Fluid Removal (PMFC) Catheter

Connect the vacuum connector on the proximal end of the Catheter

to a 2-way stopcock (not supplied), and attach the stopcock to one of

the luer fittings on the ECS Monitor Fluid Overflow Reservoir. NOTE:

Be sure the stopcock valve is in the “Closed” position.

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Place Catheter Using Introducer

Open Sterile

Package

In sterile environment, open contents of Catheters onto sterile tray.

For each muscle compartment, up to 2 PMFC Catheters can be

used.

Insert

Introducer

into Muscle

Compartment

Prepare the skin surface of the targeted insertion site using standard

aseptic methods.

Remove the Introducer’s protective cover and insert the Introducer

into the targeted site of injury. Avoid excessive bending or

manipulation of Introducer during insertion to minimize distortion of

Sheath when Trocar is removed.

Figure 6: Insert Introducer

Warning: Care should be taken when inserting introducer to

avoid any nerves or large blood vessels in vicinity of treatment

site.

Remove

Trocar

Gently grasp the Trocar Hub and pull back to disengage from the

Sheath Hub and then gently remove the Trocar and dispose of

according to normal Sharps procedure.

Figure 7: Remove Trocar

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Insert Twin

Star Catheter

Remove and dispose of the protective cover from the Catheter.

Carefully insert the Catheter’s tip into the tear-away Sheath’s Hub.

Care should be taken during insertion to ensure that the slit tubing at

the Catheter’s tip is not damaged or distorted. Continue inserting

the Catheter into the Sheath until the clear tubing on the Catheter

touches the Sheath hub. This will place the distal tip of the Catheter

approximately 2 to 3 mm from the distal end of the Sheath.

Figure 8: Insert Catheter into Sheath Hub

Caution: Tubing tip and hollow fiber bundle are fragile. Care

should be taken when inserting Catheter into Sheath. Damage

to tip may lead to false pressure readings.

Remove

Tear-Away

Sheath

With the Catheter in a desired position, tear the Sheath in two by

first splitting the Sheath’s hub. As the Sheath is being removed,

continue to tear apart the Sheath while holding the Catheter in

place. Two people may be necessary to ensure a steady Catheter

position during Sheath removal. Dispose of the separated Sheath.

Caution: Immediately secure the catheters to the patient’s leg

with adhesive tape to prevent catheters from migrating out of

insertion site.

Figure 9: Tear Sheath Away from Catheter

Caution: If Catheter is not located in desired location, remove

Catheter and insert a new Introducer to reposition catheter at

new location.

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Maintain

Indwelling

Catheter

Use standard of care for indwelling catheters at the Catheter

entrance/exit site. Stabilize Catheter shaft with adhesive tape to

prevent excessive bending and kinking of the Catheter. Make sure

collection chamber and collection port are exposed outside of tape.

Position

Catheter

Tubing

After visually confirming the Catheter has been properly placed,

position the extension tubing to avoid kinking. Affix Catheter to the

leg using tape.

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Blood Pressure

Chose BP

Method

To take blood pressure readings using the ECS Monitor, select “Cuff

BP”.

If the patient’s blood pressure is being monitored with another device,

the blood pressure values can be manually entered by selecting

“Manual BP”.

CMS Cuff BP

Place blood pressure cuff around arm of patent and connect to ECS

Monitor.

NOTE: To ensure consistent readings during the treatment period, it

is recommended that the same cuff be used throughout the 24 hour

period.

When completed to initiate a BP reading select “Begin Measure”.

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If the reading is successful, the blood pressure will be displayed.

Select OK to continue.

NOTE: If the value displayed seems incorrect (loose cuff, incorrect

placement, etc.), select “Measure Again” to take a new measurement.

If the monitor fails to obtain a reading, “Measurement Failed” will be

temporarily displayed (see below). Select “Measure Again” to take a

new measurement, or “Stop/PrevScr” to return to the main Blood

Pressure screen to select “Manual BP”.

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Twin-Star International PMFC Instructions For Use Manual

Brand: Twin-Star International

Model: PMFC

Category: Measuring, testing & control

Type: Instructions For Use Manual

This manual is also suitable for

Twin-Star International PMFC

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Twin-Star International PMFC Instructions For Use Manual

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Twin-Star International PMFC Instructions For Use Manual

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