TRUCLEAR System Setup Quick Guide Rev A Dec 2012

Instrument Tray Layout 1

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TRUCLEAR™ Handpiece a. Hysteroscope 5.0 b. Calibration Insert 2.9 c. S  heath 5.6

a. H  ysteroscope 8.0 b. Calibration Insert 4.0 c. Sheath 9.0 d. Obturator

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Accessories: Light cord adapters and seal cap

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Instrument Set-up: Scrub 1

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1. Attach seal to working channel.

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3. Connect inflow tube to hysteroscope.

2 2a. F or 5.0 scope: snap sheath on to scope 2b. For 8.0 scope: insert obturator into sheath by aligning notches with the scope

4. Connect outflow tubings: • Blue tubing to patient drape • Yellow luer to sheath outflow • White tubing to handpiece barb

2c. For both scopes: attach light cord and camera

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Canister Set-up: Circulator 5

1. Insert specimen collection trap. 2. Connect color coded tubing to corresponding canister (blue, yellow, white).

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3. Connect bottom barb to vacuum source. 4. Set side barb suction lever to 45°. 5. Test suction regulator to achieve

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• 1 50 mmHg – Rotary Morcellator 4.0 •2  50 mmHg – ULTRA Reciprocating Morcellator 4.0

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•3  00 mmHg – Incisor Plus Blade 2.9

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Fluid Management Set-up and Calibration 1. T urn on pump console. Listen for 2 sets of 3 beeps, one from fluid management system and one from scale.

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2. Remove blue protective cover from inflow tubing. Insert cartridge and snap into place. Hang fluid and spike fluid bags; open clamps. 3. P  lace calibration insert or morcellator into working channel and open inflow stopcock. To begin priming, hold the scope even with pump or working height of patient’s uterus. 4. Push start/stop button once and listen for a beep. Wait for 30 seconds. Second beep indicates that calibration is complete. Check that flashing green LED has become steady. 5. After second beep, close inflow stopcock. 6. Once fluid is suctioned out of the drape, press the reset button to ZERO out the deficit.

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Window Lock The window lock function causes the morcellator to allow suction only when the morcellator is actively cutting, which results in less fluid use 1. T urn hand piece suction lever to off position. Press and hold window lock button on foot switch.

1 press here

2. Inner sheath will turn. Align black line on inner sheath with black line on outer sheath. 3. Turn hand piece suction lever to ON position.

2 TRUCLEAR™ INCISOR Plus Blade 2.9 Hysteroscopic Rotary Morcellator 4.0

Note: The TRUCLEAR™ ULTRA Reciprocating Morcellator 4.0 is pre-window locked.

TRUCLEAR™ ULTRA Reciprocating Morcellator 4.0

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TRUCLEAR™ System Components Rotary Morcellator (Soft Tissue) OSCILLATE ON Default Speed: <800> rpm (up to 1500 rpm)

TRUCLEAR™ INCISOR Plus Blade 2.9 Hysteroscopic Rotary Morcellator 4.0

Recommended Speed: <800> rpm

ULTRA Reciprocating Morcellator (Dense Tissue) OSCILLATE OFF Default Speed: 1100 rpm (up to 2500 rpm)

TRUCLEAR™ ULTRA Reciprocating Morcellator 4.0

Recommended Speed: 2500 rpm

Foot Switch 1. Oscillate Lock To change mode

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• Press OSCILLATE LOCK button once and • Press either pedal to verify setting 2. Window Lock Proprietary and Confidential. Do not disclose, copy, distribute or otherwise reproduce without the written consent of an officer of Smith & Nephew. ©2012 Smith & Nephew.

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Adding/Removing Fluid: Bag Mode 1. T o add or remove fluid bags, pause the scale function by pressing firmly on the gray bar. 2. System will automatically restart when it no longer senses vibration. 3. L eave empty bags hanging on system (weight is equal to 80 ml of fluid). 4. System will beep if the pause mode lasts longer than 30 seconds.

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Error Codes Issue

Solution

You’ve kept the machine in bag mode for longer than 30 seconds!

step away Scale will take a measurement as soon as you step away.

You’ve reached a 1500 cc deficit. Pump will alarm every 100 cc after that!

Be Aware of facility protocol and AAGL loss limit standards (2500 cc for isotonic solutions).

There is a 300 cc deficit or Be Aware more in less than a minute! Where is the fluid? Floor? Leak? Bag? Patient? Surgeon’s lap and socks? The scale wants more fluid back. Patient’s IUP has reached 200 mm Hg or higher for 5 seconds!

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step away The pump will auto reduce pressure.

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Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA

www.sntruclear.com T +1 978 749 1000 US Customer Service: +1 800 343 5717 International Customer Service: +1 978 749 1140

™Trademark of Smith & Nephew. Certain marks Registered US Patent and Trademark Office. ©2012 Smith & Nephew. All rights reserved. Printed in USA. 12/12 10600779 Rev. A