10k Irrigation System Instruction Manual Rev AA Oct 2006

Page

Table of Contents

1.0

2.0

INTRODUCTION 1.1

Intended Use... E-1

1.2

Contraindications... E-1

1.3

General Warnings... E-1

1.4

Extravasation Management... E-2

1.5

Symbol Definitions... E-4

1.6

System Indicators... E-5 1.6.1

Pump Front Panel... E-5

1.6.2

Pump Back Panel... E-6

1.6.3

C7115 Remote Control... E-7

SYSTEM INSTALLATION and OPERATION 2.1

Cart Installation... E-8

2.2

Pole Mount Installation... E-9

2.3

Hand Held Remote Installation and Operation... E-10

2.4

Irrigation Tubing Set Installation and Pump Operation... E-11

2.5

Programming the 10k Console... E-13

E-i

Page

Table of Contents

3.0

MAINTENANCE 3.1

Cleaning and Sterilization... E-15 3.1.1

Pump Cleaning... E-15

3.1.2

Remote Cleaning... E-16

3.1.3

Remote Sterilization... E-16

3.2

Troubleshooting... E-17

3.3

Fuse Replacement... E-18

3.4

Leakage Test... E-18

3.5

Pressure Sense Test... E-19

3.6

Technical Specifications... E-20 3.6.1

Pump Operating Specifications... E-20

3.6.2

System Environmental Requirements... E-21

3.6.3

Power Cord Requirements... E-21

3.7

Ordering Information... E-27

3.8

Bibliography... E-28

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1.0 INTRODUCTION

1.2

t is recommended that personnel study this manual before attempting to operate, clean or sterilize the ConMed Linvatec 10k® Irrigation System. The safe and effective use of this equipment requires the understanding of and compliance with all warnings, cautionary notices, and instructions marked on the product, and included in this manual.

I

The ConMed Linvatec 10k Irrigation Pump uses an assortment of single-use tubing sets to deliver sterile fluid to the operative site during either arthroscopic or laparoscopic surgical procedures.

1.

The ConMed Linvatec 10k Irrigation System is not intended for hysteroscopic procedures.

2.

The ConMed Linvatec 10k Irrigation System is not intended for use in acute arthroscopic procedures or in instances where capsular integrity is suspect.

1.3

There are several individual tubing sets: catalog number 10k100/10k100D, which is a basic tubing set with no suction, used for arthroscopic procedures; catalog number 10k150, which is a tubing set equipped with a suction line, also used for arthroscopic procedures; and tubing sets used for laparoscopic procedures.

This equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment. Read and follow all warning and cautionary notices and instructions marked on the product and included in this manual.

2.

Do not open the pump, as this may void your warranty. There are no user-serviceable parts inside. Removing the cover may introduce an electric shock hazard by exposing you to dangerously high voltages or other risks.

3.

Eye protection is recommended when operating equipment.

4.

Use only associated ConMed Linvatec tubing sets.

5.

Prior to each use, inspect all equipment for proper operation (see “2.4 Irrigation Tubing Set Installation and Pump Operation” on page E-11).

6.

Handle the pump carefully. If the pump is dropped or damaged in any way, return it immediately for service.

Intended Use

he ConMed Linvatec 10k Irrigation System provides controlled fluid distension and irrigation to the operative site during arthroscopic procedures and irrigation during laparoscopic procedures.

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E-1

General Warnings

1.

Suggested supplemental reading referenced in the Bibliography on page E-28 includes selections to help the arthroscopy team ensure safe and efficient use of the 10k Pump.

1.1

Contraindications

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7.

E 8.

9.

Do not excessively bend or kink the power cord. Always inspect for signs of excessive wear or damage. If wear or damage are found, discontinue use and replace immediately.

1.4

Arthroscopically induced compartment syndrome is a potential patient complication and can be caused by several means, whether inflow is by gravity or a mechanized fluid infusion system.

Disposable irrigation tubing sets are one-time use only. Do not clean, disinfect, resterilize or reuse. After use, dispose of properly. All associated tubing sets are latex free.

Extravasation Management

The surgical team should understand how to prevent and treat arthroscopic fluid induced compartment syndrome. LATEX

1.

Closely monitor the patient during and after the operative procedure for signs of complications resulting from excess fluid absorption.

2.

Accurate cannula placement is essential to avoid extravasation of fluids. Placement of the cannula should be verified to ensure the distal end is within the joint capsule.

3.

Excessive intra-articular pressure or improper inflow cannula placement may result in extravasation.

13. Do not allow this device to run unattended. Patient safety requires that the pump be continuously monitored during operation.

4.

14. After each use, thoroughly clean the unit (See “3.1 Cleaning and Sterilization” on page E-15).

Visually inspect, examine and palpate the patient’s joint periodically to check for proper distention.

5.

An established outflow is recommended during arthroscopic surgery.

6.

The volume of distention fluid instilled and drained should be monitored throughout the procedure. The amount of fluid collected from the outflow device, combined with the amount of fluid on the floor, should be approximately equal to the amount of instilled fluid.

10. Use tubing set only for indicated use. Not intended for hysteroscopic procedures. 11. Do not allow the tubing line(s) to become crimped. 12. Do not use the pump in the presence of flammable anesthetics, gases, disinfecting agents, cleaning solutions, or any material susceptible to ignition due to electrical sparking.

15. Equipment grounding is vital to ensure safe operation. Plug the power cord into a properly earthed mains supply outlet whose voltage and frequency characteristics are compatible with those listed on the unit or in this manual. Do not use plug adapters or extension cords; such devices defeat the safety ground and could cause injury.

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7.

Periodically examine the location of the inflow cannula to ensure that the cannula is within the joint capsule. Extravasation may occur as a result of improper cannula placement or excessive intra-articular joint pressure.

8.

Monitor fluid intake carefully in cases of known joint trauma with possible capsular defects to avoid excessive effusion.

9.

Avoid abrupt changes in joint position which may result in high intra-articular pressure spikes.

TREATMENT Swelling of an extremity due to fluid extravasation into soft tissue can occur during any arthroscopic surgical procedure. Arthroscopic fluid induced compartment syndrome is caused by a non-crystalline substance (e.g., normal saline) that does not localize or clot. Once infusion of fluids is stopped, excess fluid is rapidly resorbed and passed as waste, reducing elevated compartment pressures to near normal levels within 30-60 minutes. There may, however, be clinical signs of swelling present for a longer period of time.

10. Synovial injury may warrant lower intraarticular pressure and distention and more frequent visual examination.

What this suggests is that arthroscopically induced compartment syndrome can be initially treated conservatively for the first hour. If conservative treatment fails to lower intra-muscular compartment pressures to below threshold levels, a fasciotomy may be necessary.

11. Extravasation can occur more rapidly when using a mechanized fluid infusion system than when using a gravity system. Carefully palpate and visually inspect the extremity and operative site frequently throughout the procedure for possible signs of extravasation.

Orthopedic literature supports management of extravasation by time, elevation, and serial compression wrapping (see the Bibliography section on page E-28). Fasciotomy is rarely indicated.

12. Extravasation may occur when passing the arthroscope in or out of the operative site if fluid flow is not stopped. Be sure to temporarily stop fluid flow whenever the scope is removed from the operative site.

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1.5

Remote control connection

Symbol Definitions Stand-by (ON/OFF)

Remote Tamponade Assist Button. Gives a short duration of increased set pressure.

Attention, consult accompanying documents.

Remote Flow Button. Toggles the flow rate between preset High and Low settings.

Type BF equipment. Remote Flow Button. Toggles the flow rate between preset High and Low settings.

Single Use Only.

Increase Pressure Button (front panel) Mains Fuse

~

Alternating Current

Decrease Pressure Button (front panel)

No user service recommended. Refer servicing to qualified ConMed Linvatec service personnel.

Run/Stop Button (remote)

Eye Protection Required. Run/Stop Button (front panel) Warning - For continued protection against risk of fire, replace only with the same type and rating fuse. Protective earth ground

Latex Free LATEX

Rx ONLY

Caution: Federal Law restricts this device to sale by or on the order of a physician.

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E ❶ ❻ ❷ ❸

❼

❹ ❺

❽ ❾

1.6

System Indicators

1.6.1

Pump Front Panel

❺ Standby Power Switch - To activate the pump, place this switch in the on position. To set the pump to stand-by mode, place this switch to the off position.

❻ Pressure Increase Button - Press to

❶ Pump Rotor - Contains the pump rollers

increase pressure.

that the tubing set loop mounts over. Rollers rotate to assist fluid flow.

❼ Pressure Decrease Button - Press to

❷ “Run/Stop” LED - Illuminated LED

decrease pressure.

indicates when the pump is in RUN mode. Note: Rotor may stop while pump is in RUN mode if set pressure is achieved.

❽ Hand Held Remote Control Receptacle Accepts the connector of the C7115 Remote Control.

❸ “Run/Stop” Button - Press to start the

❾ Pressure Sensor Window - Contains

pump. Press again to stop the pump.

❹ Illuminated Display - Displays pressure,

pressure sensors that detect the pressure flowing through the attached tubing set.

in mmHg, for arthroscopic procedures, or percentage of fluid flow (%) for laparoscopic procedures. The designated indicator will illuminate. Also displays any user information codes or special instructions.

CAUTION: Keep the pressure sensor window area clean. Do not allow sharp objects to come in contact with this area.

E-5

E ❶

❷ ❸

1.6.2

Pump Back Panel

❶ Pole Mounting Bracket - An integrated clamp used to mount the pump to an infusion pole.

❷ Fuse Module - Houses the fuses (See “3.3 Fuse Replacement” on page E-18 and “3.6 Technical Specifications” on page E-20 for more information).

❸ Mains Receptacle - Accepts the supplied power cable to provide AC power.

E-6

E ❶

❶ ❷

❹

❸

❺

1.6.3

other button returns the pump to the original set point. Note: This button has no functionality when the Laparoscopic Tubing Set is in use.

C7115 Remote Control

The Hand Held Remote Control allows the operator full functionality of the 10k Pump from within the sterile field.

❸ Pressure Decrease Button - Press to decrease set pressure.

❶ Flow Buttons - Press either of these

❹ Pressure Increase Button - Press to

buttons to toggle between the preset High (2000 ml/min.) and Low (1000 ml/min.) flow rates. Note: These buttons have no functionality when the Laparoscopic Tubing Set is in use.

increase set pressure.

❺ “Run/Stop” Button - Press to start the pump roller when the Standby switch is in the on position. Press again to stop the pump roller.

❷ Tamponade Assist Button - When the pump is running, press this button for a 20 mmHg increase in set pressure. After two minutes, set pressure automatically returns to the original set point. Each consecutive press of the button results in another 20 mmHG increase. Pressing any

E-7

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2.0 2.1 1.

(c) Press each mating piece of the DUALLOCK fasteners to the previously mounted strips on the bottom of the pump.

SYSTEM INSTALLATION and OPERATION

Cart Installation To install the pump into a cart, perform the following (the pump mounting kit, Catalog number 10k009, is recommended for mounting the pump to a flat surface): (a) Wipe the contact areas of the cart shelf and the underside of the pump with alcohol wipes. (b) Remove the protective liner from one side of the DUAL-LOCK fastener and adhere to the bottom of the pump, as shown. Apply firm, uniform pressure to ensure contact with the pump surface. Repeat with second fastener.

(d) Remove the protective liner from each piece and position the pump into its desired position on the cart. Apply firm, uniform pressure to the pump to ensure good adhesive contact with the cart surface. NOTE: After installation of the DUALLOCK fasteners and pump, do not remove from cart for 72 hours for maximum bond strength. 2.

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The pump may be removed by lifting from front to back.

3.

2.2

Pole Mount Installation

CAUTIONS: 1.

The base of the infusion pole in use must be at least 21.5 inches (54.5 cm) in diameter.

2.

Do not mount the pump higher than 49 inches (1.25 m) from the floor or pump and pole may tip.

3.

Do not move the infusion pole with saline bag(s) attached. Remove bag(s) prior to transporting.

4.

When moving the pump, grasp the pole, do not pull using the pump.

1.

To install the pump onto the infusion pole, support the pump in one hand and insert the infusion pole into the integrated pole mounting bracket on the back of the pump.

2.

Position the pump at approximately the same height as the inflow portal and securely tighten the clamping knob.

The bag hanger should be no more than 32 inches (81.25 cm) above the pump with the bag height not exceeding 76 inches (1.9 m) from the floor.

NOTE: When removing the pump from the pole, always support the unit by placing your hand underneath the pump prior to loosening the clamping knob.

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2.3

Hand Held Remote Installation and Operation

The Hand Held Remote Control allows the operator full functionality of the 10k Pump from within the sterile field. WARNINGS: 1.

Prior to installing the remote, ensure the contact surfaces of the connector are dry. Moisture in the connector can cause system malfunctions.

2.

Prior to using the remote, ensure it is cool to the touch. A hot remote can cause system malfunctions and lead to patient injury.

Flow Buttons - Press either of these buttons to toggle between the preset High (2000 ml/min. - “HI” will display) and Low (1000 ml/min. - “LO” will display) flow rates. Note: This button has no functionality when the Laparoscopic Tubing Set is in use. Tamponade Assist Button - Press for a 20 mmHg increase in set pressure. After two minutes, set pressure automatically returns to the original set point. Each consecutive press of the button results in another 20 mmHG increase. Pressing any other button returns the pump to the original set point. Note: This button has no functionality when the Laparoscopic Tubing Set is in use. Pressure Decrease Button - Press to decrease set pressure. Pressure Increase Button - Press to increase set pressure.

1.

Use surgical aseptic technique to connect the remote to the pump. (a) Circulator - Hold the sterilization container in the vicinity of the Scrub. (b) Scrub - Remove the remote from the sterilization container and place it in the sterile field.

“Run/Stop” Button - Press to start the pump roller when the Standby switch is in the on position. Press again to deactivate Run-mode. Note: the pump rotor may not begin spinning, if the in-joint pressure is equal to the set pressure. The rotor will remain stationary until the in-joint pressure decreases below the set pressure.

(c) Scrub - Hand the connector body to the Circulator. The remainder of the remote and cord stays in the sterile field. (d) Circulator - Line up the alignment marks on the connector body and remote receptacle on the pump, and insert the connector completely.

E-10

2.4

(a) Circulator - Open the Tubing Set package. Present the package contents to the Scrub.

Irrigation Tubing Set Installation and Pump Operation

(b) Scrub - Remove the Tubing Set from its sterile package and pass the cassette and bag spike line out of the sterile field to the Circulator.

The ConMed Linvatec 10k Irrigation Pump is designed for use with the following sterile, disposable tubing sets. •

Cat. No. 10k100 - Arthroscopy Tubing Set

•

Cat. No. 10k100D - Arthroscopy Tubing Set

•

Cat. No. 10k150 - Arthroscopy Tubing Set equipped with a suction/gravity line

•

Laparoscopic Suction/Irrigation Tubing Set

1.

Plug the power cord into the pump receptacle and a properly earthed mains supply outlet (i.e., receptacle marked “Hospital Grade” or “Hospital Only”).

2.

Press the standby power switch on the front of the pump to the ON position.

3.

The pump will perform a self-diagnostic check. Settings default to last used settings.

4.

With no Tubing Set connected, the display will indicate “CAS”.

5.

Install the appropriate Tubing Set using aseptic technique:

(c) Circulator - Position the tubing loop over the pump rotor with the Linvatec name on the cassette facing upward.

(d) Circulator - Pull the cassette down and stretch the tubing over the pump display. Position the cassette under the pump display and allow the cassette to snap into place.

If an Arthroscopic Tubing Set is being used, the display will indicate the SET pressure (mmHg) once the Tubing Set is connected. If a Laparoscopic Tubing Set is being used, the display will indicate “LAP”, then toggle to the set percentage (%) once the Tubing Set is connected.

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(f) Scrub - Separate the outflow line from the inflow line, as needed, by pulling the two lines apart. Connect the outflow tubing line to the outflow device or shaver.

(e) Circulator - Close the bag clamps.

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(f) Circulator - Hang the fluid bag(s) on the infusion pole, so that the bottom of the bag(s) is at a minimum of 12 inches from the top of the pump, and spike the bag(s). 6.

(g) Circulator - Connect the suction/ gravity tubing line to the appropriate hospital discharge mechanism.

Prime the Tubing Set: Using the 10k100 and 10k100D

Using the Laparoscopic Tubing Set

(a) Scrub - Ensure the inflow clamp is open. Hold the patient end of the tubing over a basin.

(a) Scrub - Direct the distal tip of the cannula towards the basin and depress and hold the blue inflow button.

(b) Circulator - Open the bag clamps.

(b) Circulator - Open the bag clamps.

(c) Circulator - Press the “Run/ Stop” button on the pump or the remote control.

(c) Circulator - Press the “Run/ Stop” button on the pump or the remote control.

(d) Scrub - After all air is purged from the tubing, close the patient inflow clamp.

(d) Scrub - After all air is purged from the tubing, release the blue inflow button.

(e) Scrub - Attach the luer fitting on the Tubing Set to the inflow device.

(e) Circulator - Connect the suction/ gravity tubing line to the appropriate hospital discharge mechanism.

Using the 10k150 (a) Scrub - Ensure the inflow clamp is open. Hold the patient end of the tubing over a basin.

7.

The pump is now ready for use.

8.

To adjust irrigation pressure: (a) Press the appropriate button to increase or decrease the amount of pressure.

(b) Circulator - Open the bag clamps. (c) Circulator - Press the “Run/ Stop” button on the pump or the remote control.

(b) To continuously adjust the irrigation pressure, press and hold the appropriate button. The pressure will increase in increments of 5 for three (3) seconds, then accelerate to increments of 15.

(d) Scrub - After all air is purged from the tubing, close the patient inflow clamp. (e) Scrub - Attach the luer fitting on the Tubing Set to the inflow device.

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(c) To quickly adjust the pressure, press and release the appropriate button. The pressure increases or decreases as fast as the button is pressed and released, in increments of 5. 9.

To begin fluid flow, open the inflow clamp. NOTE: if using the Laparoscopic Tubing Set, press the blue inflow button.

2.5

Programming the 10k Console

The 10k Console is capable of two display modes: “Set point” and “Pressure feedback”. The console is shipped from the factory in the “Set point” mode. 1.

10. To stop fluid flow, press the “Run/ Stop” button again, either on the pump or the remote control, or close the inflow clamp.

If the “Pressure feedback” mode is preferred, first ensure that there is not a tubing set loaded. Ensure the power is off and perform the following steps: (a) Press and hold the Pressure Down, Pressure Up, and Run/ Stop buttons simultaneously while turning the console power on. Release all buttons once the display indicates “d 1”.

11. When the procedure is complete, remove the Tubing Set by pulling down on the cassette and removing the tubing loop from around the pump rotor. Dispose of Tubing Set properly.

(b) Place a finger on the face of the pump to the right of the standby power switch, and to the left of the pressure sensor window. While applying slight pressure, slide your finger toward the pressure sensor window until the display indicates “Pr”.

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(c) Cycle the power off and then back on. the console will now be in “Pressure feedback” mode. The display will now indicate a representation of in-joint pressure once a tubing set has been loaded.

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(b) Place a finger on the face of the pump to the left of the remote control receptacle, and to the right of the pressure sensor window. While applying slight pressure, slide your finger toward the pressure sensor window until the display indicates “Poi”.

(d) To display the pressure setpoint, press the Pressure Up or Down button once. The display will indicate the current set pressure for approximately three (3) seconds and then revert back to a representation of in-joint pressure. This procedure need only be performed once, as the console retains this mode in memory, even if power is turned off or interrupted. 2.

To change the display to the “Set Point” mode, first ensure that there is not a tubing set loaded. Ensure the power is off and perform the following steps: (a) Press and hold the Pressure Down, Pressure Up, and “Run/Stop” buttons simultaneously while turning the console power on. Release all buttons once the display indicates “d 1”.

(c) Cycle the power off and then back on. The console will now be in “Set Point” mode.

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3.0

MAINTENANCE

Regular and proper maintenance of your ConMed Linvatec 10k Irrigation Pump are the best ways to protect your investment. It is essential that you have your equipment serviced, as scheduled, in order to retain its optimum performance and reliability, which will reward you with safer, less problematic product performance over time. Recommended care and handling of the pump includes proper day-to-day operation and cleaning, which are extremely important to ensure safe and efficient operation. Your authorized ConMed Linvatec service department is the most knowledgeable about the pump and will provide competent and efficient service. Service at ConMed Linvatec, at least once every 12 months, is mandatory to keep your product warranties in effect. Any services and/or repairs done by any unauthorized repair facility may result in reduced performance of the instruments or instrument failure.

3.1

Cleaning and Sterilization

3.1.1

Pump Cleaning

CAUTION: Never immerse the pump in any solution. WARNING: The disposable irrigation tubing sets are one-time use only. Do not clean, disinfect, resterilize or reuse. Dispose of properly. 1.

Follow universal precautions for protective apparel when handling and cleaning contaminated instruments.

2.

Disconnect the pump from the electrical power source.

3.

Wipe the pump with a clean, soft cloth dampened with a mild, pH-balanced detergent.

4.

Thoroughly clean the tubing roller area. Ensure rollers are free of all debris.

5.

Wipe equipment again with distilled or sterilized water.

6.

Dry all areas thoroughly.

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E

3.1.2

Remote Cleaning

3.1.3

1.

Follow universal precautions for protective apparel when handling and cleaning contaminated equipment.

2.

Prior to any cleaning, sterilization or disinfection, the door must be opened to a partially opened position.

3.

To clean, immerse remote in warm, soapy water and scrub with a soft brush.

Remote Sterilization

WARNING: The use of disinfecting solutions for an exterior instrument wipe will not sterilize the remote and is not recommended. NOTE: Sterilization validation has been conducted in accordance with the requirements of AAMI TIR12.

Method

Cycle

Minimum Temperature

Minimum Exposure

Steam (wrapped)

Pre-vacuum

270°F (132°C)

4 minutes

Steam (wrapped)

Gravity

270°F (132°C)

8 minutes

Steam (wrapped)

Gravity

250°F (121°C)

30 minutes

All Cycles: 8 Minute Dry Time

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3.2

Troubleshooting

E Table 1: Troubleshooting Guide

Symptom

Possible Cause

Corrective Action

Pump does not power up when the stand-by power switch is turned on.

♦

Power cord is unplugged.

♦

♦ ♦

Suspect power cord. Blown fuse(s).

♦ ♦

No fluid flowing through tubing.

♦ ♦

Fluid bag is empty. Tubing line is severely bent or kinked.

♦ ♦

♦

Clamps not open.

♦

♦ ♦

Fluid bag is empty. Tubing line is severely bent or kinked.

♦ ♦

♦

Clamps not open.

♦

Fluid flow rate is not consistent.

♦

User Information Code consistently displayed.

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Plug power cord into the pump and/ or a properly grounded receptacle. Replace power cord. Check fuses. Replace. Replace fluid bag. Remove all severe bends and/or kinks. If tubing is damaged, replace tubing set. Open clamps. Replace fluid bag. Remove all severe bends and/or kinks. If tubing is damaged, replace tubing set. Open clamps. Ensure no buttons are being depressed on the pump or remote. Verify the cassette is seated properly or completely removed. Cycle power off, wait at least five seconds, then cycle back on to clear the code. If code is still present, or returns, return pump to ConMed Linvatec for service.