TRABECTOME Model 550014-01 I-A Console Operations Manual Rev B

NeoMedix – TRABECTOME® I/A Console Operations Manual (230V)

Table of Contents 1. SAFETY AND PRODUCT INDICATION STATEMENTS 1.1. General Safety ... 4 1.2. Indications For Use... 4 1.3. Cautions and Warnings... 5

2. INTRODUCING THE TRABECTOME® I/A CONSOLE 2.1. Console Overview ... 7 2.2. Trabectome® I/A Console Accessories ... 8

3. SETTING UP THE TRABECTOME® I/A CONSOLE 3.1. Unpacking Instructions ... 9 3.2. Mounting Instructions ... 9 3.3. Accessory Connections ... 10

4. OPERATING THE TRABECTOME® I/A CONSOLE 4.1. Symbols and Indicators ... 11 4.2. Front Panel Controls and Indicators ... 12 4.3. Rear Panel Controls and Connections ... 13 4.4. Operation With Remote Footswitch ... 14 4.5. Operational Guidelines – Connections, Loading/Unloading, Settings ... 15

5. MAINTAINENCE AND TROUBLESHOOTING 5.1. Storage Conditions ... 18 5.2. Cleaning Instructions ... 18 5.3. Troubleshooting Procedures ... 19

6. WARRANTY AND REPAIR POLICIES 6.1. Warranty Statement ... 29 6.2. Repair Procedures ... 29

7. TECHNICAL SPECIFICATIONS 7.1 Mechanical and Environmental Specifications ... 31 7.2 Electrical and Safety Specifications ... 31 7.3 Functional Specifications and Flow Graphs... 32 APPENDIX A: ELECTROMAGNETIC IMMUNITY TABLE ... 34 APPENDIX B: ELECTROMAGNETIC EMISSIONS TABLE ... 35 3

NeoMedix – TRABECTOME® I/A Console Operations Manual (230V)

1. SAFETY AND PRODUCT INDICATION STATEMENTS 1.1 General Safety Safe and effective electronic equipment usage is dependent not only on equipment design, but also to a large extent on factors under the control of the operator. It is important that the instructions supplied with this equipment and any additional instructional documentation provided with the attached accessories or procedural disposables be read, understood, and followed in order to assure safety and effectiveness. 1.2 Indications For Use The Trabectome® I/A Console is an aspiration pump intended for use in general surgery applications where aspiration of irrigation and waste fluid from a surgical site is desired. The device is not indicated for liposuction use.

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NeoMedix – TRABECTOME® I/A Console Operations Manual (230V) 1.3 Cautions And Warnings CAUTION: Federal (U.S.A.) law restricts the sale of this device to or on the order of a physician or health care professional. CAUTION: This device is supplied non-sterile. WARNING: The risk of igniting flammable gases or other materials is inherent with the use of powered electronic devices. Precautions must be taken to avoid device or accessory contact with flammable materials and substances. CAUTION: Use of electronic devices can cause severe electromagnetic interference in other devices, particularly cardiac pacemakers; precautions should be taken to ensure patient safety is maintained in the event of such interference. WARNING: Do not remove the enclosure cover, as there is high-risk of electric shock. There are no user serviceable parts inside. CAUTION: Do not immerse device or related accessory options. These items are not sealed against liquid ingress and damage may occur. CAUTION: Do not use device or accessories that have been dropped or visibly damaged. Contact the manufacturer, local distributor, or manufacturer-trained service personnel to verify proper performance prior to continued usage. CAUTION: Use only NeoMedix-supplied replacement parts to service device. Improper device performance may otherwise result creating dangerous conditions and may void applicable warranty. CAUTION: Use only NeoMedix-supplied accessories (including disposable procedure sets). Use of non-proscribed accessories could result in harm to the operator, patient, or both. WARNING: Device should only be connected to properly regulated DC voltage power source as supplied by NeoMedix. Device malfunction, shock hazard, and/or fire hazard may otherwise occur. CAUTION: Device and related durable device accessories are not compatible with EtO, Gas, Steam, Radiation or other sterilization means. Do not place any of these items in the sterile field. WARNING: Device is not indicated for liposuction use. 5

NeoMedix – TRABECTOME® I/A Console Operations Manual (230V) CAUTION: Periodically check fluid level in collection container and empty or replace as required to prevent overflow. CAUTION: This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. 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 receiving device. - Increase the separation between the equipment. - Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected. - Consult the manufacturer or field service technician for help. WARNING: To avoid risk of electrical shock, this equipment must be connected only to a supply mains with protective earth. WARNING: Do not position equipment in such a way as to make it difficult to operate the disconnect device when an appliance coupler or separable plug is used as an isolation means. CAUTION: Contact local authorities for proper disposal of equipment to eliminate or reduce any waste products, residues, etc. WARNING: No modification of this equipment is allowed.

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NeoMedix – TRABECTOME® I/A Console Operations Manual (230V)

2. INTRODUCING THE TRABECTOME® I/A CONSOLE 2.1 Console Overview The Trabectome® I/A Console integrates an adjustable speed peristaltic pump with a tubing pinch valve to provide fluid management of up to two (2) fluid tube set lines. This configuration is ideal for procedures requiring both a pinch-valve regulated irrigation capability (e.g., from an elevated drip chamber spiked irrigation bottle or bag) and a separate, controlled-rate aspiration or suction capability using a volumetric flow-based peristaltic pump. Both the peristaltic pump and pinch valve have been configured to allow easy and reliable loading/unloading of tube set lines. The Trabectome® I/A Console Model 550014-01 has a flow range of 1-40 ml/min depending on the size of peristaltic pump tubing utilized. Please refer to Section 7.3 of this manual for additional flow performance and compatible tube set sizing information. The Trabectome® I/A Console is housed in a rugged, compact enclosure with a single, convenient front panel mounted rotary switch knob to select the device’s operational mode. Operational modes include an automatic “PRIME” mode, wherein the peristaltic pump operates continuously at high speed and the pinch valve is open to allow fluid flow; and a “FIXED FLOW” mode wherein the flow rate of the peristaltic pump is selected from a range of four (4) increasing flow rate presets. The actual flow rates in the four (4) “FIXED FLOW” mode preset positions depend upon the tube set size loaded through the peristaltic pump. Various standard tubing size options have been characterized in graph form in Section 7.3 of this manual. The Trabectome® I/A Console is powered by an external DC power supply that accepts a full range of international AC operating power inputs from 100VAC to 240VAC at 50-60Hz. The console can be secured to the Trabectome® roller stand using the console’s rear panel mounting hardware. This mounting configuration allows remote activation of the Trabectome® I/A Console using the Remote Footswitch and remote pass-through activation of a compatible external companion device using rear console panel cable connections as described in Section 4.3. Accessory equipment connected to the Trabectome® I/A Console shall comply with the system standard IEC 60601-1. Everybody who connects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of IEC 606011. If in doubt, consult the technical services department or your local representative.

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NeoMedix – TRABECTOME® I/A Console Operations Manual (230V)

2.2 TRABECTOME® I/A Console Accessories TRABECTOME® I/A CONSOLE ACCESSORIES Operations Manual – Trabectome® I/A Console (230V) Hospital Grade 2.5m AC Line Cord (VIIG “Schuko” Continental Europe male plug to EN60320 C13 connector) Trabectome® I/A Console Remote Footswitch Trabectome® Roller Stand (includes articulating tray, accessory basket, adjustable IV pole with 4-position bottle/bag holder, and mounting bracket for Trabectome® I/A Console and Trabectome® High Frequency Generator) Trabectome® I/A Console External DC Power Supply (100-240 VAC input, 12 VDC output) Model 550014-01 Trabectome® I/A Console (Low Flow) 0.5 mm – 1.6 mm ID Peristaltic Pump Tubing (1-40 ml/min) Trabectome® Activation Cables (contact NeoMedix for questions regarding device compatibility) Please contact NeoMedix Corporation (1-714-258-8355) or your local authorized distributor for information about compatible accessories.

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NeoMedix – TRABECTOME® I/A Console Operations Manual (230V)

3. SETTING UP THE TRABECTOME® I/A CONSOLE 3.1 Unpacking Instructions Upon receipt of your Trabectome® I/A Console System, carefully unpack the shipping container contents and remove all items from their protective plastic bag covers. Verify shipping contents against the contents list below to verify that all items are present and undamaged. If damage has occurred during shipment or an item is missing, retain the shipping container and contact NeoMedix within ten (10) days of receipt. Trabectome® I/A Console Shipping Contents: • One (1) I/A Console • One (1) Footswitch • One (1) Power Cord • One (1) Power Supply • One (1) Activation Cable • One (1) Operations Manual 3.2 Mounting Instructions The Trabectome® I/A Console may be mounted to the mounting bracket provided with the Trabectome® Roller Stand (see Trabectome® I/A Console Accessories List in Section 2.2). The mounting of the Trabectome® I/A Console to the bracket on the Trabectome® Roller Stand is via a 4-fastener arrangement in the console’s rear panel (see figure in Section 4.3). The appropriate #8-32 mounting screws required for mounting the Trabectome® I/A Console onto the bracket of the Trabectome® Roller Stand are provided with the console (pre-inserted into the 4-fastener arrangement on the console’s rear panel). Please read the assembly instructions provided with the Trabectome® Roller Stand carefully prior to starting the mounting procedure.

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NeoMedix – TRABECTOME® I/A Console Operations Manual (230V) 3.3 Accessory Connections The Trabectome® I/A Console requires connection to an AC power source by means of an inline external DC power supply (standard accessory) and an AC line cord (standard accessory).  Fully seat the female socket end of the AC line cord into the 3-prong receptacle in the body of the external power supply housing.  Aligning the red indicator dots on the plug and receptacle, fully insert (a tactile detent click should be both felt and heard) the latching female connector at the plug end of the DC power supply output cable into the DC Power Input Receptacle (see Section 4.3) in the lower left corner of the Trabectome® I/A Console’s rear panel.  Insert the male plug end of the AC line cord into a hospital grade AC power receptacle. In order to remotely actuate the Trabectome® I/A Console, a Remote Footswitch (standard accessory, see Section 4.4) must be attached.  Aligning the red indicator dots on the plug and receptacle, fully insert (a tactile detent click should be both felt and heard) the latching male connector at the plug end of the Remote Footswitch’s cable into the Remote Footswitch Connector (see Section 4.3) in the lower right corner of the Trabectome® I/A Console’s rear panel. Note that the plug and receptacle for connection of the Remote Footswitch are color coded in blue.  Position the Remote Footswitch on a stable, flat surface (e.g., the floor) with no twists or kinks in the cable routing prior to use. In order to remotely actuate a compatible Trabectome® companion device, an accessory Activation Cable must be attached.  Aligning the red indicator dots on the plug and receptacle, connect the latching male connector at the plug end of the accessory Activation Cable by fully inserting (a tactile detent click should be felt and heard) into the Activation Output Connector (see Section 4.3) in the lower left corner of the Trabectome® I/A Console’s rear panel. Note that the plug and receptacle for connection of an accessory Activation Cable are color coded in yellow.  Connect the opposite end of the accessory Activation Cable into the corresponding input jack of the Trabectome® companion device.

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NeoMedix – TRABECTOME® I/A Console Operations Manual (230V)

4. OPERATING THE TRABECTOME® I/A CONSOLE 4.1 Symbols and Indicators SYMBOL

DESCRIPTOR ON / STANDBY

PRIME

FLOW PRESET ADJUSTMENT INCREASING

LOUD AUDIBLE

NORMAL AUDIBLE

MUTE AUDIBLE

FOOTSWITCH

NO SERVICEABLE PARTS

REFER TO MANUAL DC-VOLTAGE TYPE BF EQUIPMENT

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NeoMedix – TRABECTOME® I/A Console Operations Manual (230V)

4.2 Front Panel Controls and Indicators

Power LED: Flow Control Knob:

Lights green when console is connected to DC power Selects between 6-positions of Flow Modes

Peristaltic Pump:

Multi-speed, motor-driven component to generate fluid flow through an inserted tube set

Pinch Valve:

2-position valve to allow or block flow through an inserted tube set

Pinch Valve LED:

Lights blue when pinch valve is open and console is powered 12

NeoMedix – TRABECTOME® I/A Console Operations Manual (230V)

4.3 Rear Panel Controls and Connections

Main Product Label:

Contains Model #, S/N, and product information

DC Power Input Receptacle:

Connects to external DC power supply

Activation Output Connector:

Connects to activate compatible companion devices

Remote Footswitch Connector: Connects to remote footswitch Audio Volume Switch:

Selects Mute, Normal, or Loud Audio Volume

Mounting Screws:

For attaching console to mounting bracket of Trabectome® Roller Stand or other mounting brackets 13

NeoMedix – TRABECTOME® I/A Console Operations Manual (230V) 4.4 Operation With Remote Footswitch In order to remotely actuate the Trabectome® I/A Console, a Remote Footswitch (standard accessory) must be properly attached [refer to Section 3.3].

When properly connected, the Remote Footswitch controls the functions of the Trabectome® I/A Console when the Flow Control Knob is in any of the four (4) fixed flow settings. Note that the Remote Footswitch, even when properly connected, does not control any of the functions of the Trabectome® I/A Console when the Flow Control Knob is in either the “STANDBY” or “PRIME” settings. When the Actuation Pedal of the Remote Footswitch is not being depressed, depressing and releasing the Pinch Valve Toggle Switch of the Remote Footswitch toggles the pinch valve of the Trabectome® I/A Console between the open and closed states. The Pinch Valve Toggle Switch may be used, for example, to control availability of irrigation to the surgical field when the Actuation Pedal is not being depressed. Depressing the Actuation Pedal from the un-depressed position to the fully depressed position causes the Actuation Pedal to move through a progressive series of actuation zones, each of which produces particular functional actions of the Trabectome® I/A Console:

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NeoMedix – TRABECTOME® I/A Console Operations Manual (230V)

ACTUATION PEDAL POSITION Not Depressed Actuation Zone 1 Actuation Zone 2 Actuation Zone 3

TRABECTOME® I/A CONSOLE Activation Output Pinch Valve Peristaltic Pump Triggered? Open/Closed (*) Off No Open Off No Open On No Open On Yes

(*) Controlled by Pinch Valve Toggle Switch. When the Remote Footswitch Actuation Pedal is not depressed, the Pinch Valve may be toggled between the open and closed states by the Pinch Valve Toggle Switch. Depressing the Actuation Pedal initiates travel through Zone 1 and the Pinch Valve of the Trabectome® I/A Console always goes to the open state. Further depressing of the Actuation Pedal causes travel through Zone 2 and the Peristaltic Pump of the Trabectome® I/A Console begins rotating, pumping at the flow rate corresponding to the setting of the Flow Control Knob of the Trabectome® I/A Console. Finally, further depressing the Actuation Pedal causes travel through Zone 3, adding activation of a Trabectome® companion device via an accessory Activation Cable). 4.5 Operational Guidelines – Connections, Loading/Unloading, Settings CAUTION: Verify proper functional operation of the Trabectome® I/A Console and attached accessories prior to making patient fluid line connections. Prior to Setup:  Ensure the Trabectome® I/A Console is disconnected from live power source by verifying that the front panel Power LED is not lit and that one of the power source connections is detached.  Place the front panel Flow Control Knob in the “STANDBY” setting.  Place console in a secure location (e.g., preferably mounted to the Trabectome® Roller Stand, wall, or other suitable equipment mount).  Verify equipment has been cleaned/disinfected (refer to Section 5.2).

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NeoMedix – TRABECTOME® I/A Console Operations Manual (230V) Connect Trabectome® I/A Console Accessories:  Attach all durable equipment accessories (e.g., Remote Footswitch, accessory Activation Cable, and/or other accessories) to the console as described in Section 3.3 and route all cables to avoid kinking or entanglement. Load Pinch Valve Tubing Set (if applicable):  Refer to Instructions For Use provided with any disposable procedure set and use as primary guideline for setup and use.  Load the compliant pinch valve tubing segment of the appropriate disposable fluid line set (e.g., from an irrigation bottle/bag procedure kit) into the pinch valve by aligning the tubing with the pinch valve’s vertical slot and applying force to fully seat the tube into the valve slot. [Note: Fluid line loading/unloading procedures should be performed when the console is not powered since the pinch valve is in its open (loading/unloading) position.] Load Peristaltic Pump Tubing Set (if applicable):  Refer to Instructions For Use provided with any disposable procedure set and use as primary guideline for setup and use.  Open the peristaltic pump head fully by swinging open the (blue-colored) hinged front pump head cover while applying upward and rearward pressure.  Load the compliant peristaltic pump tubing segment of the appropriate disposable fluid line set (e.g., from an aspiration set with collection bag) centered on the pump head rollers.  Hold the tubing under axial tension and centered on the rollers while closing the hinged pump head cover. [Note: Verify that the tubing is centered on the v-grooves of the tubing guide ramps at both sides of the pump head body.]  Ensure that the pump head cover is fully closed by applying additional downward pressure on its top-front edge. [Note: Proper pump operation will not be achieved if the cover is not fully seated. Furthermore, to prevent a potential pinch hazard, the pump is equipped with a switch that prevents operation of the pump head if the cover is not closed.] Completing Operational Setup:  Connect collection container to discharge side of pump tubing.

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NeoMedix – TRABECTOME® I/A Console Operations Manual (230V)

CAUTION: The pinch valve will be closed and not allow fluid flow whenever a nonactivated Remote Footswitch is connected to the console or the Flow Control Knob is positioned in “STANDBY”. Under all other conditions, the pinch valve will be open and allow fluid flow. The Trabectome® I/A Console is designed to automatically open the pinch valve whenever the device is disconnected from power. Apply power to the Trabectome® I/A Console and verify that the console’s front panel POWER LED is lit green [Note: Refer to Section 5.3 if the Power LED is not lit and the external DC power supply is connected to both the console’s rear panel DC Power receptacle and to a live AC power source.]  Adjust the Flow Control Knob to the desired operational mode setting. [Note: A “PRIME” cycle is recommended to displace air from tubing sets prior to use. Priming will also help verify that the tubing sets are in good condition and that connections to the Trabectome® I/A Console have been made properly.]  Set the Audio Volume Setting Switch (located on the console’s rear panel) to the desired position for optimal sound performance.  Perform procedure using Remote Footswitch actuation or manual actuation control of the unit using the Flow Control Knob. 

Unloading Pinch Valve and Peristaltic Pump Tubing Sets (if applicable):

 Reverse the steps taken to load the tubing sets as previously described.

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NeoMedix – TRABECTOME® I/A Console Operations Manual (230V)

5. MAINTENANCE AND TROUBLESHOOTING 5.1 Storage Conditions Store the Trabectome® I/A Console in a cool, dry place out of direct sunlight subject to the conditions in Section 7.1. It is recommended that all accessory cables be unplugged to minimize the potential for damaging cable connectors. To disconnect latching plugs, firmly grasp central portion of plug and pull directly out of receptacle. Accessories such as the external power supply or removes footswitch should be stored with the console in a secure, convenient location (e.g., the accessory basket of the optionally available Trabectome® Roller Stand). 5.2 Cleaning Instructions The Trabectome® I/A Console and its related accessories may require periodic cleaning and disinfection of external surfaces that come in contact with the user. The console and its accessories are not compatible with sterilization methods, but should be cleaned using standard durable equipment disinfecting procedures. Observe safety precautions during cleaning procedures and limit the amount of cleaning solution to what is necessary to clean external surfaces without introducing liquid into the equipment’s interior. CAUTION: Disconnect device from power (e.g., unplug the AC line cord from either the external DC power supply or wall outlet) prior to cleaning. CAUTION: Exercise care to ensure that the electrical connections (primarily on the console’s rear panel and at the connector ends of cabled accessories) do not come in direct contact with water or cleaning solution. CAUTION: Do not immerse device or related accessory options. These items are not sealed against liquid ingress and damage may occur.  Verify console is disconnected from power by observing the front panel Power LED indicator to be unlit (i.e., not lit green).  Dampen a clean, lint-free soft cloth with anti-microbial detergent solution (e.g., mild anti-bacterial soap and water).  Wipe all external surfaces thoroughly while being careful not to apply excessive pressure over surfaces with labeling or other markings.  Rinse cloth in clean water and wring out excess moisture.  Wipe all external surfaces again to remove detergent solution residue.  Dry all external surface with a new, dry, lint-free cloth.  Dispose of cleaning items per accepted practices for contaminated waste. 18

NeoMedix – TRABECTOME® I/A Console Operations Manual (230V) 5.3 Troubleshooting Procedures

Observed Symptom

Potential Cause

Suggested Corrective Action

External DC Power Supply cable connector not connected to console rear panel DC Power Receptacle AC line cord not plugged into External DC Power Supply input socket.

TRABECTOME® I/A CONSOLE WILL NOT FUNCTION AND FRONT PANEL POWER LED IS NOT LIT.

AC line cord not plugged into a live AC Power Outlet.

Failure of the External DC Power Supply or associated power cables and connectors.

Internal failure of the Trabectome® I/A Console.

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Verify output cable plug extending from external power supply is securely inserted into console’s rear panel DC Power Receptacle. Verify an AC line cord with the proper EN60320 C13 cable plug is fully seated in the external DC power supply’s mating enclosure input socket. Verify that the AC line cord extending from the external DC Power Supply is fully plugged into an AC power socket with a line voltage of 100240VAC (50-60Hz). When AC cord is plugged into a multi-outlet power strip or other “switched outlet”, verify that the outlet switch is in the live AC position and that any fuses (e.g., in a power strip) are not blown. [Plugging a different knowngood device into the same outlet or moving the AC line cord plug into a different outlet are recommended methods of verifying that AC outlets are powered.] Contact NeoMedix or local authorized distributor to request a replacement External DC Power Supply after verifying that no other Trabectome® I/A Console power supply accessories are available at the facility and that a 12VDC output from the power supply cannot be obtained by qualified electronics technicians using a DC volt meter. Contact NeoMedix or your local authorized distributor for Technical Support and to request an RGA per Section 6.2 of this manual.

NeoMedix – TRABECTOME® I/A Console Operations Manual (230V)

Observed Symptom

Potential Cause

Suggested Corrective Action

Flow Control Knob in “STANDBY” position.

TRABECTOME® I/A CONSOLE WILL NOT FUNCTION AND FRONT PANEL POWER LED IS LIT GREEN.

An external accessory remote Trabectome® I/A Console actuator (e.g., a footswitch) is connected but not activated.

A connected external accessory remote Trabectome® I/A Console actuator (e.g., a footswitch) is either temporarily stuck, has a kinked or loosely secured cable connection, or is otherwise defective.

Internal failure of the Trabectome® I/A Console.

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Refer to the illustration in Section 4.2 of this manual and verify that the console’s front panel Flow Control Knob is in any position other than the “STANDBY” position. [Rotating the Flow Control Knob to the fully counter-clockwise “PRIME” setting position will automatically trigger the pinch valve to open and the peristaltic pump to operate at high speed, regardless of whether or not any remote console actuator devices (such as a footswitch) are connected or what actuation state they are in. Placing the Trabectome® I/A Console in “PRIME” mode is an easy method for determining if all internal components are functioning and may help isolate troubleshooting problems to accessory connection errors or failures in external accessory components (such as a footswitch.)] Determine if an external accessory remote actuator (such as a footswitch) is securely connected at the plug connection in the lower right corner of the Trabectome® I/A Console’s rear panel. If remote actuator accessory is connected, please note that the console will not function in any other mode except “PRIME” unless the remote actuator mechanism is activated (e.g., the pedal on a footswitch is being depressed.). Disconnect the accessory’s cable connector from the console’s mating rear panel connector and verify the Trabectome® I/A Console functions normally in the “PRIME” setting of the Flow Control Knob. If console functions normally with the remote actuation accessory disconnected, reconnect the accessory cable connector and reverify that the console will still not respond to activation of the external remote actuation accessory. Verify that the activation mechanism of the external accessory remote actuator can be smoothly transitioned through its range to verify that there is no debris that has obstructed the mechanism. Verify that the connecting cable is not kinked and that its terminating connector is securely seated and mated to the console. If none of the steps above correct the problem, replace the remote accessory with an identical NeoMedixsupplied replacement (see Section 2.2). If problems persist after replacing the accessory, contact NeoMedix or your local authorized distributor for Technical Support and to request an RGA per Section 6.2 of this manual. Contact NeoMedix or your local authorized distributor for Technical Support and to request an RGA per Section 6.2 of this manual.

NeoMedix – TRABECTOME® I/A Console Operations Manual (230V)

Observed Symptom

Potential Cause

Suggested Corrective Action

Flow Control Knob is not in intended flow setting position or is not positioned in a knob detent orientation.

Apply firm downward pressure to the front of the top edge of the peristaltic pump head’s hinged cover to verify that it is fully seated. The pump is equipped with a switch that will not allow the pump head to operate if the pump head cover is not closed. Open the peristaltic pump head’s hinged cover and verify that the tubing is resting centered on the pump rollers. Hold the tubing under axial tension while centered on the rollers and close the pump head cover again ensuring that it is fully seated. Examine the full length of connected tubing set lines looking for kinks, leaky fitting connections, air bubbles or other obstructions. Verify any inline devices (e.g., roller clamp, check valve, stopcock, etc.) are not in a closed or flow limiting orientation. Disconnect inline tube set connection from Trabectome® I/A Console and verify a nonoccluded system by verifying unrestricted flow through the tube set with a fluid-filled syringe or similar means. Verify that the attached tube sets are intended for use with the specific Trabectome® I/A Console model (see Section 7.3) and the correct segment of tubing has been routed through the pump head. Disconnect the Trabectome® I/A Console from power and then open the hinged peristaltic pump head cover. Rotate the pump head rollers in a clockwise direction and verify that the mechanism is not sticky or otherwise jammed through a complete revolution of the roller assembly. Contact NeoMedix or your local authorized distributor for Technical Support and to request an RGA per Section 6.2 of this manual.

Peristaltic pump head cover not fully closed.

Tubing set not loaded properly through peristaltic pump head.

NO FLOW OR SUBSTANTIALLY REDUCED FLOW THROUGH PERISTALTIC PUMP HEAD.

Adjust Flow Control Knob to intended flow setting position or and check that knob is positioned in a knob detent orientation.

Tubing set or inline disposable accessory is kinked, closed (as with a roller clamp), or otherwise occluded.

Tubing set tubing wall thickness or ID/OD of incompatible size.

Jammed pump head rollers.

Internal failure of the Trabectome® I/A Console.

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