FMS VUE Operators Manual Rev C Jan 2022

Contents PREFACE CHAPTER 1 OVERVIEW 6 1.1 Description... 6 1.2 Pump Accessories (sold separately)... 6 1.3 Principle of Operation... 6 1.3.1 Fluid Management... 6 1.3.2 Tissue Debridement... 7 1.4 Indications for Use... 7 1.5 Intended Use... 7 1.6 Contraindications... 7 CHAPTER 2 OPERATING PRECAUTIONS AND GENERAL SAFETY 8 2.1 Warnings... 8 2.1.1 Electrical Safety... 8 2.1.2 Operating Warnings... 8 2.2 Precautions... 10 2.3 Possible Adverse Reactions... 10 CHAPTER 3 OPERATOR CONTROLS, DISPLAYS AND ALERTS 11 3.1 Front Panel Controls and Displays... 11 3.2 Back Panel Symbols... 14 3.2.1 Back Panel Connectors... 15 CHAPTER 4 UNPACKING, ASSEMBLY AND SYSTEM CHECK 18 4.1 Overview... 18 4.2 Unpacking... 18 4.3 Pump Placement... 18 4.4 Pump Assembly and System Check... 19 CHAPTER 5 CONNECTING AND DISCONNECTING PUMP TUBING 20 5.1 Connecting the Inflow Tubing... 20 5.2 Connecting the Intermediary Tubing... 22 5.3 Connecting the Outflow Tubing (DUO Mode)... 23 5.4 Connecting the Handpiece – STERILE ZONE... 24 5.5 Connecting the Cannula – STERILE ZONE... 24 5.6 Tubing Connections for SOLO Mode... 24 5.7 End of Operation... 24 5.8 Set Up for Next Operation... 25 5.9 End of Operating Day... 25

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CHAPTER 6 PUMP SYSTEM FUNCTIONS 26 6.1 RUN/STOP... 26 6.1.1 Recommended Initial Pressure Settings... 26 6.1.2 Pump Pressure... 28 6.2 Setting Pump System Defaults... 29 6.3 Filling the Chamber... 32 6.4 SOLO Mode (Irrigation and Handpiece Control)... 32 6.5 Pressure Warnings and Alarms... 33 6.6 Suction Settings... 34 6.6.1 FLOW+ Feature... 34 6.6.2 BLOODSTOP Feature... 35 6.7 FMS VUE Accessories... 35 6.7.1 5-Way Foot Pedal (Ref. 283573)... 35 6.7.2 Foot Pedal Pressure Control Functions... 36 6.7.3 Tornado Micro Shaver Handpiece (Ref. 283512)... 37 6.7.4 Tornado Micro II Shaver Handpiece (283812 & 283712)... 38 6.7.5 Handpiece Controls When Foot Pedal is Connected... 39 6.7.6 Inserting and Removing Blades and Burrs... 40 6.7.7 Remote Hand Control (Ref. 283551)... 40 CHAPTER 7 ROUTINE MAINTENANCE AND CLEANING PROCEDURES 41 7.1 Factory Settings... 41 7.2 Cleaning the FMS VUE Pump... 41 7.3 Cleaning the FMS VUE Accessories... 41 7.4 Preventive Maintenance... 42 7.4.1 Replacing Fuse... 42 7.4.2 Physical Inspection... 42 7.5 Equipment Disposal... 43 CHAPTER 8 TROUBLESHOOTING

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CHAPTER 9 SERVICE PROCEDURES 47 9.1 Functional Test... 47 9.1.1 Verify Motors and Electro-valve... 47 9.1.2 Functional Test of Pinch Valve... 47 9.2 Repairs... 47 9.3 Electrical Safety Testing Information... 48 9.4 Fault Codes... 48 CHAPTER 10 SPECIFICATIONS AND PERFORMANCE CHARACTERISTICS 50 10.1 Composition... 50 10.2 Ingress Protection... 50 10.3 Dimensions... 50 10.4 Electrical Specifications... 50 10.5 Degree of Protection (Applied Parts)... 50

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10.6 Performance Characteristics... 50 10.7 Operating Conditions... 51 10.8 Storage and Shipping Conditions... 51 APPENDIX A APPLIED PARTS 52 A.1 FMS VUE Isolation Diagram... 52 APPENDIX B PART NUMBERS 54 B.1 FMS VUE Related Part Numbers... 54 APPENDIX C WARRANTY AND SERVICE

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APPENDIX D EMC TABLES

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FIGURES Figure 1.  FMS VUE Connections... 7 Figure 2.  FMS VUE Front Panel... 11 Figure 3.  FMS VUE Back Panel Connectors... 15 Figure 4.  Connect Pump Accessories... 19 Figure 5.  Inflow Tubing... 20 Figure 6.  Position Fill Chamber... 21 Figure 7.  Intermediary Tubing... 22 Figure 8.  Outflow Tubing... 23 Figure 9.  System Default Controls... 29 Figure 10.  Reset Defaults Menu... 29 Figure 11.  Suction Settings... 34 Figure 12.  BLOODSTOP Indicator... 35 Figure 13.  5-Way Foot Pedal... 35 Figure 14.  Handpiece Control Override Deactivated... 39 Figure 15.  Handpiece Control Override Activated... 39 Figure 16.  Remote Hand Control... 40 Figure 17.  Lithium-based Non-rechargeable Coin Cell Battery... 43 Figure 18.  FMS VUE Isolation Diagram... 53 TABLES Table 1.  Front Panel Controls... 12 Table 2.  Back Panel Symbol Descriptions... 14 Table 3.  General Symbol Descriptions... 16 Table 4.  Recommended Initial Pressure Setting for the FMS VUE... 27 Table 5.  Pump Defaults... 30 Table 6.  Pressure Alarms... 33 Table 7.  Suction Settings... 34 Table 8.  Inspection Schedule... 42 Table 9.  Fault Codes... 48 Table 10.  Pump Part Numbers... 54 Table 11.  Tubing Part Numbers... 54 Table 12.  Micro Handpiece Blade and Burr Part Numbers... 55 2022-01-18 12:23:43

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Preface This manual describes the FMS VUE™ Fluid Management and Tissue Debridement System, and provides instructions for the proper use of the pump and accessories. It is important to review this manual thoroughly before installing and operating the System. Additional information, training, and product servicing are available from DePuy Synthes Mitek Sports Medicine. When using FMS VUE accessories, please refer to the appropriate Instructions for Use (IFUs). IFU part numbers for each product are listed in Appendix B of this manual. Read all instructions carefully. Refer to this manual when operating the FMS VUE pump. The information contained in this manual is based upon the most current information available at the time of printing. Figures are representative. The entire content of this manual is the property of Mitek Sports Medicine and is protected by all relevant copyright laws. Do not reproduce any portion of this manual, in any form, without express written approval of Mitek Sports Medicine. Worldwide Patents pending. IEC-60601-1 Compliance Intertek Semko evaluated the FMS VUE Pump and its accessories for Electromagnetic Compatibility, to regulations IEC 60601-1 edition 3.1: 2012 and IEC 60601-1-2 4008089 4th edition: 2014. The pump and accessories were found to be compliant. FCC15C Labeling Requirement FCC ID: 2AAVI-JDK2254

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. Canadian Labeling Requirement IC ID: 11355A-JDK2254

This device complies with the Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Some products may not be licensed in all jurisdictions.

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Chapter 1

Overview 1.1

Description

The FMS VUE™ Fluid Management and Tissue Debridement System is an arthroscopic pump system designed to provide optimal visibility of the surgical field by computer-controlled fluid regulation of intra-articular pressure during arthroscopic procedures. The shipping box contains: • FMS VUE Pump • Operator’s Manual (Outside USA only) For USA refer to e-IFU website www.e-IFU.com for Instructions for Use.

1.2

Pump Accessories (sold separately)

Mitek Sports Medicine provides Instructions for Use for all accessories. Refer to Appendix B for a complete list of accessory part numbers and associated Instructions for Use. NOTE: Not all parts are sold in all countries. Please contact your Mitek Sports Medicine Sales Representative for items available for your country.

1.3

Principle of Operation

1.3.1 Fluid Management The FMS VUE pump controls irrigation and suction independently which can help minimize the risk of tissue extravasation by elminating the need to increase fluid pressure in the joint. The pump may be operated in either DUO or SOLO mode: • DUO Mode (irrigation, handpiece control and suction). When operating in DUO mode, the pump provides irrigation, handpiece control and suction. • SOLO Mode (irrigation and handpiece control). When operating in SOLO mode, the pump provides irrigation and handpiece control. SOLO mode is activated by pressing the SOLO pad on the control panel.

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Figure 1. FMS VUE Connections

1.3.2 Tissue Debridement The FMS VUE system includes an integrated shaver console. The light-weight, high-speed Micro handpiece is designed for use with blades listed in Appendix B. When the shaver is running, the FMS VUE automatically activates suction through the shaver and clamps off other suction ports (Figure 1).

1.4

Indications for Use

The FMS VUE Fluid Management and Tissue Debridement System is intended to provide controlled fluid distention and suction, controlled cutting, burring, shaving and abrading of bone and tissue for use in arthroscopic surgery of the shoulder, knee, ankle, elbow, wrist and hip joints.

1.5

Intended Use

The FMS VUE Fluid Management and Tissue Debridement System is intended for use in a surgical setting by personnel trained in arthroscopy.

1.6

Contraindications

The FMS VUE System is contraindicated in any non-arthroscopic surgical procedure and is for use with saline irrigation only. The system is not appropriate for patients for whom an arthroscopic procedure is contraindicated for any reason. • DO NOT use the FMS VUE in instances where capsular integrity is suspect. • DO NOT use the FMS VUE with a gas distension medium. Use only with sterile irrigation solution for distension of the operative site. • DO NOT use the FMS VUE to administer drugs, IV-fluids, blood or blood substitutes.

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Chapter 2

Operating Precautions and General Safety Read and understand this manual before using the FMS VUE system. Consult Instructions for Use on e-IFU website The following list of warnings and precautions applies to the general operation of the FMS VUE System.

2.1

Warnings

NOTE: Tips for optimal operation and other useful information. CAUTION! Failure to observe caution can result in damage to the device. WARNING! Failure to observe warning can result in injury to the patient or user.

2.1.1 Electrical Safety • Electrical safety testing should be performed by a biomedical engineer or other qualified person. • Risk of electrical shock: Do not remove the pump housing. Refer servicing to authorized Repair Service Center. • Do not connect the device to a power source that is not properly earthed (grounded). If the power source is not grounded, use the equipotential connector. • Disconnect the device from the main power source when cleaning, servicing or inspecting. • Inspect all equipment and cables periodically for wear. If damage is noted, replace or return to Repair Service Center. • Avoid fluid contact with the system and its electrical connectors. • To avoid risk of fire, replace fuses with same type and rating. • Do not restrict access to the power switch. Ensure that the pump is positioned so that access to power main is not obstructed. To remove all mains power from the unit, disconnect the power cord from the appliance inlet. • The FMS VUE pump power supply detachable cord serves as the means of isolation between the power supply and the power main. Ensure that the placement of the equipment does not interfere with access to the power supply cord.

2.1.2 Operating Warnings • This equipment may be operated only by arthroscopic surgeons. The surgeon using this device must be trained in arthroscopic surgical procedures, be aware of the risks associated with those procedures, and have current knowledge of technological advances in surgical products and techniques. • While using the tubing with one-way valve, if additional joint pressure is created by the surgeon during joint manipulation, the pressure displayed at the pump will not reflect the pressure change, which could possibly lead to extravasation. 2022-01-18 12:23:43

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• Do not use the pump adjacent to or stacked with other electrical equipment. If adjacent or stacked use is necessary, observe both the equipment and pump to verify normal operation in the configuration in which it will be used. • Portable and mobile RF communications equipment can affect Medical Electrical Equipment. • Do not use in the presence of a flammable anesthetic mixture with air, or in the presence of a flammable anesthetic mixture with oxygen or nitrous oxide. • Factory settings should only be used as guidelines. The surgeon is responsible for settings pertaining to the surgical procedure. • Failure to follow all applicable instructions may result in serious surgical consequences to the patient. • Use the FMS CONNECT Interface Cable to connect handpieces other than those manufactured by Mitek Sports Medicine (Contact your Mitek Sports Medicine representative for availability). For instructions and supported handpieces, refer to FMS CONNECT Cable for FMS VUE Instructions for Use. (P/N: IFU-111105). • Any modifications to the system must be authorized by Mitek Sports Medicine. Modifying the device in a manner other than specified by Mitek Sports Medicine may result in injury. Contact Customer Service at 1-800-382-4682 for service requests. Outside the United States, contact your local affiliate. • The FMS VUE pump is equipped with a terminal for the connection of a Potential Equalization Connector as required by Electrical Safety Standard IEC 60601-1. To install the connector, connect one end to the terminal on the back of the pump. Attach the other end to the bus bar of the electrical installation. The Potential Equalization Connector is provided to prevent electric shock hazards by maintaining a constant potential (voltage) to all exposed metal parts so a person cannot simultaneously make contact with two different potentials. Use of the potential equalization connector should be determined by the facility where it is installed based on the design of the electrical distribution system. • This device has been tested and found in compliance with limits of medical devices according to IEC 60601-1-2 standard. These limits are designed to provide resonable protection in a typical medical installation, against harmful interference when devices are located in close proximity. If the pump is causing harmful interference, turn the main power off, then on again to determine the cause of the interference, relocate the system or separate it from other devices. If you cannot resolve the problem contact Mitek Sports Medicine Customer Service at 1-800-382-4682. Outside the United States, contact your local affiliate. • Accessories labeled “REUSABLE” must be processed only according to the recommended procedures. Refer to the applicable Instructions for Use. • Do not wrap handpiece, foot pedal or pump power cables around metal objects. Wrapping cables around metal objects may induce currents that could lead to electric shock, fire and/or injury to patient or surgical personnel. • The use of accessories, transducers and cables other than those specified, with the exception of transducers and cable sold by the Manufacturer of the ME Equipment or ME System, may result in increased emissions or decreased immunity of the ME Equipment or ME System. • No parts of the FMS VUE system can be serviced or maintained while the pump is in use. • The product shall be used in accordance with instructions and standard aseptic techniques, otherwise cross-contamination, infection may occur.

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2.2

Precautions

• Read the instructions, cautions, and warnings provided with all FMS VUE System accessories before use. Your sales representative can advise which accessories are used with the FMS VUE System. • The manufacturer and licensed seller of this device do not accept any liability for direct or consequential damage or injury caused by improper use of disposables other than Mitek Sports Medicine products. Any alterations to this device, repair from an unlicensed service center, or use of non-Mitek Sports Medicine disposables, may void Mitek Sports Medicine warranty, and product liability coverage.

2.3

Possible Adverse Reactions

1. Adverse effects associated with the use of this device may include wound issues, and or infection. 2. Local or systemic tissue reaction including allergic reaction. 3. Excess fluid extravasation may lead to edema near the surgical site.

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Chapter 3

Operator Controls, Displays and Alerts This chapter describes operator controls, displays, and alerts on the FMS VUE System. Operating instructions for system accessories are described in separate instructions for use (refer to Appendix B). All operator controls are located on the front of the FMS VUE pump (Figure 2).

3.1

Front Panel Controls and Displays

Figure 2. FMS VUE Front Panel

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Table 1. Front Panel Controls No.

Description

1

Transparent safety doors Doors must be closed for pump operation.

2

IRRIGATION roller pump Provides fluid inflow.

3

PRESSURE adjustment pads (mmHg) Controls the pressure level in increments of 5 mmHg.

4

PRESSURE display (mmHg) Displays both the preset pressure when the base pressure is being set, and the dynamic pressure following the release of the pressure adjustment pads.

5

FLOW+ Suction setting Sets the flow rate through the cannula.

6

SHAVER speed display (RPM) Indicates the preset handpiece speed and direction of rotation.

7

SHAVER Speed Selection pads (RPM) Increases and decreases handpiece speed.

8

SUCTION roller pump Provides fluid outflow.

9

SUCTION Auto-locking slot Locks the tubing in place around the SUCTION roller pump.

10

RFID antenna Detects correct pump tubing.

11

PINCH VALVE Moves automatically when the handpiece rotates and selects the appropriate suction tube.

12

SHAVER Suction setting Increases and decreases handpiece suction.

13

SOLO pad Press to switch to SOLO mode.

14

POWER SWITCH Provides power to the pump.

15

FOOT PEDAL connection Connection port for 5-Way Foot Pedal.

16

RUN/STOP PAD Starts and stops the pump.

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No.

Description

17

REMOTE HAND CONTROL connection Connection port for the remote hand control.

18

HANDPIECE interface connection Connection port for handpiece or FMS CONNECT Interface Cable (Contact your Mitek Sports Medicine representative for availability).

19

Fill Chamber pad Press to fill the Fill Chamber.

20

Fill Chamber bracket Supports Fill Chamber.

21

PRESSURE SENSOR QUICK CONNECT port Connects/disconnects the pressure sensor to the pump.

22

IRRIGATION Auto-locking slot Locks the tubing in place around the IRRIGATION roller pump.

23

LOW PRESSURE Alarm Indicates low joint pressure.

24

HIGH PRESSURE Alarm Indicates high joint pressure.

25

BLOODSTOP™ Indicator When illuminated, indicates pump is in BLOODSTOP mode.

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3.2

Back Panel Symbols

Table 2 provides back panel symbol descriptions. Table 2. Back Panel Symbol Descriptions Symbol

Description REFER TO INSTRUCTION MANUAL / BOOKLET Consult Instructions for Use on e-IFU website

REF

Catalog number The Equipotential terminal provides a connection between the unit and the potential equalization bus bar of the electrical installation. Protective earth ground (IEC 60417-5019). Internal to box.

Type BF applied part This device is an electronic equipment. It must not be disposed of as unsorted waste and it must be collected separately according to applicable national and institutional policies. IP40

International Protection Rating Warning. See Instructions for Use.

SHAVER

Manufacturer CAUTION. Federal (USA) law restricts this device to sale by or on the order of a physician. MADE IN

Country of manufacture Electric shock hazard. Do not remove cover.

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Symbol

4008089

Description Intertek Semko evaluated the FMS VUE System and its accessories per standards IEC-60601-1 edition 3.1: 2012 and IEC-60601-1-2:2014. The pump and accessories were found to be compliant. Replace the fuse with a 5A Time Delay Fuse rated for 250 VAC. Breaking Capacity: L Serial Number RCM (Regulatory Compliance Mark) Product complies with Australian electrical safety and/or electromagnetic compatibility (EMC) legislative requirements. Non-Ionizing electromagnetic radiation due to RFID system within the device

3.2.1 Back Panel Connectors Figure 3 shows back panel connectors. NOTE: Only approved electronic equipment (IEC60950-1, IEC60601-1) can be connected to the four rear panel communications connectors (Figure 3).

1

2

3

4

1 USB-A: Used for software upgrades and for retrieving fault log 2 USB-B: For future expansion 3 Ethernet 10BaseT: For future expansion 4 RS-232: Used for diagnostics Figure 3. FMS VUE Back Panel Connectors

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Table 3. General Symbol Descriptions This table provides descriptions of other symbols used on packaging, labels, and instructions for use. A complete list of symbol descriptions can be found at www.e-ifu.com/symbols-glossary. Symbol

Description Catalog number Serial number Quantity Date of manufacture Caution - Consult the Instructions for Use for important cautionary information such as warnings and precautions. REFER TO INSTRUCTION MANUAL / BOOKLET

4008089

Intertek Semko evaluated the FMS VUE System and its accessories per standards IEC-60601-1 edition 3.1: 2012 and IEC-60601-1-2:2014. The pump and accessories were found to be compliant.

Type BF applied part This device is an electronic equipment. It must not be disposed of as unsorted waste and it must be collected separately according to applicable national and institutional policies. Non-sterile Made In CAUTION. Federal (USA) law restricts this device to sale by or on the order of a physician. Consult Instructions for Use on e-IFU website Manufacturer

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Symbol

Description Atmospheric pressure limitation

Humidity limitation

–10°C 14°F

50°C 122°F

Temperature limit

Keep dry

This way up

Keep out of direct sunlight

Maximum stack height 4

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Chapter 4

Unpacking, Assembly and System Check 4.1

Overview

This section describes how to unpack the pump and connect the accessories. After unpacking and assembly, follow the system check procedure to ensure that the FMS VUE System is working properly.

4.2

Unpacking

To unpack the pump: 1. Place hands in the open areas between the two pieces of packaging foam on both sides of the console until you can securely grasp the underside of the pump. 2. Carefully remove the pump from the box and place it on a level and sturdy surface. 3. Verify that all items on the packing list match the products you have received. 4. Report damage immediately to a Mitek Sports Medicine Sales Representative or call Mitek Sports Medicine Customer Service in the USA at +1-800-382-4682. Save all packing materials to use in the event you must return product(s) to Mitek Sports Medicine. Outside the United States, contact your local affiliate. 5. Recycle all FMS VUE packaging material, including cardboard, foam inserts and anti-static bag.

4.3

Pump Placement

Position the FMS VUE pump outside the sterile field, and where required depending on operator requirements. Ensure that there is enough space for Circulating Nurses to access the pump controls. Position the pump so that access to power main is not obstructed. Place the pump (fill line of Fill Chamber) at the same level as the patient joint.

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4.4

Pump Assembly and System Check

To assemble the FMS VUE pump: 1. Connect the power cord to the power source. 2. Connect the other end of the power cord to the rear panel of the pump. 3. Connect the accessories to the pump (Figure 4). 4. Turn the pump ON by pressing “|” on the power switch on the front of the pump (Figure 4). The software versions appear on the display followed by the initial settings.

1 Handpiece (optional) 2 Remote Hand Control (optional) 3 Foot Pedal (optional) 4 Power Switch Figure 4. Connect Pump Accessories

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Chapter 5

Connecting and Disconnecting Pump Tubing This section describes how to connect the pump tubing which includes inflow tubing for irrigation, intermediary tubing for maintaining sterility in the sterile zone, and outflow tubing for removing fluid from the joint. WARNING! Do not reuse or re-sterilize. The FMS tubing is not designed to be re-sterilized. Reprocessing may lead to changes in material characteristics such as deformation and material degradation, which may affect the strength of the device and compromise device performance. These risks may potentially affect patient safety.

5.1

Connecting the Inflow Tubing

NOTE: This procedure may be used when operating the pump in either DUO (Irrigation, Handpiece and Suction) or SOLO (Irrigation and Handpiece) modes. The Inflow Tubing (Figure 5) can be used for an entire surgical day. Sterility is preserved only if the tube installation procedures have been performed precisely. WARNING! Discard all tubing unless using the Inflow Tubing with intermediary tubing with one-way valve (Ref 281142) or outflow tubing with Intermediary tube with one-way valve (Ref 284649). Reuse of the tubing without the one-way valve may cause cross-contamination leading to possible patient infection. Refer to the appropriate procedure below.

Figure 5. Inflow Tubing ON TI

IRR IG A

IRR IG A

ON TI

MITEK SPORTS MEDICINE COMPANIES OF

MITEK SPORTS MEDICINE COMPANIES OF

1. Remove the Inflow tubing from the package and close three (3) white clamps on the Inflow tubing.

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2. Lift the door and position the green autolock on the tube in the green autolock slot on the pump.

3. Place and center the tube around the roller. 4. Pull gently on the tube to engage the tube fitting opposite the auto-lock while maintaining tension on the tube.

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