FMS VUE II Operators Manual Rev C Aug 2017

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Contents PREFACE CHAPTER 1 OVERVIEW 9 1.1 Description... 9 1.2 Pump Accessories (sold separately)... 9 1.3 Principle of Operation... 9 1.3.1 Fluid Management... 9 1.3.2 Joint Pressure Estimation and Control (JPEC)... 9 1.3.3 Tissue Debridement... 10 1.4 Indications for Use... 10 1.5 Intended Use... 10 1.6 Contraindications... 10 CHAPTER 2 OPERATING PRECAUTIONS AND GENERAL SAFETY 11 2.1 Warnings... 11 2.1.1 Electrical Safety... 11 2.1.2 Operating Warnings... 11 2.2 Precautions... 13 CHAPTER 3 OPERATOR CONTROLS, DISPLAYS AND ALERTS 15 3.1 Front Panel Controls and Displays... 15 3.2 Back Panel... 18 3.2.1 Back Panel Connectors... 20 CHAPTER 4 UNPACKING, ASSEMBLY AND SYSTEM CHECK 23 4.1 Overview... 23 4.2 Unpacking... 23 4.3 Pump Placement... 23 4.4 Pump Assembly and System Check... 24 CHAPTER 5 CONNECTING AND DISCONNECTING PUMP TUBING 25 5.1 Connecting the Inflow Tubing... 25 5.2 Connecting the Intermediary Tubing... 27 3

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5.3 5.4 5.5 5.6 5.7 5.8 5.9

Connecting the Outflow Tubing (DUO Mode)... 28 Connecting the Handpiece – STERILE ZONE... 29 Connecting the Cannula – STERILE ZONE... 29 Tubing Connections for SOLO Mode... 29 End of Operation... 29 Set Up for Next Operation... 30 End of Operating Day... 30

CHAPTER 6 PUMP SYSTEM FUNCTIONS 31 6.1 Pump Setup (Start/Stop)... 31 6.1.1 Setting the Joint-to-Pump Elevation... 31 6.1.2 Selecting Set-point Pressure for Joint Pressure Estimation and Control (JPEC)... 33 6.1.3 Recommended Initial Pressure Settings... 34 6.2 Setting Pump System Defaults... 36 6.3 Filling the Chamber... 39 6.4 SOLO Mode (Irrigation and Handpiece Control)... 39 6.5 Pressure Warnings and Alarms... 39 6.6 Suction Settings... 41 6.6.1 FLOW+ Feature... 41 6.6.2 BLOODSTOP Feature... 42 6.7 FMS VUE II Accessories... 42 6.7.1 5-Way Foot Pedal (Ref. 283573)... 42 6.7.2 Foot Pedal Pressure Control Functions... 43 6.7.3 Micro Handpiece (Ref. 283512)... 44 6.7.4 Handpiece Controls When Foot Pedal is Connected... 45 6.7.5 Inserting and Removing Blades... 46 6.7.6 Remote Hand Control (Ref. 283551)... 47 CHAPTER 7 ROUTINE MAINTENANCE AND CLEANING PROCEDURES 49 7.1 Factory Settings... 49 7.2 Cleaning the FMS VUE II Pump... 49 7.3 Cleaning the FMS VUE II Accessories... 49 7.4 Preventive Maintenance... 50 7.4.1 Replacing Fuse... 50 7.4.2 Physical Inspection... 50 7.5 Equipment Disposal... 51

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CHAPTER 9 SERVICE PROCEDURES 55 9.1 Functional Test... 55 9.1.1 Verify Motors and Electro-valve... 55 9.1.2 Functional Test of Pinch Valve... 55 9.2 Repairs... 56 9.3 Electrical Safety Testing Information... 56 9.4 Fault Codes... 56 CHAPTER 10 SPECIFICATIONS AND PERFORMANCE CHARACTERISTICS 59 10.1 Composition... 59 10.2 Ingress Protection... 59 10.3 Dimensions... 59 10.4 Electrical Specifications... 59 10.5 Degree of Protection (Applied Parts)... 59 10.6 Performance Characteristics... 59 10.7 Operating Conditions... 60 10.8 Storage and Shipping Conditions... 60 APPENDIX A APPLIED PARTS 61 A.1 FMS VUE II Isolation Diagram... 61 APPENDIX B PART NUMBERS 63 B.1 FMS VUE II Related Part Numbers... 63 APPENDIX C WARRANTY AND SERVICE

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APPENDIX D EMC TABLES

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CHAPTER 8 TROUBLESHOOTING

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FIGURES Figure 1.  FMS VUE II Connections... 10 Figure 2.  FMS VUE II Front Panel... 15 Figure 3.  FMS VUE II Back Panel Label... 18 Figure 4.  FMS VUE II Back Panel Connectors... 20 Figure 5.  Connect Pump Accessories... 24 Figure 6. Inflow Tubing... 25 Figure 7.  Position Fill Chamber... 26 Figure 8.  Intermediary Tubing... 27 Figure 9. Outflow Tubing... 28 Figure 10.  System Default Controls... 36 Figure 11.  Reset Defaults Menu... 36 Figure 12.  Suction Settings... 41 Figure 13.  BLOODSTOP Indicator... 42 Figure 14.  5-Way Foot Pedal... 42 Figure 15.  Handpiece Control Override Deactivated... 46 Figure 16.  Handpiece Control Override Activated... 46 Figure 17.  Remote Hand Control... 47 Figure 18.  FMS VUE II Isolation Diagram... 62 TABLES Table 1.  Front Panel Controls... 16 Table 2.  Back Panel Symbol Descriptions... 18 Table 3.  Packaging Label Descriptions... 21 Table 4.  Selecting Joint Pressure Set-Point... 33 Table 5.  Recommended Initial Pressure Settings... 34 Table 6.  Pump Defaults... 37 Table 7.  Pressure Alarms... 40 Table 8.  Suction Settings... 41 Table 9.  Inspection Schedule... 50 Table 10.  Fault Codes... 56 Table 11.  Pump Part Numbers... 63 Table 12.  Tubing Part Numbers... 63 Table 13.  Sheath Part Numbers... 64 Table 14.  Micro Handpiece Blades and Burr Part Numbers... 64

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Preface This manual describes the FMS VUE™ II 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. When using FMS VUE II 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 II 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 DePuy Synthes and is protected by all relevant copyright laws. Do not reproduce any portion of this manual, in any form, without express written approval of DePuy Synthes. Worldwide Patents pending. IEC-60601-1 Compliance

4008089

Intertek Semko evaluated the FMS VUE II Pump and its accessories for Electromagnetic Compatibility, to regulations IEC 60601-1 3rd edition: 2005 and IEC 60601-1-2 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.

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Chapter 1

Overview 1.1

Description

The FMS VUE™ II 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 II Pump • Operator’s Manual

1.2

Pump Accessories (sold separately)

DePuy Synthes 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 DePuy Synthes Sales Representative for items available for your country.

1.3

Principle of Operation

1.3.1 Fluid Management The FMS VUE II fluid management system consists of two pumps; the irrigation pump which controls joint pressure, and the suction pump, which controls the flow of saline and waste from the joint. The irrigation pump is controlled using a proprietary joint pressure estimation and control (JPEC) algorithm. The joint pressure algorithm estimates and controls joint pressure while also compensating for losses in joint pressure due to external suction flow sources such as electrosurgical tools. The FMS VUE II system provides two modes of operation: • 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.

1.3.2 Joint Pressure Estimation and Control (JPEC) The FMS VUE II pump estimates joint pressure based on pressure losses due to irrigation tubing and a standard 6 mm outside diameter (OD) high flow sheath. The joint pressure estimate is the tubing/sheath loss subtracted from the measured pump pressure. A control algorithm is then used to regulate joint pressure.

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Figure 1. FMS VUE II Connections

1.3.3 Tissue Debridement The FMS VUE II 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 II automatically activates suction through the shaver and clamps off other suction ports (Figure 1).

1.4

Indications for Use

The FMS VUE II 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 II 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 II 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 II in instances where capsular integrity is suspect. • DO NOT use the FMS VUE II with a gas distension medium. Use only with sterile irrigation solution for distension of the operative site. • DO NOT use the FMS VUE II to administer drugs, IV-fluids, blood or blood substitutes. 10

Operating Precautions and General Safety Read and understand this manual before using the FMS VUE II system.

The following list of warnings and precautions applies to the general operation of the FMS VUE II System.

2.1

Warnings

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 II 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.

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Chapter 2

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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 DePuy Synthes (Contact your DePuy Synthes representative for availability). For instructions and supported handpieces, refer to FMS CONNECT Cable for FMS VUE II Instructions for Use. (P/N: IFU-111105). • Any modifications to the system must be authorized by DePuy Synthes. Modifying the device in a manner other than specified by DePuy Synthes 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 II 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 DePuy 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 II system can be serviced or maintained while the pump is in use.

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Precautions

• Read the instructions, cautions, and warnings provided with all FMS VUE II System accessories before use. Your sales representative can advise which accessories are used with the FMS VUE II 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 DePuy Synthes products. Any alterations to this device, repair from an unlicensed service center, or use of non-DePuy Synthes disposables, may void DePuy Synthes warranty, and product liability coverage.

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2.2

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Chapter 3

Operator Controls, Displays and Alerts This chapter describes operator controls, displays, and alerts on the FMS VUE II 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 II pump (Figure 2).

3.1

Front Panel Controls and Displays 3

2

4

5

7

6

8

1

SU CT

ON TI

N IO

25

IRR IG A

1

24

SUCTION

BLOOD STOP HIGH PRESSURE

MITEK SPORTS MEDICINE COMPANIES OF

23

FLOW +

FMS VUE II

SHAVER

9

LOW PRESSURE

RUN

22

10

SOLO

STOP

11

20 21

17 19

15

18

14

13

12

16

Figure 2. FMS VUE II 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.

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No.

Description

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

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 DePuy Synthes 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

Figure 3 shows the FMS VUE II back panel label. Table 2 provides back panel symbol descriptions.

Figure 3. FMS VUE II Back Panel Label Table 2. Back Panel Symbol Descriptions Symbol

Description

See instructions for use

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)

Type BF. Conforms to standard IEC 60601-1

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Symbol

Description

Per Directive 2002/96/EC, product must be collected separately. Do not dispose of as unsorted municipal waste. Contact your DePuy Synthes Sales Representative for disposal information. 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

EC REP

EC Representative Electric shock hazard. Do not remove cover.

Intertek Semko evaluated the FMS VUE II System and its accessories per standards IEC 60601-1 3rd edition: 2005 and IEC 60601-1-2 4th edition: 2014. The pump and accessories were found to be compliant. 4008089

CE Mark. DePuy Synthes declares that this product meets the provisions of the Council Directive 93/42/EEC of June 14, 1993, and amending directive 2007/47/EC concerning Medical Devices. All supporting documentation is retained under the premises of the manufacturer. Replace the fuse with a 5A Time Delay Fuse rated for 250VAC S/N A 11 A A 0001

Serial Number RCM (Regulatory Compliance Mark) Product complies with Australian electrical safety and/or electromagnetic compatibility (EMC) legislative requirements.

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3.2.1 Back Panel Connectors Figure 4 shows back panel connectors. NOTE: Only approved electronic equipment (IEC60950-1, IEC60601-1) can be connected to the four rear panel communications connectors (Figure 4).

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 4. FMS VUE II Back Panel Connectors

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Symbol

Description Keep dry

This way up

Keep out of direct sunlight

Maximum stack height: 4

Attention

Atmospheric pressure range

Humidity range

–10°C 14°F

50°C 122°F

Temperature range

Fragile

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Table 3. Packaging Label Descriptions