FMS Solo Instruction Manual

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CHAPTER 4. PUMP SYSTEM FUNCTIONS 4.1. 4.2. 4.3. 4.4. 4.5. 4.6.

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Run/Stop ... 24 Preset Pressure ... 24 Filling the Chamber ... 24 Recommended Initial Settings ... 25 Pressure Alarm ... 25 Pressure Cycle Mode ... 26

CHAPTER 5. MAINTENANCE: CLEANING & DECONTAMINATION

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CHAPTER 6. TROUBLESHOOTING

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CHAPTER 7. PRODUCT SPECIFICATIONS

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Warranty and Service DePuy Mitek products are guaranteed to be free from defects in material and workmanship for the warranty period of a particular product, beginning from date of invoice.

Contact your DePuy Mitek representative for specific product warranty information.

DePuy Mitek offers an expedited service replacement program for its products to minimize downtime in your operating room. For a return authorization number or for additional information on this program, call DePuy Mitek Customer Service at +1 (800) 382-4682 and choose Option 2 in the United States or contact your DePuy Mitek representative.

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Unpacking, Assemby and Initial System Check Unpacking:

Initial System Check:

Verify that all items on packing list match the products you have received (verify serial numbers and references). Damage should be reported immediately to your DePuy Mitek Sales Representative or contact DePuy Mitek Customer Service in the USA at +1-800-382-4682, select Option 2. Save all packaging material, as they will be required to ship products in the event of a product return.

- Switch the I/O switch (14) on “I”.

Assembly: - Connect the power cord to the power connection (14). - Connect the foot pedal to the foot pedal connection (16) on the back of the pump.

Note: numbers in ( ), refer to diagram in section 1.5.

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- Turn the device ON by pressing the POWER (4) pad. - Press on all pads. An audible tone should be heard for each pad pressed, except for Pressure Cycle, (Pad 8) (Pressure Cycle is inactive until the pump is primed.)

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Inspection Schedule Weekly inspection:

Annual inspection:

DePuy Mitek recommends a weekly inspection of all equipment. These inspections can be performed on a less frequent basis depending on the duration and frequency of use.

DePuy Mitek recommends that a bio-medical engineer or authorized service personnel annually check all equipment to assess its functionality and technical safety.

- Perform a visual inspection of the device. If damage is noted, contact your DePuy Mitek Sales Representative or call DePuy Mitek Customer Service in the USA at +1-800-3824682. Select Option 2 to speak to a biomed. - Inspect that the transparent safety cover (1) and black hinges are in good working order. - Inspect power cord and all cables for wear or cuts. - Ensure that the foot pedal and shaver interface connector pins are not missing or bent. - Plug the power cord to the power connection. - Switch the I/O switch (14) on “I”. - Turn the device ON by pressing the POWER (4) pad. Press on all pads. An audible tone should be heard for each pad pressed, except for Pressure Cycle, (Pad 8) Pressure Cycle is inactive until the pump is primed.

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1.1. Product Description Warning: Irrigation system. The FMS SOLO is an advanced, lower cost irrigation system that uses patented technology to improve visualization and distension while controlling pressure during arthroscopic surgery.

Flow compensation. The FMS SOLO can recognize when a shaver is in rotation and subsequently improve by activating the "Flow compensator" cycle. Please contact your DePuy Mitek representative for FMS Shaver Interface products due to the variety of products offered.

Pressure cycle red pedal. One of the most critical aspects of arthroscopy is visualization. The field of view is often obstructed by blood and debris. To alleviate this problem the FMS SOLO has a pressure cycle feature. By stepping on the red foot pedal you will activate a timed cycle of increased pressure to control bleeding. Once the cycle is completed, the FMS SOLO will return to its original configuration.

1.2. General Warnings and Cautions It is recommended that hospital personnel read this manual before operating or cleaning this product and its accessories. Failure to follow these instructions may result in potential injury and damage or malfunction of the equipment. 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 FMS products. Any alterations to this device, repair from an unlicensed service center, or use of non-FMS disposables, may void CE marking, FMS warranty and product liability coverage.

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The FMS SOLO is a Class I Type B device according to the Electrical Safety Standard EN 60601-1 for medical devices.. Ensure that you are using the correct interface cable when connecting to another shaver. For more details, refer to Interface Cable Instructions for Use. Contact your DePuy Mitek Sales Representative to review Shaver Interface Cable interface offerings. The system may be affected by electromagnetic interferences from other instruments. Verify that all other instruments and appliances (associated or not with the system) comply with the standard EN 60601-1-2 (EMC). If the system continues to be affected, isolate it from the offending instrument and connect to a different mains outlet.

1.3. Intended Use The FMS SOLO is intended to be used in arthroscopic surgery in the following joints: shoulder, knee, ankle, elbow, wrist, and hip.

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Chapter 1. Introduction

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1.4. Symbol Definitions

Front Panel

Back Panel

Power pad

On

Turns the power ON & OFF if the main power switch on the back of the pump is on (the green standby light is on).

Off

Alarm

Equipotential symbol (ground)

The red indicator will light up if a safety parameter is violated.

Pressure cycle. Alleviates bleeding during surgery, by increasing base pressure for two minutes.

Protected from water spray

1 – way foot pedal board

Type B Class 1

Used to activate or cancel a pressure cycle.

Conforms to standard EN 60601-1.

CE mark

Increase

Identification of notified body.

Warning

Decrease

see instructions for use.

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Explosion hazard

Main fuse

Replace fuses as marked Per Directive 2002/96/EC, product must be collected separately. Do not dispose of as unsorted municipal waste. Contact local distributor for disposal information. Do not wet

Store between these temperatures

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1.5. System Indicators

A – Front Panel 1

2

3

4

5

6

13

12

1

Transparent safety covers. This cover must be closed for the roller pump to rotate.

2

IRRIGATION roller pump. Provides fluid inflow.

3

Tension rocker arm. Holds the tubing on the roller pump head.

4

POWER pad. Turns the power ON & OFF if the main power switch in the back of the pump is on (the green “standby” light is on).

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10

9

8

7

5

PRESSURE display. Displays both the preset pressure when the base pressure is being set, and the dynamic pressure (1 sec) following the release of the pressure adjustment pads.

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ALARM. The red indicator will light up if a safety parameter is violated.

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Remote Control connector. Connects the remote control to the FMS SOLO.

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Pressure cycle. Alleviates bleeding by increasing base pressure for a 2 minute cycle.

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PRESSURE adjustment pads. Press the arrows to increase or decrease the pressure in increments of 5. The initial setting is 50.

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Pump Run/Stop pad. Turns the pump ON and OFF. If the pump is activated, <PUMP> appears on the pressure display. Green LED blinks when pump is on stop.

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Built-in Pressure transducer connection. To connect the One Day Set™ Irrigation Tube and measure the pressure in the pressure chamber.

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Fill Chamber pad. Manually fills the chamber and turns off the LOW PRESSURE alarm.

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Patented auto-locking device. Allows the disposable tubing to be properly positioned and locked in place around the roller pump.

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B – Rear Panel 19

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17 14

16

15

14

I/O switch, fuses and power connection.

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Identification & specification.

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Foot pedal connection. 9 - pin connector to plug foot pedal.

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Shaver interface connection. 25 - pin hand and foot control interface cables connector. Contact your DePuy Mitek Sales Representative for Shaver Interface Cable ordering information due to the variety of products available.

1.6. Other Indicators (Audible Tones).

. An audible tone sounds when the POWER pad is pressed and the pump turns on. . An audible tone sounds when the PRESSURE

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Serial number. • The first two digits represent the year of manufacturing. • The second set of digits represents the week of manufacturing and serial number.

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Reference number.

. Two audible tones sound when the PRESSURE mode is deactivated (see chapter 4 to deactivate the cycle).

mode is activated (see pressure cycle section to activate the cycle).

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Chapter 2. Operating Precautions, Checks and Warnings 2.1. Storage and Handling: Warnings: Factory Settings: Factory settings are based on experience, they should only be used as guidelines. The surgeon is responsible for settings depending on the surgical procedure performed. Electrical safety testing should be performed by a biomedical engineer or other qualified person. Risk of electrical shock: Do not remove the cover. Refer servicing to your DePuy Mitek Representative or DePuy Mitek Customer Service in the USA at +1 (800) 382-4682, Option 2. Do not connect the device to a power source that is not properly earthed (grounded). Disconnect the device from the main power source when cleaning, servicing, or inspecting. Inspect all equipment and cables periodically for wear. Contact your DePuy Mitek Representative or DePuy Mitek Customer Service in the USA at +1 (800) 382-4682, Option 2 if damage is noted. Avoid fluid contact with the FMS SOLO, and its electrical connectors. Do not use flammable agents when cleaning and disinfecting the FMS SOLO. To avoid risk of fire, replace fuses with same type and rating.

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Storage temperature: Do not expose the FMS SOLO to temperatures above 50°C (122°F) or below –10°C (14°F). Operating Conditions: Do not operate the pump in conditions above 40°C (104°F) or below 10°C (50°F). Damage: Do not use a FMS SOLO that has been dropped or shows signs of damage. Disposal: Do not incinerate. Contact your DePuy Mitek Representative or DePuy Mitek Customer Service in the USA at +1 (800) 382-4682, Option 2 to arrange for safe disposal.

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Chapter 3. Set-up Procedures 3.1. Pump Set-up.

Power on back of the pump on “I”.

Open the cover.

Press Power pad. The LCD will light up.

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3.2. Tubing Set-up.

A. Installing the One Day Set™ Irrigation Tube Ref. 284504 or 284503

This tube connects the saline solution bags to the irrigation tubing. Solution goes from the spikes (A) around the roller pump, through the pressure chamber, where the pressure is read through a filter (B) by a built-in pressure transducer.

Contact your DePuy Mitek Representative for ordering information since certain tubes are not offered in all countries. WARNING: Sterility is preserved only if the tube changing procedures have been performed precisely according to the set-up instructions below and in Section 3.2.E. Contact your DePuy Mitek Sales Representative for supporting documentation (A)

Clamps GREEN Auto-locking device

From solution bags

PRESSURE CHAMBER

(C) Intermediary Irrigation Tube

Clamps Clamps

To the Pressure transducer

(B) Filter

(A)

Close all three clamps and connect to fluid bags.

Slide the green part of the tube into the auto-locking deviced on the pump.

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Place and center the tube around the roller pump.

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Pull on the tube and close the tension rocker arm against the tube.

Position the pressure chamber in the holder. Connect the transducer to the pump by firmly screwing it in clockwise.

Green LED blinks. Press Run/ Stop. The green LED blinks initially, then remains on.

Press the Fill chamber pad several times until the chamber is 1/3 full. The green LED blinks until pad is pressed.

Close the cover.

Warning: It is mandatory that the pressure chamber remains vertical during the procedure and that the pump be positioned at the same level as the patient. Over filling the chamber may result in the filter (shown in 3.2.A) becoming wet prior to the pressure transducer and therefore interfere with accurate pressure measurement. Should over filling of the chamber occur, see Chapter 6 for Troubleshooting.

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B. Installing the Intermediary Irrigation Tube Ref. 281103, 281142, or 281103* (D) From the One Day Set™ Irrigation Tube Ref. 284504 or 284503

Sterile Buffer Zone One-Way Blue

Blue

Red To the arthroscope Sheath

White

This tube connects the irrigation tube to the sheath in a sterile manner * Ref. 281103 does not include the Sterile Buffer Zone One-Way Valve. Ref. 281103 is intended for single use of the One Day Set™ Irrigation tube. (D) (C) (D) (C)

After checking that the luerlock is properly tightened, the sterile nurse takes the irrigation tube and passes the blue end (D) to a non-sterile person.

The non-sterile person removes the blue caps from the irrigation tube (D) and the One Day Set™ Irrigation Tube (C)...

The pump must be in the Run mode (10), with the light on. Prime the irrigation tube by opening the clamp under the pressure chamber. When primed, close the clamp or the stopcock on the arthroscope (in the sterile zone).

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... and immediately connects the One Day Set™ Irrigation Tube (C) luer-lock, to the irrigation tube (D) luer-lock.

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C. Getting Started.

STERILE ZONE

Insert the cannula tube onto the cannula.

STERILE ZONE

Insert the shaver tube onto the shaver suction port.

STERILE ZONE

Connect the luer-lock to the arthroscope. Open the stop-cock on the scope.

NON-STERILE ZONE

Open the clamp under the chamber.

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D. End of the Operation.

Close the clamp under the pressure chamber.

Press Run/Stop pad (or open transparent safety cover).

NOTE: When another surgery is scheduled for the same operating day, the One Day Set™ Irrigation Tube can remain in place.

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Disconnect the blue luerlock (E) of the Intermediary Irrigation tube.

Warning: The Sterile Buffer Zone One-Way Valve must remain attached to the One Day Set™ Irrigation Tube which ensures sterility between surgeries.

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E. Set-up for Next Operation. The One Day Set™ Irrigation Tube can be left in place at the end of the previous operation with the sterile buffer zone one-way valve attached.

(C) (D)

(C) (D)

After checking that the luerlock is tightened, the sterile nurse takes the irrigation tube and passes the blue end (D) to a non-sterile person.

The non-sterile person removes the old sterile buffer zone by disconnecting the luerlocks of the One Day Set™ Irrigation Tube (C) and the Intermediary irrigation tube...

Warning: Never attach one sterile buffer zone one-way valve to another.

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... and immediately connects the blue luer-lock (D) of the new irrigation tube to the blue luer-lock (C) of the One Day Set™ Irrigation Tube.

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F. End of Operating Day.

Close all white clamps.

Turn off the pump by pressing the POWER pad. Throw away all of the tubing.

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