fms duo + Instruction and Service Manual

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4.1. Run/Stop ... 28 4.2. Preset pressure ... 28 4.3. Filling the chamber ... 28 4.4. Pressure alarms ... 29 4.5. Suction settings . ... 30 A – Cannula Suction ... 30 B – Shaver suction . ... 30 4.6. Lavage mode ... 30 4.7. Foot pedal activation . ... 31 4.8. Recommended initial pressure settings . ... 33 4.9. Interface Cables ... 34 A. Hand control interfaces ... 34 B. Foot control interfaces ... 35 Chapter 5. Shaver system functions 36 5.1. Handpiece set-up ... 37 5.2. Handpiece operation ... 37 5.3. Inserting and removing cutters and burrs . ... 38 5.4. fms duo®+ Shaver console operation and settings ... 38 5.5. Maintenance: Cleaning and decontamination ... 39 5.6. Shaver blade indicators . ... 40 5.7. Limited reusable shaver blades, cleaning and decontamination . ... 41 Chapter 6. Troubleshooting 42 Chapter 7. Ordering information and product specification 44 7.1. Ordering informations and product specifications ... 44 7.2. FMS cutter, burr & mini blades guide ... 45 Service Manual

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Chapter 4. Pump System Functions

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Unpacking, assembly 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 FMS Customer Service Department. Save all packing material, as they will be required to ship products in case of a product return.

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Assembly: -

Connect the power cord to the power connection (23). Connect the foot pedal to the foot pedal connection (25) on the back of the pump.



Turn the device ON by pressing the POWER (4) pad. Switch the I/O switch (23) on “I”. Press the Pump (13) and Shaver Run/Stop pads (18) to Run. Press on all pads (an audible tone should be heard for each pad pressed).

Annual inspection:

FMS recommends a weekly inspection of all equipment. These inspections can be performed on a less regular bases depending on the duration and frequency of use. - Perform a visual inspection of the device. If damage is noted return to FMS Service Centre for internal damage inspection. - Inspect that the transparent safety covers (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 handpiece connector pins are not missing or bent. - Plug the power cord to the power connection. - Switch the I/O switch (23) on “I”. - Turn the device ON by pressing the POWER (4) pad. - Press the Pump (13) and Shaver Run/Stop pads (18). - Press on all pads (an audible tone should be heard for each pad pressed).

FMS recommends that a bio-medical engineer or authorized service personnel annually check all equipment to assess its fuctionality and technical safety. Refer to Service manual for annual inspection procedures.



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Weekly inspection:

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Chapter 1. Introduction 1.1. Product description

Integrated shaver system.

Dual pump system.

The fms duo®+ is also an integrated shaver console. The Tornado is a lightweight high-speed titanium shaver handpiece. When the shaver rotates, the fms duo®+ automatically activates suction through the shaver and clamps off other suction ports. If you prefer to use your current shaver system, the same functions are provided using an interface cable.

The fms duo®+ provides irrigation and suction in one unit. Both roller pumps are computercontrolled and automatically manage fluid. The integrated suction pump automatically controls both shaver and cannula suction, reducing laborintensive manipulations. By controlling both inflow and outflow, the fms duo®+ accurately regulates pressure and flow.

1.2. Declaration of conformity

Blue pedal (cannula suction).

We, at Future Medical Systems S.A. (CE-0197) declare that the products in this manual are in conformity according to 93/42/EEC Medical Device Directive. It is CE approved by the Tüv Rheinland (notified body registered under n° 0197) and approved under the Food and Drug Administration (FDA) 510K Process. This product is manufactured in an ISO 9001 facility.

To increase flow without increasing joint pressure, step on the blue foot pedal. The suction pump will accelerate and the irrigation pump will immediately increase inflow to compensate for the increased fluid loss. This feature is particularly useful when eliminating debris.

Red pedal (lavage mode). One of the most critical aspects of arthroscopy is visualization, which is often obstructed by blood and debris. To alleviate this problem the fms duo®+ has a lavage mode. By stepping on the lavage pedal you will activate a timed cycle of increased flow and pressure which controls bleeding and clears the field of view. Once the cycle is complete, the fms duo®+ will return to its original settings.



It is recommended that hospital personnel read this manual before operating, cleaning or sterilizing 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, will void CE marking, and FMS warranty, and product liability coverage. Warning: The fms duo®+ 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, see section 4.9. (Interface cables). The system may be affected by electromagnetic interference 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 main output. The fms duo®+ system is covered by US patents N° 4 902 277, N° 5 000 733 and N° 5 131 823, European patents N° 0 306 445 and N° 0 448 909 B1, Japanese patents N° 2 107 259 and 2 892 852. arthro fms® and fms duo®+ are registered trademarks of Future Medical System S.A. Reproduction, transfer, distribution of part or all of the contents in this document in any form without the prior written permission of fms is prohibited.

1.4. Intended use The fms duo®+ is intended to be used in arthroscopic surgery in the following joints: shoulder, knee, ankle, elbow, wrist, hip.

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1.3. General warnings and cautions

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1.5. Symbol definitions Power pad Turns the power on if the main power switch on the back of the pump is on (the green standby light is on).

On

Alarm Off

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

Lavage pad This feature automatically sets off a sequence of pressure and flow increases to clear blood and debris from the field of view.

Shaver handpiece

Shaver handpiece

Increase

suction level

Decrease

Forward

4 - way foot pedal Four-way color-coded foot-pedal to activate shaver and pump functions.

Reverse

2 - way foot pedal Oscillate

Two-way color-coded foot-pedal to activate the pump functions only.

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Equipotentiality symbol

Use by year and month

(ground)

Waterproof for projections

Do not wet

Type B Class 1 Do not reuse

Conforms to standard EN 60601-1

CE mark and identification of notified body

Warning

Reusable for only one day

Date of manufacture year and month

see instructions for use

Explosion hazard Do not use in presence of flammable anesthetics or gases.

Store between these temperatures

Main fuse

Latex free

Replace fuses as marked

Sterile unless the package is damaged or open. Sterilization by Ethylene Oxyde

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

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- Disposable products labeling.

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1.6. System indicators A – Front panel 2

3

4

5

6

7

8

1 22

21 20

9

19

1

18 17 15

16 15 14 13 12

Transparent safety cover.

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. 6 ALARM. The red indicator will light up if a safety parameter is violated. 7 SHAVER speed display. Indicates the speed and direction of rotation.

This cover must be closed for the roller pump to rotate. 2

IRRIGATION roller pump. Provides fluid inflow.

3

11 10

Tension rocker arm.

Holds the tubing on the roller pump head. 4 POWER pad. Turns the power ON if the main power switch, in the back of the pump is on (the green “standby” light is on).

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17 Cannula suction setting. Sets the flow rate through the cannula. (Min, Low, Med, High). 18 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 the pump is stopped. 19 Built in pressure transducer  connection. Measures the pressure in the pressure chamber of the “One Day Set™”. 20 Fill chamber pad. Manually fills the chamber and turns off the LOW PRESSURE alarm. 21 PRESSURE adjustment pads. Press the arrows to increase or decrease the pressure level in increments of 5. The initial setting is 50. 22 Auto-locking device. The patented device allows the disposable tubing to be properly positioned and locked in place around the two roller pumps. For safety reasons, it has been color-coded green for the IRRIGATION and orange for the SUCTION tubing.

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8 SUCTION roller pump. Provides outflow of fluid. 9 Pinch valve. Moves automatically when the shaver is in rotation, selecting the appropriate suction tube. 10 Lavage mode pad. Automatically starts a two-minute sequence of pressure and flow increases to clear blood and debris from the field of view. 11 Pinch valve pad. This automatically opens the pinch valve to insert or remove the suction tubings. 12 SHAVER Speed Selection pads. Select Low, Med or High pre-set shaver speeds. 13 SHAVER Run/Stop pad. Starts and stops the shaver mode when using the FMS shaver. 14 SHAVER Suction setting. Indicates the suction rate selected through the shaver (Min, Low, Med, High). 15 SHAVER Speed increase/ decrease pads. Increases or decreases the shaver rotation speed (rpm - rotation per minute). This can also be achieved using the foot pedal. 16 SHAVER handpiece connection. Line up the red dots on the male and female connectors to connect the shaver handpiece.

B I

B – Rear panel ENGLISH

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27 DISTRIBUTED BY : FUTURE MEDICAL SYSTEM SA 38 Chemin du Grand-Puits 1217 GENEVA SWITZERLAND

LEGAL MANUFACTURER: FUTURE MEDICAL SYSTEMS SA 265, Route de la Baronne 06640 SAINT JEANNET FRANCE

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FUTURE MEDICAL SYSTEMS, Inc. 504 McCormick Drive GLEN BURNIE, MD 21061 USA

www.fmsgroup.com

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TYPE B CLASS I

25

24

23 I/O switch, fuses and

DISTRIBUTED BY :

27 Serial number. FUTURE MEDICAL SYSTEM SA power connection. • The first two digits represent the 38 Chemin du Grand-Puits 1217 GENEVA year of manufacturing. 25 Foot pedal connection. SWITZERLAND • The second set of digits LEGAL MANUFACTURER: 9 - pin connector to plug the the week Inc. FUTURE MEDICAL 2 - way and 4 - way foot SYSTEMS pedal. SA FUTURE MEDICAL SYSTEMS,represents 504 McCormick Drive 265, Route de la Baronne of manufacturing. 26 Shaver interface connection. GLEN BURNIE, MD 21061 06640 SAINT JEANNET 28 FMS reference number. USA FRANCE 25 - pin hand and foot control interface cables connector.www.fmsgroup.com 24

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29

30

31

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C – 4 - Way foot pedal 32 29 REVERSE Pedal. 30 FORWARD Pedal. 31 CANNULA SUCTION Pedal (blue). 32 LAVAGE MODE Pedal (red). 30 + 31 Together = SPEED -31 + 32 Together = SPEED +

1.7. 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 Lavage mode is activated (see section 4.6. to activate the cycle). • Two audible tones sound when the Lavage mode is deactivated.

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Chapter 2. Operating precautions, checks and warnings Warnings: 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 qualified or authorized FMS Repair Service Center. 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 equipment and cables periodically for wear. Replace and return to FMS Repair Service Center if damage is noted. Avoid fluid contact with the fms duo®+, and its electrical connectors. Do not use flammable agents when cleaning and disinfecting the fms duo®+. To avoid risk of fire, replace fuses with same type and rating.

Studies can be downloaded on our website at: In English: www.fmsgroup.com/files/sales/viralen.pdf www.fmsgroup.com/files/sales/biologicalen.pdf In French: www.fmsgroup.com/files/sales/viralfr.pdf www.fmsgroup.com/files/sales/biologicalfr.pdf All other tube sets are marked with a indicating that they are single-use only.

2.2. Storage and Handling Storage temperature: Do not expose the fms duo®+ 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 the fms duo®+ or arthro fms® shaver if dropped or showing signs of damage. Disposal: Do not incinerate. Return to FMS for safe disposal. Factory Settings: Factory settings are based on experience and should only be used as guidelines. The surgeon is responsible for settings depending on the surgical procedure performed.

2.1. Sterile Packaging Carefully examine the shipping package and sterile wrap. If the package is damaged, the sterile seal is broken, or if the Expiration Date has passed, do not use. The “One Day Set™” (see section 3.2.), Ref. 4503, can be reused for an entire surgical day not exeeding eight consecutive hours. Biological and viral studies have shown the efficacy against contamination from one patient to the next during the operating day. Sterility is guaranteed only if the tube changing procedures have been performed precisely according to the set-up guide in Chapter 3.

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3.1. Pump set-up

Power on back of the pump on “I”.

Open both covers.

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Press Power pad. The LCD will light up.

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Chapter 3. Set-up Procedures

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3.2. Tubing set-up Disposable tubings used with the fms duo®+ (A)

“One Day Set™” Ref. 4503

Clamps

GREEN Auto-locking device

From solution bags

(A)

PRESSURE CHAMBER

To irrigation tubing

Clamps

(B)

To the transducer

Clamps

(C)

This tubing connects the irrigation bags to the irrigation tubing via the spikes (A) and the pressure chamber, where the pressure is read through a filter (B) by a built-in transducer.

Patient set Ref. 4509

- Irrigation tubing (D) Blue

Sterile Buffer Zone

From the “One Day Set™” Ref. 4503

Red

Blue

To the arthroscope

White

This tubing connects the “One Day Set™” to the arthroscope in a sterile manner.

- Suction tubing Red clamp

(Y) (Z)

ORANGE Auto-locking device

To waste collection bag

This tubing allows suction from the joint, either directly from a cannula or through an auxiliary suction (shaver or basket punch). Both suction modes are controled by the pinch valve.

Irrigation tubing Ref. 1102 (D) From the “One Day Set™” Ref. 4503

Blue

Sterile Buffer Zone

Blue

Clamp

Red

This tubing is individually wrapped and allows a simple diagnosis to be performed when the irrigation tubing (Ref. 4503) is already set up.

Single suction tubing Ref. 4505 Red clamp From surgical site

To waste collection bag

This tubing is set up with the Irrigation Tubing Ref. 1102 for simple operation (generally when a shaver is not used).

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This tubing connects the saline solution bags to the irrigation tubing. Solution flows from the spikes (A) around the roller pump, through the pressure (A)

Clamps GREEN Auto-locking device

From solution bags

(A)

chamber, where the pressure is read through a filter (B) by the built-in pressure transducer.

Clamps

Close all white clamps and connect to fluid bags.

To the transducer

PRESSURE CHAMBER

(B)

Slide the green part of the tubing into the auto-locking device on the pump.

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

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(C) Clamps

To irrigation tubing

Place and center the tubing around the roller pump.

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A. Installing the “One Day Set™” Ref. 4503

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Position the pressure chamber in the holder.

Connect the transducer to the pump by firmly screwing it in, clockwise.

Close the left 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.

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

Press the Fill Chamber pad several times until the chamber is 1/3 full.

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B. Installing the Patient Set Ref. 4509 I. Irrigation tubing set up. (D)

From the “One Day Set™” Ref. 4503

(E)

Sterile Buffer Zone

Blue

Red

Blue

To the arthroscope

White

This tubing connects the irrigation tubing to the sheath in a sterile manner.

(D)

(C) (D) (C)

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

The non-sterile person removes the blue caps from the irrigation tubing (D) and the “One Day Set™” (C)...

The pump must be in the Run mode (18), with the light on. Prime the irrigation tubing by opening the clamp under the pressure chamber. When primed, close the stop-cock on the arthroscope (in the sterile zone).

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... and immediately connects the “One Day Set™” (C) luer-lock, to the irrigation tubing (D) luer-lock.

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II. Suction tubing set up. Red clamp

(Y) (Z)

ORANGE Auto-locking device

To waste collection bag

This tubing allows suction from the joint, either from a cannula (Y) or through a shaver (Z). Do not close the red clamp. The red clamp should only be used to reduce or stop flow during surgery.

The scrub nurse passes the waste extremity of the suction tube to the non-sterile person (circulating nurse).

The circulating nurse inserts the waste end in a waste collection bag (Ref. 1380).

Place and center the tubing around the roller pump.

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Slide the orange part of the tubing into the auto-locking device on the pump.

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Pull on the tubing. Close the tension rocker arm against the tube.

Insert the right tube into the right Pinch valve slot.

Slide the tubes behind the tube holder under the Pinch Valve.

Close the right cover.

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Press on the Pinch valve pad and insert the left tube into the left Pinch valve slot (the LED will stop blinking).