fms solo Instruction Manual Jan 2007

fms solo® system

Pressure cycle

A Italiano

Português

A. 2 portals in the knee

A. 2 accessi al ginocchio

A. 2 portas no joelho

Español

Deutch

Русский

English

A. 2 vías de acceso en la rodilla

A. 2 Zugänge im Knie

A. 2 портала в колене

Français

A. 2 voies dans le genou

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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 FMS Customer Service Department: Tel: +33 4 92 12 33 93 or email: [email protected] Save all packing material, as they will be required to ship products in the event of a product return.

- Turn the device ON by pressing the POWER (4) pad. - Switch the I/O switch (14����� ) on “I”. ���� - Press the Pump Run/Stop pads (10) to Run. - Press on all pads (an audible tone should be heard for each pad pressed).

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 1.6.



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Weekly inspection:

Annual inspection:

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

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

- 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 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 the Pump Run/Stop pads (10). - Press on all pads (an audible tone should be heard for each pad pressed).

Refer to Service manual for annual inspection procedures.



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Table of contents CHAPTER 1. INTRODUCTION 1.1. 1.2. 1.3. 1.4. 1.5. 1.6. 1.7.

8

Product description ... 8 Declaration of conformity ... 8 General warnings and cautions ... 8 Intended use ... 9 Symbol definitions ... 10 System indicators ... 12 A. Front panel ... 12 B. Rear panel ... 14 Other indicators ... 14

CHAPTER 2. OPERATING PRECAUTIONS, CHECKS & WARNINGS

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2.1. Sterile packaging ... 15 2.2. Storage and handling ... 15 CHAPTER 3. SET-UP PROCEDURES 3.1. 3.2.

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Pump set-up ... 16 Tubing set-up ... 17 A. Installing the “One Day Set™” Ref. 4503 ... 18 B. Irrigation tubing set up Ref. 1102 ... 20 C. Getting Started ... 21 D. End of operation ... 22 E. Set up of next operation . ... 23 F. End of operating day ... 24

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CHAPTER 4. PUMP SYSTEM FUNCTIONS 4.1. 4.2. 4.3. 4.4. 4.5. 4.6. 4.7. 4.8.

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Run/stop ... 25 Preset pressure ... 25 Filling the chamber . ... 25 Recommended initial preset pressure . ... 26 Pressure alarm . ... 26 Pressure Cycle mode (red pedal) ... 27 Maintenance: cleaning & decontamination ... 27 Interface cables ... 28

CHAPTER 5. TROUBLESHOOTING

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CHAPTER 6. PRODUCT SPECIFICATIONS & ORDERING INFORMATION 31



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Chapter 1. Introduction 1.1. Product description

1.2. Declaration of conformity

The fms solo is an advanced, and user friendly irrigation system that uses patented technology to improve visualization and lower cost.

We, at fms group declare under our sole responsibility that the product fms solo® is in conformity according to CE 93/42 EEC Medical Device Directive. This product is manufactured in an ISO 9001:2000/13485 facility.

Flow compensation.

1.3. General warnings and cautions

Pressure cycle red pedal.

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.

Irrigation system. ®

The fms solo® communicates with your current shaver, improving visualization by activating the “Flow compensator” cycle while the shaver is in rotation. 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. 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.

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, FMS warranty and product liability coverage.



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1.4. Intended use

Warning: The fms solo is a Class I Type B device. Ensure that you are using the correct interface cable when connecting to another shaver. For more details see section 4.8. Interface cables. ®

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 main output. The fms solo® is covered by US patent N° 5 131 823, European patent N° 0 448 909 B1, Japanese patent N° 2 892 852. fms solo® is a registered trademark 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.



The fms solo® is intended to be used in arthroscopic surgery in the following joints: shoulder, knee, ankle, elbow, wrist, hip.

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1.5. 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 Equipotentiality symbol

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.

Waterproof for projections

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

and identification of notified body.

Warning

Decrease

see instructions for use.

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Explosion hazard

Expiration date

Main fuse

Do not wet

Replace fuses as marked

Do not reuse

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

To be used for only one day

Date of manufacture year and month Store between these temperatures

Latex free Sterile unless the package is damaged or open. Sterilization by ethylene oxide.

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Disposable Product labeling

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1.6. System indicators A – Front panel 1

2

3

4

5

6

13

12

11

10

1 Transparent safety covers. This cover must be closed for the roller pump to rotate. 2

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.

IRRIGATION roller pump. Provides fluid inflow.

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

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

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).

7 Remote Control connector. Connects the remote control to the fms solo®.

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9 PRESSURE adjustment pads. Press the arrows to increase or decrease the pressure in increments of 5. The initial setting is 50. 10 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. 11 Built-in Pressure transducer

connection. To connect the “One Day Set™” and measures the pressure in the pressure chamber. 12 Fill Chamber pad. Manually fills the chamber and turns off the LOW PRESSURE alarm. 13 Patented auto-locking device. Allows the disposable tubing to be properly positioned and locked in place around the roller pump.

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

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B – Rear panel 19

18

17 14

16

15

14 I/O switch, fuses and

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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.

19

Reference number.

power connection.

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Identification & specification.

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

Shaver interface connection. 25 - pin hand and foot control interface cables connector. 17

1.7. Other indicators (Audible tones).

. An audible tone sounds when the POWER pad is . Two audible tones sound when the PRESSURE pressed and the pump turns on. mode is deactivated (see chapter 4 to deactivate the cycle). . An audible tone sounds when the PRESSURE mode is activated (see pressure cycle section to activate the cycle).

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Chapter 2. Operating precautions, checks and warnings Studies can be downloaded on our website at:

Warning: Electrical safety testing should be performed by a biomedical engineer or other qualified person.

In English: www.fmsgroup.com/files/sales/viralen.pdf www.fmsgroup.com/files/sales/biologicalen.pdf

Risk of electrical shock: do not remove the cover. Refer servicing to qualified or authorized fms Repair Service Center.

In French: www.fmsgroup.com/files/sales/viralfr.pdf www.fmsgroup.com/files/sales/biologicalfr.pdf

Do not connect the device to a power source that is not properly earthed (grounded).

All other tube sets, are marked with a that they are single-use only

Disconnect the device from the main power source when cleaning, servicing, or inspecting.

2.2. Storage and Handling:

Inspect all equipment and cables periodically for wear. Replace and return to fms Repair Service Center if damage is noted. Avoid fluid contact with the fms solo®, and its electrical connectors.  o not use flammable agents when cleaning and D disinfecting the fms solo®. To avoid risk of fire, replace fuses with same type and rating.

2.1. Sterile Packaging: Carefully examine the shipping package and sterile wrap. If the package is damaged, the sterile seal is broken, or the Expiration Date is passed, do not use. The “One Day Set™” 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 our set-up guide in Chapter 3.

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indicating

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 +10°C (50°F) to +40°C (104°F). Damage: Do not use a fms solo® that has been dropped or shows signs of damage. Disposal: Do not incinerate. Return to fms for safe disposal.

Factory Settings: Factory settings are based on experience, they should only be used as guidelines. The surgeon is responsible for settings pertaining to his surgical procedure.

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Chapter 3. Set-up Procedures

3.1. Pump set-up.

Power on back of the pump

Open the cover.

Press Power pad. The LCD will light up.

on “I”.

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3.2. Tubing set-up.

(A)

Clamps

GREEN Auto-locking device

From solution bags

(A)

“One Day Set™” Ref. 4503

Clamps

PRESSURE CHAMBER

(B)

To the transducer

Clamps

To irrigation tubing

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

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

Blue

Sterile Buffer Zone

Blue

Red To the arthroscope

White

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

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

This tubing connects the saline solution bags to the irrigation tubing. Solution goes from the spikes (A)

Clamps GREEN Auto-locking device

From solution bags

PRESSURE CHAMBER To irrigation tubing

Clamps

To the transducer

Clamps

(B)

(A)

Close all three clamps and connect to fluid bags.

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

Pull on the tubing and close the tension rocker arm against the tube. 18

Place and center the tubing around the roller pump.

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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 cover.

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

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

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B. Installing the Irrigation tubing Ref. 1102 (D) From the One Day Set™ Ref. 4503

Sterile Buffer Zone Blue

Blue

Red 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 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 (10), with the light on. Prime the irrigation tubing by opening the clamp under the pressure chamber. When primed, close the clamp or the stop-cock on the arthroscope (in the sterile zone).

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... and immediately connects th��e “One ��������������� Day Set™” (C) luer-lock, to the irrigation tubin���������������� g (D) luer-lock.

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C. Getting started.

STERILE ZONE

STERILE ZONE

Insert the cannula tubing onto the cannula.

Insert the shaver tubing onto the shaver suction port.

STERILE ZONE

NON-STERILE ZONE

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

Open the clamp under the chamber.

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