DePuy Mitek FMS SOLO User manual

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CHAPTER 1. INTRODUCTION 9
1.1. Product Description ........................................................................ 9
1.2. General Warnings and Cautions .................................................... 9
1.3. Intended Use .................................................................................. 9
1.4. Symbol Denitions ........................................................................ 10
1.5. System Indicators ......................................................................... 12
A. Front Panel ............................................................................... 12
B. Rear Panel ............................................................................... 14
1.6. Other Indicators (Audible Tones) .................................................. 14
CHAPTER 2. OPERATING PRECAUTIONS, CHECKS & WARNINGS 15
2.1. Storage and Handling .................................................................. 15
CHAPTER 3. SET-UP PROCEDURES 16
3.1. Pump Set-up ................................................................................ 16
3.2. Tubing Set-up ............................................................................... 17
A. Installing the One Day Set Irrigation Tube ............................... 17
B. Installing the Intermediary Irrigation Tube ............................... 19
C. Getting Started ......................................................................... 20
D. End of Operation ...................................................................... 21
E. Set-up for Next Operation ........................................................ 22
F. End of Operating Day ............................................................... 23
Table of Contents
WARRANTY AND SERVICE 6
UNPACKING, ASSEMBLY AND INITIAL SYSTEM CHECK 7
INSPECTION SCHEDULE 8
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CHAPTER 4. PUMP SYSTEM FUNCTIONS 24
4.1. Run/Stop ....................................................................................... 24
4.2. Preset Pressure ............................................................................ 24
4.3. Filling the Chamber ...................................................................... 24
4.4. Recommended Initial Settings ..................................................... 25
4.5. Pressure Alarm ............................................................................. 25
4.6. Pressure Cycle Mode ................................................................... 26
CHAPTER 5. MAINTENANCE: CLEANING & DECONTAMINATION 27
CHAPTER 6. TROUBLESHOOTING 28
CHAPTER 7. PRODUCT SPECIFICATIONS 30
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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 specic 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 [phone] and choose Option 2 in the United States or contact
your DePuy Mitek representative.
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Unpacking, Assembly and Initial
System Check
Unpacking:
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 [phone], select
Option 2. Save all packaging material, as they
will be required to ship products in the event of a
product return.
Once box is open, remove, read, and follow the
Instructions for Use. To remove the FMS SOLO
console, place hands on both sides of console,
until you can securely grasp the underside.
Carefully remove the console from the box and
place it on a level and sturdy surface.
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.
Initial System Check:
- 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.)
Note: numbers in ( ), refer to diagram in section 1.5.
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Inspection Schedule
Weekly 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.
- 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 +1-800-382-
4682. 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.
Annual inspection:
DePuy Mitek recommends that a bio-medical
engineer or authorized service personnel annually
check all equipment to assess its functionality and
technical safety.
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1.1. Product Description
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 eld 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
conguration.
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.
The tube sets contain DEHP, a phthalate
chemical known to cause birth defects and other
reproductive harm, including in children and in
pregnant or nursing women.
Warning:
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. Indication for Use
The FMS SOLO Arthroscopic Fluid Management
System is indicated for use in a surgical setting by
personnel trained in arthroscopy.
Chapter 1. Introduction
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1.4. Symbol Denitions
Front Panel Back Panel
Power pad
Turns the power ON & OFF if
the main power switch on the
back of the pump is on (the
green standby light is on).
On
Off
Alarm
The red indicator will light up if
a safety parameter is violated.
Equipotential symbol
(ground)
Pressure cycle
Alleviates bleeding during
surgery, by increasing base
pressure for two minutes.
IP50
No protection from liquid
One-way foot pedal board
Used to activate or cancel a
pressure cycle.
Type B Class 1
Conforms to standard
EN 60601-1.
Increase Caution
See instructions for use.
Decrease
Refer to instruction manual/
booklet
Refer to instruction manual/
booklet
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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
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1
Transparent safety covers.
This cover must be closed for the
roller pump to rotate.
2
IRRIGATION roller pump.
Provides uid inow.
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).
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
Remote Control connector.
Connects the remote control to the
FMS SOLO.
A – Front Panel
1.5. System Indicators
1 2 3 4 5
6
78910111213
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8
Pressure cycle.
Alleviates bleeding by increasing base
pressure for a 2 minute cycle.
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 Irrigation
Tube and measure the pressure in the
pressure chamber.
12
Fill Chamber pad.
Manually lls 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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14
I/O switch, fuses and
power connection.
15
Identication & specication.
16
Foot pedal connection.
9-pin connector to plug foot pedal.
17
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.
18
Serial number.
• The rst two digits represent the year
of manufacturing.
• The second set of digits represents
the week of manufacturing and serial
number.
19
Reference number.
B – Rear Panel
14
15
16
17
18
19
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
mode is activated (see pressure cycle section to
activate the cycle).
. Two audible tones sound when the PRESSURE
mode is deactivated (see chapter 4 to
deactivate the cycle).
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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 qualied 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
[phone], 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
[phone], Option 2 if damage is noted.
Avoid uid contact with the FMS SOLO, and its
electrical connectors.
Do not use ammable agents when cleaning and
disinfecting the FMS SOLO.
To avoid risk of re, replace fuses with same type
and rating.
2.1. Storage and Handling:
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
[phone], Option 2 to arrange for safe
disposal.
Chapter 2. Operating Precautions,
Checks and Warnings
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Chapter 3. Set-up Procedures
3.1. Pump Set-up.
Power on back of the
pump
on “I”.
Press Power pad.
The LCD will light up.
Open the cover.
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WARNING: This product is for single-use only. It
has not been designed to be re-used/re-sterilized.
Reprocessing may lead to changes in material
characteristics such as deformation and material
degradation which may impact the strength of the device
and compromise device performance. Reprocessing of
single use devices can also cause cross-contamination
leading to patient infection. These risks may potentially
affect patient safety.
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.
This product contains DEHP, a phthalate chemical
known to cause birth defects and other reproductive
harm, including in children and in pregnant or nursing
women.
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 lter (B) by a built-
in pressure transducer.
A. Installing the One Day Set Irrigation Tube
Ref. 284504 or 284503
Contact your DePuy Mitek Representative for ordering
information since certain tubes are not offered in all
countries.
3.2. Tubing Set-up.
From
solution
bags
To the Pressure
transducer
Intermediary
Irrigation Tube
(A)
(A)
Clamps (B)
GREEN
Auto-locking device PRESSURE CHAMBER
Clamps
Clamps
(C)
Filter
Close all three clamps and
connect to uid bags. Slide the green part of the
tube into the auto-locking
device on the pump.
Place and center the tube
around the roller pump.
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Position the pressure chamber
in the holder. Connect the
transducer to the pump by
rmly screwing it in clockwise.
Green LED blinks. Press Run/
Stop. The green LED blinks
initially, then remains on.
Close the cover.
Press the Fill chamber
pad several times until the
chamber is 1/3 full. The
green LED blinks until pad is
pressed.
Pull on the tube and close the
tension rocker arm against the
tube.
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 lling the chamber may result in the lter (shown in 3.2.A) becoming wet prior to the pressure
transducer and therefore interfere with accurate pressure measurement. Should over lling of the chamber
occur, see Chapter 6 for Troubleshooting.
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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/Intermediary Tubing with One-Way
Check Valve. Ref. 281103 is intended for single use of the One Day Set Irrigation tube.
B. Installing the Intermediary Irrigation Tube Ref. 281103, 281142, or 281103*
After checking that the luer-
lock 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)...
... and immediately
connects the One Day Set
Irrigation Tube (C) luer-lock, to
the irrigation tube (D) luer-lock.
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 stop-
cock on the arthroscope (in the sterile zone).
(D)
(C)
(C)
(D)
To the
arthroscope
Sheath
From the One Day
Set Irrigation Tube
Ref. 284504 or 284503
(D)
Sterile Buffer Zone One-Way
Valve/Intermediary Tubing with
One-Way Check Valve
White
Blue Blue Red
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C. Getting Started.
Connect the luer-lock to the arthroscope. Open
the stop-cock on the scope. Open the clamp under the chamber.
STERILE ZONE
STERILE ZONE
STERILE ZONE
NON-STERILE ZONE
Insert the cannula tube onto the cannula. Insert the shaver tube onto the shaver
suction port.
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Close the clamp under the
pressure chamber.
Disconnect the blue luer-
lock (E) of the Intermediary
Irrigation tube.
Press Run/Stop pad (or open
transparent safety cover).
D. End of the Operation.
Note: Ref. 284503 & 284504
“One Day Set” can be
re-used for multiple
procedures during the same
surgical day. Warning:
Sterility is preserved only if
proper set-up and tube
changing procedures have
been followed.
Warning:
The Sterile Buffer Zone
One-Way Valve/Intermediary
Tubing with One-Way Check
Valve must remain attached
to the One Day Set Irrigation
Tube which ensures sterility
between surgeries.
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After checking that the luer-
lock is tightened, the sterile
nurse takes the irrigation tube
and passes the blue end (D)
to a non-sterile person.
... 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.
The non-sterile person
removes the old sterile buffer
zone by disconnecting the
luer-locks of the One Day Set
Irrigation Tube (C) and the
Intermediary irrigation tube...
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/Intermediary Tubing with One-Way Check Valve attached.
Warning:
Never attach one Sterile
Buffer Zone One-Way
Valve/Intermediary
Tubing with One-Way
Check Valve to another.
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