Flosteady Repair Manual PDF
Flosteady Repair Manual PDF
Sheet of
05/13/09 A C 1000-400-973 1 44
Stryker Endoscopy
5900 Optical Court, San Jose, CA 95138
K. DOMAS 05/13/09
SIZE REV. DOCUMENT NO. SHEET OF
A C 1000-400-973 1 44
REVISIONS REVISIONS
LTR ECN NO. DATE APPROVED LTR ECN NO. DATE APPROVED
A ECO104733 02/26/07 S/A.INFELISE
B ECO31316 04/15/09 S/K.DOMAS
C ECO31321 05/13/09 S/K.DOMAS
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Servicehandbuch DE
Service manual EN
1 Safety Notes
1.1 Liability
Device and accessories have been carefully inspected at the factory before
shipping. However, the manufacturer is only liable for safety and reliability as
well as functionality if all inspections and repairs have been performed by
authorized technicians and if the device and the accessories are used only as EN
intended.
An authorized service technician has to inspect and service the device every two
years to ensure the safety and functionality of the unit. If the service interval is
not maintained, the manufacturer does not assume any liability for the
functional safety of the device.
Service and maintenance of the device and its accessories has to be carried out
as per instructions to ensure a safe operation of the device. Test and check
function and completeness of the device after every service or maintenance
activity to ensure the safety of the patient and user/operator are not affected or
diminished in any way. Factory-new and repaired products must be prepared and
tested according to the manual prior to use.
1.2 Certification
The operator of the device has to receive a certificate from the service technician
stating the type and scope of the performed service or maintenance tasks. This
certificate has to list the date of the service or maintenance task as well as the
company and signature. Please use the maintenance and checklist enclosed in
back of the service manual.
1
Before Commencing Work
*localized
2
Before Commencing Work
(1)
(2)
(3)
(4)
Fig. 2-2 depicts a specially prepared test tube set to calibrate the pump. The tube
has a length of 200 mm.
Fig. 2-2 Test tools/test tube set
(2) (3) (4) (1) Tube cut off and clamped off
(1)
3
Before Commencing Work
Pressure calibrator specification The device must be calibrated in a retraceable manner and must be listed as a
test tool/resource by the user/operator. Calibration and display should be in mm
Hg to avoid having to convert values.
Measurement range: At least 350 mm Hg, (max. 800 mm Hg, to avoid sensor
defects caused by incorrect operation)
EN Measuring <0.5% referring to 250 mm Hg (approx. 1 mm Hg)
uncertainty:
Temperature effect: <0.02%/K in temp. range of 10-40 degrees Celsius
Long-time stability: <0.2% referring to 250 mm Hg/year (0.5 mm Hg)
Resolution (display): 0.05% referring to 250 mm Hg (approx. 0.1 mm Hg)
Connections/ports: Suitable for Stryker tubes (possibly adapter,
depending on measuring setup)
4
Device Setup
3 Device Setup
3.1 FLOSTEADY Pump Function Diagram
p1
M1 N +
ELECTRONIC
0000
5
Device Setup
(7)
(6)
EN (5)
(4)
(3)
(8)
(3)
(6)
(6)
(9)
No. Designation
(1) Faceplate
(2) Control foil
(3) Sealing kit
(4) Touch panel
(5) UNI board
(6) Plastic connector screw 3x10 DIN7981
(7) Chassis cpl.
(8) Battery pack
(9) U-shaped washer 3.2 DIN125 VA
(10) Reflective light barrier
6
Device Setup
BLACK
NET EN
BLACK
BLACK
BLUE
RED
BATTERY
GREEN
RED
YELLOW
BLACK
YELLOW
RED
RED
GREEN
BLACK
BLACK
7
Device Setup
(3)
A
(2)
(4)
Fig. 3-3 Detail A: Plug connections
A UNI board
(4) Cable leading to pressure sensor
(5) Cable leading to battery
(8)
(6) Cable leading to control membrane
(5)
(7) Cable leading to power supply unit
(8) Cable leading to light barrier
(6)
(7)
8
Device Setup
(5)
(6)
9
Service Menu
4 Service Menu
4.1 Launching the Service Menu
• Use the service menu to calibrate the device.
• Use the keys below the LED display or the touch panel to input data.
• Confirm (Enter) with the (Enter) key.
EN • To switch from one menu item to the next or the previous item, use the (&/%) keys.
• To exit the menu level (Esc), press the (ESC) key.
Display depicts:
Turn device on with switch (I)
Device check
Display depicts:
Press the (MENU) key
User menu
Display depicts:
Press the (%) key Service menu
Display depicts:
Press the (Enter) key to confirm Service code
0
Display depicts:
Press the (%) key Service code
1
Display depicts:
Press the (Enter) key 3x Service code
1000
10
Service Menu
A table listing a summary of possible errors that may occur during calibration is provided in chapter 8.1 Calibration Error Codes,
page 34.
EN
Display depicts:
Pressure sensor calibration
Display depicts:
Adjust pressure 0
Digits PMS......
Display depicts:
Press the (Enter) key to confirm Adjust pressure 270
Digits PMS......
Set a pressure of
Display depicts:
90 mm Hg and confirm with the Calibration success
(Enter) key
Press the (Enter) key and remove Press the (%) key to access the
the tube cassette next menu
11
Service Menu
A table listing a summary of possible errors that may occur during calibration is provided in chapter 8.1 Calibration Error Codes,
page 34.
EN
Display depicts:
Inflow speed calibration Press the (Enter) key
Display depicts:
Program version Press the (Enter) key
Display depicts:
Program version Press the (%) key
XP1 BAM 000X 0000
Display depicts:
Program version Press the (%) key
XP1 MAM 000X 0000
12
Service Menu
Display depicts:
Program version Press the (Enter) key
XP1 IOM 000X 0000
Display depicts:
Program version Press the (%) key
Display depicts:
Display depicts: Customer version
Customer version XP1 BAM 0xx xx
Display depicts:
Press the (%) key Customer version
XP1 MAM 0xx xx
Display depicts:
Press the (%) key Customer version
XP1 IOM 0xx xx
13
Annual Inspection
5 Annual Inspection
The annual inspection includes the following tests:
• Safety test
• Basic function test
• Pressure measuring test
EN • Pressure sensor test
The following chapters describe how to carry out these tests. An inspection tag
attached to the bottom of the device documents this inspection.
At cables
Check all cables for any damage and proper fit. Replace any cable(s) suspected of
insufficient insulation, lack of contact, and brittleness.
At electronics boards
To ensure the safety of the device, replace any boards showing corrosion or other
damage at contact or soldering points.
Check faceplate and case for damage. Check for function and safety
impairments. Check control panels and displays for proper function.
14
Annual Inspection
1 m / 39,37 inch
1. Switch device on. Wait until the device check has finished.
2. Insert the cassette.
3. Suspend fluid bag at a height illustrated in Fig. 5-1 and connect bag with
irrigation tube.
4. Immerse the end with the Luer lock into the measuring cup.
5. Select a joint.
6. Set the nominal values:
Nominal pressure 150 mm Hg
Max. flow 1 l/min
7. Press the START/STOP key; the arrow starts to rotate.
8. Wait until the tube set is filled and a red dot appears in the rotating arrow.
9. Clamp off the instrument tube end in the measuring cup without stopping
the pump.
10. Empty the measuring cup.
11. Release the tube end. The pump is running.
12. Press the START/STOP key after 1 min. The measuring cup then contains
approx. 1l (±10%) of fluid.
The basic function test has been successfully completed once these values have
been reached.
15
Annual Inspection
EN
The pressure test checks the pressure chamber, the pressure sensor, and the
pressure measuring to ensure all elements are functioning properly. This test
requires the complete cassette tube set and a container filled with water.
The height of the water column (hydrostatic pressure) is used for measuring and
then converted to mm mercury column (mm Hg). The height of the water column
above the pressure chamber has to match the value of the actual pressure
display after conversion.
The test of the pressure measurement is successfully completed when the values
of the actual pressure display correspond to those of the converted water column
height.
16
Maintenance
6 Maintenance
This device has to be serviced every year. This chapter describes the service and Performing maintenance tasks
maintenance tasks to be performed. First, carry out the safety test according to
5.1 Safety test, page 14 followed by the basic function test according to 5.3 Basic
Function Test, page 15. Use the maintenance and checklist included in the back
of this service manual to log the individual inspection steps performed.
EN
6.1 Checking for External Damage
Disinfectants used within the operating room as well as the ozone released when
using UV-emitting devices may alter the surfaces of the device components. This
thus requires conducting the following visual inspections on a regular basis:
Check all cables inside of the device for any damage and proper fit. Replace any
cable(s) suspected of insufficient insulation, lack of contact, or brittleness.
To ensure the safety of the device, replace any boards showing corrosion or other
damage at contact or soldering points.
Check front plate and case for any damage. Check for function and safety
impairments. Check control panel, touch panel, and LED for proper function.
The membrane of the pressure sensor must be intact and free of any damage.
This part must be replaced immediately if damage such as cracks or holes are
detected in the membrane during the visual inspection.
Use the test tube set to check fit and position of the cassette inside of the pump. The
cassette must be easy to insert and remove.
Check the battery inside of the device for damage and leaking battery acid. The
battery must be replaced if the operation time while running on battery power is
severely limited!
17
Maintenance
The device has to be recalibrated if the acoustic warning signal is emitted too early
or not all (see 4.1.1 Service Menu - Pressure Sensor Calibration, page 11). If the
device does not function properly after the recalibration, the A119 UNI PCB and/or
the pressure sensor must be replaced.
(1)
The wired remote control and/or the UNI PCB must be replaced if these functions
cannot be performed with the wired remote control.
18
Replacing Components and Modules
EN
Always use an antistatic (ESD) mat and cuff when replacing electronic modules,
components, or parts.
NOTE
A list of available spare parts is included in the back of this manual in chapter 9
Spare Parts List, page 35. The following describes how to replace these
components. Always perform all safety and function tests after replacing a
component or part.
• Battery
• Power unit
• Mains socket (with cable)
• Cassette snap-in mechanism
• Roller wheel
• Motor
• UNI board
• Fuse (not described)
• Clamp (not described)
• LCD touch panel
• Sealing kit
• Pressure sensor
• Chassis plate
7.2 Update
Connect the interface with a PC using a serial 9-pin 1:1 cable (serial - USB) and go
to the following Internet Website:
www.womservice.com
Read the update instructions on this page first and then carry out the indicated
steps!
19
Replacing Components and Modules
EN (1)
(2) (2)
You need a crosstip (Phillips) screwdriver size 2 to open the device. Follow the
steps depicted in Fig. 7-2:
1. Place the pump front side down onto an antistatic mat or cover.
2. Use your hand to unscrew the toggle screw (1) counterclockwise.
3. Use the Phillips screwdriver to remove the 4 screws in the case (2).
4. Carefully remove case by pulling up.
The device is always energized (current-carrying) due to the battery pack! To avoid
electrical shock, always disconnect the plug-type connection to the battery pack
inside of the device before commencing any work.
WARNING
20
Replacing Components and Modules
The chassis must be removed for almost all replacement work performed on the
device.
EN
Disconnect device from power supply.
DANGER
1. Open the device as described in chapter 7.3, page 20.
2. Unscrew the screws of the mains socket and lift it up by approx. 2 cm.
3. Remove from the board the electronic plug connector for battery, power
supply, motor, and pressure sensors.
4. Open Velcro closure and remove battery from holding bracket.
Fig. 7-3 Cable connections
(1) Power supply 18 V plug-type
connector
(2) Battery pack plug-type connector
(3) Pressure sensor plug-type connector
(4) Motor plug-type connector
(1)
(2)
(3)
(4)
Detail
21
Replacing Components and Modules
(4)
22
Replacing Components and Modules
(2)
(3)
(4)
(3)
(4)
23
Replacing Components and Modules
5. Hold the sensor holder (6) firmly with your right hand (see Fig. 7-8
Removing sensor sleeve, page 24). Use your left hand to unscrew the sensor
sleeve (5) from the chassis using a socket wrench size SW24.
Fig. 7-8 Removing sensor sleeve
(5)
(5) Sensor sleeve
(6)
6. Unscrew the sensor sleeve (7) from the sensor socket (9) by turning
counterclockwise (see Fig. 7-9). Make sure the spring (8) is under tension.
Fig. 7-9 Removing the pressure sensor
(7) (8) (9)
(7) Sensor sleeve
(8) Spring
(9) Sensor socket with pressure sensor
7. Remove the pressure sensor from the sensor socket (9) by pulling towards
the rear.
8. Follow these steps in reverse to install a (new) pressure sensors.
The following tests must be performed after installing a (new) pressure sensor:
24
Replacing Components and Modules
(1)
25
Replacing Components and Modules
The following tests must be performed after installing a new power supply unit:
26
Replacing Components and Modules
(3)
(3)
DANGER
1. Open the device as described in chapter 7.3, page 20.
2. Loosen the two fastening screws of the mains socket and pull the plug a little
towards the back. Remove the plug-type connector (3) from the power
supply unit and remove mains socket.
3. Follow these steps in reverse for assembly.
The following tests must be performed after installing a new mains socket with
fuse holder:
27
Replacing Components and Modules
DANGER
1. Open the device as described in chapter 7.3, page 20.
EN 2. Place the device on its side with the pressure sensor (1) pointing up (see Fig.
7-13). Insert a suitable tube (4) (or tube section) firmly onto the contact
spring (3) of the cassette snap-in mechanism (2).
Fig. 7-13 Replacing cassette snap-in
mechanism
(1) Pressure sensor (1)
(2)
(3)
(4)
3. Unscrew the 2 fastening screws (5) from the cassette snap-in mechanism at
the rear of the device (see Fig. 7-14).
Fig. 7-14 Removing the snap-in
mechanism
(5) 2x fastening screws
(5)
4. Pull the tube (4) and the cassette snap-in mechanism out off (2) the device
case (see Fig. 7-13).
5. Follow these steps in reverse for assembly.
The following tests must be performed after installing a (new) cassette snap-in
mechanism:
28
Replacing Components and Modules
Make sure the device is physically disconnected from the power supply.
WARNING
1. Open the device as described in chapter 7.3, page 20.
2. Remove chassis from front as described in chapter 7.4 Removing the Chassis, EN
page 21.
3. Remove cassette snap-in mechanism as described in chapter 7.10 Replacing
the Cassette Snap-in Mechanism, page 28.
The roller wheel is affixed with a grub screw. For safety reasons, this grub screw is
held securely in place with a liquid screw-locking compound (e.g. Loctite 221).
To remove the roller wheel, this compound has to be warmed in order to prevent
damage to the grub screw (this might require 100 degrees Celsius or more).
WARNING
(1)
(2)
3. Carefully warm roller wheel (1) in the area of the screw using a hot air blower
until the grub screw (2) is removed easily with an Allen wrench.
4. Pull roller wheel (1) off its axis and replace with new roller wheel.
5. Make sure the spacer sleeve is mounted on the motor shaft.
6. Use Loctite 221 on the grub screw before screwing into the roller wheel.
Insert grub screw right away and tighten firmly.
The following test must be performed after replacing the roller wheel:
• Function test
29
Replacing Components and Modules
(3)
(3)
(4)
(5)
(6)
30
Replacing Components and Modules
(2)
(3)
DANGER
1. Open the device as described in chapter 7.3, page 20.
2. Remove chassis as described in chapter 7.4, page 21.
3. Pull flat ribbon cable for keyboard (1).
4. Remove plug-type connector of the reflective light barrier board (2).
5. Unscrew the 4 screws (3) from the board.
6. Carefully remove the board and detach the flat ribbon cable of the keyboard
foil from the plug-type connector on the UNI board.
7. Follow these steps in reverse for assembly. Check the layout of the plug-type
connectors (see chapter 3.4 Plug connection UNI board, page 8).
The following tests must be performed after installing a new UNI board:
• Update
• Electrical safety tests
• Basic function test
31
Replacing Components and Modules
EN
The following tests must be performed after installing a new LCD touch panel:
32
Error and Warning Messages
Device defective/call • Motor blocked, defective, or not connected • Check roller wheel, must rotate
service/motor defective • Roller wheel defective • Check motor connection cable
• Impulse transmitter defective • Replace motor
• Board defective • Check plug, cable and board
5 acoustic signal, cyclical • Check board and replace if
necessary
Insert tube set • Attempted device start without inserted or • Insert tube set correctly
improperly inserted tube set • Realign pump head with reference
3x short beep centering block
Critical overpressure • Safety threshold for pressure exceeded • Reduce pressure. The pump starts
automatically with the preset
Actual pressure display values once the pressure has been
flashes reduced below the critical
threshold value.
1x acoustic signal,
continuous
Remove tube set • Device was switched on with disposable tube set • Remove tube set from pump head
inserted, which is the reason the sensor could Restart the device without inserted
not be checked. disposable tube set
33
Error and Warning Messages
34
Spare Parts List
Please indicate the device number (see identification plate) and customer number when ordering spare parts!
35
Technical Data
10 Technical Data
36
Service and Checklist
Mechanischer Zustand / Mechanical condition Frontplatte und Gehäuse / Front panel and case
III.Bemerkungen / Notes
37
Produced for:
Stryker Endoscopy
5900 Optical Court San Jose
CA 95138 (USA)
+1.408.754.2000
+1.800.624.4422
www.stryker.com