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Distributed By:
Integra LifeSciences Corporation
Plainsboro, NJ 08536 USA
Integra LifeSciences (Ireland) Limited
IDA Business and T
echnology Park
Sragh
T
ullamore, County Offaly
, Ireland
© 2007 Integra LifeSciences. All Rights Reserved.
Printed in USA
945102217ILS
Cusa EXcel Ultrasonic Surgical Aspirator User’
s Guide
USER’S GUIDE
2
Table of Contents
00 CUSA UG.I+D
2
User’s Guide
2
CUSAEXcel™ Ultrasonic Surgical Aspirator System
2
CUSAEXcel™ Ultrasonic Surgical Aspirator System User’s Guide
3
Preface
4
System Features
4
User’s Guide Features
4
Organization
5
Intended Uses
6
Conventions Used in this Guide
7
Indicates an operating tip or maintenance suggestion.
7
00 CUSA UG.I+DLOF
8
List of Figures
8
00 CUSA UG.I+DTOC
10
Table of Contents
10
Part 1.Safety
10
Part 2.Console
10
Part 3.Handpieces and Accessories
13
Part 4.Troubleshooting and Maintenance
15
Part 5.Appendix
16
01 CUSA UG.I+D
19
Patient and Operating Room Safety
19
Indications for Use
19
The CUSA EXcel Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures w...
19
Safety Information
19
The safe and effective use of ultrasonic surgery depends to a large degree on factors solely unde...
19
Physicians have used ultrasonic equipment safely in numerous procedures. Before starting any surg...
19
Warnings, Cautions, and Notices
20
To promote the safe use of the CUSAEXcel ultrasonic surgical aspirator, this section presents th...
20
General
20
Setting Up the CUSAEXcel System
20
Shutting Down the CUSAEXcel System
21
Handpiece Components
21
Assembling the Handpiece in a Nonsterile Area
22
Disassembling CUSAEXcel Handpieces
22
Troubleshooting the CUSAEXcel System
22
Maintaining the CUSAEXcel System
22
Appendix A. Technical Specifications
23
01 Part 1 CUSA UG.I+D
18
Safety
18
02 CUSA UG.I+D
27
Introduction to the Console
27
For Your Information
27
Overview
28
Fragmentation
28
Electromechanical Operation
28
Cooling
29
Irrigation
29
Aspiration (Suction)
30
Handpieces
31
Wide Variety of Tips
31
Intended Uses
32
03 CUSA UG.I+D
33
Console Components
33
For Your Information
33
Console Overview and Structural Features
34
I.V. Pole
35
Control Panel
35
Arm and Arm Housing
35
Housing for Irrigation Pump Head and Suction Pinch Valve
35
Console Body
35
Shelf for Suction Canister
35
Casters
35
Control Panel
36
Alerts
37
Lap Mode, Prime, Test, and Status Buttons
37
Displays
37
Status Indicators
39
Setpoint Adjustment Buttons
39
Console Body – Front Panel
40
Handpiece Connector Receptacle
41
Suction Pinch Valve
41
System Power Switch
41
Irrigation Pump Head
41
Contamination Guard
41
The guard is hydrophilic and becomes blocked when wet.
41
Retaining Bail for Suction Canister
41
Console Body – Side Panel
42
Control Panel
43
Rotation Lock Handle
43
Housing for Irrigation Pump Head and Suction Pinch Valve
43
I.V. Pole
43
I.V. Pole Release Button
43
Arm and Arm Housing
43
Arm Release Tab
43
Cooling Water Reservoir
43
Console Body – Rear Panel
44
Speaker
45
Volume Control
45
Footswitch Connector Receptacle
45
AC Main Switch
45
Fuses
45
Footswitch
45
AC Power Cord
47
Equipotential Grounding Lug
47
Labels
47
Cord Wrap
47
Storage Compartment
47
Symbols on the Control Panel
48
04 CUSA UG.I+D
49
Using CUSAEXcel ConsoleControls
49
For Your Information
49
Using Power Switches
50
AC Main Switch
50
System Power Switch
50
Understanding the Control Panel
51
Footswitch Alert
51
Handpiece Alert
51
Wait/Cooling Water
52
Cooling Water Alert
52
Test
53
Vibration Alert
53
Prime
54
Standby Status
54
Adjusting Setpoint Values
55
Aspiration
55
Irrigation
55
Amplitude
55
TISSUESelect™
55
Changing Functions
56
Run Status
56
Laparoscopic Mode
56
Fast Flush
56
Quiet Function
56
Using Other Features
57
Filling the Cooling Water Reservoir
57
1. Gently open the rubber lid on the reservoir top.
57
2. Fill the reservoir with 1000cc distilled water (to the line).
57
3. Close the rubber lid on the reservoir top.
57
Raising/Lowering the Arm
57
1. With one hand, press the release tab (rectangular) on the arm housing to disengage the lock. O...
57
2. With the other hand, grasp the arm and push gently up or down. A counterweight balances the ar...
57
3. Continue to move the arm up or down until it reaches the next position at which the lock engag...
57
4. If you want to move the arm to another position, press the release tab again and continue to p...
57
Rotating the Control Panel
58
1. Grasp the release handle located under the control panel, and pull the handle toward the front...
58
2. While holding the handle in this position, rotate the control panel out of its previous positi...
58
3. Continue to rotate the control panel. At its next locking position, it will automatically lock...
58
Adjusting the Tone Volume
58
Adjusting the I.V. Pole
59
Do not try to raise the pole from Position A. Do not try to rotate the pole when it is in the upp...
59
1. Grasp the pole and rotate it to position B.
59
2. With one hand, hold the pole; with the other hand, press the button to release the locking pin.
59
3. Raise the pole. As the pole clears its lower locking position, release the button.
59
4. Continue to move the pole upward until it locks into position.
59
1. With one hand, hold the pole; with the other hand, press the button to release the locking pin.
59
2. Gently lower the pole. As the pole clears its upper locking position, release the button.
59
3. Continue to move the pole downward until it locks into position.
59
4. After the pole has locked into its lower position, you can rotate it to position A.
59
Using TISSUESelect
60
(1) It draws tissue toward the vibrating tip and creates a tip/tissue coupling effect.
60
(2) It removes irrigation and fragmentation debris from the surgical site.
60
Inherent Tissue Selectivity
61
Increasing Tissue Selectivity
61
TISSUESelect™ Reduces Reserve Power to the Tip
62
Benefits of TISSUESelect
64
A Common Misunderstanding of the Amplitude Setting
65
05 CUSA UG.I+D
67
Setting Up the CUSAEXcel System
67
For Your Information
67
Quick Reference – Setup
68
Handpiece Assembly
68
1. Attach a nosecone, either standard or CEM, onto the handpiece.
68
2. Attach the flue.
68
3. Attach the sterile manifold tubing (if not attached before sterilization).
68
4. Attach the aspiration and irrigation tubes at the handpiece.
68
Console Assembly
68
1. Plug the power cord into a wall receptacle.
68
2. Confirm that the AC Main Switch located on the rear panel is on and that the footswitch is plu...
68
3. Spike an irrigation bag (lactate Ringer’s or normal saline) with large drip I.V. administratio...
68
4. Fill the cooling water reservoir with distilled water, then slide it into place.
68
5. Connect the suction canister to the console at the contamination guard.
68
6. Connect a sterile handpiece to the system.
68
7. Turn on ( | ) the System Power Switch located on the front panel.
68
8. Connect the suction manifold tubing to the console and the suction canister.
68
9. Connect the irrigation manifold tubing to the console and the I.V. administration set. Open th...
68
10. Wait until the Wait (flashing) and Cooling Water indicators go off.
68
11. Press the Test button to check the setup of the handpiece. If the red vibration indicator doe...
68
12. Press the Prime button to prime the handpiece with sterile irrigant.
68
13. Adjust settings for amplitude, suction, and irrigation.
68
14. Press the Status button to select the Run mode when the surgeon is ready to use the CUSAEXce...
68
Complete the Handpiece Assembly
69
Items Needed
69
Attach a Nosecone
70
1. If using a CEM nosecone, put the standard nosecone into the sterilizer tray for safe storage.
70
2. Holding the handpiece, insert the tip into the nosecone.
70
3. Align the dot on the nosecone with the dot on the neck of the handpiece.
70
4. Push the nosecone onto the handpiece so that the dots are on top of each other.
70
5. Twist the nosecone clockwise until it locks into place.
70
6. The dot on the nosecone must now align with the dot on the handpiece.
70
7. Remove the tip cleaner, and slide the flue that corresponds to the selected tip over the tip a...
70
Clip the Manifold Tubing to the Handpiece Cable
71
1. Remove the manifold tubing with clips from the packaging. Uncoil some of the tubing.
71
2. Snap the handpiece clip in place on the handpiece housing.
71
3. Insert the irrigation tube from the flue into the handpiece clip.
71
4. Connect the manifold irrigation tubing to the Luer fitting on the handpiece flue:
71
a. Connect the Luer fitting.
71
b. Twist the knob clockwise to lock the fitting.
71
5. Connect the manifold suction tubing and clip to the suction port in the nosecone.
72
6. Push one to three manifold tubing clips onto the handpiece cable.
72
7. Hand off the remaining manifold tubing, handpiece cable, and handpiece electrical connector to...
72
Prepare the System for Startup
73
At the Rear Panel
73
1. Plug the CUSAEXcel system power cord into a wall receptacle.
73
2. Confirm that the AC Main Switch on the rear panel is on ( | ).
73
3. Verify that the CUSAEXcel system footswitch is connected to the rear of the console.
73
4. Follow hospital policies and procedures regarding placing footswitches in plastic bags.
73
On the Side Panel: Cooling Water
73
1. Remove the cooling water reservoir from the console:
73
a. Press the button (just above the reservoir) on the Arm Housing to release the fittings inside ...
73
b. Slide the reservoir toward the rear of the console, then remove it from its slot.
73
2. Gently open the black rubber lid on the reservoir top.
73
3. Fill the cooling water reservoir to the line with 1000cc distilled water (sterile water is di...
73
4. Gently close the black rubber lid.
73
5. Slide the cooling water reservoir into the slot on the console side panel until it snaps into ...
73
On the Front Panel: Suction
74
1. Put a hospital provided suction canister on the shelf in the front of the console.
74
2. Verify that the contamination guard is in place in the console.
74
3. Attach the green Lshaped connector from the contamination guard to the VACUUM port on the suc...
74
4. Secure the canister with the retaining bail.
74
On the Front Panel: Handpiece
75
1. Connect the handpiece to the console.
75
a. Line up the notch on the handpiece connector to the key in the receptacle (at the 12 o’clock p...
75
b. Gently push the handpiece connector onto the console connector.
75
c. Turn the connecting ring in the clockwise direction until the yellow dot on the handpiece alig...
75
Turn On the CUSAEXcel System
76
1. Turn on(|) the black System Power Switch (located on the front panel).
76
2. While waiting for the Wait and Cooling Water indicators to go off, proceed with connecting the...
76
Connect the Suction Tubing
76
1. Align the green band on the manifold suction tubing with the green line on the front of the co...
76
2. Above the green band, hold the suction tubing with one hand; with the other hand, stretch the ...
77
3. Connect the green Lshaped connector on the suction tube to the PATIENT port on the suction ca...
77
Figure 5-1. The assembled suction system
77
Connect the Irrigation Tubing
78
1. Prepare a standard I.V. administration set and sterile irrigation solution and put it on the I...
78
2. Connect the irrigation tubing (from the handpiece) to the CUSAEXcel system.
78
a. To open the pump latch (if it is not already open), rotate the lever to the left.
78
b. Align the blue stripe on the irrigation tube with the blue line on the front of the console, t...
78
c. To close the pump latch, rotate the lever to the right.
78
3. Remove the cap from the irrigation tubing.
79
4. Connect the irrigation tubing to the I.V. administration set tubing.
79
5. Make sure that the person assembling the handpiece has connected the irrigation tubing to the ...
79
6. Open the roller clamp on the I.V. tubing.
79
Figure 5-2. The assembled irrigation system
79
Test the Handpiece
80
1. Press the Test button (orange box on a black button at the top of the amplitude display column...
80
2. Verify the following:
80
Test the CEM Nosecone
81
1. Plug the CEM generator power cord into a wall receptacle.
81
2. Plug the CEM nosecone cable connector into the CEM accessory port on the electrosurgical gener...
81
3. Apply the patient return electrode to the patient and connect it to the REM receptacle on the ...
81
4. Verify that you have set up the generator properly, and that you have turned it on. For instru...
81
5. Press the blue Coag button on the CEM nosecone and verify that the Coag indicator illuminates....
81
ForceFX CEM output is limited to 100watts in Cut or 70watts in Coag.
81
6. Adjust the settings on the generator control panel to the surgeon’s requirements.
81
When the Surgeon Is Ready
82
1. Make sure the I.V. administration set roller clamp is open.
82
2. Prime the irrigation system:
82
a. Press the Prime button (blue box on a black button at the top of the Irrigation display column...
82
b. Make sure irrigation fluid drips from the tip.
82
3. Adjust the Amplitude, Irrigation, Aspiration, and TISSUESelect settings to the surgeon’s requ...
82
4. Press the Status button (green box on a black button at the upper right of the control panel) ...
82
5. Put the footswitch where it is easily accessible to the surgeon.
82
06 CUSA UG.I+D
84
Shutting Down theCUSAEXcelSystem
84
Shut Down the CUSA EXcel System
85
1. Press the Status button on the system control panel.
85
2. Turn off ( ) # the System Power Switch.
85
3. While the system displays the flashing Wait light and the Cooling Water indicator, remove the ...
85
Disconnect Suction Tubing, Irrigation Tubing, and the Handpiece
86
1. Disconnect the green Lshaped connector on the manifold suction tubing from the suction canist...
86
2. Disconnect the green Lshaped connector on the contamination guard tubing from the suction can...
86
3. Close the roller clamp on the I.V. tubing.
86
4. Disconnect the I.V. tubing from the irrigation tubing.
86
5. Open the irrigation pump latch.
86
6. Remove the blue-striped manifold irrigation tubing.
87
7. Close the irrigation pump latch.
87
8. After all lights on the control panel are off, remove the handpiece:
87
a. Turn the handpiece connector ring counterclockwise.
87
b. Remove the connector from the console.
87
A standard nosecone is not a disposable component. Do not discard a standard nosecone.
87
9. Remove and discard disposable components from the handpiece:
87
10. If you used a CEM system,
87
11. Empty cooling water from the cooling water reservoir:
87
a. Press the button (just above the reservoir) on the Arm Housing to release the fittings inside ...
87
b. Slide the reservoir toward the rear of the console, then remove it from its slot.
88
c. Gently open the black rubber lid on the reservoir top and discard the distilled water.
88
d. Gently close the black rubber lid.
88
e. Slide the empty reservoir back into the slot at the base of the adjustable arm until it snaps ...
88
Clean the Console
89
1. Unplug the unit power cord from the wall receptacle.
89
2. Using standard procedures for your facility, thoroughly wipe all surfaces, cords, and footswit...
89
3. Make sure that the surface is completely dry before using the system again.
89
07 CUSA UG.I+D
91
Introduction to Handpieces
91
For Your Information
91
Description
92
Functions
92
Configurations
93
Wide Variety of Tips
93
08 CUSA UG.I+D
95
Handpiece Components
95
For Your Information
95
Components of Assembled Handpieces
96
Figure 8-1. The components of a handpiece
96
Handpiece
96
O-Rings
97
Nosecone
97
Tip
98
Flue
99
Manifold Tubing
99
CUSAEXcel manifold tubing contains NOlatex.
99
Additional Components
100
Nonsterile Tip Torquing Base and Torque Wrench
100
Figure 8-2. The tip torquing base and torque wrench for use when not changing tips on the sterile...
100
Sterilizable Torque Bases
101
Figure 8-3. The sterilizable torque bases for use when changing tips on the sterile field
101
Sterile Torque Wrenches
101
Figure 8-4. The sterile torque wrench for use when changing tips on the sterile field
102
Sterilizer Cases
102
Figure 8-5. The 23kHz CUSAEXcel sterilizer case
103
09 CUSA UG.I+D
105
Assembling the Handpiece inaNonsterile Area
105
For Your Information
105
1. NOT Changing Tips on the Sterile Field – If assembling the tip to the handpiece in a nonsteril...
105
2. Assembling or Changing Tips on the Sterile Field – For instructions on how to assemble and dis...
105
Items Needed
106
Figure 9-1. The items you need to assemble a handpiece: handpiece, nosecone, and tip pack
106
Figure 9-2. Tip torquing base and torque wrench
107
Figure 9-3. Manifold tubing
107
Attach the Tip to the Connecting Body
108
1. Thread the tip of choice onto the handpiece connecting body. Turn the tip until it is finger t...
108
2. Locate the slot in the tip torquing base that matches the color on the handpiece connector (23...
108
3. Hold the handpiece in place in the tip torquing base.
108
4. Match the colored end of the torque wrench with the handpiece color. Slide the color coded sid...
109
5. Rotate the wrench clockwise until you feel and hear a click. Rotate again until you feel and h...
109
6. Remove the wrench from the tip.
109
7. Remove the handpiece from the tip torquing base.
109
Put On the O-Rings
110
1. Locate the o-rings for the handpiece you are assembling:
110
2. Slide the larger o-ring over the connecting body and into the groove in the neck of the handpi...
110
Clip the Manifold Tubing to the Handpiece Cable (Optional)
111
1. Remove the manifold tubing with clips from the packaging. Uncoil the tubing.
111
2. Snap the handpiece clip in place on the handpiece housing.
111
3. Push one to three manifold tubing clips onto the handpiece cable.
111
Package the Handpiece for Sterilization
112
Items Needed
112
Figure 9-4. The sterilizer case
112
1. Put the handpiece into the case first. Align the handpiece with the outline on the case bottom...
113
2. Place the nosecone and flue with the tip cleaner in the handpiece compartment.
113
3. Close the protective cover over the handpiece.
113
4. Coil the cable and manifold tubing (if attached) around the inside of the case.
113
5. Put the handpiece connector in the center compartment and secure it in place.
113
6. Put on the lid. Close and latch the case.
113
Figure 9-5. The handpiece and connector secured into the sterilizer tray
113
10 CUSA UG.I+D
115
Sterilizing Handpieces and Accessories
115
For Your Information
115
Sterilization Parameters
116
Handpieces without Manifold Tubing
116
Handpieces with Manifold Tubing Attached
116
Sterilize the Handpiece
117
Sterilizing with Steam
117
Validation of Steam Sterilization Parameters
117
11 CUSA UG.I+D
119
Completing Handpiece Setup ontheSterile Field
119
For Your Information
119
Quick Reference – Setup
120
Handpiece Assembly
120
1. Attach a nosecone, either standard or CEM, onto the handpiece.
120
2. Attach the flue.
120
3. Attach the sterile manifold tubing (if not attached before sterilization).
120
4. Attach the aspiration and irrigation tubes at the handpiece.
120
Complete the Handpiece Assembly
121
Items Needed
121
Attach a Nosecone
122
1. If using a CEM nosecone, put the standard nosecone into the sterilizer tray for safe storage.
122
2. Holding the handpiece, insert the tip into the nosecone.
122
3. Align the dot on the nosecone with the dot on the neck of the handpiece.
122
4. Push the nosecone onto the handpiece so that the dots are on top of each other.
122
5. Twist the nosecone clockwise until it locks into place.
123
6. The dot on the nosecone must now align with the dot on the handpiece.
123
7. Remove the tip cleaner, and slide the flue that corresponds to the selected tip over the tip a...
123
Clip the Manifold Tubing to the Handpiece Cable
124
1. Remove the manifold tubing with clips from the packaging. Uncoil some of the tubing.
124
2. Snap the handpiece clip in place on the handpiece housing.
124
3. Insert the irrigation tube from the flue into the handpiece clip.
124
4. Connect the manifold irrigation tubing to the Luer fitting on the handpiece flue:
125
a. Connect the Luer fitting.
125
b. Twist the knob clockwise to lock the fitting.
125
5. Connect the manifold suction tubing and clip to the suction port in the nosecone.
126
6. Push one to three manifold tubing clips onto the handpiece cable.
126
7. Hand off the remaining manifold tubing, handpiece cable, and handpiece electrical connector to...
126
12 CUSA UG.I+D
128
Disassembling Handpieces
128
For Your Information
128
Disassemble the Handpiece
129
Table 12-1. What to discard and what to keep
129
1. Using a soft cloth moistened with a germicidal solution, wipe the handpiece to remove gross co...
129
2. Remove the flue, if not already removed.
129
3. Remove the nosecone:
130
a. Release the nosecone by twisting it counter clockwise.
130
b. Pull the nosecone away from the handpiece.
130
4. Remove the o-rings and discard them.
130
5. Locate the slot in the tip torquing base that matches the color on the handpiece connector (23...
130
6. Hold the handpiece in place in the tip torquing base.
130
7. Match the colored end of the torque wrench with the handpiece color. Slide the color coded sid...
131
8. Rotate the wrench counter-clockwise until the tip is loose.
131
9. Remove the handpiece from the tip torquing base.
131
10. Unscrew the tip.
131
Clean the Handpiece
132
1. For general cleaning, using a soft cloth, manually clean the handpiece, handpiece cable, handp...
132
2. Using a soft cloth, pipe cleaner, or cotton tipped applicator, manually clean the lumen, inter...
132
3. Rinse the nosecone, connecting body, handpiece housing, and handpiece cable thoroughly with wa...
132
4. Manually wipe the handpiece electrical connector with a cloth moistened with water.
132
5. Using a soft cloth, dry the nosecone, connecting body, handpiece housing, handpiece cable, and...
132
Clean the Tip Torquing Set
133
1. Using a soft cloth and mild cleansing solution or blood dissolving detergent, manually clean t...
133
2. Rinse the tip torquing base and torque wrench thoroughly with water.
133
3. Using a soft cloth, dry the tip torquing base and torque wrench.
133
13 CUSA UG.I+D
135
Troubleshooting theCUSAEXcelSystem
135
For Your Information
135
Responding to Alerts
136
General Troubleshooting
139
a. Remove the handpiece from the sterile field.
144
b. Use the tip torquing base and wrench to tighten the tip.
144
c. Test the tip.
144
d. Sterilize the handpiece.
144
a. Use the sterilizable torque base and a disposable sterile wrench to tighten the tip. (Refer to...
144
b. Test the tip.
144
a. Remove the handpiece from the sterile field.
145
b. Use the tip torquing base and wrench to replace the tip.
145
c. Test the tip.
145
d. Sterilize the handpiece.
145
a. Use the sterilizable torque base and a disposable sterile wrench to replace the tip. (Refer to...
145
b. Test the tip.
145
13 Part 4 CUSA UG.I+D
134
Troubleshooting and Maintenance
134
14 CUSA UG.I+D
150
Maintaining theCUSAEXcelSystem
150
For Your Information
150
Quick Reference
151
Table 14-1. Routine maintenance tasks
151
Clean the Sterilizer Case
152
Maintain the Handpiece
152
Lubricate the Handpiece Connector O-Rings
152
Replace the Handpiece Connector O-Rings
152
Figure 14-1. Replacing o-rings on the handpiece connector water prongs
152
Recalibrate the Handpiece
153
Store the CUSAEXcel System and Accessories
153
CUSAEXcel Console
153
Handpiece
153
Footswitch
153
CEM Nosecone
153
Return Equipment for Service
153
Obtaining a Return Authorization Number
154
Returning the Console
154
Returning Handpieces
154
Ordering Replacement Parts
154
Integra Service Center
155
1A CUSA UG.I+D
156
Technical Specifications
156
Console Dimensions
156
CUSAEXcel Console
156
Height
156
1.32 m (52 in.)
156
Width
156
55.88cm (22 in.)
156
Depth
156
71.12cm (28 in.)
156
Weight
156
95.3kg (210 lb.)
156
Footswitch
156
Height
156
5.08cm (2 in.)
156
Width
156
30.48cm (12 in.)
156
Cable length
156
4.575m (15 ft)
156
Console Subsystems
157
Ultrasonic
157
Nominal Frequency
157
23kHz
157
35.75kHz
157
Maximum Tip Amplitude (23kHz)
157
Up to 355microns for straight handpiece
157
Up to 183microns for angled handpiece
157
Maximum Tip Amplitude (36kHz)
157
Up to 210microns
157
Fluidic System
157
Cooling System
157
Cooling water flow is 35 – 50cc/min.
157
Irrigation Rate
157
The irrigation rate display shows digits 1 – 10
157
The irrigation rate is approximately 1 – 10cc/min., normal; 25–30cc/min., Fast Flush
157
Suction System
157
Up to 660mm (26 inches) mercury at the pump intake at sea level
157
The suction level will be lower at higher altitudes.
157
Electrical Requirements
158
Input Power Source
158
Power Ratings
158
The CUSAEXcel system operates on one of the following voltage ranges:
158
95 - 120 Volt
158
220 - 240 Volt
158
Frequencies
158
60 Hz ± 2 Hz
158
50 Hz ± 2 Hz
158
Line fusing resides in fuse receptacles on the rear panel. The fuse values for 95–120volt operat...
158
Power Cords
158
Cord
158
UL listed 3-conductor
158
Connector
158
Hospital grade, three-prong, 95-120Van connector
158
If a facility intends to use the CUSAEXcel system in an operating room with another type of rece...
158
Low Frequency Leakage
158
Enclosure leakage current
158
<300µA
158
Patient leakage current
158
<100µA
158
Duty Cycle
158
Under maximum loading conditions, the CUSAEXcel console is suitable for ultrasonics activation t...
158
Environment
159
Operating temperature range
159
10°C (50°F) to 40°C (104°F)
159
Operating humidity range
159
15 to 80%, relative humidity, non-condensing
159
Operating atmospheric pressure range
159
70 CPA to 106 CPA (10.15 to 15.38 psi)
159
Storage and shipping temperature
159
-34°C (-29°F) to 65°C (149°F)
159
Storage and shipping humidity
159
25 to 85% relative humidity, non-condensing
159
The system requires a minimum of one hour exposure at its operating temperature range before you ...
159
Standards and IEC Classifications
159
ATTENTION Consult accompanying documents.
159
DANGER Explosion risk if used with flammable anesthetics.
159
EQUIPOTENTIAL GROUND Connect equipotential ground cable here.
159
POWER ON Applies power at the AC Main Switch and the System Power Switch.
159
POWER OFF Removes power at the AC Main Switch.
159
Protective earth ground
159
CAUTION To reduce the risk of electric shock, do not remove the cover. Refer servicing to qualifi...
159
Classified with respect to electrical shock, fire, mechanical, and other specified hazards only i...
159
Class I Equipment (IEC 601-1)
160
Accessible conductive parts cannot become live in the event of a basic insulation failure because...
160
Type BF Applied Part Equipment (IEC 601-1)
160
The CUSAEXcel console provides a high degree of protection against electric shock, particularly ...
160
IPX - 8 (IEC 529, UL60601) Footswitch
160
The CUSAEXcel footswitch includes protection against the effects of continuous immersion in water.
160
Electromagnetic Interference
160
The CUSAEXcel console minimizes electromagnetic interference to other equipment used in the oper...
160
Note that other devices in the operating room may generate electromagnetic interference. Use caut...
160
System Power Off / Standby
160
When you turn off the System Power Switch, the system automatically drains water from the cooling...
160
Pinch Point in the Suction Pinch Valve
160
The suction pinch valve may pose a hazard during normal use.
160
Fuse Replacement
160
Indicates the location of the fuse drawer on the rear panel.
160
Footswitch Symbols
161
The following symbols appear on the CUSAEXcel footswitch:
161
Activate vibration.
161
Activate fast flush (irrigation).
161
Voluntary Standards
161
The CUSAEXcel system meets the following standards:
161
EMC Compatibility
161
Handpieces
162
Nominal Frequencies
162
23kHz Straight
162
23kHz
162
23kHz Angled
162
23kHz
162
36kHz Straight
162
35.75kHz
162
Dimensions
162
Length
162
22.2cm (8.74 in.)
162
Diameter
162
20.8mm (0.82 in.)
162
Length
162
22.2cm (8.74 in.)
162
Diameter
162
20.8mm (0.82 in.)
162
Length
162
13.9cm (5.47 in.)
162
Diameter
162
16.4mm (0.65 in.)
162
Tip Specifications
162
The table on pages A8 shows specifications for tips that attach to the 23kHz handpiece.
162
The table on pages A9 shows specifications for tips that attach to the 36kHz handpiece.
162
23kHz
163
Table A-1. Tip Specifications—23kHz
163
36kHz
164
Table A-2. Tip Specifications—36kHz
164
1A Part 5 CUSA UG.I+D
166
Appendix
166
1B CUSA UG.I+D
168
Warranty
168
1S CUSA UG Sup.I+D
172
Assembling or Changing Tipsonthe Sterile Field
172
For Your Information
172
1. Assembling or Changing Tips on the Sterile Field – This addendum tells you how to assemble and...
172
2. NOT Changing Tips on the Sterile Field – If assembling the tip to the handpiece in a nonsteril...
172
Items Needed
173
Figure 1. The sterilized handpiece
173
Figure 2. The sterilized standard nosecone and the sterile CEM nosecones
173
Figure 3. Sterile tip/flue pack contents. The tip cleaner is inside the flue.
174
Figure 4. Sterilizable tip torquing base
175
Figure 5. Sterile torque wrench (23kHz or 36kHz)
175
Figure 6. Sterile manifold tubing
175
Assembly
176
Attach the Tip and O-rings
176
1. Thread the tip of choice onto the handpiece connecting body. Turn the tip until it is finger t...
176
2. The sterilized torque base should be in the sterilizer tray. Verify that the handpiece support...
176
3. Put the handpiece in the torque base so that the metal connecting body fits snugly in the meta...
176
4. Match the colored ring on the sterile torque wrench with the handpiece connector color or hand...
177
5. Hold the handpiece in place in the tip torquing base.
177
6. Rotate the wrench clockwise until you feel and hear one click. Rotate again until you feel and...
177
7. Carefully remove the sterile wrench from the tip.
177
8. Remove the handpiece from the tip torquing base.
177
9. Locate the o-rings for the handpiece you are assembling:
177
10. Slide the larger o-ring over the connecting body and into the groove in the neck of the handp...
178
Attach a Nosecone and Flue
178
1. If using a CEM nosecone, put the standard nosecone into the sterilizer tray for safe storage.
178
2. If reattaching a CEM nosecone while changing tips on the sterile field, use a soft cloth to dr...
178
3. If reattaching a CEM nosecone, replace the o-rings on the handpiece each time you change a tip.
178
4. Holding the handpiece, insert the tip into the nosecone.
178
5. Align the dot on the nosecone with the dot on the neck of the handpiece.
179
6. Push the nosecone onto the handpiece so that the dots are on top of each other.
179
7. Twist the nosecone clockwise until it locks into place.
179
8. Remove the tip cleaner from the flue and set it aside. You may need it during the surgical pro...
179
9. Slide the flue that corresponds to the selected tip over the tip and onto the nosecone.
179
Attach the Manifold Tubing
180
1. Remove the manifold tubing with clips from the packaging. Uncoil some of the tubing.
180
2. Snap the handpiece clip in place on the handpiece housing.
180
3. Insert the irrigation tube from the flue into the handpiece clip.
180
4. Connect the manifold irrigation tubing to the Luer fitting on the handpiece flue.
180
5. Connect the manifold suction tubing and clip to the suction port in the nosecone.
181
6. Push one to three manifold tubing clips onto the handpiece cable.
181
7. Uncoil the CEM cable and insert it into the handpiece and manifold tubing clips.
181
Disassembly to Change Tips on the Sterile Field
181
1. Press the Status button to put the system in Standby.
182
Disconnect the Manifold Tubing
182
1. Disconnect the irrigation tubing from the handpiece flue.
182
2. Remove the flue irrigation tube from the handpiece clip.
183
3. Remove the flue and set it aside.
183
4. Disconnect the manifold suction tubing and its clip from the handpiece and nosecone.
183
Remove the Nosecone, O-rings, and Tip
183
1. Remove the standard or CEM nosecone:
183
a. Release the nosecone by twisting it counterclockwise.
183
b. Pull the nosecone away from the handpiece and set it aside.
183
2. Remove the o-rings only if using a CEM nosecone.
183
3. Locate the sterile torque base in which the handpiece support color matches the color on the h...
183
4. Put the handpiece in the torque base so that the metal connecting body fits snugly in the meta...
183
5. Match the colored ring of the sterile torque wrench with the handpiece connector color or hand...
184
6. Hold the handpiece securely in place in the torque base.
184
7. Rotate the wrench counterclockwise until the tip is loose.
184
8. Carefully remove the sterile wrench from the tip.
184
9. Remove the handpiece from the tip torquing base.
184
10. Unscrew the used tip. Set the tip and flue aside for further use or disposal at the end of th...
184
11. Using a soft cloth, wipe the handpiece connecting body surface to remove gross contaminants.
185
Disassembly After the Surgical Procedure
185
Reprocess the Handpiece
186
Clean the Handpiece
186
1. For general cleaning, using a soft cloth, manually clean the handpiece housing, connecting bod...
186
2. Using a soft cloth, pipe cleaner, or cotton tipped applicator, manually clean the lumen, inter...
186
3. Rinse the nosecone, connecting body, handpiece housing, and handpiece cable thoroughly with wa...
186
4. Manually wipe the handpiece electrical connector with a cloth moistened with water.
186
5. Using a soft cloth, dry the nosecone, connecting body, handpiece housing, handpiece cable, and...
186
Reprocess the Sterilizable Torque Base
187
Clean the Base
187
1. Remove all gross matter (blood, mucous, and tissue):
187
a. Dampen a soft cloth with a cleaning agent.
187
b. Thoroughly wipe all surfaces of the base. Follow the procedures approved by your institution.
187
2. Soak at least two minutes in an enzymatic cleaning agent (for example, Klenzyme® or Enzol™) ac...
187
3. Scrub all surfaces with a small soft brush.
187
4. Rinse thoroughly with water.
187
5. Dry with a clean soft cloth.
187
Package the Handpiece for Sterilization
188
1. Put the disassembled handpiece into the case first. Align the handpiece with the outline on th...
188
2. Close the protective cover over the handpiece.
188
3. Place the nosecone into the opening in the protective cover.
188
4. Coil the cable and manifold tubing (if attached) around the inside of the case.
188
5. Put the handpiece connector in the center compartment and secure it in place.
188
Figure 7. The handpiece and connector secured into the sterilizer tray
188
Package the Base for Sterilization
189
1. Load the sterilizable torque base into the CUSA EXcel sterilizer tray and secure it with the s...
189
2. Put on the lid. Close and latch the sterilizer case.
189
Sterilize the Handpiece and Base
189
Other manuals for Integra Cusa Excel
Service Manual
213 pages
Instructions For Use
28 pages
Manual
43 pages
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Integra Cusa Excel Specifications
General
Brand
Integra
Model
Cusa Excel
Category
Medical Equipment
Language
English
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