Operator
& Service Manual
A.T.S.™ 2000
TOURNIQUET SYSTEM
REF 60-2000-101-00
LIMITED ONE YEAR WARRANTY (U.S.A. only)
SCOPE OF WARRANTY
Zimmer, Inc. warrants the Product (A.T.S.™ 2000 Tourniquet System) for one year from date of purchase. During the warranty period, Zimmer will repair or replace, at its option, any product which is defective in materials or workmanship or which fails to meet the published specification for that model. This Limited Warranty is made only to the original purchaser of the product and is non-transferable. The remedies described in the Limited Warranty are the exclusive remedies for breach of warranty. THIS WARRANTY SHALL NOT APPLY TO ANY PRODUCT WHICH HAS BEEN ALTERED OR
MODIFIED IN ANY WAY, OR WHICH HAS BEEN SUBJECTED TO MISUSE OR ABUSE.
DISCLAIMER OF IMPLIED WARRANTIES
The foregoing Express Limited Warranty is given in lieu of any and all other express or implied warranties. ZIMMER
MAKES NO OTHER WARRANTIES INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
LIMITATION OF REMEDIES
In no case shall Zimmer, Inc. be liable for any special incidental or consequential damages whether based on breach of warranty or other legal theory. Some states do not allow limitations on warranties or on remedies for breach in certain transactions. In such states, the limits in this paragraph and the preceding paragraph do not apply.
WARRANTY CLAIMS
In the event of a warranty claim within the warranty period please take the following steps:
1.Notify Customer Service Department, Zimmer Orthopaedic Surgical Products at 800-348-2759 or contact your local Zimmer representative. Please provide details about the nature of the problem and include the product serial number. Upon receipt of this information, Zimmer will provide a date for service or a return shipping authorization.
2.Upon receipt of the shipping authorization, forward the equipment, freight prepaid, to the location specified in the shipping authorization.
Your compliance with these steps will help assure that you receive prompt warranty service for your product.
WARRANTY (OUTSIDE U.S.A.)
Please contact your local Zimmer Representative for warranty information.
Unit Serial Number ________________
TABLE OF CONTENTS
A.T.S. 2000 TOURNIQUET SYSTEM
SECTION TITLE |
PAGE |
1.0GENERAL INFORMATION
1.1 |
Features..................................................................................... |
3 |
1.2 |
Specifications............................................................................. |
3 |
1.3 |
Intended Use ............................................................................. |
4 |
1.4 |
Contraindications ....................................................................... |
4 |
1.5 |
Precautions in Use..................................................................... |
4 |
1.6 |
Adverse Effects.......................................................................... |
5 |
2.0INSTALLATION AND OPERATING INSTRUCTIONS
2.1 |
Initial Inspection.......................................................................... |
5 |
2.2 |
Functional and Calibration Check .............................................. |
5 |
2.3 |
Installation.................................................................................. |
6 |
2.3.1 |
Pressure and Time Default Selections ...................................... |
6 |
2.3.2 |
Volume Selection ....................................................................... |
7 |
2.4 |
Controls, Indicators, and Connectors ........................................ |
7 |
2.5 |
Single Cuff Operation ................................................................ |
8 |
2.6 |
Dual Cuff Operation ................................................................... |
9 |
2.7 |
Bier Block Cuff Operation, (IVRA) ............................................. |
9 |
2.8 |
Alarm Conditions ....................................................................... |
9 |
2.8.1 |
Pressure Alarms ........................................................................ |
9 |
3.0MAINTENANCE
3.1 |
General Maintenance Information............................................ |
12 |
3.2 |
General Theory of Operation ................................................... |
12 |
3.3 |
Access to Parts ....................................................................... |
12 |
3.4 |
Periodic Maintenance .............................................................. |
12 |
3.4.1 |
Cleaning .................................................................................. |
12 |
3.4.2 |
Inspection ................................................................................ |
12 |
3.4.3 |
Functional and Calibration Checks .......................................... |
12 |
3.4.4 |
Calibration ............................................................................... |
13 |
3.4.5 |
Leak Testing ............................................................................ |
13 |
3.4.6 |
Battery Voltage and Battery Service ........................................ |
14 |
3.5 |
Unscheduled Maintenance ...................................................... |
14 |
3.6 |
Expected Test Point Readings ................................................. |
14 |
1
SECTION |
TITLE |
PAGE |
3.7 |
Troubleshooting Guide ............................................................. |
14 |
3.8 |
Replacement Parts................................................................... |
18 |
3.9 |
Storage .................................................................................... |
20 |
FIGURE |
TITLE |
PAGE |
1 |
Main and Second Calibration Setup Assembly........................ |
21 |
2 |
Controls, Indicators & Connectors ........................................... |
22 |
3 |
Block Diagram ......................................................................... |
23 |
4–7 |
Removing Chassis From Rear Case........................................ |
24 |
8–10 |
Separating Chassis ................................................................. |
25 |
11 |
CPU Board............................................................................... |
26 |
12 |
Power Supply Board ................................................................ |
27 |
13 |
CPU Schematic Sheet 1 of 3.................................... |
ENCLOSED |
14 |
CPU Schematic Sheet 2 of 3 ................................... |
ENCLOSED |
15 |
CPU Schematic Sheet 3 of 3 ................................... |
ENCLOSED |
16 |
Power Supply Schematic ......................................... |
ENCLOSED |
17 |
Warnings, Cautions, and Symbol Definitions..................... |
28, 29 |
TABLE |
TITLE |
PAGE |
2.1 |
Alarm Conditions ..................................................................... |
10 |
2.2 |
Hardware Malfunction Codes .................................................. |
11 |
3.1 |
Expected Test Point Readings ................................................. |
15 |
3.2 |
Troubleshooting ....................................................................... |
16 |
2
English
SECTION 1.0
A.T.S. 2000 TOURNIQUET SYSTEM* GENERAL INFORMATION
*U.S. Patents B1 4,469,099; 4,548,198; 5,556,415; 5,607,447; 5,855,589
1.1 FEATURES
The A.T.S. 2000 Tourniquet System is an automatic, micro- processor-based pneumatic tourniquet system. Its features include:
•The ability to independently control and monitor two cuffs in a Bier Block or bilateral procedure.
•Microprocessor control for improved reliability and to help prevent loss of occlusion during Bier Block cuff switching.
•Dual line tubing and dual port cuffs to facilitate monitoring of cuff pressure from one line as well as supplying air to pressurize the cuff via the other.
•A built-in battery charger.
•Precision pressure transducers in conjunction with a microprocessor-based control system.
•Time and pressure defaults that can be customized to fit user preference.
•Built-in inflation time alarm system to alert the operating room staff when the anticipated cuff inflation time has been reached. This system also provides a convenient means to monitor and record total inflation time.
•Large, bright LED displays for easy viewing from a distance.
•High output pump for increased inflation rate.
•Internal reservoir for increased inflation rate.
•Self-testing of alarm tones, displays, system calibration, and certain portions of the hardware and software each time the unit is turned on. In addition, some self-testing occurs continuously during normal operation.
•Multiple audible and visual alarms to alert the user of abnormal conditions: detects pressure not within acceptable limits, time alarm, low battery voltage, hardware failure. For certain types of equipment malfunctions, the unit will also display error messages for
certain equipment malfunctions that identify the cause of error, thus reducing fault isolation time.
•Easily accessible Quick Reference Cards containing general use instructions and help codes.
•Alarm silence switch permits silencing of most alarm tones for 30 seconds.
•Adjustable alarm volume (medium to high tone).
•Simple calibration that may be performed without disassembly.
•Modular construction for easy maintenance and repair.
•Portable and designed for tabletop or tourniquet stand mounting.
1.2 SPECIFICATIONS
Line Voltage Range:
90–240 V~, 50/60 Hz, auto switching
Line Current:
670 mA RMS @ 120 V~
Input Power:
53 Watts Typical
AC Indicator Light:
Green LED
Battery Type:
2 Rechargeable, 12 V 
sealed lead acid, 2.3 Amp hours
Battery Discharge Time:
Unit will operate on battery power for 60 minutes minimum with fully charged batteries.
Battery Recharge Time:
24 hours (Maximum)
Unit should be plugged in 24 hours before initial use.
Power Cord:
Type SJT, AWG 16, 14 ft. (4.27 m)
Power Plug:
Hospital grade, 3 prong straight blade, 15 Amp
Line Protection:
2 time delayed 1.0 Amp 250 volt fuses
Cuff Pressure Range:
50–475 mm Hg
Pressure Accuracy:
±3 mm Hg (50–475 mm Hg)
Pressure Regulation:
±4 mm Hg of set point
(10 second average under non-transient conditions without external leaks)
Maximum Pressures:
475 mm Hg cuffs
700 mm Hg reservoir
Time Alarm Set Ranges:
0–240 minutes; 1 minute increments
Timer Accuracy:
0.25% ±1 second
Internal Diagnostics:
Program, memory, watchdog timer, transducer calibration, improper valve actuation.
SIZE:
Height:
12.75 in. (32.4 cm)
Width:
10 in. (25.4 cm)
Depth:
10.5 in. (26.7 cm) (including clamp)
Weight:
19.8 lbs (9 kg)
3
CONTROLS: On/Standby Switch:
Applies power to unit / sets unit to STANDBY
Pressure Touch-Switches:
Increase or decrease pressure set points.
Time Touch-Switches:
Increase or decrease the time alarm set points.
Cuff Touch-Switches:
Control inflation or deflation of the main cuff and/or second cuff.
Alarm Silence Switch:
Allows operator to manually silence certain alarms for 30 seconds.
DISPLAYS:
Pressure:
Red 14 segment light emitting diodes (LED)
Time:
Red 14 segment light emitting diodes (LED)
AC Indicator Light:
Green LED
UL 60601-1 Classification:
Class I and Internally Powered, Type B, continuous operation. Use ordinary protection against ingression of liquids. Not for use with flammable anesthetic or gases.
The A.T.S. 2000 Tourniquet System complies with EMC criteria set forth in IEC 60601-1-2.
1.3 INTENDED USE
The A.T.S. 2000 Tourniquet System is intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient’s extremities during surgical procedures on those extremities. Tourniquets have been found useful in producing a bloodless operation field in surgical procedures involving the extremities including:
•Reduction of certain fractures
•Kirschner wire removal
•Tumor and cyst excisions
•Subcutaneous fasciotomy
•Nerve injuries
•Tendon repair
•Bone grafts
•Total wrist joint replacement
•Replacement of joints of the fingers
•Knee joint replacements
•Amputations
•Replantations
WARNING: Do not use tourniquet cuffs to control the distal flow of CO2 or any other gases used as distention media. Tourniquet cuffs have not been evaluated for safety or effectiveness in controlling gas flow beyond the surgical site during arthroscopic insufflation procedures. Possible effects of using a tourniquet cuff in this manner include serious subcutaneous emphysema proximal to the cuff.
1.4 CONTRAINDICATIONS
The medical literature lists the following as possible contraindications. However, in every case, the final decision whether to use a tourniquet rests with the attending physician.
•Open fractures of the leg
•Post-traumatic lengthy hand reconstruction
•Severe crushing injuries
•Elbow surgery (where there is concomitant excess swelling)
•Severe hypertension
•Skin grafts in which all bleeding points must be readily distinguished
•Compromised vascular circulation, e.g., peripheral artery disease
•Diabetes mellitus
•The presence of sickle cell disease is a relative contraindication. (See Precautions in Use.)
A tourniquet should also be avoided in patients who are undergoing secondary or delayed procedures after immobilization.
1.5 PRECAUTIONS IN USE
•The tourniquet system must be kept well calibrated and in operable condition. Accessories should be checked regularly for leaks and other defects.
•The tourniquet cuff should never be punctured. Therefore, towel clips used near the system must be handled with special care. Cuffs with inner rubber bladders must be completely enclosed by the outer envelope to preclude ballooning and possible rupture of the bladder. Cleaning and assembly instructions of the cuff manufacturer should be followed carefully.
•Do not use an elastic bandage for exsanguination in cases where this will cause bacteria, exotoxins, or malignant cells to spread to the general circulation, or where it could dislodge thromboemboli that may have formed in the vessels.
•The tourniquet cuff must be applied in the proper location on the limb, for a “safe” period of time, and within an appropriate pressure range. Never apply a tourniquet over the area of the peroneal nerve or over the knee or ankle. Do not readjust an already inflated cuff by rotating it because this produces shearing forces which may damage the underlying tissue.
•Prolonged ischemia may lead to temporary or permanent damage to tissues, blood vessels, and nerves. Tourniquet paralysis may result from excessive pressure. Insufficient pressure may result in passive congestion of the limb with possible irreversible functional loss. Prolonged tourniquet time can also produce changes in the coagulability of the blood with increased clotting time.
•Inflation should be done rapidly to occlude arteries and veins as near simultaneously as possible.
•Careful and complete exsanguination reportedly prolongs pain free tourniquet time and improves the quality of IVRA (Bier Block anesthesia). In the presence of infection and painful fractures, after the patient has been in a cast, and in amputations because of malignant tumors, exsanguination before tourniquet application may be done without the use of an elastic bandage by elevating the limb for 3 to 5 minutes.
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•In case of failure, the tourniquet cuff must be fully deflated and the limb exsanguinated again before reinflation. Reinflation over blood-filled vasculature may lead to intravascular thrombosis.
•Tourniquet users must be familiar with the inflationdeflation sequence when using a dual-cuff tourniquet, or two tourniquet cuffs together for IVRA (Bier Block anesthesia), so that the wrong tourniquet will not be released accidentally.
•Test for hemoglobin type and level before using a tourniquet on patients with sickle-cell anemia. When the tourniquet is used for these patients, the limb should be
carefully exsanguinated and the PO2 and pH should be closely monitored.
•Select the proper cuff size to allow for an overlap of about 3 to 6 inches (7.6 to 15.2 cm). Too much overlap may cause cuff rolling and telescoping, and may lead to undesired pressure distribution on the limb. The skin under the tourniquet cuff must be protected from mechanical injury by smooth, wrinkle-free application of the cuff. If the tourniquet cuff is applied over any
material that may shed loose fibers (such as Webril) the fibers may become embedded in the contact closures and reduce their effectiveness. As an under padding, a section of stockinette may be used. The deflated cuff and any underlying bandages should be completely removed as soon as tourniquet pressure
is released. After the cuff has been fully deflated and removed from the patient, the unit can be set to STANDBY. Even the slightest impedance of venous return may lead to congestion and pooling of blood in the operative field.
•If skin preparations are used preoperatively, they should not be allowed to flow and collect under the cuff where they may cause chemical burns.
•Whenever the tourniquet cuff pressure is released, the wound should be protected from blood surging back by applying pressure dressings and, if necessary, elevating the limb. Transient pain upon tourniquet pressure release can be lessened by elevation of the limb. If
full color does not return within 3 to 4 minutes after release, the limb should be placed in a position slightly below body level.
•Whenever Intravenous Regional Anesthesia (IVRA, a Bier Block anesthesia) is used, it is recommended that the tourniquet remain inflated for at least 20 minutes from the time of injection.
1.6 ADVERSE EFFECTS
A dull aching pain (tourniquet pain) may develop throughout the limb following use.
Pathophysiologic changes due to pressure, hypoxia, hypercarbia, and acidosis of the tissues occur and become significant after about 1 1/2 hours of tourniquet use. Symptoms of tourniquet paralysis are motor paralysis and loss of sense of touch, pressure, and proprioceptive responses.
Intraoperative bleeding may be caused:
1.By the slight impeding effect exerted by an unpressurized cuff (and its padding, if used), which prevents venous return at the beginning of the operation.
2.By blood remaining in the limb because of insufficient exsanguination.
3.By inadequate tourniquet pressure (between systolic and diastolic blood pressure of the patient), or slow inflation and deflation, all of which allow arterial blood to enter while preventing
venous return.
4.By blood entering through the nutrient vessels of the long bones, such as the humerus.
SECTION 2.0
A.T.S. 2000 TOURNIQUET SYSTEM INSTALLATION & OPERATING INSTRUCTIONS
2.1 INITIAL INSPECTION
Unpack the A.T.S. 2000 Tourniquet upon receipt and inspect the unit for any obvious damage that may have occurred during shipment. We recommend that this inspection be performed by a qualified biomedical engineer or other person thoroughly familiar with electronic medical devices. If the unit is damaged, notify the carrier and your Zimmer representative immediately. If the initial inspection results are satisfactory, a functional and calibration check should be performed.
2.2 FUNCTIONAL AND CALIBRATION CHECK
The unit shall produce the results explained in the following steps, exactly as indicated. Failure to do so indicates that the device is not to be used until necessary repairs are made.
1.Connect the power plug to the power entry module on the back of the unit, then plug the unit into a source of power compatible with the unit’s power rating.
a)Observe that the ~ (AC) indicator is on.
b)Unit should be connected to A/C power 24 hours before initial use.
2.Turn the unit on by pressing the ON/STANDBY (I/O) touch-switch and observe the following:
a)A series of zeros and asterisks appear on the PRESSURE and TIME displays;
b)The unit emits three tones; high, medium, low;
c)The word “SELF” appears in the main PRESSURE display and the word “TEST” appears in the main TIME display;
d)The word “VER” appears in the second PRESSURE display and the software version number appears in the second TIME display;
e)The Alarm Silence Switch illuminates;
f ) The word “CAL” appears in both PRESSURE displays;
g)The PRESSURE and TIME displays all read zeros.
3.Test the PRESSURE set point system as follows:
a)Press and hold the main PRESSURE INCREASE
(+) or DECREASE (–) touch-switch;
b)The PRESSURE display reads “*250”, the default pressure set point, for approximately 1.5 seconds;
c)The main PRESSURE display increases (or decreases) by units of one until reaching a multiple of 5. Then the main PRESSURE display increases (or decreases) by units of 5 to a maximum of 475 (or a minimum of 0), thus altering the pressure set point;
d)Releasing the touch-switch causes the sensed pressure of “0” to be displayed;
e)Once again, press the main PRESSURE INCREASE (or DECREASE) touch-switch; the main PRESSURE display should read the last setting from step c (above);
f)Release the main PRESSURE touch-switch;
g)Repeat steps a through f above for the second PRESSURE display functional check.
5
b)The main TIME display reads “*60”, the default pressure set point, for approximately 1.5 seconds;
c)The main TIME display increases (or decreases) by units of one until reaching a multiple of 5. Then the main TIME display increases (or decreases) by units of 5 to a maximum of 240 (or a minimum of 0), thus altering the time set point;
d)Release the touch-switch. This should cause the actual time of “0” to be displayed;
e)Once again, press the main TIME INCREASE (or DECREASE) touch-switch; the main TIME display should read the last setting from step c (above);
f)Release the main TIME touch-switch;
g)Repeat steps a through f above for the second TIME display functional check.
Notes for steps 3 & 4:
1.Anytime an asterisk (*) is displayed in the left display digit, the data being displayed is its set point.
2.The default factory set point for pressure is 250 mm Hg.
3.The default factory set point for time is 60 minutes.
5.Calibration Check
Note: During the power-up diagnostic self-test described above, the unit, which must hold a tolerance of ± 3 mm Hg, will test calibration. Should an out of calibration condition be detected, the unit will display “AMP” “FAIL” in the PRESSURE and TIME displays. Even though the unit completes this check during power-up, the following quantitative check is recommended at regular intervals.
a)Set the unit to STANDBY by pressing and holding the ON/STANDBY (I/O) touch-switch. Note that the unit will not be set to STANDBY immediately. The ON/STANDBY touch-switch has a 2-second delay built in to help prevent accidental turn off.
b)Wait approximately 10 seconds, then turn the unit back on by pressing the ON/STANDBY (I/O) touchswitch. Press and hold the second PRESSURE
(+) and (–) touch-switches until “CUFF” “CAL” is displayed.
c)Connect a calibrated pressure meter, with a minimum range of 0 to 700 mm Hg, to the Calibration Hose Assembly. See Fig. 1.
d)Connect a pressure source capable of supplying (at minimum) 700 mm Hg of pressure. See Fig. 1.
e)Insert the second cuff line with connector into the Second Cuff sense port. See Fig. 1.
f)Insert the main cuff line with connector into the Main Cuff sense port. See Fig. 1.
g)Apply 50 mm Hg of pressure to the cuff sense ports. The displays should each read 50 ±3 mm Hg.
h)Increase the pressure to 250 mm Hg. Again, the displays should each read 250 ±3 mm Hg.
i)Repeat step h (above) for 475 mm Hg.
j)Remove the main and second cuff line from the cuff sense ports.
k)Press and hold the second PRESSURE (+) and
(–) touch-switches until “RES” is displayed in the second PRESSURE display. The main PRESSURE display should be reading 0 ±3 mm Hg.
l)Insert the main cuff line with connector and second cuff line with connector into the reservoir sense ports. See Fig. 1.
m)Apply 250 mm Hg of pressure to the reservoir sense ports. The display should read 250 ±3 mm Hg.
n)Repeat step m for 475 mm Hg and 700 mm Hg.
o)Remove pressure as well as the main and second cuff line with connectors from the unit.
p)Set the unit to STANDBY by pressing and holding the ON/STANDBY (I/O) touch-switch.
NOTE: During the calibration check, if any reading is off by more than 3 mm Hg, the unit must be calibrated. See CALIBRATION in MAINTENANCE Section 3.
6. Under Pressure Alarm Check
Create a leak in the main cuff while it is inflated. Make the leak large enough that even though the unit will be attempting to maintain pressure, the pressure still falls more than 15 mm Hg below set point. Observe:
a)The Main PRESSURE display window indicates low pressure by “LO-P”.
b)The Alarm Silence Switch illuminates.
c)After approximately 1 second, an audible tone will sound announcing the low pressure condition. This delay is used to preclude nuisance alarms.
d)Stop the leak and observe that the pressure returns to within limits, the audible tone ends, and the Alarm Silence Switch light extinguishes.
Repeat the above procedures for the second cuff.
2.3 INSTALLATION
The A.T.S. 2000 Tourniquet is designed to be mounted on a table top or tourniquet stand (REF 60-4022-001). The adjustment range of the pole clamp on the right side of the unit will accommodate pole diameters of 0.5 to 1.5 inches (1.25 to 3.8 cm). Caution: Do not hang articles on the tourniquet stand which are not related to tourniquet use.
Inspect and ensure that the correct fuse drawer with appropriately rated fuses is present. 100–120 V uses the grey fuse drawer with 1.0 A time delay fuses. 220–240 V uses the black fuse drawer with 500 mA time delay fuses.
Connect the power cord of the unit to a properly polarized and grounded power source whose voltage and frequency characteristics are compatible with those listed on the nameplate of the unit.
The A.T.S. 2000 Tourniquet is now ready for use.
2.3.1 PRESSURE AND TIME DEFAULT SELECTIONS
An operator may want to modify the start up default pressure of 250 mm Hg and the default time of 60 minutes for one or both cuffs.
The following steps will allow a user to customize the default settings for both cuffs.
1.Prior to any cuff inflation, set the cuff target pressure and the maximum inflation time to the new desired default values.
2.Press the main cuff PRESSURE (+) and (–) touchswitches simultaneously and hold until an audible tone is sounded, indicating that the new default values have been stored. The display should also read “UP” “DATE”.
The new pressure and time defaults will be written to nonvolatile storage and will provide the default pressure and
6
2.3.2 VOLUME SELECTION
An operator may want to change the speaker volume setting from the default value of 2.
The following steps will allow a user to customize the speaker volume default.
1.Prior to any cuff inflation, set the speaker volume by pressing and holding the second cuff PRESSURE (+) and (–) touch-switches simultaneously. Hold until “VOL” is displayed in the second cuff PRESSURE display.
2.Adjust the volume to the desired level by pressing the second cuff TIME (+) or (–) touch-switches. The (+) increases volume while the (–) decreases volume. The volume can be set from 1 to 4, with 1 being the lowest volume.
3.Exit the volume mode by pressing the second cuff PRESSURE (+) and (–) touch-switches simultaneously. The new speaker volume setting will be written to nonvolatile storage and used as the default setting.
2.4CONTROLS, INDICATORS, AND CONNECTORS
Refer to Fig. 2 for the locations of the unit’s controls, indicators, and connectors. Their primary functions are:
1.ON/STANDBY (I/O) touch-switch
Turns the unit on or sets the unit to STANDBY. This switch has approximately a 2-second time delay. When setting the unit to STANDBY, this switch must be held in for the 2-second duration. This helps prevent the unit from being accidentally set to STANDBY. This switch will not set the unit to STANDBY when the cuff pressure is at a non-zero value. Ensure cuffs are fully deflated and have been removed from the patient prior to setting the unit to STANDBY.
Note: During STANDBY, power to the A.T.S. 2000 instrument and all instrument functions (i.e. inflation, deflation, etc) are off but power continues to supply the battery charging circuitry anytime
~ (AC) power is present.
2.PRESSURE SETTING Touch-Switches
a)The MAIN CUFF controls, indicators and connectors operate the main cuff. The SECOND CUFF controls, indicators and connectors operate the second cuff. To view the current pressure setting, depress either pressure setting touch-switch (+) or
(–). The PRESSURE display will display the pressure setting with an asterisk (*) in the far leftmost digit. The asterisk helps the operator identify that the data displayed is the set point data, not the actual sensed pressure. This is helpful when needing to view the set point data during a procedure.
b)To change the pressure setting, depress and hold the increase (+) or decrease (–) touch-switch until the desired setting is reached. The setting will change in 1 mm Hg increments for the first
5 counts or until reaching a multiple of 5, then in increments of 5 until the touch-switch is released or the limits (0 and 475) are reached.
3.TIME SETTING Touch-Switches
a)To view the current time setting, depress either time setting touch-switch (+) or (–). The TIME display will display the time setting with an asterisk in the far left digit. The asterisk helps the operator identify that the data being displayed is the set point data, not the actual elapsed time. This is helpful when viewing the setpoint data during a procedure.
b)To change the time setting, depress and hold the increase (+) or decrease (–) touch-switch until the desired setting is reached. The setting will change in 1 minute increments for the first 5 counts or until reaching a multiple of 5, then in increments of 5 until the touch-switch is released, or the limits (0 and 240) are reached.
c)The accumulated inflation time may be reset to zero by depressing the TIME increase (+) and decrease (-) touch-switches simultaneously for 2-sec- onds. This enables the unit to be used for multiple procedures at the same pressure setting without setting the unit to STANDBY (and thus erasing the selected pressure set point if other than the default is used.)
4.INFLATE/DEFLATE Touch-Switches
Inflation or deflation of the cuff(s) is accomplished by depressing the appropriate touch-switch. For greater safety, the deflate touch-switch has a delay and, therefore, must be held for 1.5 seconds before the unit will allow a cuff to deflate.
Note: It is not possible to deflate one cuff while the other cuff is inflating.
5.ALARM SILENCE SWITCH
This push-button switch will light when any of a number of alarm conditions exist. The audible tone associated with most of these alarms may be silenced for 30 seconds by depressing this switch. The push-button will remain lighted until the alarm condition is corrected. Note: In general, when an alarm sounds because of an internal circuit malfunction, the tone cannot be silenced by this switch.
6.PRESSURE DISPLAYS
During normal operation with no touch-switches being depressed, the displays will show the pressure sensed in the cuff(s) over the range of 0 to 475 mm Hg. At other times, depending on alarm conditions and touchswitches, these displays may communicate other information such as alarm messages or pressure set point. The pressure set point may be viewed on the displays when the PRESSURE SETTING touch-switches are operated in accordance with point 2 above.
7.TIME DISPLAYS
During normal operation, with no touch-switches being depressed, the displays will show the inflation time of the cuff(s) in 1-minute increments, up to a maximum of 240 minutes. At other times, depending on alarm conditions and touch-switches, these displays may communicate other information such as alarm messages or time set point. The time set point may be viewed on the displays when the TIME SETTING touch-switches are operated in accordance with point 3 above. If the inflation time has exceeded the time alarm setting, the display will flash between inflation time and “TIME” “UP” message.
7
8.AC INDICATOR LIGHT
Identifies that the unit is plugged into an ~ (AC) power source. The unit is operating on battery if this light is not illuminated.
9.QUICK REFERENCE CARDS
Pull-out cards that contain general use instructions and help codes.
10.CUFF CONNECTORS
Ports to connect hoses to cuff(s).
11.POLE CLAMP
Adjustable clamp to mount the unit on a tourniquet stand.
2.5SINGLE CUFF OPERATION
1.Connect the power cord to an electrical power source that is compatible with the ratings listed on the nameplate of the unit.
2.Connect a dual port cuff to the unit at the main cuff connectors.
3.Press the ON/STANDBY touch-switch to turn the unit on. The unit will execute a self-check diagnostic test as described in Section 2.2 of this manual. Successful completion of the self-check indicates the unit is ready for use.
CAUTION: If either cuff is pressurized to 50 mm Hg or more during power-up, the A.T.S. 2000 Tourniquet will declare it an abnormal start-up sequence. It will assume that a surgical procedure is in process, and will adopt pressures sensed in each cuff as the new set point. It will automatically go into the regulate mode on the cuff(s) which had the excess pressure. To alert the operator of this condition, the unit will sound a high pitch tone and illuminate the Alarm Silence Switch Light. The operator should immediately check the pressure set point and readjust to the proper set point if necessary. The alarm will be cleared as soon as the set point is examined.
4.The default settings for cuff pressure and time are retrieved from the nonvolatile storage during power up. These values may be changed prior to cuff inflation by following Section 2.4 step 2b.
For each patient, tourniquet pressure should be set to the minimum effective pressure. The minimum effective pressure should be determined by factors such as: whether the cuff is to be applied to an upper or lower limb; whether the limb is normal, hypertrophied, or obese; the patient’s preoperative systolic pressure; and the maximum anticipated rise in systolic pressure during the procedure.
5.Prepare the patient in accordance with your established procedures and cuff manufacturer’s instructions. The precautions of Section 1 and the following are offered as a guide to assist in
this process.
In most cases a tourniquet cuff should be applied to the widest part of the limb to allow as much tissue as possible to lie between the cuff and any nerves or vascular structures susceptible to damage. The optimum positions are the upper arm and the proximal third of the thigh. In certain cases of forefoot surgery, the tourniquet cuff can be applied around the calf or to the area proximal to the malleoli. For emergency surgery of the hand, a suf-
ficiently small tourniquet can be fitted around the wrist.
Apply a leak-free tourniquet cuff smoothly without wrinkles. The valve port and hose connections should be placed so that the hose will not be kinked when the limb is positioned for surgery. The limb is then prepared and draped for surgery. The viability of the skin and deeper tissues should be established prior to exsanguination of the limb and tourniquet inflation.
Exsanguinate the limb by elevating it for a minimum of 2 minutes and wrapping it, distal to proximal, using an Esmarch, Martin, or elastic bandage. The bandage should come up approximately to 1 in. (2.5 cm) from the edge of the tourniquet cuff. The elastic bandage is removed following inflation of the cuff. If regional anesthesia is being used, the anesthetic agent or nerve block is then administered. The tourniquet time depends greatly on the patient’s anatomy, age, and absence of vascular disease. The surgeon will determine: 1. when the tourniquet is to be inflated; 2. to what pressure; 3. for how long; 4. whether to allow for intermittent aeration of tissues by deflating the cuff for 10 to
15 minutes; 5. at what point in the operation the tourniquet should be released. In many operating rooms, it is customary to prominently note the time of inflation, and to warn the surgeon after a certain time has elapsed. This will allow the surgeon to assess the need for further tourniquet time.
There is a general agreement that, for reasonably healthy adults, about 1 1/2 hours is safe and 2 hours should not be exceeded without releasing the tourniquet to allow the underlying tissue to breathe. During this time, the limb should be elevated about 60 degrees, and steady pressure should be applied to the incision with sterile dressing.
Under optimum conditions, the tourniquet cuff can be kept inflated until the final compression dressings are in place. Postoperative swelling is then kept to a minimum.
6.The cuff is inflated by pressing the MAIN CUFF INFLATE touch-switch. The unit will pressurize the main cuff to the preset pressure and start the inflation clock. If the unit cannot pressurize the
cuff to within 15 mm Hg of the set point in less then 30 seconds, a pressure alarm will be sounded. See Section 2.8 for information about possible alarm conditions.
7.At the end of the procedure, deflate the cuff by pressing the MAIN CUFF DEFLATE touch-switch. The PRESSURE display will show the deflation of the cuff, and the inflation clock will stop. Record the elapsed time if desired.
8.Remove the tourniquet cuff and any underlying bandages immediately following final deflation.
The time of tourniquet cuff removal should be noted, and circulation of the limb should be checked.
9.The time clock display(s) may be reset to zero without turning the unit off. This would enable the unit to be used for multiple procedures without turning the unit off (and thus erasing the selected pressure set point if other than the default is used). see Section 2.4 step 3c.
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