ZIMMER

A.T.S. 3000 AUTOMATIC TOURNIQUET Operator and Service Manual Dec 2010

Operator and Service Manual

44 Pages

Operator & Service Manual A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM Zimmer A.T.S.® 3000 AUTOMATIC TOURNIQUET SYSTEM REF 60-3000-101-00

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Operator & Service Manual

A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM

Zimmer A.T.S.® 3000 AUTOMATIC TOURNIQUET SYSTEM REF 60-3000-101-00

LIMITED ONE YEAR WARRANTY (U.S.A.)

A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM SCOPE OF LIMITED WARRANTY

Zimmer, Inc. warrants the Product (A.T.S. 3000 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 this 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 forgoing of 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 whether or not such damages are foreseeable. 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 Surgical, at 1-800-348-2759 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.

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 _______________________

A.T.S. ENGLISH 3000 AUTOMATIC TOURNIQUET SYSTEM

TABLE OF CONTENTS ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM SECTION 1.0 1.1 1.2 1.3 1.4 1.5

TITLE PAGE GENERAL INFORMATION Specifications ... 3 Intended Use ... 6 Contraindications ... 6 Precautions in Use ... 6 Adverse Effects ... 7

2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12

INSTALLATION AND OPERATING INSTRUCTIONS Initial Inspection ... Controls, Indicators, and Connectors ... Initial Setup ... Functional and Calibration Check ... Pressure and Time Defaults ... Limb Occlusion Pressure (LOP) Determination ... Single Cuff Operation ... Dual Cuff Operation ... Bier Block Cuff Operation (IVRA) ... Speaker Volume Setting ... Contrast Display Setting ... Alarm Conditions ...

8 8 9 9 11 11 13 14 15 15 15 15

3.0 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11 3.12 3.13 3.14

MAINTENANCE General Maintenance Information ... Access to Parts ... Limb Occlusion Pressure (LOP) Sensor Cleaning and Disinfecting ... Periodic Maintenance ... Calibration... Leak Testing ... Battery Voltage and Battery Service ... Fuse and Fuse Drawer Replacement ... Unscheduled Maintenance ... Troubleshooting Guide ... Expected Test Point Readings ... Replacement Parts... Storage ... Warnings, Cautions, and Symbology...

24 24 24 24 25 26 27 27 28 28 28 32 32 39

TABLES

A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM Alarm Conditions ... 16

2.1 2.2 2.3 2.4 2.5 2.6 2.7 3.1 3.2 3.3 3.4

LOP Alarm Conditions ... Error Codes ... EMC Guidance and Declaration - EMC Emissions ... EMC Guidance and Declaration - EMC Immunity/Disturbances ... EMC Guidance and Declaration - EMC Immunity/RF ... EMC Guidance and Declaration - EMC Immunity/Separation Distances ... Board Plug Designators ... Troubleshooting ... Expected Test Point Readings ... Parts List ...

18 18 20 20 22 23 24 29 31 32

1 2 3 4 5 6 7 8 9

ILLUSTRATIONS A.T.S. 3000 Overview – front ... A.T.S. 3000 Overview – rear ... Main and Second Calibration Kit Setup ... Battery Removal Overview ... Rear Power Cord Cover Removal ... Rear Clamp Removal ... Wiring View of Control Board ... Rear Case Separation ... Control Board Layout ...

33 34 35 35 36 36 36 37 38

A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM GENERAL INFORMATION SECTION 1.0 ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM

1.1 SPECIFICATIONS

PRESSURE Button:

Mains Line Voltage Range:

PRESSURE

100–240 V ~ (AC), 50/60 Hz. Auto switching Line Current: 670 mA RMS @ 120 V ~ (AC) Input Power: 53 Watts typical Battery Type: Rechargeable, 12 VDC sealed lead acid, 4.0 amp hours Battery Discharge Time:

Used in conjunction with the shuttle knob to adjust the pressure set point. Can also be pressed to verify the set point. The Main Cuff and Second Cuff have separate Pressure buttons. TIME Button:

Unit will operate on battery power for 240 minutes minimum with a fully charged battery. Battery Recharge Time: 24 hours Unit should be plugged in 24 hours before initial use. In the event of a deep battery discharge that cannot be recovered in the first 24 hours, a second 24 hour charging period may be required. In this event, the A.T.S. unit should be unplugged for 60 seconds and reconnected to AC power prior to starting the second charging session. Power Cord: Type SJT or international equivalent of HO5VV-F, AWG 16 (1.31mm2), 14 ft. (4.27 m) Power Plug: Hospital grade, 3 prong straight blade, 15 amp or proper equivalent power plug Line Protection: 2 time delayed 1.0 amp 250 volt fuses

TIME

Used in conjunction with the Shuttle Knob to adjust the time alarm set point. Can also be pressed to verify the set point. The Main Cuff and Second Cuff have separate Time buttons.

Cuff INFLATE / DEFLATE Buttons: INFLATE

DEFLATE

CONTROLS:

Controls inflation or deflation of the respective cuff. The Main Cuff and Second Cuff have separate INFLATE / DEFLATE buttons.

ON/STANDBY Button:

ALARM SILENCE Button:

Turns the unit ON / sets unit to STANDBY.

Allows operator to manually silence most alarms for 30 seconds.

A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM Limb Occlusion Pressure (LOP) Button: Cuff Pressure Range: 50–475 mmHg, 1 mmHg increments

LOP

Pressure Accuracy: ±3 mmHg (50–475 mmHg) Pressure Regulation: ±4 mmHg of set point (10 second average under non-transient conditions without external leaks)

Controls the LOP feature. When the pulse sensor is in place and cuff applied, pressing this button will start the process to measure the patient’s LOP and give the user a recommended tourniquet pressure (RTP).

Maximum Pressure: 475 mmHg cuffs

AC Indicator Light Icon (Green LED): Time Alarm Set Range: 5–240 minutes; 1 minute increments Timer Accuracy: 0.25% of elapsed time Internal Diagnostics: Program, memory, watchdog timer, transducer calibration, improper valve actuation.

Indicates unit is operating on AC Mains. This is the normal means of operation (battery power is only intended for emergency power loss or patient transport).

SIZE: Height: 13.0 in. (33.02 cm) Width: 9.5 in. (24.1 cm) Depth: 10.375 in. (26.35 cm) (including clamp and ports) Weight: 16.3 lbs. (7.4 kg)

Battery Indicator Light Icon (Orange LED):

Indicates unit is operating on backup battery. This indicator always flashes. Alarm Indicator Light Icon (Red LED):

DISPLAYS: The A.T.S. 3000 uses a backlit 1/4 panel LCD. Pressure Display: Displays pressure setting, sensed cuff pressure, and hardware failure conditions / other messages. Visual indicator to show the unit is in an alarm condition. Time Display: Displays time alarm set point, elapsed time, and hardware failure conditions / other messages.

LOP Heart Indicator Icon (Yellow LED):

Visual indicator to show the LOP function has been invoked.

A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM UL60601-1 Classification: Type of protection against electric shock:

Class I or Internally Powered Equipment*

Degree of protection against electric shock:

Type BF applied part

Classification according to the degree of protection against ingress of water:

IPX0

Mode of operation:

Continuous operation

*When the unit is operating on backup battery, the type of protection against electric shock changes to internally powered equipment.

This device is not suitable for use in the presence of flammable anesthetic or gases.

Emissions/Immunity: The A.T.S. 3000 Tourniquet System complies with EMC criteria set forth in EN 60601-1-2. The user of this device should be aware that precautions should be taken in regards to EMC. The device should be installed and used according to the EMC information provided in the instructions for use. See EMC Guidance Tables included in this manual. Cables

Maximum length

Zimmer LOP sensor cable

98 inches (249 cm)

Mains power cord

170 inches (432 cm)

WARNING: use of an LOP sensor cable or mains power cord with a length other than those specified may result in increased emissions and decreased immunity.

A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM 1.2 INTENDED USE

1.4 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 must 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 Intravenous Regional Anesthesia, (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. ◆ 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 in. (7.6–15 cm). Too much overlap may cause cuff rolling and telescoping, and may lead to undesired

The A.T.S. 3000 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 in 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 a 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. 1.3 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 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.

A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM 1.5 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 humerous.

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 bandage or protective sleeve 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 IVRA, Bier Block anesthesia, is used, it is recommended that the tourniquet remain inflated for at least 20 minutes from the time of injection. ◆ WARNING: Cuffs will not deflate in STANDBY mode. Ensure cuffs are fully deflated before setting the unit to STANDBY.

A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM

INSTALLATION AND OPERATING INSTRUCTIONS SECTION 2.0 ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM 2.1 INITIAL INSPECTION

Unpack the A.T.S. 3000 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 after a 24-hour charge. The attention label covering the ON/STANDBY button can be removed and discarded after the 24-hour charge.

2.2 CONTROLS, INDICATORS, AND CONNECTORS Refer to Figure 1 in the back of the manual for the locations of the unit’s controls, indicators, and connectors. 1.

NOTE: The alarm messages will continue to flash on the displays until the alarm condition is corrected.

ON/STANDBY button Turns the unit ON or sets the unit to STANDBY. This button will not set the unit to STANDBY when the cuff pressure is at a non-zero value. Ensure both cuffs are fully deflated and have been removed from the patient as well as all underlying bandages or protective sleeve prior to setting the unit to STANDBY.

AC INDICATOR light The AC INDICATOR light indicates that the unit is plugged in and is being powered by AC Mains. This is the normal means of operation (battery power is only intended for emergency power loss or patient transport). 9. BATTERY INDICATOR light The BATTERY INDICATOR light indicates that the unit is operating on backup battery. The light will flash continuously while the unit is running on battery backup power. 10. PRESSURE displays (independent) During normal operation with no buttons being pressed, the independent PRESSURE display areas will show the monitored cuff(s) pressure. At other times, depending on alarm conditions and buttons pressed, the display may communicate other information such as alarm messages, set pressure, or default set pressure. 11. TIME displays (independent) During normal operation with no buttons being pressed, the independent TIME display area will show elapsed inflation time of each cuff. At other times, depending on alarm conditions and buttons pressed, the display may communicate other information such as alarm messages, set time, or default set time.

NOTE: During STANDBY, the power to the A.T.S. 3000 instrument and all instrument functions (i.e. inflation, deflation, etc.) are OFF but power continues to supply the battery charging circuitry anytime ~ (AC) power (Mains) is present. 2.

3. 4.

INFLATE buttons Inflation of the respective cuff is initiated by depressing the INFLATE button. DEFLATE buttons Deflation of the respective cuff is initiated by depressing the DEFLATE button. For greater safety, the DEFLATE button has a delay and, therefore must be held for approximately 2 seconds before the unit will allow a cuff to deflate. ALARM SILENCE button The ALARM SILENCE button will silence most audible alarms for 30 seconds after the button is pressed. When an alarm sounds because of an internal hardware malfunction, the alarm cannot be silenced.

Shuttle Knob Changes the value of set time or default time and set pressure or default pressure. Turn knob clockwise to increase the value; turn knob counterclockwise to decrease the value. PRESSURE button Press to verify or modify set pressure. TIME button Press to verify or modify set time. 8

A.T.S. 3000 TOURNIQUET SYSTEM A.T.S. 3000 AUTOMATIC 1.

Connect the power plug of the unit to a properly polarized and grounded power source with voltage and frequency characteristics compatible with the specifications listed in Section 1.1. Observe that the green AC Mains indicator light turns on. 2. Turn the unit ON by pressing the ON/STANDBY button and observe the following: a) “Zimmer” along with the circle “Z” appears on the LCD display. b) The unit displays “SELF TEST” below the “Zimmer” name. The unit is self-testing specific system hardware and software. c) Emits tones while “SELF TEST” is displayed. d) The front panel “Alarm”, “LOP”, and “Battery” indicators flash on and off while “SELF TEST” is displayed. e) “CAL” is displayed in the PRESSURE display areas during the calibration check. f) “0” is displayed in the PRESSURE and TIME display areas after the startup routing is complete. If a number other than zero is displayed in the PRESSURE display, the unit should be calibrated. 3. Test the PRESSURE set point system as follows: a) Press either PRESSURE button. b) The PRESSURE display should read “*250” (the factory default set point) for approximately 2 seconds. c) Within the 2 second time frame, rotate the SHUTTLE KNOB to change the pressure set point (clockwise to increase, counter-clockwise to decrease). The set pressure can be maintained between 50 mmHg and 475 mmHg in increments of 1 mmHg. d) Repeat step 3 for the other PRESSURE set point. 4. Test the TIME set point system as follows: a) Press either TIME button. b) The main TIME display should read “* 60” (the factory default set point) for 2 seconds. c) Within the 2 second time frame, rotate the SHUTTLE KNOB to change the time set point (clockwise to increase, counter-clockwise to decrease). The set time can be maintained between 5 and 240 minutes in increments of 1 minute. d) Repeat step 4 for the other TIME set point.

NOTE: The elapsed inflation time can be “zeroed” at any point in the procedure by pressing the TIME and PRESSURE buttons for the respective cuff simultaneously. 12. Cuff connector ports The Cuff connectors are the ports used to connect the unit to the cuff hoses. Please note that the Main Cuff is the RED ports and the Second Cuff is the BLUE ports. The A.T.S. 3000 is designed and tested for use with Zimmer dual port cuffs. Zimmer does not recommend the use of any cuff other than Zimmer dual port cuffs. Do not use single port cuffs with the A.T.S. 3000. 13. Pole Clamp The Pole Clamp is used to mount the unit on an I.V. pole. NOTE: Do not hang articles on the tourniquet pole that are not related to tourniquet use. For stability reasons, do not use an I.V. pole with a base less than 27.56 inches (70 cm) in diameter. 14. Hose hangers The A.T.S. 3000 is equipped with hose hangers that pull out of the unit’s handle. The cuff hoses can be temporarily hung on the hangers for transport or when disconnecting from the cuff. NOTE: Do not hang articles on the tourniquet’s hose hangers that may cause the tourniquet to become unstable. Cuff hoses or the LOP sensor should be the only item to utilize the hose hangers. 2.3 INITIAL SETUP Inspect to ensure the correct fuse drawer with the appropriately rated fuses is present. The 100–120 V unit uses the gray fuse drawer with 1.0 A time delay fuses. The 220–240 V unit uses the black fuse drawer with 1.0 A time delay fuses. See Section 3.8 Fuse and Fuse Drawer Replacement. The power cord should be plugged into the power entry module on the back of the unit. The unit should be plugged into ~ (AC) power (Mains) for 24 hours before initial use. During shipping and storage, the unit’s battery could become weak. Always charge 24 hours before any initial use including any calibration checking procedures, initial checks, tests and any institutional performed biomedical evaluations.

NOTE: Anytime an asterisk (*) appears in the left most display digit, the data being displayed is the set point. Set pressure and time will revert back to the default pressure and time settings when the unit is set to STANDBY.

2.4 FUNCTIONAL AND CALIBRATION CHECK The unit shall produce the results explained in the following steps exactly as indicated. Failure to do so indicates that a problem may exist and the device is not to be used until necessary repair or calibration has been made. 9

A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM 5.

Calibration Check

Increase the pressure to 475 mmHg. Both PRESSURE displays should read 475±5 mmHg. j) Decrease the pressure to 0 mmHg and remove the calibration hose assembly from the unit. The PRESSURE displays should return to 0 mmHg. k) Press and hold in the Main Cuff INFLATE and Main Cuff DEFLATE buttons to advance to the reservoir calibration check.

NOTE: During the power-up diagnostic self-test described above, the unit will test the calibration. Should an out of calibration condition be detected, the unit will display either “CAL” “FAIL”, “CAL M” “FAIL” or “CAL 2” “FAIL” in the PRESSURE and TIME display areas. Even though the unit performs this check at every power-up, the following quantitative check is recommended at regular intervals.

NOTE: At this point the reservoir pressure, if pressurized, will be exhausted through the source ports and the Main Cuff PRESSURE display should go to “0” while the Main Cuff TIME display should continue to display “CAL” “0” as described earlier.

a) Verify the unit is in the STANDBY mode. b) Enter the calibration mode by pressing then releasing the ON/STANDBY button then immediately depress and hold in the Main Cuff INFLATE and Main Cuff DEFLATE buttons during power on self test. The unit will enter calibration mode after momentarily displaying “ZIMMER” “SELF TEST”. When “CALIBRATION” is momentarily displayed, release the Main Cuff INFLATE and Main Cuff DEFLATE buttons. The unit will also display the software revision level in the lower left corner. The software revision level can be recorded for future reference.

Insert one end of the calibration hose assembly connector into the Main Cuff source port on the unit (red port). The source port is the first port from the left side of the unit. m) Insert the other end of the calibration hose assembly connector into the Second Cuff source port on the unit (blue port). The source port is the third port over from the left side of the unit. n) Increase the pressure in the calibration hose assembly to 250 mmHg. The display should read 250±5 mmHg. o) Increase the pressure to 475 mmHg. The display should read 475±5 mmHg. p) Increase the pressure to 700 mmHg. The display should read 700±5 mmHg.

NOTE: The calibration is only being checked in this section. For complete calibration, see Maintenance Section 3.0. c)

Connect a calibrated 0 to 700 mmHg pressure meter (minimum requirement) to the calibration hose assembly. The calibrated meter will be used as the pressure standard (See Figure 3 in the back of the manual). d) Connect a pressure source capable of supplying 0 to 700 mmHg of pressure, minimum. e) Insert one end of the calibration hose assembly connector into the Main Cuff sense port on the unit (red port). The sense port is the second port over from the left side of the unit. f) Insert the other end of the calibration hose assembly connector into the Second Cuff sense port on the unit (blue port). The sense port is the fourth port over from the left side of the unit.

NOTE: If any reading is off by more than ±5 mmHg, the entire unit must be recalibrated by following the calibration procedure as outlined in Maintenance Section 3.0. q) To complete this procedure, turn the unit OFF by holding in the ONSTANDBY button until the unit is set to STANDBY. r) Calibration check is complete. 6. Low Pressure Alarm Check – Turn the unit ON by pressing the ON/STANDBY button. Connect a cuff and standard length hose set to the Main Cuff ports. Inflate the cuff to 250 mmHg. Create a leak in the cuff by partially detaching the hose (either port) from the unit while a cuff is inflated. Make the leak large enough that the pressure drops more than 15 mmHg below set point. Observe: a) A 1.5 second delay is instituted to reduce nuisance alarms. b) The PRESSURE display flashes between “LO-P” and the monitored pressure (if a substantial leak has been present for more than 9 seconds, the PRESSURE display will show “CUFF” “LEAK”). c) An audible tone will sound and the red alarm indicator will illuminate announcing the alarm condition.

NOTE: The unit will be displaying “0” where the cuff pressures are normally displayed and alternating “CAL” and “0” where the cuff times are normally displayed. g) Increase the pressure in the calibration hose assembly to 50 mmHg. Both PRESSURE displays should read 50±5 mmHg when compared to the calibrated meter. h) Increase the pressure to 250 mmHg. Both PRESSURE displays should read 250±5 mmHg. 10

A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM d) Stop the leak and observe the monitored pressure returns to regulated state, the audible tone stops, the red alarm indicator turns off, and the alarm message is no longer displayed. Repeat this procedure with the Second Cuff ports.

2.6 LIMB OCCLUSION PRESSURE (LOP) DETERMINATION

2.5 PRESSURE AND TIME DEFAULTS

The patient’s limb occlusion pressure is the lowest pressure required to stop the flow of blood in the extremity. The A.T.S. 3000 has the ability to estimate the patient’s limb occlusion pressure based on their physiological characteristics. The A.T.S. 3000 will also take into account anticipated changes in blood pressure during the procedure by adding an additional pressure margin to the LOP measurement at the end of the LOP determination. This additional pressure margin added to the LOP measurement is referred to as the Recommended Tourniquet Pressure or RTP. The RTP is calculated using the LOP with the following:

NOTE: Limb Occlusion Pressure (LOP) determination is not intended for use in pediatric procedures.

To modify the default pressure or time limits for either cuff, follow the following steps. 1. Default Pressure a) The Default Pressure is selected by depressing and holding either PRESSURE button for 2 seconds. When the default mode is entered, the audible alarm beeps once and a “D” is displayed in the first position on the selected cuff PRESSURE display. b) The Default Pressure is modified via the Shuttle Knob and can be set between 50 and 475 mmHg in increments of 1 mmHg. c) After the correct value is selected, it is saved by momentarily depressing the PRESSURE button or it will be saved automatically in 3 seconds. d) The new default value will be displayed for 1.5 seconds and the audible alarm will beep once signifying a new default value has been stored. e) The new default pressure will be stored and remains the default every time the machine is turned on. 2. Default Time Limit a) The Default Time Limit is selected by pressing and holding either TIME button for 2 seconds. When the default mode is entered the audible alarm beeps and a “D” is displayed in the first position on the selected cuff TIME display. b) The Default Time Limit is modified via the Shuttle Knob and can be set between 5 and 240 minutes in increments of 1 minute. c) After the correct value is selected, it is saved by momentarily depressing the TIME button or it will be saved automatically in 3 seconds. d) The new default value will be displayed for 1.5 seconds and the audible alarm will beep once signifying a new default value has been stored. e) The new time limit default will be stored and remains the default every time the machine is turned ON.

LOP 100–130 mmHg

LOP + 50 mmHg = RTP

LOP 131–190 mmHg

LOP + 75 mmHg = RTP

LOP 191–300 mmHg

LOP + 100 mmHg = RTP

The RTP can be accepted or rejected based on the physician’s discretion. The RTP value is presented at the end of the LOP determination. When deciding to accept the RTP value or not the physician may take into account other factors such as the patient’s blood pressure, anesthetic technique to be used, expected procedure duration, cuff location, cuff type, cuff width, snugness of cuff application and surgical procedure to be performed. The physician may also choose to use an alternative method such as the Doppler stethoscope to manually determine the patient’s LOP, or to confirm the LOP determined by the A.T.S. 3000. The accuracy of the automatic determination of LOP can be verified manually, by employing a Doppler stethoscope and carefully following the published technique for manual LOP determination. The A.T.S. 3000 will suggest the RTP as the lowest pressure for the extremity to ensure the field will remain clear even during changes in blood pressure. However large changes in the patient’s blood pressure during surgery may result in reduced visibility in the field. The pressure may need to be adjusted slightly to improve visual quality. The RTP may be overridden at any time simply by changing the pressure set point.

NOTE: The elapsed inflation time can be “zeroed” at any point in the procedure by pressing the TIME and PRESSURE buttons simultaneously for each respective cuff time.

A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM NOTE: If the LOP determination is performed on the Main Cuff, all readings and recommendations are for the Main Cuff only. If the LOP determination is performed on the Second Cuff, all readings and recommendations are for the Second Cuff only.

It should be noted that certain physiologic conditions in some patients may prevent the A.T.S. 3000 from making a determination of LOP, in which case the instrument will display an appropriate message and will terminate the attempt to measure LOP. In that event, the physician’s judgment should be used to set tourniquet pressure in the absence of LOP and RTP values. The determination of LOP is intended as additional, supplementary information for the physician responsible for selecting the tourniquet pressure to be employed for a specific patient and procedure. The physician’s best judgment should always be paramount in the selection of tourniquet pressure.

2.6.1 Single Bladder Cuff LOP Measuring

Connect the LOP pulse sensor to the LOP socket in the front of the A.T.S. 3000. d) 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 fore-foot surgery, the tourniquet cuff can be applied around the calf or to the area proximal to the malleoli. The valve port and hose connections should be placed so that the hose will not be kinked when the limb is positioned for surgery. e) Attach the LOP pulse sensor to the patient’s index finger or second toe on which the tourniquet cuff has been applied.

NOTE: LOP determination temporarily inflates then deflates the tourniquet cuff automatically to obtain the patient’s LOP.

NOTE: The LOP Pulse Sensor is applied to a finger or toe on the operative limb.

NOTE: The pulse sensor appears very similar to other sensors used for pulse measurements. It should be noted, the A.T.S. 3000’s pulse sensor does not measure oxygen saturation nor can it be modified to do so. The A.T.S. 3000 uses a custom sensor. Non Zimmer sensors will not work with the A.T.S. 3000. Use of a non Zimmer sensor could damage the A.T.S. 3000 or cause unpredictable operation. Never use any sensor other than approved Zimmer pulse sensors.

Ensure the sensor is fully engaged to achieve the best possible and most accurate reading. g) With the cuff and sensor applied to the patient, press the corresponding LOP icon to start the LOP determination. The A.T.S. 3000 will begin to inflate the cuff incrementally while continuously analyzing the patient’s pulse. If the sensor or cuff were not properly installed, the unit will display alarm messages. The meanings to the alarm messages are found in Table 2.2. h) The LOP determination will last approximately 30 seconds depending on the quality of pulse sensed. i) At the end of the LOP determination, the A.T.S. 3000 will beep and display the LOP and RTP pressures in the lower display area for that cuff. The unit will automatically display the RTP in the cuff pressure display area preceded by a “*”.

Press the ON/STANDBY button to turn the unit ON. The unit will execute a self-check diagnostic test as described in Section 2.4 of this manual. Successful completion of the self-check indicates the unit is ready for use. CAUTION: If a connected cuff is pressurized to 50 mmHg or more during power-up, the A.T.S. 3000 Tourniquet will declare it an abnormal start-up sequence. It will assume that a surgical procedure is in process, and will adopt the pressure sensed in the cuff as the new set point. It will automatically go into the regulate mode on the cuff. To alert the operator of this condition, the unit will sound a tone and display a “CUFF” “INFL” alarm. 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, (press the correct pressure button).

NOTE: The RTP is the summation of the pressure margin and the LOP which ensures the field visibility remains clear during the procedure.

b) Connect a dual port cuff to the unit at the Main Cuff or Second Cuff port connectors. The Main Cuff and Second Cuff both have the ability to perform the LOP function.

j) 12

To accept the RTP and return to normal operation press the corresponding PRESSURE button. To reject

A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM the RTP value and enter a user defined pressure value, turn the Shuttle Knob and follow the procedure in Section 2.4.3.c. k) To retry the LOP procedure, repeat section 2.6 steps f thru i.

be “cleared” from the display but will return following a 3-second delay. 6.

NOTE: The A.T.S. 3000 will not automatically inflate the cuff at the end of the LOP determinations. It is the user’s responsibility to accept or reject the RTP.

If the RTP is acceptable and no other adjustments are required, pressing the respective INFLATE button will inflate the cuff to the RTP. m) In the event the quality of visibility is reduced by an increase in patient blood pressure, the tourniquet pressure can be increased manually. To increase the tourniquet pressure manually, momentarily press the corresponding PRESSURE button and rotate the Shuttle Knob clockwise to increase the pressure set point. n) After the LOP has been measured and the unit has offered an RTP, the unit is ready to be used. However, the user need not perform a LOP measurement to use the tourniquet system.

If the RTP from the first LOP determination is higher than the second RTP, turn the Shuttle Knob and follow the procedure in Section 2.4.3.c to adjust the second RTP to equal the first RTP. If the RTP from the first LOP determination is lower than the second RTP, press the corresponding PRESSURE button to accept the RTP from the second LOP determination. Next, follow the procedure in Section 2.4.3.c to adjust the first RTP to equal the second RTP.

2.7 SINGLE CUFF OPERATION 1.

CAUTION: If a connected cuff is pressurized to 50 mmHg or more during power-up, the A.T.S. 3000 Tourniquet will declare it an abnormal start-up sequence. It will assume that a surgical procedure is in process, and will adopt the pressure sensed in the cuff as the new set point. It will automatically go into the regulate mode on the cuff. To alert the operator of this condition, the unit will sound a tone and display a “CUFF” “INFL” alarm. 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 cuff set point is examined, (press the correct PRESSURE button).

NOTE: The LOP is only used to obtain patient LOP prior to tourniquet use. Once the patient LOP measurement is complete, remove the LOP sensor from the patient and store. 2.6.2 Dual Bladder Cuff LOP Measuring NOTE: LOP determination temporarily inflates then deflates the tourniquet cuff automatically to obtain the patient’s LOP. LOP measurement for a dual bladder cuff is identical to a single bladder cuff except for the following points: 1. A dual bladder dual port cuff is connected to the unit (Reminder: Main Cuff is the Red ports, Second Cuff is the Blue ports). 2. At the end of the LOP determination using the first bladder, press the corresponding PRESSURE button to accept the RTP for that cuff. 3. Initiate an LOP determination using the second bladder by pressing the corresponding LOP button. 4. At the end of the LOP determination using the second bladder, the RTP will appear in the corresponding pressure display area preceded by a “*”. 5. Compare the RTP currently being displayed with the RTP that was accepted in step 2 above.

2. 3.

NOTE: The RTP accepted in step 2 above is now the pressure set point for that cuff. To verify the RTP, momentarily press the corresponding PRESSURE button. During this activity the RTP in step 4 will temporarily 13

Connect a dual port cuff to the unit at the Main Cuff connectors (red ports). The default settings for cuff pressure and time limit are retrieved from the nonvolatile memory during power up. For each patient, tourniquet pressure required to occlude blood flow to the operative site 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. The A.T.S. 3000 has the unique ability to estimate the minimum effective pressure. This pressure is referred to as the Limb Occlusion Pressure or LOP. Refer back to Section 2.6 for using the LOP measuring feature.

A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM 4.

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 fore-foot 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 sufficiently 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 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:

NOTE: The elapsed inflation time can be “zeroed” at any point by pressing the TIME and PRESSURE buttons simultaneously. 7.

8. 9.

Remove the tourniquet cuff and any underlying bandages or protective sleeve immediately following final deflation. The time of tourniquet cuff removal should be noted, and the circulation of the limb should be checked. After the cuff has been removed, disconnect the cuff from the A.T.S. 3000. During normal use, the A.T.S. 3000 should not be set to STANDBY if pressure is present in either cuff. Once the cuff has been properly deflated, removed from the patient, and disconnected from the A.T.S. 3000, the unit can be set to STANDBY.

2.8 DUAL CUFF OPERATION Operation of the unit is identical to Single Cuff operation (see Section 2.7) except for the following points: 1. Two dual port cuffs are connected to the unit (Reminder: Main Cuff is the Red ports, Second Cuff is the Blue ports). 2. The Main and Second LCD screen section will display inflation information and begin timing the cuff inflation. 3. Deflation of one cuff will not be permitted while the other cuff is inflating. 4. When inflating a second cuff with the other cuff already inflated, the unit will continuously check the original cuff to ensure that the pressure is within allowable limits. The unit will stop its inflation and maintain the original cuff to within 10 mmHg of the set point before returning to the inflating cuff. This ensures that at least one cuff maintains occlusion at all times. If there is a significant leak in the original cuff, this feature could cause the inflation rate of the subsequent cuff to be longer and perhaps even cause the 30-second inflation alarm to sound.

1) 2) 3) 4)

When the tourniquet is to be inflated; What pressure is applied; How long the tourniquet is applied; Whether to allow for intermittent aeration of tissue by deflating the cuff for 10 to 15 minutes; 5) To what point in the operation the tourniquet should be released.

time alarm clock. The Main Cuff inflation information will be displayed on the LCD screen. If the unit cannot pressurize the cuff to within 15 mmHg of the set point in less than 30 seconds, a leak alarm will be sounded. See Section 2.12 for information about possible alarm conditions. Once the cuff is inflated, the time display will track elapsed inflation time. At the end of the procedure, deflate the cuff by pressing the Main Cuff DEFLATE button for minimum of 2 seconds. The Main Cuff PRESSURE display will show the deflation of the cuff and the elapsed inflation time alarm clock will stop.

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, 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 to about 60 degrees, and steady pressure should be applied to the incision with sterile dressings. The cuff is inflated by pressing the red Main Cuff INFLATE button. The unit will pressurize the Main Cuff to the set pressure and start the elapsed inflation 14

A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM 5.

When both cuffs are inflated, the LCD screen displays independent information for each cuff. That is, the PRESSURE and TIME displays are independently operated and controlled for each cuff. In order to deflate the final cuff, a sequence must be followed to prevent accidental deflation: a) Press and hold the DEFLATE button on the cuff to be deflated; b) When the “CUFF” “DEFL” alarm is active, release the DEFLATE button; c) Within 5 seconds of the alarm discontinuing, press the DEFLATE button once again; d) The cuff will deflate. This safety feature is particularly useful when using the unit for Bier Block Cuff Operation, (IVRA).

2.9 BIER BLOCK CUFF OPERATION (IVRA) Review Sections 2.7 and 2.8, SINGLE CUFF OPERATION and DUAL CUFF OPERATION. 1. The following are suggested cuff connections: a. The proximal cuff connected to the Red Main Cuff ports using the white/red cuff tubing; b. The distal cuff connected to the Blue Second Cuff ports using the white/blue cuff tubing. 2. Follow the cuff inflation sequence adopted by your institution or requested by the surgeon. 3. Deflation of a cuff is not possible while the other is inflating. 4. When requested, the first can be deflated simply by pressing and holding the DEFLATE button for a minimum of 2 seconds. 5. In order to deflate the final cuff, a sequence must be followed to prevent accidental deflation: a) Press and hold the DEFLATE button on the cuff to be deflated; b) When the “CUFF” “DEFL” alarm is active, release the DEFLATE button; c) Within 5 seconds of the alarm discontinuing, press the DEFLATE button once again; d) The cuff will deflate. 6. For Bier Block procedures follow the cuff inflation/ deflation sequence adopted by your institution or requested by the surgeon.

Press and hold both the Main Cuff TIME and Main Cuff PRESSURE buttons for approximately 3 seconds. When the volume selection screen appears, the user can adjust the volume up or down by turning the Shuttle Knob. Clockwise rotation increases volume while a counterclockwise rotation decreases volume. With every increment or decrement the speaker will sound to give the user feedback of the volume level setting selected. After 5 seconds of inactivity the system will accept the volume setting as displayed and return the display back to its normal mode of operation. The user can accept the volume setting by pressing the Main Cuff PRESSURE button which stores the setting and returns the display to its normal mode. Or, wait approximately 5 seconds as noted above to allow the system to accept the new volume setting.

2.11 CONTRAST DISPLAY SETTING An operator may want to change the display contrast setting from the default. The following steps will allow a user to customize the display contrast default setting. 1. Press the ON/STANDBY button to turn the unit ON. The unit will execute a self-check diagnostic test as described in Section 2.4. 2. Press and hold both the Second Cuff TIME and Second Cuff PRESSURE buttons for approximately 3 seconds. 3. When the contrast control setting selection screen appears, the user can adjust the display contrast by turning the Shuttle Knob. Clockwise rotation increases display contrast while a counterclockwise rotation decreases display contrast. With every increment or decrement the display will show the new contrast setting selected. After approximately 5 seconds of inactivity the system will accept the contrast control setting as displayed and return the display back to its normal mode of operation. 4. The user can accept the new setting by pressing the Second Cuff PRESSURE button which stores the setting and returns the display to its normal mode. Or, wait approximately 5 seconds as noted above to allow the system to accept the setting. 2.12 ALARM CONDITIONS There are a number of conditions for which the A.T.S. 3000 Tourniquet will produce a visual and/or audible alarm. Those conditions, indications, and appropriate actions are shown in Table 2.1. The appropriate actions indicated are based on the most probable causes and should only be used as a guide. Other causes of alarm conditions may indicate a need for other actions. In addition to the conditions shown in Table 2.1, it is conceivable that a malfunction could occur for which the indications are unintelligible and unpredictable. In this

2.10 SPEAKER VOLUME SETTING An operator may want to change the speaker volume setting from the default. The following steps will allow a user to customize the speaker volume default setting. 1. Press the ON/STANDBY button to turn the unit ON. The unit will execute a self-check diagnostic test as described in Section 2.4. 15

A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM will cause the cuff to hold pressure (in the absence of leaks). Clamp the cuff lines with hemostats and replace the tourniquet unit.

situation, it is likely that the valves will be disabled causing the system to hold cuff pressure. It is also likely that a tone will sound under these conditions. Most audible alarm tones may be silenced for 30 seconds by pressing the ALARM SILENCE button. The tone will be re-enabled at the end of the silenced period. Pressing the ALARM SILENCE button will cause the alarm tone to be silenced again. The A.T.S. 3000 Tourniquet will also provide Error Code information for critical alarms as shown in Table 2.3. To minimize nuisance alarms (i.e. “HI-P”, “LO-P”) that can be caused by vigorous movement of the patient’s limbs, a 1.5-second delay has been designed into the alarm actuation. Under certain conditions, such as when a FAIL indication appears in the TIME display or the information that appears in the TIME and PRESSURE displays is unintelligible, the operator should conclude that a hardware failure has occurred, rendering the unit unusable. The appropriate action is to set the unit to STANDBY by pressing the ON/ STANDBY button. Since this removes power from the internal instrument circuitry, all instrument functions, commands to the valves and pump will cease. This

2.12.1 PRESSURE ALARMS A pressure alarm will occur when the pressure in a cuff is more than 15 mmHg from the pressure set point. It is also possible for a cuff to have a leak that is substantial but which the unit can compensate for by continual pumping. This type of leak could be due to a pin hole in a cuff bladder, or a loose pneumatic fitting. This type of leak could progress into a total failure of a cuff to hold pressure. To alert the operator that a substantial leak is present, a pressure alarm is declared when this type of leak is continuously present for more than 9 seconds. If a pressure alarm occurs, and the displayed pressure is not more than 15 mmHg from the set point, then this type of substantial leak has been detected and all cuffs and pneumatic fittings should be checked for leaks.

Table 2.1 Alarm Condition CONDITION

PRESSURE DISPLAY

TIME DISPLAY

APPROPRIATE ACTION/REMARKS

CUFF PRESSURE LOW The pressure in the cuff is 15 mmHg below set point

LO-P

normal

This condition is generally caused by a leak in the system, or a hose occlusion. All lines and connections should be checked.

CUFF PRESSURE HIGH The pressure in the cuff is 15 mmHg above set point

HI-P

normal

Normally caused by transient conditions such as patient movement, controller overshoot, or hose occlusion. This condition, for an extended period, would indicate a hardware failure and the A.T.S. 3000 unit should be replaced.

CUFF SIDE LEAK A leak has been present for at least 9 seconds.

CUFF LEAK

normal

A substantial leak has been present for more the 9 seconds. All lines and connections should be checked.

RESERVOIR LEAK A leak is present between the pump and valves

RES LEAK

normal

Do not use the unit. Service the unit.

INFLATION TIME IN EXCESS OF SETTING The cuff has been inflated beyond the set time limit

normal

TIME UP

Surgeon should be warned of time up condition. Only on the direction of the surgeon, time should be set to new value.

CUFF INFLATION ON POWER UP Cuff pressurized to 50 mmHg or greater at power up

CUFF

INFL

The system assumes that a procedure is in progress and adopts the sensed pressure as the new set point. The operator should immediately check the set value to determine if it needs reset.

CUFF NOT DEFLATED Pressure in deflated cuff is a nonzero value

normal

CUFF NOT DEFL

Check for kinks in hose. If alarm persists, disconnect hose from cuff. If attempting to set the unit to STANDBY, ensure that cuff is fully deflated.

A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM Table 2.1 Alarm Condition Continued CONDITION

PRESSURE DISPLAY

TIME DISPLAY

LINE OCCLUSION An occlusion is present in the cuff tubing

LINE OCCL

normal

LOW BATTERY VOLTAGE Low battery voltage

normal

BATT LOW PLUG IN

CHECK CUFF An increase in cuff pressure has not been sensed within 1 second after depressing the inflate key

CHK

CUFF

APPROPRIATE ACTION/REMARKS Check for hose kinks or other defects.

Plug unit in. If the unit is not plugged in, a battery failure condition will occur and the unit will shut down in a fail safe mode closing all valves. While running with a Low Battery Voltage Alarm Condition other alarm conditions can not be guaranteed. Check to see that a cuff and hose assembly is connected to the proper ports on the unit.

BATTERY FAILURE Battery voltage is too low to ensure proper operation

BATTERY FAIL

Plug unit in and cycle the ON/STANDBY Button.

CALIBRATION OUT OF SPEC The transducer calibration is out of specification

CAL M or CAL 2 FAIL

CAL M (CALIBRATION MAIN) or CAL 2 (CALIBRATION SECOND) indicates a cuff transducer circuitry is out of calibration. Pressure in error by at least 6 mmHg will cause these failures. Calibrate the unit.

CALIBRATION OUT OF SPEC A transducer calibration is out of specification

CAL FAIL

Indicates general calibration fail. Calibrate the unit.

AMPLIFIER FAILURE Amplifier is out of range

AMP FAIL