Zimmer A.T.S.1200 User manual

Operator

& Service Manual

A.T.S.

™

1200

TOURNIQUET SYSTEM

REF 60-1200-101-00

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

SCOPE OF WARRANTY

Zimmer, Inc. warrants the Product (A.T.S. 1200 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 Orthopaedic Surgical Products, 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.

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

CONTENTS

A.T.S. 1200 TOURNIQUET SYSTEM

SECTION TITLE PAGE

1.0 GENERAL INFORMATION

1.1 Specifications............................................................................................................. 3

1.2 Intended Use .............................................................................................................. 5

1.3 Contraindications ....................................................................................................... 5

1.4 Precautions in Use ..................................................................................................... 5

1.5 Adverse Effects.......................................................................................................... 6

2.0 INSTALLATION AND OPERATING INSTRUCTIONS

2.1 Initial Inspection ........................................................................................................ 7

2.2 Controls, Indicators, and Connectors ........................................................................ 7

2.3 Initial Setup................................................................................................................8

2.4 Functional and Calibration Check ............................................................................. 8

2.5 Pressure and Time Defaults....................................................................................... 9

2.6 Single Cuff Operation................................................................................................ 10

2.7 Dual Cuff Operation .................................................................................................. 11

2.8 Bier Block Cuff Operation (IVRA)........................................................................... 11

2.9 Alarm Conditions....................................................................................................... 11

3.0 MAINTENANCE

3.1 General Maintenance Information............................................................................. 15

3.2 Access to Parts........................................................................................................... 15

3.3 Periodic Maintenance ................................................................................................ 15

3.4 Calibration..................................................................................................................15

3.5 Leak Testing............................................................................................................... 17

3.6 Battery Voltage and Battery Service.......................................................................... 17

3.7 Unscheduled Maintenance......................................................................................... 18

3.8 Troubleshooting Guide .............................................................................................. 18

3.9 Expected Test Point Readings ................................................................................... 18

3.10 Replacement Parts...................................................................................................... 22

3.11 Storage ....................................................................................................................... 22

3.12 Warnings, Cautions, and Symbol Definitions ........................................................... 29

ENGLISH

TABLES

2.1 Alarm Conditions....................................................................................................... 13

3.1 Board Plug Designators ............................................................................................. 15

3.2 Troubleshooting ......................................................................................................... 19

3.3 Expected Test Point Readings ................................................................................... 21

3.4 Parts List .................................................................................................................... 22

ILLUSTRATIONS

1 A.T.S. 1200 Tourniquet Overview – front ................................................................ 23

2 A.T.S. 1200 Tourniquet Overview – rear ................................................................. 24

3 Calibration Setup Overview ...................................................................................... 25

4 Disassembly – front case opening ............................................................................. 26

5 Disassembly – front case removal............................................................................. 26

6 Disassembly – disconnecting wiring ......................................................................... 26

7 Disassembly – rear case removal .............................................................................. 26

8 Disassembly – overview ............................................................................................ 27

9 Electronic circuit layout............................................................................................. 28

10 Labels......................................................................................................................... 30

GENERAL INFORMATION

SECTION 1.0

A.T.S. 1200 TOURNIQUET SYSTEM

1.1 SPECIFICATIONS

Mains Line Voltage Range:

100–240 V ~ (AC), 50/60 Hz. Auto switching

Line Current:

670 mA RMS @ 120 V ~ (AC)

Input Power:

53 W typical

Battery Type:

Rechargeable, 12 VDC sealed lead acid,

2.3 A hours

Battery Discharge Time:

Unit will operate on battery power for 45 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, AWG 16, 14 ft. (4.27 m)

Power Plug:

Hospital grade, 3 prong straight blade, 15 A

Line Protection:

2 time delayed 1.0 A 250 V fuses

CONTROLS: ON/STANDBY Button:

Turns the unit on/sets unit to STANDBY.

PRESSURE Button:

Used in conjunction with the ROTARY knob to adjust the pressure set point. Can also be pressed to verify the set point.

TIME Button:

Used in conjunction with the ROTARY knob to adjust the time alarm set point. Can also be pressed to verify the set point.

MAIN CUFF INFLATE/DEFLATE Buttons:

Controls inflation or deflation of the Main cuff. Orange LED bar indicates inflation of the main cuff or pressure alarm in the main cuff when flashing in conjunction with the PRESSURE display.

SECOND CUFF INFLATE/DEFLATE Buttons:

Controls inflation or deflation of the Second cuff. Orange LED indicator bar indicates inflation of the second cuff or pressure alarm in the second cuff when flashing in conjunction with the PRESSURE display.

ALARM SILENCE Button:

Allows operator to manually silence most alarms for 30 seconds.

AC MAINS Indicator Light (Green LED):

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).

BATTERY Indicator Light (Orange LED):

Indicates unit is operating on backup battery. This indicator always flashes.

Cuff Pressure Range:

50-475 mm Hg, 5 mm Hg increments

Pressure Accuracy:

±5 mm Hg (50–475 mm Hg)

Pressure Regulation:

±6 mm Hg of set point (10 second average under non-transient conditions without external leaks)

Maximum Pressure:

475 mm Hg (Normal Operation)

Time Alarm Set Range:

5–240 minutes; 5 minute increments

Timer Accuracy:

0.25 % of elapsed time

Internal Diagnostics:

Program, memory, watchdog timer, transducer calibration, improper valve actuation.

SIZE:

Height:

12.50 in. (31.75 cm)

Width:

10.25 in. (26 cm)

Depth:

8.1 in. (20.6 cm) (including clamp and ports)

Weight:

11.2 lbs. (5.1 Kg)

DISPLAYS:

PRESSURE Display:

Red 14-segment light emitting diodes (LED). Displays pressure setting, sensed cuff pressure, and hardware failure conditions/other messages.

TIME Display:

Red 14-segment light emitting diodes (LED) Displays time alarm set point, elapsed time, and hardware failure conditions/other messages.

UL 60601-1 Classification:

*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. 1200 Tourniquet System complies with EMC criteria set forth in EN 60601-1-2.

Mode of operation: Continuous operation

Classification according to the degree of IPX0 protection against ingress of water:

Degree of protection against electric shock: Type BF applied part

Type of protection against electric shock: Class I or Internally Powered Equipment*

A.T.S. 1200 TOURNIQUET SYSTEM

1.2 INTENDED USE

The A.T.S. 1200 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 CO2or 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.

1.4 PRECAUTIONS IN USE

N The tourniquet system must be kept well calibrated and

in operable condition. Accessories should be checked regularly for leaks and other defects.

N 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.

N 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.

N 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.

N 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.

N Inflation should be done rapidly to occlude arteries and

veins as near simultaneously as possible.

N 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.

N 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.

N Tourniquet users must be familiar with the inflation-

deflation 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.

N 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 PO2and pH should be closely monitored.

N Select the proper cuff size to allow for an overlap of

about 3 to 6 in. (7.6 cm – 15 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

A.T.S. 1200 TOURNIQUET SYSTEM

(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.

N If skin preparations are used preoperatively, they should

not be allowed to flow and collect under the cuff where they may cause chemical burns.

N 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.

N 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.

N WARNING: Cuffs will not deflate in STANDBY

mode. Ensure cuffs are fully deflated before setting the unit to STANDBY.

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 1.5 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.

A.T.S. 1200 TOURNIQUET SYSTEM

2.1 INITIAL INSPECTION

Unpack the A.T.S. 1200 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 char

ge. 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 and 2 in the back of the manual for the locations of the unit’s controls, indicators, and connectors.

1. 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 prior to setting the unit to STANDBY. NOTE: During STANDBY, the power to the A.T.S. 1200 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. ROTARY knob

Changes the value of set time or default time and set pressure or default. Turn knob clockwise to increase the value; turn knob counterclockwise to decrease the value.

3. PRESSURE button

Press to verify or modify set pressure.

4. TIME button

Press to verify or modify set time.

5. MAIN CUFF INFLATE button

Inflation of the Main cuff is initiated by depressing the red INFLATE button.

6. MAIN CUFF DEFLATE button

Deflation of the Main cuff is initiated by depressing the red 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.

7. SECOND CUFF INFLATE button

Inflation of the Second cuff is initiated by depressing the blue INFLATE button.

8. SECOND CUFF DEFLATE button

Deflation of the Second cuff is initiated by depressing the blue 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.

9. 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.

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

10. AC MAINS indicator light

The AC MAINS 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).

11. 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.

12. PRESSURE display

During normal operation with no buttons being pressed, the PRESSURE display will show the monitored cuff(s) pressure. At other times, depending on alarm conditions and buttons pressed, this display may communicate other information such as alarm messages, set pressure, or default set pressure.

13. TIME display

During normal operation with no buttons being pressed, the TIME display will show elapsed inflation time of the first cuff that was inflated in 1-minute increments. At other times, depending on alarm conditions and buttons pressed, this display may communicate other information such as alarm messages, set time, or default set time.

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

INSTALLATION

AND OPERATING

INSTRUCTIONS

SECTION 2.0

A.T.S. 1200 TOURNIQUET SYSTEM

14. 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 port and the SECOND CUFF is the blue port. The A.T.S. 1200 Tourniquet is designed and tested for use with Zimmer single port cuffs. Zimmer does not recommend the use of any cuff other than Zimmer single port cuffs. Do not use dual port cuffs with the A.T.S. 1200 Tourniquet.

15. CUFF indicators

The CUFF indicators illuminate steady when stable cuff pressure is sensed in the cuff. The CUFF indicators will also flash during inflation or to indicate an alarm condition in the respective cuff.

16. 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 27.27 inches (70 cm) in diameter.

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 to 1.0 A time delay fuses. 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.

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.

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) A “0*0*”/“*0*0” sequence appears on the

PRESSURE and TIME displays followed by the text “ATS” “1200” on the respective display.

b) The unit emits tones when “0*0*”/“*0*0” and text

is displayed.

c) The unit will display “SELF” “TEST” for an instant.

The unit is self-testing specific system hardware and software.

d) “CAL” is displayed in the PRESSURE displays

during the calibration check.

e) “0” is displayed in the PRESSURE and TIME

display 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 the PRESSURE button. b) The PRESSURE display should read “*250” (the

default set point) for 2 seconds.

c) Within the 2-second time frame, rotate the

ROTARY knob to change the pressure set point (clockwise to increase, counter-clockwise to decrease). The set pressure can be maintained between 50 mm Hg and 475 mm Hg in increments of 5 mm Hg.

4. Test the TIME set point system as follows: a) Press the TIME button. b) The main TIME display should read “*60” (the

default set point) for 2 seconds.

c) Within the 2-second time frame, rotate the

ROTARY 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 5 minutes.

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

5. Calibration Check

NOTE: During the power-up diagnostic self-test described above, the unit will test calibration. Should an out of calibration condition be detected, the unit will display either “CAL” “FAIL”, “CALM” “FAIL” or “CAL2” “FAIL” in the PRESSURE and TIME displays. Even though the unit performs this check at every power-up, the following quantitative check is recommended at regular intervals.

a) Verify the unit is in the STANDBY mode. b) Enter the calibration mode by pressing and holding

the Main cuff Inflate and Deflate buttons while powering the unit ON. The unit will enter the calibration mode when the Pressure and Time display momentarily displays “CAL” “MODE”. After the “CAL” “MODE” is displayed, the unit will display the software revision level. The software revision level can be recorded for future reference.

NOTE: The calibration is only being checked in this section.

For complete calibration, see Maintenance Section 3.0.

A.T.S. 1200 TOURNIQUET SYSTEM

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