A.T.S.1200
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 _______________________
2
TABLE
OF
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
1
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
2
3
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).
4
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
5
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.
6
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
7
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.
8
A.T.S. 1200 TOURNIQUET SYSTEM
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