Zimmer A.T.S. 750 User manual
Operator
& Service Manual
A.T.S.™ 750
TOURNIQUET SYSTEM
REF 60-0750-101-00
Unit Serial Number _____________________
LIMITED ONE YEAR WARRANTY (U.S.A.)
SCOPE OF WARRANTY
Zimmer, Inc. warrants the Product (A.T.S. 750 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 specifi cation 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 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 or
warranty or other legal theory. Some states do not allow limitations on warranties or on remedies for breach in certain
transactions. In such states, the limits in this paragraph and the preceding paragraph do not apply.
WARRANTY CLAIMS
In the event of a warranty claim within the warranty period please take the following steps:
1. Notify Customer Service Department, Zimmer Orthopaedic Surgical Products, at 800-348-2759 or contact your
local Zimmer representative. Please provide details about the nature of the problem and include the product serial
number. Upon receipt of this information, Zimmer will provide a date for service or a return shipping authorization.
2. Upon receipt of the shipping authorization, forward the equipment, freight prepaid, to the location specifi ed 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.
1
SECTION TITLE PAGE
1.0 GENERAL INFORMATION
1.1 Specifi cations ..................................................................................................2
1.2 Intended Use ...................................................................................................3
1.3 Contraindications ............................................................................................3
1.4 Precautions in Use ...........................................................................................3
1.5 Adverse Effects ...............................................................................................4
2.0 INSTALLATION AND OPERATING INSTRUCTIONS
2.1 Initial Inspection .............................................................................................5
2.2 Controls, Indicators, and Connectors ..............................................................5
2.3 Initial Setup .....................................................................................................7
2.4 Functional and Calibration Check ...................................................................7
2.5 Pressure and Time Defaults .............................................................................8
2.6 Cuff Operation ................................................................................................8
2.7 Dual Cuff Operation ........................................................................................9
2.8 Alarm Conditions ............................................................................................9
3.0 MAINTENANCE
3.1 General Maintenance Information ................................................................12
3.2 Access to Parts ..............................................................................................12
3.3 Periodic Maintenance ....................................................................................12
3.4 Calibration .....................................................................................................12
3.5 Leak Testing ..................................................................................................13
3.6 Battery Voltage and Battery Service .............................................................13
3.7 Unscheduled Maintenance ............................................................................13
3.8 Troubleshooting Guide ..................................................................................14
3.9 Expected Test Point Readings .......................................................................14
3.10 Replacement Parts .........................................................................................18
3.11 Storage ..........................................................................................................18
3.12 Warnings, Cautions, Symbol Defi nitions ......................................................19
FIGURE TITLE PAGE
2.1 Controls, Indicators & Connectors ..................................................................6
3.1 Control Board and Test Points ......................................................................16
TABLE TITLE PAGE
2.1 Alarm Conditions ..........................................................................................11
3.1 Troubleshooting ............................................................................................15
3.2 Expected Test Point Readings .......................................................................17
TABLE OF
CONTENTS
A.T.S. 750 TOURNIQUET SYSTEM
1.1 SPECIFICATIONS
Line Voltage Range:
100-240 V~, 50/60 Hz. auto switching
Line Current:
670 mA RMS @ 120 V~
Input Power:
53 Watts typical
AC Indicator Light:
Green LED
Battery Type:
Rechargeable, 12 V sealed lead acid,
1.2 amp hours
Battery Discharge Time:
Unit will operate on battery power for 30 minutes
minimum with fully charged batteries
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 fi rst 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 amp
Line Protection:
2 time delayed 1.0 amp 250 volt fuses
Cuff Pressure Range:
50-475 mmHg, 5 mmHg increments
Pressure Accuracy:
±5 mmHg (50-475 mmHg)
Pressure Regulation:
±6 mmHg of set point
(10 second average under non-transient conditions
without external leaks)
Maximum Pressure:
475 mmHg cuffs
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:
8 in. (20.3 cm)
Width:
7 in. (17.8 cm)
Depth:
7.9 in. (20.1 cm)(including clamp and port)
Weight:
7.7 lbs (3.5 Kg)
CONTROLS
On/Standby Switch:
Applies power to unit / sets unit to STANDBY
Pressure Switch:
Press to set pressure set point.
Time Switch:
Increases or decreases the time alarm set points.
Cuff Infl ate:
Control infl ation or defl ate of the cuff.
Alarm Silence Switch:
Allows operator to manually silence certain alarms for
30 seconds.
DISPLAYS
Pressure:
Red 14 segment light emitting diodes (LED)
Time:
Red 14 segment light emitting diodes (LED)
AC Indicator Light:
Green LED
* U.S. Patents B1 4,469,099; 5,607,447; 5,681,339;
5,935,146
UL 60601-1 Classifi cation: Class I and Internally Powered, Type B continuous operation.
Use ordinary protection against ingression of liquids. Not for
use with fl ammable anesthetic or gases.
The A.T.S. 750 Tourniquet System complies with EMC criteria set forth in EN 60601-1-2.
2
GENERAL INFORMATION
SECTION 1.0
A.T.S. 750 TOURNIQUET SYSTEM
A.T.S. 750 TOURNIQUET SYSTEM
1.2 INTENDED USE
The A.T.S. 750 Tourniquet System is intended to be used
by qualifi ed 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 fi eld in
surgical procedures involving the extremities including:
Reduction of certain fractures
Kirschner wire removal
Tumor and cyst excisions
Subcutaneous fasciotomy
Nerve injuries
Tendon repair
Bone grafts
Total wrist joint replacement
Replacement of joints of the fi ngers
Knee joint replacements
Amputations
Replantations
WARNING: Do not use tourniquet cuffs to control the
distal fl ow 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 insuffl ation 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
ontraindications. 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
◆
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 infl ated 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.
Insuffi cient 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.
◆
Infl ation 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
reinfl ation. Reinfl ation over blood-fi lled vasculature may
lead to intravascular thrombosis.
◆
Tourniquet users must be familiar with the infl ation-
defl ation 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.
3
A.T.S. 750 TOURNIQUET SYSTEM
◆
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 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 fi bers (such as Webril) the
fi bers may become embedded in the contact closures and
reduce their effectiveness. As an under padding, a section
of stockinette may be used. The defl ated cuff and any
underlying bandages should be completely removed
as soon as tourniquet pressure is released. After the
cuff has been fully defl ated 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 fi eld.
◆
If skin preparations are used preoperatively, they
should not be allowed to fl ow 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 infl ated for at
least 20 minutes from the time of injection.
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
signifi cant 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.
1. Intraoperative bleeding may be caused:
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
insuffi cient exsanguination.
3. By inadequate tourniquet pressure (between
systolic and diastolic blood pressure of the patient),
or slow infl ation and defl ation, 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.
4
INSTALLATION
AND OPERATING
INSTRUCTIONS
SECTION 2.0
A.T.S. 750 TOURNIQUET SYSTEM
2.1 INITIAL INSPECTION
Unpack the A.T.S. 750 Tourniquet upon receipt and
inspect the unit for any obvious damage that may have
occurred during shipment. We recommend that this
inspection be performed by a qualified biomedical
engineer or other person thoroughly familiar with
electronic medical devices. If the unit is damaged, notify
the carrier and your Zimmer representative immediately.
If the initial inspection results are satisfactory, a
functional and calibration check should be performed.
2.2 CONTROLS, INDICATORS, AND
CONNECTORS
Refer to Figure 2.1 for the locations of the unit’s controls,
indicators, and connectors.
1. ON/STANDBY Touch-Switch
Turns the unit on or sets the unit to STANDBY.
This switch will not set the unit to STANDBY
when the cuff pressure is at a non-zero value.
Ensure the cuff is fully defl ated and has been
removed from the patient prior to setting the
unit to STANDBY.
Note: During STANDBY, power to the A.T.S.
750 instrument and all instrument functions
(i.e. infl ation, defl ation, etc) are off but power
continues to supply the battery charging
circuitry anytime ~ (AC) power is present.
2. ROTARY knob
Changes the value of set or default time and
pressure. Turn knob clockwise to increase a value;
turn knob counterclockwise to decrease value.
3. PRESSURE switch
Press to verify or modify set pressure.
4. TIME switch
Press to verify or modify set time.
5. INFLATE switch
Infl ation of the cuff is initiated by depressing the
INFLATE switch.
6. DEFLATE switch
Defl ation of the cuff is initiated by depressing
the DEFLATE switch. For greater safety, the
DEFLATE switch has a delay and, therefore, must
be held for approximately 2 seconds before the unit
will allow a cuff to defl ate.
7. ALARM SILENCE switch
The ALARM SILENCE switch will silence most
audible alarms for 30 seconds after the switch is
depressed. When an alarm sounds because of an
internal circuit malfunction, the alarm cannot be
silenced.
NOTE: The alarm messages will continue to fl ash
on the displays until the alarm condition is
corrected.
8. AC INDICATOR light
The AC INDICATOR light indicates that the unit
is plugged in and is being powered by alternating
current.
9. PRESSURE display
During normal operation with no switches being
depressed, the PRESSURE display will show the
monitored cuff pressure. At other times, depending
on alarm conditions and switches, this display may
communicate other information such as alarm
messages, set pressure, or default set pressure.
10. TIME display
During normal operation with no switches being
depressed, the TIME display will show elapsed
infl ation time of the cuff in 1 minute increments.
At other times, depending on alarm conditions and
switches, this display may communicate other
information such as alarm messages, set time limit,
or default time limit.
11. CUFF connector
The CUFF connector is the port used to connect the
unit to cuff hose.
12. 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 which are not related to tourniquet use.
5
A.T.S. 750 TOURNIQUET SYSTEM
FIGURE 2.1 Controls, Indicators, & Connectors
6
AC INDICATOR light
TIME switch
PRESSURE switch
ON/STANDBY
switch
ROTARY knob
ALARM SILENCE
switch
PRESSURE
display
CUFF connector
INFLATE
switch
DEFLATE
switch
TIME
display
POLE clamp
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