Zimmer A.T.S. 4000TS User manual

A.T.S.®4000TS
Operator /
Service Manual
REF 60-4000-101-00
ENGLISH

Page 1
WARRANTY
LIMITED ONE YEAR WARRANTY INSIDE U.S.A.
SCOPE OF LIMITED WARRANTY
Zimmer, Inc. warrants the Product (A.T.S. 4000TS 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:
• 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.
SCOPE OF WARRANTY
Please contact your local Zimmer Representative for warranty information.
Unit Serial Number _____________________________________________________________

Page 2
CONTENTS
TABLE OF CONTENTS
1GENERAL INFORMATION ............................................................... 4
INTENDED USE...................................................................................................................4
CONTRAINDICATIONS .......................................................................................................4
PRECAUTIONS IN USE.......................................................................................................5
ADVERSE EFFECTS ...........................................................................................................6
SPECIFICATIONS AND PERFORMANCE CHARACTERISTICS.......................................6
ES 60601-1 CLASSIFICATION............................................................................................8
EMISSIONS/IMMUNITY .......................................................................................................8
2INSTALLATION AND OPERATING INSTRUCTIONS........................ 9
INITIAL VISUAL INSPECTION ............................................................................................9
FEATURES AND OPERATING PRINCIPLES .....................................................................9
BUTTONS AND ICONS............................................................................................................................. 9
TOUCH SCREEN GUI........................................................................................................14
INITIAL SETUP ..................................................................................................................15
TESTS AND CHECKS .......................................................................................................15
AUTOMATIC DIAGNOSTIC AND CALIBRATION CHECK.....................................................................15
MANUAL TESTS AND CHECKS ............................................................................................................16
SYSTEM FUNCTIONS .......................................................................................................22
SETTINGS ...............................................................................................................................................22
DOCUMENTATION..................................................................................................................................27
OPERATION.......................................................................................................................27
SURGEON DECISIONS ..........................................................................................................................28
PATIENT PREPARATION........................................................................................................................28
LIMB OCCLUSION PRESSURE (LOP) ..................................................................................................29
LOP MEASUREMENT.............................................................................................................................31
CUFF OPERATION .................................................................................................................................35
ALARM CONDITIONS .......................................................................................................40
PRESSURE ALARMS.............................................................................................................................41
ADVANCED LEAK DETECTION.............................................................................................................41
ALARM/WARNING COLORS AND AUDIBLE TONES...........................................................................42
ALARM CONDITION AND ERROR CODE TABLES ..............................................................................42
ELECTROMAGNETIC COMPATIBILITY (EMC) GUIDANCE TABLES .............................48

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CONTENTS
3MAINTENANCE............................................................................. 52
GENERAL MAINTENANCE INFORMATION.....................................................................52
LOP SENSOR CLEANING AND DISINFECTING .............................................................52
PERIODIC MAINTENANCE...............................................................................................52
SERVICING ........................................................................................................................53
SERVICE MENU ACCESS ......................................................................................................................53
CALIBRATION.........................................................................................................................................53
ATS LEAK TESTING ...............................................................................................................................59
UNIT INFORMATION ACCESS...............................................................................................................60
BURN MODE ...........................................................................................................................................60
TOUCH TEST...........................................................................................................................................61
PROTECTIVE EARTH RESISTANCE TESTING.....................................................................................62
EARTH (EQUIPMENT) LEAKAGE CURRENT TESTING.......................................................................62
INSULATION RESISTANCE TESTING ...................................................................................................62
BACKUP BATTERY SERVICE...........................................................................................62
BATTERY-HANDLING RECOMMENDATIONS ......................................................................................63
FUSE AND FUSE DRAWER REPLACEMENT..................................................................64
UNSCHEDULED MAINTENANCE.....................................................................................64
TROUBLE SHOOTING GUIDE ..........................................................................................65
TROUBLESHOOTING.............................................................................................................................65
REPLACEMENT PARTS....................................................................................................66
PARTS LIST.............................................................................................................................................66
ORDER INFORMATION ..........................................................................................................................68
CONTACT INFORMATION.................................................................................................68
ENVIRONMENTAL CONDITIONS .....................................................................................69
WARNINGS, CAUTIONS & SYMBOLOGY........................................................................69
TEST AND EVALUATION REPORT (BLANK)........................................................................................73

Page 4
GENERAL INFORMATION
GENERAL INFORMATION
APPLICATION SPECIFICATION
The application specification for the A.T.S. 4000TS including characteristics related to the use of the device, intended
use, intended patient population, intended part of the body, intended user profile, intended conditions of use and
operating principles is contained in this manual.
INTENDED USE
The A.T.S. 4000TS 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.
•Subcutaneous fasciotomy. •Nerve injuries.
•Bone grafts. •Total wrist joint replacement.
•Knee joint replacements. •Amputations.
•Tumor and cyst excisions. •Tendon repair.
•Replacement of joints in the fingers. •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.
CONTRAINDICATIONS
The medical literature lists the following as possible contraindications:
•Open fractures of the leg.
•Post-traumatic lengthy hand reconstruction.
•Severe crushing injuries.
•Elbow surgery (where there is excess swelling).
•Severe Hypertension.
•Diabetes mellitus.
•Skin grafts in which all bleeding points must be
readily distinguished.
•Compromised vascular circulation, e.g., peripheral
artery disease.
•The presence of sickle cell disease is a relative
contraindication (See PRECAUTIONS IN USE).
CAUTION:
•In every case, the final decision whether to use a Tourniquet rests with the attending physician.
•A Tourniquet should also be avoided in patients who are undergoing secondary or delayed procedures
after immobilization.
•Certain physiologic or anatomical conditions, including small fingers and toes of infants and children, may
prevent the A.T.S. 4000TS 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 the LOP feature.