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Zimmer A.T.S. 4000TS Operators & Service Manual Download Page 74

Page 73

MAINTENANCE

TEST AND EVALUATION REPORT

Defi ciency / Notes:

Overall Assessment:

 

 

 

 

No safety or functional defi ciencies were detected   

†

No direct risk, defi ciencies detected may be corrected on short term   

†

Equipment shall be taken out of service until defi ciencies are corrected   

†

Next recurrent test necessary in:  

 

   3 

months 

†

 

6 months  

†

 12 

months 

†

 

Name:

 __________________________

Signature:

 __________________________

Date:

 ___________

Testing Organization: 

_________________________

Name of Testing Person:

 _______________________

Test before putting into service 

(reference value)

 

†

Recurrent test

 

†

Test after repair

 

†

Responsible Organization:

 _________________________________________________________

Equipment:

 ___________________________

ID – Number:

 __________________________

Type:

 ________________________________

Serial Number:

 ________________________

Manufacturer:

   Zimmer

Class of Protection:

  Class I 

†

  Class II 

†

  Battery 

†

Applied Part Type: 

0 

†

    B 

†

     BF  

†

   CF 

†

Mains Connection:

 

        Permanently Installed 

†

     

              Non-detachable Power Cord 

†

     Detachable Power Cord 

†

Accessories:

 _______________________________________________________________________

Measuring Equipment: 

_______________________________________________________________

Measurements: Specifi cation 

Measured

Protective earth resistance: 

<300m

Ω

 _________ 

m

Ω

Earth (equipment) Leakage: 

<500

μ

A _________

μ

A

Insulation Resistance: 

>50M

Ω

 _________M

Ω

Battery Health 

>50% 

_________%

Pass 

†

     Fail 

†

Pass 

†

     Fail 

†

Pass 

†

     Fail 

†

Pass 

†

     Fail 

†

Functional Test: 

Specifi cation 

Function

DIAGNOSTIC OKAY (during startup) 

Pass/Fail N/A

CALIBRATION OKAY (during startup)  Pass/Fail N/A
PRESSURE set-point system test 

Perform as described 

Main 

†

  Second 

†

TIME set-point system test 

Perform as described 

Main 

†

  Second 

†

Low Pressure Alarm Check 

Perform as described 

Main 

†

  Second 

†

Calibration (as required) 

Perform as described 

N/A

ATS Leak Test (loss/gain) 

<-30mmHg/<+10mmHg  Main___  Second___

Touch Test 

Perform as described 

N/A

Pass 

†

     Fail 

†

Pass 

†

     Fail 

†

Pass 

†

     Fail 

†

Pass 

†

     Fail 

†

Pass 

†

     Fail 

†

Pass 

†

   Fail 

†

   N/A 

†

Pass 

†

     Fail 

†

Pass 

†

     Fail 

†

Test

Results

Visual Inspection

Pass 

†

     Fail 

†

Summary of Contents for A.T.S. 4000TS

Page 1: ...A T S 4000TS Operator Service Manual REF 60 4000 101 00 ENGLISH ...

Page 2: ...mer 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...

Page 3: ...PLES 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 ALA...

Page 4: ...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...

Page 5: ... 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 crushi...

Page 6: ...ssible Careful and complete exsanguination reportedly prolongs pain free Tourniquet time and improves the quality of Intravenous Regional Anesthesia IVRA also known as 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...

Page 7: ...slight impeding effect exerted by an unpressurized cuff and its padding if used which prevents venous return at the beginning of the operation Blood remaining in the limb because of insufficient exsanguination 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...

Page 8: ...aximum Pressure 400 mmHg per cuff 600 mmHg per cuff in extended pressure range Time Alarm Set Range 1 240 minutes 1 minute increments Timer Accuracy 0 25 of elapsed time Internal Diagnostics Program memory watchdog timer transducer calibration improper valve actuation touch screen backlight LCD Size Height 13 1 in 33 3 cm Width 9 3 in 23 6 cm Depth 10 5 in 26 7 cm including clamp Weight 13 2 lbs 6...

Page 9: ...plies with EMC criteria set forth in IEC 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 WARNING The A T S 4000TS Tourniquet System should not be used adjacent to or stacked with other equi...

Page 10: ...ease refer to Touchscreen GUI below for details on what the colors mean Button Icon Title What it means Power ON STANDBY Button Turns the unit ON or sets the unit to STANDBY The illuminated green AC INDICATOR indicates that the unit is plugged in and is being powered by AC Power Mains This is the normal means of operation battery power is only intended for emergency power loss or patient transport...

Page 11: ...LATE Button INFL Controls inflation of the respective cuff The Main Cuff and Second Cuff have separate INFLATE buttons DEFLATE Button DEFL Controls deflation of the respective cuff The Main Cuff and Second Cuff have separate DEFLATE buttons Okay Success Button Allows user to approve save and exit specific functions Cancel Fail Button Allows user to exit specific functions without saving Retry Relo...

Page 12: ...ttery Status Icon 25 capacity AC Power Mains Icon 25 charge Indicates that the system is running on backup battery currently at 25 of full capacity Low priority alarm active Indicates that the system is running on AC Power Mains and charging the battery which is currently at 25 of full charge Battery Status Icon 50 capacity AC Power Mains Icon 50 charge Indicates that the system is running on back...

Page 13: ...derlying bandages or protective sleeve prior to setting the unit to STANDBY CAUTION This button will not set the unit to STANDBY when the cuff pressure is at a non zero value During STANDBY the power to the A T S 4000TS 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 4 Alarm S...

Page 14: ...ted 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 8 Hose Hangers The A T S 4000TS is equipped with hose hangers at the back of its case The cuff hoses can be temporarily hung on the hangers for transport or when disconnecting from the cuff CAUTION Cuff hoses or the LOP sensor should be the only items to utilize the hose hangers ...

Page 15: ...us of the corresponding cuff including DEFLATED INFLATED DEFLATING INFLATING or WARNING A cuff s status bar also changes color to yellow in the WARNING state Cuff Controls INFLATE DEFLATE LOP and Stats functions for the Cuffs Inflation of the Main Cuff or Second Cuff is initiated by touching the red Main Cuff INFLATE INFL button or blue Second Cuff INFLATE INFL button depending on which cuff is de...

Page 16: ...his equipment must only be connected to an AC Power Mains with protective earth The A T S 4000TS should be plugged into AC Power Mains for 10 hours before initial setup to ensure the backup battery is fully charged During shipping and storage the unit s battery could become weak Always charge the system 10 hours before initial setup including calibration checking procedures initial checks tests an...

Page 17: ... on both PRESSURE tiles The default pressure is pre set to 250 mmHg This setting may be changed as desired The default time is shown on both TIME tiles The default time is pre set to 60 minutes This setting may be changed as desired CAUTION If CALIBRATION ERROR is displayed refer to the Calibration Error at Power On section with the Maintenance section If a number other than zero is indicated in t...

Page 18: ...pable of withstanding the extended pressure Consult the cuff instructions for cuff pressure limits Cuffs that have no specifications regarding pressure limits should not be used with high tourniquet pressures A yellow confirmation tile appears if the pressure change exceeds the nominal maximum of 400mmHg Touch the Okay button to confirm need to enter the extended pressure range and to allow contin...

Page 19: ...ontinuously held the increments will change by 5 minutes Touch the Okay button to immediately remove the displayed tile or wait approximately 5 seconds and it will automatically close Repeat TIME set point system test for the blue Second Cuff TIME set point CAUTION Anytime an asterisk appears below the TIME value in the TIME tile the data displayed is the set point Set time will revert back to the...

Page 20: ...An audible tone will sound and a red alarm indicator will flash announcing the alarm condition A yellow Warning tile drops over the PRESSURE display and indicates LOW PRESSURE as well as the monitored pressure If a substantial leak has been present for more than an extended time the LOW PRESSURE text will change to CUFF LEAK Stop the leak and observe that monitored pressure returns to regulated st...

Page 21: ...INSTALLATION AND OPERATING INSTRUCTIONS Deflate the cuff by TOUCH SLIDE and HOLDING the DEFLATE DEFL button until deflation begins Once the cuff fully deflates the Stats button appears on the Main Cuff Controls ...

Page 22: ...limb occlusion pressure LOP and recommended Tourniquet pressure RTP that was determined if the LOP feature was used All zeroes next to the LOP text indicates that the LOP feature was not used The Time icon indicates the total time the cuff was inflated Touch the Okay button to make no changes and return to the previous view Touch the Reset button to reset the Stats to default A confirmation menu a...

Page 23: ...the Maintenance section To modify the system Settings perform the following steps 1 Touch the Settings button and the Settings tool tray will slide up revealing the Settings options 2 If desired touch the Cancel button to make no changes and return to the default GUI view CAUTION After approximately 5 seconds of inactivity the system will automatically close open menus and return to its normal mod...

Page 24: ... mode of operation PREFERENCES Preferences options include changing Alarm Volume Display Brightness and or Primary Language To change any Preference perform the following steps 1 Touch the Preferences menu button The Preferences menu appears 2 If desired touch the Cancel button to make no changes and return to the default GUI view 3 Select a Preference to change as described below CAUTION After ap...

Page 25: ... system will automatically accept any changes in Volume close open menus and return to its normal mode of operation BRIGHTNESS SETTING To change the display Brightness enter the Preferences menu and perform the following steps Touch the Brightness button The Brightness menu appears Touch the negative left arrow button to decrease or positive right arrow button to increase the Brightness Increments...

Page 26: ...Cancel button to ignore any changes CAUTION No Language change will be saved unless the Okay button is touched to approve After approximately 5 seconds of inactivity the system will automatically close open menus and return to its normal mode of operation CUFF TEST To test a Cuff for leaks perform the following steps 1 Connect the Cuff to be tested with standard length hose set to the Main Cuff po...

Page 27: ...sing test shows the following view 8 Touch the Cancel button to return to the Settings menu 9 A leak during the test shows the following view 10 Touch the Cancel button to cancel the test and return to the Settings menu 11 An error in the test shows the following view A test error also briefly causes a yellow LOW PRESSURE warning tile to appear as well as the cuff status bar changing yellow These ...

Page 28: ... to scroll through the revealed text If desired touch the menu tile Cancel button to return to the Documentation tile 4 Touch the Documentation menu tile Cancel button to return to the default GUI view CAUTION After approximately 5 seconds of inactivity the system will automatically close open menus and return to its normal mode of operation OPERATION WARNING To isolate the device from AC Power Ma...

Page 29: ...and when to allow for intermittent aeration of tissue by deflating the cuff for 10 to 15 minutes There is a general medical practice 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 st...

Page 30: ...or lower limb Whether the limb is normal hypertrophied or obese The patient s preoperative systolic pressure The maximum anticipated rise in systolic pressure during the procedure The physician may also choose to use an alternative method such as the Doppler stethoscope to manually and carefully following the published technique determine the patient s LOP or to confirm the LOP automatically deter...

Page 31: ...ppears very similar to other sensors used for pulse measurements the Zimmer LOP pulse sensor is designed for use only with Zimmer A T S 4000TS tourniquets featuring LOP technology The LOP sensor does not measure Oxygen Saturation nor can it be modified to do so CAUTION Never use any sensor with the A T S 4000TS other than approved Zimmer LOP pulse sensors Non Zimmer sensors will not work with the ...

Page 32: ...uff port connectors The Main Cuff and Second Cuff both have the ability to perform the LOP function 3 Connect the LOP pulse sensor to the LOP socket in the rear of the A T S 4000TS 4 Prepare patient according to guidelines in Patient Preparation above 5 Attach the LOP pulse sensor to the patient s index finger or second toe on the limb the Tourniquet cuff has been applied to 6 Ensure the sensor is...

Page 33: ... 32 INSTALLATION AND OPERATING INSTRUCTIONS 7 Touch the corresponding LOP button to start the LOP determination 8 The A T S 4000TS evaluates the pulse signal quality during the beginning of the LOP feature ...

Page 34: ...turn to the default GUI view The meanings to the alarm messages are found in the ALARM CONDITIONS table Touch the Cancel button to cancel the LOP at any time The System will alarm LOP STOPPED Touch the Cancel button again to exit the LOP function 9 The A T S 4000TS begins to inflate the cuff incrementally while continuously evaluating the patient s pulse The LOP determination will last approximate...

Page 35: ...o reject the RTP value touch the Cancel button 13 To retry the LOP procedure repeat the steps above CAUTION The A T S 4000TS 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 14 If the RTP is acceptable and no other adjustments are required then touch the INFLATE INFL button to inflate the cuff 15 In the event t...

Page 36: ...n following a 3 second delay If the RTP from the first LOP determination is higher than the second RTP adjust the pressure setting to the higher RTP Refer to Manual Tests and Checks for how to adjust pressure If the RTP from the first LOP determination is lower than the second RTP adjust the pressure in the first RTP to the higher RTP of the second determination Refer to Manual Tests and Checks fo...

Page 37: ...imal edge of the exsanguinating bandage Place the valve port and hose connections so that the hose will not be kinked when the limb is positioned for surgery 7 Connect the dual port cuff hoses to the unit at the Main Cuff connectors Red ports 8 Set target PRESSURE and TIME set points Refer to PRESSURE and TIME set point system tests under the Manual Tests and Checks section for how to set target P...

Page 38: ...used 12 Perform the surgical procedure 13 At the end of the procedure deflate cuff by TOUCH SLIDE and HOLDING the DEFLATE DEFL button until deflation begins The Main Cuff PRESSURE display will show the deflation of the cuff and the TIME display elapsed inflation time alarm clock will stop Once the cuff fully deflates the Stats button appears on the Main Cuff Controls ...

Page 39: ...xt LOP RTP indicates the limb occlusion pressure LOP and recommended Tourniquet pressure RTP that was determined if the LOP feature was used All zeroes next to the LOP text indicates that the LOP feature was not used The Time icon indicates the total time the cuff was inflated Touch the Okay button to make no changes and return to the previous view Touch the Reset button to reset the Stats to defa...

Page 40: ... Second Pressure and Time tiles will display inflation information and begin timing the cuff inflation Deflation of one cuff will not be permitted while the other cuff is inflating 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 t...

Page 41: ... should only be used as a guide Other causes of alarm conditions may indicate a need for other actions Most audible alarm tones non technical failures 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 To minimize nuisance alarms that can b...

Page 42: ...eriod of time which takes into account normal transient pressure disruptions such as range of motion checks A determination of the magnitude of leakage that disregards transient disruptions is produced by the Advanced Leak Detector Any leakage of air from either cuff or the connection between cuff and device will cause a reduction in cuff pressure The system will maintain the cuff set point pressu...

Page 43: ...BLES Alarm Conditions are accompanied by a warning message and sometimes Error Codes along with an Indicator Light and audible Priority Tone as detailed in the ALARM CONDITIONS table Most warning messages during operation appear as yellow tiles LOP related alarms are grouped at the end of the table Error Codes are detailed in the ERROR CODES table ALARM CONDITIONS Warning Message Indicator Light P...

Page 44: ...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 CUFF LEAK Flashing Red High Condition Cuff or hose is leaking Deflated Cuff fails to inflate to set point in at least 30 seconds or Inflated cuff leaks more than 15 mmHg in at least 9 seconds Check all lines and connections CUFF DEFLATED Flashing Yellow Me...

Page 45: ...r occurred The unit has shut down in a safe state Explanation Action Microprocessor failed a ROM memory check An attempt was made to access or R W to ROM non volatile memory and the values were lost Cycle the ON STANDBY button If problem persists note error code and contact manufacturer If problem persists service the unit E0002 SYSTEM FAILURE DETECTED Constant Red Technical Failure Constant tone ...

Page 46: ...matical error within the ALU The unit has shut down in a safe state Explanation Action Divide By Zero error Result of math operation was out of range Cycle the ON STANDBY Button If problem persists service the unit E0010 SYSTEM FAILURE DETECTED Constant Red Technical Failure Constant tone Condition Watch dog timer safety circuit failure detected Specifications Internal system diagnostics feature h...

Page 47: ...n a safe state Explanation Action Transducer reference voltage is out of range Cycle the ON STANDBY Button If problem persists note error code and contact manufacturer E0026 XXXX1 SYSTEM FAILURE DETECTED Constant Red Technical Failure Constant tone Condition Amplifier voltage error detected in the reservoir Specification The unit has detected a failure in the amplifier circuit reservoir voltage Th...

Page 48: ...ANDBY button If problem persists note error code and contact manufacturer E0034 XXXX1 SYSTEM FAILURE DETECTED Constant Red Technical Failure Constant tone Condition Primary power supply rails out of specification Specification Loss of voltage on one of the DC power rails will cause a failure to trigger The unit has shut down in a safe state Explanation Action Voltage lost from one or more of the D...

Page 49: ...execution event or data values detected Specification Internal system diagnostics feature has detected an illegal program execution event or illegal data The unit has shut down in a safe state Explanation Action The system has detected an occurrence of an illegal program execution event or data values If problem persists note error code and contact manufacturer 1 Some Error Codes are followed by a...

Page 50: ...n may malfunction but all other functions should continue to operate Power down the device to reset Consult the operator and Service Manual for additional specifications 2 kV line s to earth 2 kV line s to earth 120 Vac 60 Hz 230 Vac 50 Hz Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT For 0 5 cycle 5 UT 95 dip in UT For 0 5 cyc...

Page 51: ... as determined by an electro magnetic site survey a should be less than the compliance levels in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m NOTES At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation...

Page 52: ...nt Rated maximum output power of transmitter in Watts W Separation distance according to frequency transmitter in Meters m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m c...

Page 53: ...sinfecting Disinfect the sensor by wiping the sensor and patient contact surfaces with disinfecting solution Isopropyl alcohol is recommended as a disinfecting solution PERIODIC MAINTENANCE This manual includes a blank Test and Analysis form This is provided at the back of this manual This form may be photocopied and used to document the visual electrical safety and functional tests Cleaning The e...

Page 54: ...l engineer or other person thoroughly familiar with electronic medical devices within the healthcare organization By default the Service button is grayed out and locked as shown by a padlock icon If the button combination was not correctly touched and held the Systems Function Menu will not allow access and automatically close the menu due to inactivity While in the Service mode the system will ke...

Page 55: ...minimum pressure range of 0 to 700 mmHg and be no greater than the maximum monitored by the pressure meter 3 Calibration Hose Kit Provided Routes air pressure between a regulated pressure supply to a pressure meter and the A T S 4000TS unit s cuff ports The Calibration Hose Kit is supplied by Zimmer and included with the unit CAUTION The clamp on the calibration hose remains opened not clamped dur...

Page 56: ...tempt is made the system will accept the value and place a checkmark by the numeric value to indicate the new input pressure was accepted Touch the 0 button to calibrate the 0 mmHg pressure point A correct input will cause the system to play the confirmation tone and place a checkmark beside the numeric input value Touch the Next button to continue to the next calibration point The system will be ...

Page 57: ...rical value waiting for the pressure to be applied Once the pressure has been applied and is stable touch the 600 button to calibrate the cuff transducers at the 600 mmHg point A correct input will cause the system to play the confirmation tone and place a checkmark beside the numeric input value Once all the cuff transducer values have been calibrated the list of values will be shown with checkma...

Page 58: ...numerical value waiting for the pressure to be applied Once the pressure has been applied and is stable touch the 475 button to calibrate the reservoir transducer at the 475 mmHg point A correct input will cause the system to play the confirmation tone and place a checkmark beside the numeric input value Touch the Next button to continue to the next calibration point The system will be looking for...

Page 59: ...The cuff transducer ports are the right side port for each of the cuffs 3 Using a calibrated meter and external pressure source apply 50 mmHg of pressure to the cuff transducer sense ports CAUTION During the calibration check the system will be detecting pressure in the Deflated mode This will cause the system to alarm This is normal and expected The alarm silence button can be activated to silenc...

Page 60: ...free If the calibration hoses are suspected of any leaks the hoses should be replaced before performing the leak test 5 Press the Next button to start the Leak test 6 The Leak test will automatically start the countdown timer once stable pressure is detected 7 If the Leak test successfully passes the system will issue a passing result The numbers in the bottom left and right indicate the total pre...

Page 61: ...rations Total time the system has been successfully calibrated in its life 4 Total Time Used in Backup Battery Total time in minutes the system has been used in backup battery mode 5 Battery Health Health state of the battery expressed in percent 6 Last 3 Error Codes Displays the last error codes encountered This may initially include error codes that was intentionally generated during the factory...

Page 62: ...ical devices within the healthcare organization the ability to perform a touch screen test The touch screen in the system is pre tuned and does not require any calibration The Touch Test allows the touch screen to be exercised in the X and Y direction to ensure proper function This function is located in the SERVICE menu To access this information perform the following steps 1 Access the Service m...

Page 63: ...ins when measuring the insulation resistance The insulation resistance testing is conducted by measuring the Mains Part to the Protective Earth ground The test equipment used shall be capable of performing the measurements with 500VDC The insulation resistance will be a very high level since the insulation is intended to provide no means for electrical conductivity Therefore values 50MΩ will be co...

Page 64: ...liquid to come in contact with the skin or eyes If contact has been made wash the affected area with copious amounts of water and seek medical advice Do not use any charger other than that specifically provided for use with the equipment Observe the plus and minus marks on the battery and ensure correct use Do not use any battery which is not designed for use with the equipment Keep cells and batt...

Page 65: ...ULED MAINTENANCE The A T S 4000TS Tourniquet is designed with several specific self test features to assist in fault isolation These features are designed to show messages in the display The meanings of these messages are delineated in the ERROR CODES table In the unlikely event the system malfunctions the pneumatics are designed to close in a SAFE STATE which will cause the valves and pump to be ...

Page 66: ...properly TOUCH SLIDE and HOLD the button until deflation starts Deflate valve is stuck shut Valve s electrical harness damaged Defective valve driver circuitry No green AC Indicator light Unit not plugged into wall outlet AC Power Mains No Power at wall outlet AC Power Mains harness not properly plugged in Blown fuse s Membrane Panel not properly plugged in Defective AC indicator Defective AC indi...

Page 67: ...ane panel not properly plugged in ON STANDBY button defective Blown Fuse s Unit not plugged in and battery fully depleted Unit not plugged in and battery defective or battery fuse blown CAUTION HIGH VOLTAGE ELECTRICAL HAZARD High voltage will be present on the power input module and control board All service work must be completed by Zimmer or a qualified biomedical engineer or other person thorou...

Page 68: ...0460000100 ATS Power Cord Kit Central Europe Korea 60460000500 ATS Power Cord Kit Italy 60460000700 ATS Power Cord Kit Japan Taiwan 60460000600 ATS Power Cord Kit Australia 60460000800 ATS Power Cord Kit India South Africa 60460000200 ATS Power Cord Kit UK Hong Kong 60460000300 ATS Power Cord Kit Switzerland 60460001000 ATS Power Cord Kit China 60400010500 XL LOP Sensor English 60400030501 XL LOP ...

Page 69: ...ct your Zimmer distributor or write or phone MAIL TELEPHONE Zimmer Surgical 200 West Ohio Avenue Dover Ohio 44622 U S A 1 330 343 8801 local 1 800 830 0970 toll free ENVIRONMENTAL CONDITIONS The following are environmental conditions for operation of the A T S 4000TS unit CONDITION OPERATION Ambient temperature 68 F 20 C to 73 F 23 C Typical 50 F 10 C to 100 F 38 C Maximum Relative humidity 30 to ...

Page 70: ...lity Signifies to follow instructions for use IFU Replace fuse as marked Contains or presence of Phthalates Medical General Medical Equipment as to Electric Shock Fire and Mechanical Hazards Only in Accordance with ANSI AAMI ES60601 1 2005 3rd Ed and CAN CSA C22 2 NO 60601 1 This product contains one or more toxic or hazardous substances or elements The Environmental Protection Use Period on the l...

Page 71: ...on Battery that must be recycled CAUTION Federal law USA restricts this device to sale by or on the order of a physician Certifies that a product has met European Union consumer safety health or environmental requirements Type BF applied part Identifies any terminal which is intended for connection to an external conductor for protection against electric shock in case of a fault or the terminal of...

Page 72: ...eneral warning Used to distinguish between identical or similar devices sold in both sterile and nonsterile conditions Indicates authorized representative REP in the European Community EC Indicates catalog reorder or reference number Indicates equipment serial number QTY Quantity Consult Instructions for Use ...

Page 73: ...icates date of manufacture and is accompanied by a date Indicates suitability for alternating current only Indicates suitability for direct current only Indicates equipment or systems in the medical electrical area that include RF transmitters or that intentionally apply RF electromagnetic energy for diagnosis or treatment YYYY MM ...

Page 74: ...ry Applied Part Type 0 B BF CF Mains Connection Permanently Installed Non detachable Power Cord Detachable Power Cord Accessories _______________________________________________________________________ Measuring Equipment _______________________________________________________________ Measurements Specification Measured Protective earth resistance 300mΩ _________ mΩ Earth equipment Leakage 500μA _...

Page 75: ......

Page 76: ...3 Zimmer Surgical Inc Printed in U S A 622400048EN Zimmer U K LTD 9 Lancaster Place South Marston Park Swindon Wiltshire SN3 4FP United Kingdom 0086 P M Zimmer Surgical Inc 200 West Ohio Avenue Dover Ohio 44622 U S A ...

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