A.T.S. 4000TS TOURNIQUET Operator and Service Manual Rev B

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 _____________________________________________________________

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CONTENTS TABLE OF CONTENTS 1 GENERAL 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 2 INSTALLATION 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 Page 2

CONTENTS 3 MAINTENANCE ... 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

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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 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 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.

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GENERAL INFORMATION PRECAUTIONS IN USE •

Not for use in an oxygen rich environment with an oxygen concentration greater than 25% for ambient pressures up to 110 kPa or the partial pressure of oxygen is greater than 27.5 kPa at ambient pressures exceeding 110 kPa.

•

Normal operation has the A.T.S. 4000TS running on ~ AC Power Mains via its power cord. The backup battery is intended for emergency power or transport.

•

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 inflated 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. 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.

•

Inflation 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 (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 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 reinflation. Reinflation over blood-filled vasculature may lead to intravascular thrombosis.

•

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.

•

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 fibers (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.

•

If skin preparations are used preoperatively, they should not be allowed to flow and collect under the cuff where they may cause chemical burns.

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GENERAL INFORMATION •

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 inflated for at least 20 minutes from the time of injection.

WARNING: Cuffs will not deflate in STANDBY mode. Ensure cuffs are fully deflated before setting the unit to STANDBY.

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 1/2 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 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.

•

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 return.

•

Blood entering through the nutrient vessels of the long bones, such as the humerus.

SPECIFICATIONS AND PERFORMANCE CHARACTERISTICS ~ AC Power Mains Line Voltage Range Line Current Input Power Battery Type Battery Discharge Time

100–240V ~ (AC), 50/60 Hz. Auto switching. 1000 mA RMS @ 120V ~ (AC) (max). 120 VA Rechargeable, Li-Ion, 14.4 VDC, 4300 mAh. 360 minutes

Battery Recharge Time

Unit will automatically switch and operate on battery power for 360 minutes minimum with a fully charged battery when no ~AC Power Mains is detected. Poorly maintained cuffs, hoses, or extreme pressure transients will impact battery performance. The backlight will automatically be set to the nominal value when in backup battery mode. 10 hours Unit should be plugged in 10 hours before initial use. In the event of a deep battery discharge that cannot be recovered in the first 10 hours, a second 10 hour charging period may be required. Page 6

GENERAL INFORMATION Power Cord Power Plug Line Protection Cuff Pressure Range Cuff Extended Pressure Range

Pressure Accuracy Pressure Regulation Maximum Pressure Time Alarm Set Range Timer Accuracy Internal Diagnostics

Size

Displays

Type SJT or international equivalent of HO5VV-F, AWG 16 (1.31mm2), 14 ft. (4.27 m). Hospital grade, 3 prong straight blade, 15 amp or proper equivalent power plug. 2 time-delayed 1.0 amp 250 volt fuses. 50–400 mmHg, 1 mmHg increments. 401-600 mmHg, 1mmHg increments. A yellow tile will appear requesting confirmation to exceed 400 mmHg pressure. ±3 mmHg (50–600 mmHg). ±4 mmHg of set-point (10 second average under non-transient conditions without external leaks). 400 mmHg per cuff. 600 mmHg per cuff in extended pressure range. 1–240 minutes; 1 minute increments. 0.25% of elapsed time. Program, memory, watchdog timer, transducer calibration, improper valve actuation, touch-screen, backlight, LCD. 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. (6.0 Kg) (including power cord). The A.T.S. 4000TS uses an 8.4” SVGA LED backlit LCD panel. Pressure Display: Displays pressure setting, sensed cuff pressure, and other messages.

IV Pole

Time Display: Displays time alarm set-point and elapsed time. Height: sufficient to mount unit at ≤ 50 inches (127 cm) from floor to base of ATS unit. Pole Diameter: 0.872 to 1.125 inches. Base Diameter: ≥27.56 inches (70 cm).

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GENERAL INFORMATION ES 60601-1 CLASSIFICATION CAUTION: This device is not suitable for use in the presence of flammable anesthetic or gases.

Type of protection against electric shock Degree of protection against electric shock IPX0 Classification according to the degree of protection against ingress of water Mode of operation

Class I or Internally Powered Equipment* Type BF applied part.

IPX0 (Ordinary equipment).

Continuous operation.

*When the unit is operating on backup battery, the type of protection against electric shock changes to internally powered equipment.

EMISSIONS/IMMUNITY The A.T.S. 4000TS Tourniquet System complies 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 equipment. If adjacent or stacked use is necessary, the A.T.S. 4000TS Tourniquet System should be observed to verify it is functioning normally.

Cable

Maximum length

Zimmer Limb Occlusion Pressure (LOP) sensor cable

168 inches (427 cm).

~ AC Power Mains power cord

170 inches (432 cm).

WARNING: use of an LOP sensor cable or ~ AC Power Mains power cord with a length other than those specified may result in increased emissions and decreased immunity.

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INSTALLATION AND OPERATING INSTRUCTIONS

INSTALLATION AND OPERATING INSTRUCTIONS INITIAL VISUAL INSPECTION Unpack the A.T.S. 4000TS Tourniquet upon receipt and inspect the unit for any obvious damage that may have occurred during shipment including damage to any accessories. 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 10-hour charge. CAUTION: The A.T.S. 4000TS Tourniquet System is intended to be used outside the sterile field.

FEATURES AND OPERATING PRINCIPLES The A.T.S.4000TS has a variety of features and physical characteristics as described below.

BUTTONS AND ICONS Various colored buttons and icons are used in the A.T.S. 4000TS and described below. Please refer to Touchscreen GUI below for details on what the colors mean.

Button/Icon Title Power ON/STANDBY Button

What it means 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). CAUTION: Ensure both cuffs are fully deflated and have been removed from the patient as well as all underlying 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

Alarm Silence Button

Allows operator to manually silence most alarms for 30 seconds.

Alarm Silenced Icon

Visual indicator to show that Alarm tones are silenced.

Caution Icon

Indicates a warning condition or system failure.

Settings Button

Allows access to the system settings.

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INSTALLATION AND OPERATING INSTRUCTIONS Button/Icon Title

What it means

Brightness Icon

Appears in the system Settings when adjusting the backlight brightness.

LOP Button

Controls the Limb Occlusion Pressure (LOP) feature. When the pulse sensor is in place and cuff applied, pressing this button will start the process to measure the patient’s LOP and give the user a recommended Tourniquet pressure (RTP).

Cuff Progress Icon

Indicates that the Tourniquet system is currently testing the Tourniquet cuff attached to the Main Cuff Ports.

Cuff Success Icon

Indicates that the Tourniquet system has tested the Tourniquet cuff attached to the Main Cuff Ports and that it passed the leak test.

Cuff Fail Icon

Indicates that the Tourniquet system has tested the Tourniquet cuff attached to the Main Cuff Ports and that it failed the leak test.

Check Cuff Icon

Indicates that the Tourniquet system has detected a connection or inflation problem with the Tourniquet cuff attached to the Main Cuff Ports when attempting to leak-test the cuff.

INFLATE 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/Reload/Reset Button

Allows user to restart, reset, or retry specific functions.

Next Button

Allows user to progress to the next step in specific functions.

Progress Icon

Appears and animates to indicate that a specific function is loading or working.

A.T.S. Progress Icon

Indicates that a Tourniquet instrument level function is loading or working.

A.T.S. Fail Icon

Indicates that a Tourniquet instrument test has failed to meet the requirements.

A.T.S. Success Icon

Indicates that a Tourniquet instrument test has successfully met the requirements.

A.T.S. w/ Cuff Icon

Appears and animates to indicate that the Advanced Leak Detection feature has detected a potential leak with a cuff, hoses or the pneumatic connection between the cuff and device during cuff inflation.

Pressure Icon

Represents a Pressure function.

Time Icon

Represents a Time function.

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INSTALLATION AND OPERATING INSTRUCTIONS Button/Icon Title

What it means

Consult Manual Icon

Indicates that the user should consult the operating instructions for complete instructions.

Calibration Icon

Represents the calibration functions.

Language Icon

Appears in the system Settings when changing the Primary System Language.

Locked Icon

Indicates that service functions are currently locked.

Unlocked Icon

Indicates that service functions are currently unlocked.

Documentation Button

Allows access to quick-reference documentation.

Stats Button

Allows viewing and re-setting of end-of-procedure information.

Volume Icon

Appears in the system Settings when adjusting Alarm volume.

Battery Status Icon (critically low capacity)

Indicates that the system is running on backup battery and at critically low capacity. The system should be plugged into ~ AC Power Mains immediately. Medium priority alarm active.

Battery 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.

Battery Status Icon (50% capacity) ~ AC Power Mains Icon (50% charge)

Indicates that the system is running on backup battery, currently at 50% of full capacity.

Battery Status Icon (75% capacity) ~ AC Power Mains Icon (75% charge)

Indicates that the system is running on backup battery, currently at 75% of full capacity.

Battery Status Icon (100% capacity) ~ AC Power Mains Icon (100% charge)

Indicates that the system is running on backup battery, currently at 100% of full capacity.

Indicates that the system is running on ~ AC Power Mains and charging the battery, which is currently at 25% of full charge.

Indicates that the system is running on ~ AC Power Mains and charging the battery, which is currently at 50% of full charge.

Indicates that the system is running on ~ AC Power Mains and charging the battery, which is currently at 75% of full charge.

Indicates that the system is running on ~ AC Power Mains and charging the battery, which is currently at 100% of full charge.

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INSTALLATION AND OPERATING INSTRUCTIONS 1

16

17

8

2

9

3 4

10 12 13 14 11

6 5

15 7

Feature

What it does

1

Carrying Handle

Handle for carrying or holding the Tourniquet system.

2

Touch Screen GUI

Touch-screen based graphical user interface (GUI) for interacting with and controlling most of the Tourniquet system functions.

3

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). CAUTION: Ensure both cuffs are fully deflated and have been removed from the patient as well as all underlying bandages or protective sleeve prior to setting the unit to STANDBY. CAUTION:

4

Alarm Silence Button

•

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.

Will silence most audible alarms for 30 seconds after the button is pressed. An alarm silenced icon will appear in the cuff status display to indicate the alarm is silenced. Alarms will silence after the full priority tone has played. CAUTION: •

When an alarm sounds because of an internal hardware malfunction, the alarm cannot be silenced.

•

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

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INSTALLATION AND OPERATING INSTRUCTIONS

5

Feature

What it does

Main Cuff Ports

Connector ports used to connect the Tourniquet system to the Main Cuff hoses. The Main Cuff Ports are controlled by the left side RED GUI controls. CAUTION: The A.T.S. 4000TS is designed and tested for use with Zimmer dual port cuffs and hoses. Zimmer does not recommend the use of any cuff other than Zimmer dual port cuffs and hoses. Do not use single port cuffs with the A.T.S. 4000TS.

6

Second Cuff Ports

Connector ports used to connect the Tourniquet system to the Second Cuff hoses. The Second Cuff Ports are controlled by the right side BLUE GUI controls. CAUTION: The A.T.S. 4000TS is designed and tested for use with Zimmer dual port cuffs and hoses. Zimmer does not recommend the use of any cuff other than Zimmer dual port cuffs and hoses. Do not use single port cuffs with the A.T.S. 4000TS.

7

Pole Clamp

The Pole clamp is used to mount the unit on an I.V. pole. See Specifications section above for details. CAUTION: 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 ≥27.56 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:

9

Power Cord (not shown)

•

Cuff hoses or the LOP sensor should be the only items to utilize the hose hangers.

•

Do not hang articles on the Tourniquet’s hose hangers that may cause the Tourniquet to become unstable.

Connects to IEC320 appliance inlet on the Tourniquet system. See Specifications section above for details.

10

~ AC Power Mains Fuse Block

Contains ~ AC Power Mains Fuses. Fuse drawer is a 2-pole holder for 5x20mm fuses.

11

Potential Equalization Conductor Stud

Conductor stud that can be used to provide a connection between the A.T.S. 4000TS and the potential equalization bus-bar of the electrical installation.

12

USB Port A

Host port for Zimmer-authorized servicing of the A.T.S. 4000TS. CAUTION: Do not touch the ports or USB cable conductors and the patient at the same time.

13

USB Port B

Device port for Zimmer-authorized servicing of the A.T.S. 4000TS. CAUTION: Do not touch the ports or USB cable conductors and the patient at the same time.

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INSTALLATION AND OPERATING INSTRUCTIONS Feature

What it does

14

LOP Sensor Port

Port used to connect the Zimmer LOP sensor.

15

LOP Sensor Storage

Recess area used to store the LOP sensor when not in use.

16

Battery Compartment

Compartment that holds the A.T.S. 4000TS’s backup battery.

17

Alarm/Warning Light

Alarm priority indicator. This light will flash and change color to yellow or red depending on the alarm priority (see Alarm Conditions section for details).

TOUCH SCREEN GUI The A.T.S. 4000TS Graphical User Interface (GUI) consists of RED Main Cuff displays and controls on the left side and otherwise identical BLUE Second Cuff displays and controls on the right side. Additionally, GRAY general System functions are located on the bottom center of the screen. GUI function details:

Second Cuff Status Display

Main Cuff Status Display

Second Cuff Pressure Display Tile

Main Cuff Pressure Display Tile

Second Cuff Controls

Main Cuff Controls

Second Cuff Time Display Tile

Main Cuff Time Display Tile

System Functions Menu

GUI Component

What it means

Cuff Status Displays

Text describing the status 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 desired to be inflated. Deflation of either Cuff is initiated by TOUCH, SLIDE, and HOLD the DEFLATE (DEFL) button . For greater safety, each DEFLATE (DEFL) button has a delay at the end of the slide and therefore must be held for approximately 2 seconds before the unit will allow a cuff to deflate. When a cuff control function is unavailable (i.e. the “INFLATE” function when the cuff is already inflated), it is shown in a flat, dimmed state.

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INSTALLATION AND OPERATING INSTRUCTIONS GUI Component

What it means

System Functions Menu

Settings button , documentation button , and power status (Backup Battery or ~ AC Power Mains – see Buttons and Icons section above).

Cuff Pressure Display Tiles

Touch to modify set pressure.

Cuff Time Display Tiles

Touch to modify set time.

During normal operation with no buttons being touched, each of the independent PRESSURE display areas will show the actual cuff pressure as well as the set-point in smaller digits at the lower right side of a tile. At other times, depending on alarm conditions and buttons touched, the display may communicate other information such as alarm messages, set pressure, or end of procedure Stats.

During normal operation with no buttons being touched, each of the independent TIME display areas will show elapsed inflation time of each cuff as well as the setpoint in smaller digits at the lower right side of a tile. At other times the display will communicate time alarm messages. CAUTION: •

To prevent accidental timer reset, the elapsed inflation time can only be “zeroed” when the cuff is fully deflated or reset in the Stats feature.

•

Additional time can be added to clear a time alarm.

INITIAL SETUP WARNING: To avoid the RISK of electric shock, this 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 and any institutionperformed biomedical evaluations.

TESTS AND CHECKS 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. Refer to Alarm Conditions or Maintenance sections as appropriate.

AUTOMATIC DIAGNOSTIC AND CALIBRATION CHECK These automatic checks verify certain System Functions through diagnostics and calibration to system standards. 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 section listed above. Observe that the green ~ AC Power Mains indicator light turns on and illuminates the Power button in STANDBY mode. 2

Turn the unit ON by pressing the Power button

and observe the following:

•

The Zimmer circle “Z” icon

•

The unit displays “A.T.S. 4000TS”. The unit is self-testing specific system hardware and software.

and an animated Progress icon

Page 15

appear on the LCD display.

INSTALLATION AND OPERATING INSTRUCTIONS •

The animated Progress icon

•

“CALIBRATION” and an animated Progress icon are displayed during the calibration check. Once complete, “CALIBRATION OKAY” replaces the previous text and icon.

is replaced by the text “DIAGNOSTIC OKAY.”

CAUTION: The A.T.S. 4000TS will automatically perform an internal Diagnostic and Calibration check when powered ON. Setting the system to STANDBY and powering back ON between cases will allow the system to re-perform the automatic Diagnostic and Calibration check. •

After the startup routine is complete, the default Graphical User Interface (GUI) appears:

•

“0” is indicated in the PRESSURE and TIME tiles of both the Main and Second displays.

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The default pressure is shown on both PRESSURE tiles. The default pressure is pre-set to 250 mmHg. This setting may be changed as desired.

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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.

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If a number other than zero is indicated in the PRESSURE displays, the unit should be calibrated by a qualified biomedical engineer or other person thoroughly familiar with electronic medical devices via the Calibration section within the Maintenance section.

MANUAL TESTS AND CHECKS These manual tests and checks verify certain System Functions and include Pressure and Time set-point tests and Calibration and Low Pressure Alarm checks. 1

PRESSURE set-point system test •

Touch the red Main Cuff PRESSURE tile. A new tile will appear with a PRESSURE display and set-point arrows:

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INSTALLATION AND OPERATING INSTRUCTIONS

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The PRESSURE display should read “250” (the factory default set-point). The tile will automatically close in approximately 5 seconds.

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Within the 5 second time frame, touch the negative left-arrow button - to decrease or positive right-arrow button + to increase the PRESSURE set-point. ■ The set pressure can be maintained between 50 mmHg and 400 mmHg in increments of 1 mmHg. ■

If an arrow button is continuously held, the increments will change by 5 mmHg.

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Touch the Okay button automatically close.

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Repeat PRESSURE set-point system test for the blue Second Cuff PRESSURE set-point.

to immediately remove the displayed tile or wait approximately 5 seconds and it will

WARNING: •

When medically necessary to use the A.T.S. 4000TS in the EXTENDED PRESSURE MODE, ensure the attached tourniquet cuff and hoses are capable 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.

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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 continued increase of pressure to a maximum of 600mmHg, or touch the Cancel button to remain at 400mmHg. The cuff status bar turns yellow as an ongoing warning. The Pressure tile will also indicate the setpoint pressure in yellow and the word “extended” will appear to show the pressure exceeds that recommended.

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Anytime an asterisk (*) appears below the PRESSURE value in the PRESSURE tile, the data displayed is the set-point. Set pressure will revert back to the default pressure setting when the unit is set to STANDBY.

2

TIME set-point system test •

Touch the red Main Cuff TIME tile and a new tile will appear with a TIME display and set-point arrows:

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INSTALLATION AND OPERATING INSTRUCTIONS

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The main TIME display should read “60” (the factory default set-point). The tile will automatically close in approximately 5 seconds.

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Within the 5 second time frame, touch the negative left-arrow button - to decrease or positive right-arrow button + to increase the TIME set-point. ■ The set time can be maintained between 5 and 240 minutes in increments of 1 minute. ■

If an arrow button is continuously held, the increments will change by 5 minutes.

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Touch the Okay button automatically close.

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Repeat TIME set-point system test for the blue Second Cuff TIME set-point.

to immediately remove the displayed tile or wait approximately 5 seconds and it will

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 default time setting when the unit is set to STANDBY. 3

Low Pressure Alarm Check •

Connect a cuff and standard length hose set to the Main Cuff ports. Touch the INFLATE (INFL) button

to inflate the cuff to the set-point of 250 mmHg:

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INSTALLATION AND OPERATING INSTRUCTIONS

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Create a leak in the cuff by partially detaching the hose (either port) from the unit while a cuff is inflated.

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Make the leak large enough that the pressure drops more than 15 mmHg below set-point. Observe: ■

A short delay is instituted to reduce nuisance alarms.

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An audible tone will sound and a red alarm indicator will flash announcing the alarm condition.

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A yellow Warning tile drops over the PRESSURE display and indicates “LOW PRESSURE” as well as the monitored pressure:

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If a substantial leak has been present for more than an extended time, the “LOW PRESSURE” text will change to “CUFF LEAK.”

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Stop the leak and observe that monitored pressure returns to regulated state, the audible tone stops, the red alarm indicator turns off, and the alarm message is no longer displayed.

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