A.T.S. 5000 TOURNIQUET Operator and Service Manual Rev B Jan 2022

WARRANTY LIMITED ONE-YEAR WARRANTY INSIDE U.S.A. SCOPE OF LIMITED WARRANTY Zimmer, Inc. warrants the Product (A.T.S. 5000 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 foregoing 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 ensure 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.

Device Serial Number _________________________________________________________________

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CONTENTS TABLE OF CONTENTS GENERAL INFORMATION ... 4 APPLICATION SPECIFICATION ... 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

INSTALLATION AND OPERATING INSTRUCTIONS ... 10 INITIAL VISUAL INSPECTION ... 10 FEATURES AND OPERATING PRINCIPLES ... 10 BUTTONS AND ICONS ... 10 TOUCHSCREEN GUI ... 16

INITIAL SETUP ... 18 TESTS AND CHECKS ... 19 AUTOMATIC DIAGNOSTIC AND CALIBRATION CHECK ... 19 MANUAL TESTS AND CHECKS ... 20

SYSTEM FUNCTIONS ... 23 Advanced Features ... 23

OPERATION ... 30 SURGEON DECISIONS ... 30 PATIENT PREPARATION ... 31 CUFF IDENTIFICATION ... 32 LIMB OCCLUSION PRESSURE (LOP) ... 34 LOP MEASUREMENT ... 35 CUFF OPERATION ... 39

ALARM CONDITIONS ... 45 PRESSURE ALARMS ... 45 ADVANCED LEAK DETECTION ... 46 ALARM/WARNING COLORS AND AUDIBLE TONES ... 46 ALARM CONDITION AND ERROR CODE TABLES ... 46

ELECTROMAGNETIC COMPATIBILITY (EMC) GUIDANCE TABLES ... 56 EMC GUIDANCE AND DECLARATION – EM EMISSIONS ... 56 EMC GUIDANCE AND DECLARATION – EM IMMUNITY/DISTURBANCES ... 57 EMC GUIDANCE AND DECLARATION – EM EMISSIONS/RF ... 58 EMC GUIDANCE AND DECLARATION – IMMUNITY/SEPARATION DISTANCES .. 59

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CONTENTS MAINTENANCE ... 60 GENERAL MAINTENANCE INFORMATION ... 60 Cleaning... 60 External Visual Inspection ... 60 Functional and Calibration Check ... 60

PERIODIC MAINTENANCE ... 60 DISTAL LOP SENSOR CLEANING ... 61 Cleaning... 61

SERVICE ... 61 SERVICE MENU ACCESS ... 61 CALIBRATION ... 62 A.T.S. LEAK TEST ... 66 UNIT INFORMATION ACCESS ... 67 BURN MODE – Selectable Duration ... 68 TOUCH TEST ... 69 PROTECTIVE EARTH RESISTANCE TESTING ... 70 EARTH (EQUIPMENT) LEAKAGE CURRENT TESTING ... 70 INSULATION RESISTANCE TESTING ... 70 BACKUP BATTERY SERVICE ... 70 BATTERY HANDLING RECOMMENDATIONS ... 71

UNSCHEDULED MAINTENANCE ... 72 TROUBLESHOOTING GUIDE ... 72 TROUBLESHOOTING ... 72

REPLACEMENT PARTS ... 74 PARTS LIST ... 74 ORDER INFORMATION ... 75

CONTACT INFORMATION ... 75 REPORTING PROBLEMS ... 75

ENVIRONMENTAL CONDITIONS ... 75 STORAGE AND TRANSPORTATION CONDITIONS ... 75 WARNINGS, CAUTIONS & SYMBOLOGY ... 76

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GENERAL INFORMATION GENERAL INFORMATION APPLICATION SPECIFICATION The application specification for the A.T.S. 5000 including characteristics related to the use of the device, intended use, 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. 5000 Tourniquet Device is intended to be used by perioperative nurses, surgeons, and anesthesiologists, 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.

•

Do not use the tourniquet device as a source of pressure for infusion of IV fluids as this could result in either excessive infusion pressures leading to patient injury or burst IV fluid bags.

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, which is a relative contraindication (See PRECAUTIONS IN USE)

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GENERAL INFORMATION 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.

•

Healthcare professionals should always have a secondary means available to control blood loss in the event of sudden or unexpected rapid deflation of the Tourniquet.

•

Certain physiologic or anatomical conditions may prevent the A.T.S. 5000 from making a determination of LOP, in which case the device 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.

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 in which the partial pressure of oxygen is greater than 27.5 kPa at ambient pressures exceeding 110 kPa.

•

Under normal operation, the A.T.S. 5000 runs on ~ AC Power Mains via its power cord. The backup battery is intended for emergency power or transport.

•

The Tourniquet Device must be kept well calibrated and in operable condition (see Maintenance section for calibration instructions). Accessories should be checked regularly for leaks and other defects (see Maintenance section for cuff leak testing instructions).

•

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 to 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 incorrect Tourniquet will not be released accidentally.

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GENERAL INFORMATION •

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) with a cylindrical cuff. Too much overlap may cause cuff rolling and telescoping, and may lead to undesired pressure distribution on the limb. A larger overlap range is acceptable for a contour-shaped cuff. 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. Even the slightest impedance of venous return may lead to congestion and pooling of blood in the operative field. After the cuff has been fully deflated and removed from the patient, the device can be set to STANDBY (power OFF).

•

If skin preparations are used preoperatively, they should not be allowed to flow 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 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 device 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 following: •

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

100–240V ~ (AC), 50/60 Hz. Auto switching

Line Current

1000 mA RMS @ 120V ~ (AC) (max)

Input Power

120 VA

Battery Type

Rechargeable, Li-Ion, 14.4 VDC, 4300 mAh

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GENERAL INFORMATION Battery Discharge Time

360 minutes Device 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 or hoses, or extreme pressure transients will impact battery performance. The backlight will automatically be set to the nominal value when in backup battery mode.

Battery Recharge Time

8 hours Device should be plugged in for 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.

Power Cord

Type SJT or international equivalent of HO5VV-F, AWG 16 (1.31mm2), 14 ft. (4.27 m)

Power Plug

Hospital grade, 3-prong straight blade, 15 amp or proper equivalent power plug

Line Protection

2 time-delayed 1.0 amp 250 volt fuses

Cuff Pressure Range

20–600 mmHg, 1 mmHg increments. A confirmation will be required to exceed 400 mmHg pressure.

Pressure Accuracy

±3 mmHg (20–600 mmHg)

Pressure Regulation

±4 mmHg of setpoint (10 second average under non-transient conditions without external leaks)

Maximum Pressure

600 mmHg per cuff 400 mmHg per cuff in LOP measurement mode

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:

9.95 in. (25.27 cm)

Width:

11.5 in. (29.21 cm)

Depth:

9.90 in. (25.15 cm) (including clamp)

Weight: 12 lbs. (5.5 kg) (including clamp, power cord and Distal LOP sensor) Displays

The A.T.S. 5000 uses a 10.1” WXGA LED-backlit LCD panel. Pressure Display: Displays pressure setting, sensed cuff pressure, and other messages Time Display: Displays time alarm setpoint and elapsed time

I.V. Pole/Tourniquet Stand

Height: Sufficient to mount device at ≤ 50 inches (127 cm) from floor to base of A.T.S. device Pole Diameter: 0.872 to 1.3 inches Base Diameter: ≥25 inches (63.5 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.

IPX0

Type of protection against electric shock

Class I or Internally-Powered Equipment*

Degree of protection against electric shock

Type BF applied part

Classification according to the degree of protection against ingress of water

IPX0 (Ordinary equipment)

Mode of operation

Continuous operation

Essential Performance

The A.T.S. device's performance necessary to achieve freedom from unacceptable risk is the ability to regulate the pressure to a tourniquet cuff under normal conditions, and maintain cuff pressure under critical single fault conditions. NOTE: If Essential Performance is degraded, the device may not be within its intended Pressure Accuracy and Pressure Regulation specifications.

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

EMISSIONS/IMMUNITY The A.T.S. 5000 Tourniquet Device 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. 5000 Tourniquet Device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the A.T.S. 5000 Tourniquet Device should be observed to verify it is functioning normally.

•

The A.T.S. 5000 is suitable for use in Professional Healthcare Facility Environments except for near active HF SURGICAL EQUIPMENT and the RF-shielded room of an ME SYSTEM for magnetic resonance imaging.

•

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the A.T.S. 5000. Otherwise, degradation of the performance of this equipment could result. A minimum separation distance of 1.0 meters is recommended.

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GENERAL INFORMATION A minimum separation distance of 1.0 meters is recommended between this device and any RF-radiating equipment, including cords.

Cable

Maximum length

A.T.S. 5000 Distal Sensor Cable

168 inches (427 cm)

~ AC Power Mains power cord

170 inches (432 cm)

WARNING: Use of a Distal 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. 5000 Tourniquet upon receipt and inspect the device for any obvious damage that may have occurred during shipment, including damage to any accessories. Zimmer recommends that this inspection be performed by a qualified biomedical engineer or other person thoroughly familiar with electronic medical devices. If the device 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. 5000 Tourniquet System is intended to be used outside the sterile field.

FEATURES AND OPERATING PRINCIPLES The A.T.S. 5000 has a variety of features and physical characteristics as described below. The A.T.S. 5000 may be referred to as the “device” throughout this manual. “A.T.S. 5000 System” is used to reference the device and associated accessories, including cuffs, hoses, and distal LOP sensor.

BUTTONS AND ICONS Various colored buttons and icons are used in the A.T.S. 5000 and described below. Please refer to Touchscreen GUI section below for details on what the colors mean. Button/Icon

Title

What it means

Power On/Standby Button

Turns the device ON or sets the device to STANDBY The illuminated green AC INDICATOR indicates that the device 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 device to STANDBY. CAUTION: •

This button will not set the device to STANDBY when the cuff pressure is at a non-zero value during normal function.

•

During STANDBY, the power to the A.T.S. 5000 and all device 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

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INSTALLATION AND OPERATING INSTRUCTIONS Button/Icon

Title

What it means

Warning Icon

Indicates a warning condition or system failure

Alarm Indicator

Appears with the Warning Icon whenever an alarm is triggered for a specific channel (main or second), and displays a message corresponding to the alarm. The message is displayed in place of the “alarm message” text shown in the left column. The alarm message bar may be yellow or red depending on the alarm priority.

Advanced Features Button

Allows access to the Advanced Features Window. Provides the user access to Protocols, History, Help, Cuff Test, and Settings Screens.

Protocols Button

Allows user to view and select pre-set protocols. The name of the selected protocol is displayed in the button. For example, if a protocol titled “Default” is selected, then “Default” will be displayed in the blank space of the Protocols Button image shown in the left column.

LOP Button

Actuates the Limb Occlusion Pressure (LOP) measurement feature. This button will start the process to measure the patient’s LOP, via the Distal Method or EZ Method, depending on which method the user has selected.

STOP Button

Touch to stop the LOP measurement

LOP Icon

Represents the measured LOP on the PRESSURE Tile

INFLATE Button

Controls inflation of the respective cuff. The Main Cuff and Second Cuff have separate INFLATE Buttons.

DEFLATE Slider (DEFL)

Controls deflation of the respective cuff. The Main Cuff and Second Cuff have separate DEFLATE Buttons. The Deflate Button needs to be pressed, dragged to the right, and held for greater than 1 second to activate deflation.

Confirm Button

Allows user to approve, save and exit specific functions

Cancel Button

Allows user to cancel or exit specific functions without saving

Retry/Reload/Reset Button

Allows user to restart, reset, or retry specific functions

Increment Button

Allows user to increment the selected parameter

Decrement Button

Allows user to decrement the selected parameter

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INSTALLATION AND OPERATING INSTRUCTIONS Button/Icon

Title

What it means

Add 10 Minutes Button

Allows user to quickly add 10 minutes to time setpoint when there are 5 minutes or less left of the time setpoint.

Locked Icon

Indicates that service functions are currently locked

Unlocked Icon

Indicates that service functions are currently unlocked

Volume Icon

Appears in the system Settings when adjusting Alarm volume

Brightness Icon

Appears in the system Settings when adjusting the backlight brightness

A/C Power Indicator

Indicates device is connected to A/C Power NOTE: The A/C Power Indicator will not be shown if the device is not connected to A/C Power.

Battery Status Icon (critically low capacity)

Indicates that the device 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

Indicates device is running on battery. Indicates the current remaining battery capacity. NOTE: The Battery Status Indicator will not be shown if the device is connected to A/C Power.

Pressure Adjustment Touch and slide to adjust the pressure setpoint. Slider NOTE: This feature is only available if the selected channel is deflated. Up Button

Touch to go up a page

Down Button

Touch to go down a page

Left Button

Touch to go left a page

Right Button

Touch to go right a page

History Graph Button

Touch to display the Pressure vs. Time profile for the current case.

History Table Button Touch to display the statistics for the current case in a table format. Table includes details for initial pressure setpoint, final pressure setpoint, LOP/RTP and total time cuff inflated. Initial Pressure Setpoint Icon

Indicates the pressure to which the cuff was first set

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INSTALLATION AND OPERATING INSTRUCTIONS Button/Icon

Title

What it means

Final Pressure Setpoint Icon

Indicates the final cuff pressure if the pressure was adjusted during the procedure

LOP/RTP History Icon

Indicates the limb occlusion pressure (LOP) and recommended tourniquet pressure (RTP) that was determined if the LOP feature was used

Time Icon

Indicates total time cuff was inflated

Save Button

Touch to save a protocol

Cyclic Deflation Button

Touch to enter cyclic deflation protocol (5s or 10s). A confirmation tile will appear, then touch the Confirm Button to initiate the deflation protocol.

Step Deflation Button

Touch to enter step deflation protocol. A confirmation tile will appear, then touch the Confirm Button to initiate the deflation protocol.

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INSTALLATION AND OPERATING INSTRUCTIONS 1 2 9

10 8

13 5 7

6 11 3

6

4

Feature

Function

1. Carrying Handle

Handle for carrying or holding the tourniquet device. The handle is a built-in slot in the rear housing.

2. Touchscreen GUI

Touchscreen-based graphical user interface (GUI) for interacting with and controlling most of the Tourniquet device functions

3. Power On/Standby Button

Turns the device ON or sets the device to STANDBY The illuminated green AC INDICATOR indicates that the device 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 device to STANDBY. CAUTION: •

This button will not set the device to STANDBY when the cuff pressure is at a non-zero value during normal function.

•

During STANDBY, the power to the A.T.S. 5000 and all device functions, i.e. inflation, deflation, etc., are OFF, but power continues to supply the battery charging circuitry any time ~ AC Power Mains is present.

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INSTALLATION AND OPERATING INSTRUCTIONS Feature 4. Alarm Silence Button

Function 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:

5. Main Cuff Port

•

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.

•

If Alarm Silence Button not pressed, the alarm volume will gradually become louder until the alarm condition is resolved or the Alarm Silence Button is activated.

Connector port used to connect the Tourniquet device to the Main Cuff hoses. The Main Cuff Port is controlled by the left side RED GUI controls. CAUTION: The A.T.S. 5000 is designed and tested for use with dual-port cuffs and hoses distributed/supplied by Zimmer. Zimmer does not recommend the use of any cuff other than dual-port cuffs and hoses distributed/supplied by Zimmer. Do not use single-port cuffs with the A.T.S. 5000 connected via a “Y” adapter.

6. Second Cuff Port

Connector port used to connect the Tourniquet device to the Second Cuff hoses. The Second Cuff Ports are controlled by the right side BLUE GUI controls. CAUTION: The A.T.S. 5000 is designed and tested for use with dual-port cuffs and hoses distributed/supplied by Zimmer. Zimmer does not recommend the use of any cuff other than dual-port cuffs and hoses distributed/supplied by Zimmer. Do not use single-port cuffs with the A.T.S. 5000 connected via a “Y” adapter.

7. Pole Clamp

The Pole clamp is used to mount the device on an I.V. pole or Tourniquet Stand. See Specifications and Performance Characteristics section above for details. CAUTION: Ensure the Pole Clamp is sufficiently tightened to secure the device to the I.V. pole or Tourniquet Stand. CAUTION: Do not hang articles on the Tourniquet pole that are not related to Tourniquet use. For stability reasons, do not use a pole with a base diameter less than 25 inches (63.5 cm), or mount the pole clamp such that the height from the floor to the base of the A.T.S. 5000 is greater than 50 inches (127 cm). See “I.V. Pole/Tourniquet Stand” section under General Information above.

8. Power Cord

Connects to IEC320 appliance inlet on the Tourniquet device. See Specifications and Performance Characteristics section above for details.

9. Potential Equalization Conductor Stud

Conductor stud that can be used to provide a connection between the A.T.S. 5000 and the potential equalization bus-bar of the electrical installation.

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INSTALLATION AND OPERATING INSTRUCTIONS Feature 10. Distal LOP Sensor Port

Function Port used to connect the A.T.S. 5000 Distal Sensor

11. Cuff ID Barcode Scanner Barcode reader used to scan cuff packaging label. Known cuffs will be detected and the cuff information displayed on the screen. 12. Battery Compartment

Compartment that holds the A.T.S. 5000’s backup battery

13. Cuff Port Illuminators

A ring of lights surrounding the Main and Second cuff ports. These lights will flash and change color to yellow or red depending on the alarm priority (see Alarm Conditions section for details). If there are no alarm conditions and a channel is deflated, the bottom half of the corresponding cuff port illuminator is illuminated. If a channel is inflated, the corresponding cuff port illuminator is fully illuminated.

TOUCHSCREEN GUI The A.T.S. 5000 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 top center and middle center of the screen. GUI function details:

Main Cuff Pressure Display Tile

Second Cuff Pressure Display Tile

Main Cuff Time Display Tile

Second Cuff Time Display Tile

Advanced Features Button

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INSTALLATION AND OPERATING INSTRUCTIONS GUI Component

What it means

Cuff Controls

INFLATE Cuffs.

, DEFLATE

, LOP

, and Protocols

functions for the

Inflation of the Main Cuff or Second Cuff is initiated by touching the red Main Cuff Button or blue Second Cuff INFLATE Button depending on INFLATE which cuff is desired to be inflated. To deflate either Cuff, 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 greater than 1 second before the device will allow a cuff to deflate. Measurement of LOP is initiated by touching the LOP channel.

Button for the appropriate

Selection of a protocol for use of its settings is initiated by touching the Protocols Button. Advanced Features Window

Touch the ADVANCED FEATURES Button to open the Advanced Features Window. The Advanced Features Window allows the user to access (1) Protocols, (2) History, (3) Help, (4) Cuff Test and (5) Settings Tabs.

NOTE: Upon opening the Advanced Features Window, the PRESSURE Tile and TIME Tile for the main channel will be condensed to the left, and the PRESSURE Tile and TIME Tile for the second channel will be condensed to the right. Current pressure and time are listed in large digits. The setpoints are noted in the upper left-hand corner of each tile. •

Touch the Protocols Tab to view and select protocols.

•

Touch the History Tab to view a Pressure vs. Time profile of the current (if in INFLATED state) or immediately previous (if in DEFLATED state) case.

•

Touch the Help Tab for more information on device use.

•

Touch the Cuff Test Tab to perform a check for cuff leaks.

•

Touch the Settings Tab to adjust volume or brightness, to add or edit protocols, or to perform a maintenance activity.

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INSTALLATION AND OPERATING INSTRUCTIONS GUI Component

What it means

Cuff Pressure Display Tiles

Touch to modify set pressure between 20 mmHg and 400 mmHg for normal pressure range, 600 mmHg for extended pressure range. Pressure can be adjusted using the Increment and Decrement Buttons, or by using the pressure adjustment slider. 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 setpoint in smaller digits at the location on the pressure gauge. At other times, depending on alarm conditions and buttons touched, the main display may communicate other information such as alarm messages, set pressure, or end-of-procedure history. When other information is displayed, the cuff pressure display tiles are minimized but do not disappear.

Cuff Time Display Tiles

Touch to modify set time between 1 minute and 240 minutes. 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 right side of a tile. At other times the display may communicate other information. When other information is displayed, the cuff time display tiles are minimized but do not disappear. CAUTION: •

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

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Additional time can be added to clear a time alarm. When elapsed time reaches 5 minutes before the time setpoint limit, the text on the TIME Tile will change color to yellow, and an audible tone will alert the user to the elapsed time. Time can be added with the Increment Button or in ten-minute increments with the Add 10 Minutes Button.

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. 5000 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 device’s battery could become weak. Always charge the

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INSTALLATION AND OPERATING INSTRUCTIONS device 10 hours before initial setup, including calibration checking procedures, initial checks, tests and any institution-performed biomedical evaluations. Ensure that the device is positioned in a location that minimizes glare from overhead lights and other obstructions. The device may be mounted to an I.V. Pole/Tourniquet Stand/OR Boom, or placed on a table or shelf. If the device is placed on a table or shelf, ensure the surface is level prior to use to prevent movement due to vibration. CAUTION: Before transporting the device, ensure all cables and hoses are managed to reduce trip hazards.

TESTS AND CHECKS The device 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 device to a properly polarized and grounded power source with voltage and frequency characteristics compatible with the Specifications and Performance Characteristics 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 device ON by pressing the Power Button and observe the following: •

The device displays “A.T.S. 5000” text. An animated “Z” icon will appear on the LCD display. The LEDs around the connector ports will light up indicating progress.

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The device displays “DIAGNOSTIC” indicating self-testing specific system hardware and software. If all tests pass successfully, the “DIAGNOSTICS OKAY” message will appear.

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The “DIAGNOSTICS OKAY” message is replaced by “CALIBRATION” during the calibration check.

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Once the calibration check is complete, the on-screen text changes to “CALIBRATION OKAY”. Then the text disappears, and the circle icon minimizes.

CAUTION: The A.T.S. 5000 will automatically perform an internal Diagnostic and Calibration check when powered ON. Setting the device to STANDBY and powering back ON between cases will allow the device to re-perform the automatic Diagnostic and Calibration check. •

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

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“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 in the Protocols menu.

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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 in the Protocols menu.

CAUTION: •

If “CALIBRATION ERROR” is displayed, refer to the Calibration Error at Power-On section within the Maintenance section.

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If a number other than zero is indicated in the PRESSURE display when a cuff is not connected, the device 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.

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