SmartPump Dual Channel Tourniquet Pump Instructions for Use Rev L Aug 2015

Print Date: Aug 31, 2015 05:54:27 PM 0000012899, Rev. L Effective Date: Dec 16, 2014 9:17:33 AM

5920-011-700 Rev-L

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Contents Introduction... 4 Indications For Use... 4 Contraindications... 4 User/Patient Safety... 5 System Overview... 5 For Use With... 6 Accessories... 6 Features... 7 Definitions... 10 Information Screen Icons... 10 Audible Event Indicators... 11 Battery Charge Indicators... 12 Symbols... 12 Instructions... 13 To Prepare the Pump for Use... 13 To Mount the Pump... 13 To Charge the Battery... 13 To Set the System Time and Date Values... 13 To Initiate Setting the Values... 13 To Set the Hour Value... 13 To Set the Minute Value... 14 To Set the Month Value... 14 To Set the Day Value... 15 To Set the Year Value... 15 To Change the Time Display Format... 15 To Change the Default Time and/or Target Pressure Values... 15 To Adjust Alarm Volume... 16 To Minimize the Display of Screen Values... 16 To Connect a Cuff... 17 To Inflate a Cuff... 17 To Switch (or Backup) a Single Cuff ... 18 To Change the Procedure Time and Target Pressure Values... 18 To Deflate a Cuff... 19 To Print the Procedure Summary Report (optional)... 19 To Perform a Bier Block Procedure... 19 To Switch (or Backup) a Bier Block Cuff... 20 Inspection and Testing... 21 Cleaning... 22 Recommended Equipment... 22 Troubleshooting... 23 Storage and Handling... 26 Disposal/Recycle... 26 Specifications... 27 Appendix... 33 Factory Default Settings... 33 Software License Notice... 33

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Introduction This Instructions For Use manual is the most comprehensive source of information for the use of your product. This manual may be used by in-service trainers, physicians, nurses, surgical technologists, and biomedical equipment technicians. Keep and consult this reference manual during the life of the product.

Conventions The following conventions are used in this manual: • A WARNING highlights a safety-related issue. ALWAYS comply with this information to prevent patient and/or healthcare staff injury. • A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage. • A NOTE supplements and/or clarifies procedural information.

Contact Information For additional information, including safety information, or in-service training, contact your Stryker sales representative or call Stryker customer service at 1-800-253-3210.

Indications For Use The Stryker SmartPump Dual Channel Tourniquet Pump System (pump) is intended to be used to temporarily occlude or decrease blood flow in a patient extremity during a surgical procedure of that extremity. The tourniquet system is intended to provide greater visualization of the operating field during a surgical procedure of a patient extremity. The use of the tourniquet system is not a substitute for proper hemostasis. Typical surgical procedures of extremities include: • Arthroscopy • Tendon repair • Total wrist joint repair • Knee joint replacement • Finger joint replacement • Nerve repair • Bone grafts, and • Other surgical procedures of a patient extremity requiring temporary occlusion of blood flow.

5920-011-700 Rev-L

The dual channel design supports single cuff, bilateral cuff and Bier Block cuff procedures, and allows for the simultaneous surgery of an upper and lower limb.

Contraindications The Stryker SmartPump Tourniquet System is not intended to be used as a ligature or in lieu of cauterization to stop hemorrhages. The system should never be applied without consideration of the local anatomy. The tourniquet system and associated tourniquet cuff is contraindicated for use on the torso and patients exhibiting unusual or complicated neurological or vascular problems of the extremities such as arteriovascular impairment, phlebitis, infection, uncontrolled diabetes, and/ or other associated problems. Other potential contraindications include: • Compromised vascular circulation • Severe scar tissue in the cuff zone • Mellitus • Open leg fractures • Post traumatic lengthy reconstruction • Severe crushing injuries • Elbow surgery associated with excessive swelling • Severe hypertension • Skin grafts in which bleeding must be readily distinguished • Presence of sickle cell disease or clotting disorder

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User/Patient Safety WARNINGS: • Before using any system component or any component compatible with this system, read and understand the instructions. Pay particular attention to WARNING information. Become familiar with the system components prior to use. • Only trained and experienced healthcare professionals should use this equipment. • The healthcare professional performing any procedure is responsible for determining the appropriateness of this equipment and the specific technique for each patient. Stryker, as a manufacturer, DOES NOT recommend surgical procedure. • Upon initial receipt and before each use, inspect the equipment for damage. See the Inspection and Testing section. DO NOT use the equipment if damage is apparent. • DO NOT use this equipment in areas in which flammable anesthetics or flammable agents are mixed with air, oxygen or nitrous oxide. • To avoid the risk of electric shock, ALWAYS connect this equipment to a hospital-grade, facility power receptacle with protective earth. • ALWAYS position the equipment so that the power cord may be easily disconnected as required. • Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical equipment like this system. Install and place this system into service according to the EMC information in this manual. Portable and mobile RF communications equipment can affect the function of this system. • ALWAYS follow current hospital protocol governing the safe and effective use of a tourniquet system.

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System Overview The dual channel tourniquet system allows for the connection of two cuffs. The pressure value and elapsed inflation time value of each cuff are displayed, monitored, and controlled independently within two separate channel areas. The system maintains real-time cuff pressure within normal operating parameters relative to the set target pressure value. Variations in pressure are detected and adjusted to the set target pressure value within two/tenths of a second. These automatic adjustment responses are sequenced to deliver optimal, progressive pressure compensation without causing overpressure fluctuations, frequent pressure adjustments or false triggering due to transient pressure variations. This functionality enhances cuff pressure maintenance and addresses the unique pressure dynamics associated with various size cuffs and their relatively low inflatable volumes. Cuff pressure changes may be caused by limb extension and contraction and initial cuff conformity and tissue compression. After initial cuff inflation, minor changes in pressure above or below the set target pressure value may occur. Intraoperative limb manipulation may cause the cuff to induce a momentarily, minor high and/or low-pressure fluctuation. A momentary decrease in limb volume, associated with extension motions may cause the system to sense low pressure, as the cuff’s compressible target briefly becomes smaller. Momentary increases in pressure may also occur due to external compression of the cuff during limb contraction, which temporarily causes the limb to assume a larger compressible volume. All of these pressure fluctuations are compensated for by the system and adjusted to the set target pressure automatically. Cuff pressure conditions determined to be outside normal operating parameters will trigger an audible and visual alarm requiring immediate action. Such pressure conditions may be caused by a leaking or damaged cuff, a leaking cuff O-ring, a loose Luer connection, or a leaking fill line.

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System Overview (continued) The system also monitors the total elapsed time the cuff is inflated during a procedure. The total elapsed cuff time value, as well as the cuff activity and cuff pressure value may be printed using the optional tourniquet report printer.

For Use With This section identifies required components intended to be used with the equipment to obtain a safe combination.

WARNINGS: • DO NOT reuse, reprocess, or repackage a single use device. A single use device is intended for a single use only. A single use device may not withstand chemical, chemical vapor, or high temperature sterilization reprocessing. Design features may make cleaning difficult. Reuse may create a serious risk of contamination and may compromise the structural integrity of the device resulting in operational failure. Critical product information may be lost if the device is repackaged. Failure to comply may lead to infection or cross-infection and result in patient and/or healthcare staff injury.

DESCRIPTION

REF

Rolling Stand

5920-013-000

Tubing, Stockinettes, Fill Lines, and Adapters

5920-XXX-XXX series

Disposable Cuffs

5921-XXX-XXX series

Reusable Cuffs

5922-XXX-XXX series

DESCRIPTION

REF

NOTE: The fill line and cuff are considered to be Defibrillation Proof BF Type Applied Parts. See the Features and Specification sections.

Rolling Stand

5920-013-000

Tubing, Stockinettes, Fill Lines, and Adapters

5920-XXX-XXX series

Disposable Cuffs

5921-XXX-XXX series

Reusable Cuffs

5922-XXX-XXX series

Report Printer Kit

5920-012-000

Accessories This section identifies accessories that may be purchased to replace consumed, worn, or damaged equipment. Optional accessories may also be purchased to aid in operation. WARNINGS: • Use only Stryker-approved equipment, unless otherwise specified. • DO NOT disassemble, modify, service, or repair this equipment without authorization of the manufacturer. • Use only Stryker-approved electronic components and accessories. Failure to comply may result in increased electromagnetic emissions or decreased electromagnetic immunity of the system.

The following Stryker-approved accessories are sold separately:

NOTES: • The Stryker Report Printer Kit REF 5920012-000 is not available in all markets. • For a complete list of accessories, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary.

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Features

I J K L

A B C D M

E

N O

F G

P Q H R

Controls, Indicators, Receptacles, and Fill Line A

B

TIME Control Adjustment Buttons (each cuff channel) When in the SET mode, press the INCREASE or DECREASE buttons to increase or decrease the value of the inflation time for the selected cuff channel. Each button press will change the value by 5-minute increments. If using the 1 to 15 minute time range, each button press will change the time value by 1-minute increments. The numeric time value will change accordingly. SET/SAVE Button (each cuff channel) Press to initiate the SET mode and allow the adjustment of the TIME or PRESSURE values for the selected cuff channel. After adjustments have been made, press the button again to save the new values.

C

PRESSURE Control Adjustment Buttons (each cuff channel) When in the SET mode, press the INCREASE or DECREASE buttons to increase or decrease the value of the inflation pressure for the selected cuff channel. Each button press will change the pressure value by 5 mmHg increments. The numeric pressure value will change accordingly.

D

INFLATE Button (each cuff channel) Press to inflate the cuff of the selected channel to the target pressure.

E

DEFLATE Button (each cuff channel) Press and hold for 1.5 seconds to deflate the cuff of the selected channel.

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Features F

DEFAULT DISPLAY Button Press to clear the most recent procedure time and pressure values and reset the pump to the default time and pressure values. Press to store new default time and pressure setting values. See the To Change the Default Time and/or Target Pressure Values section.

G

ON/OFF (STANDBY) Button Press and release to start pump operation. Press and hold for 1.5 seconds to stop pump operation.

H

PRINT Port Using a serial cable, allows the connection of an optional Stryker Tourniquet Report Printer to the pump.

I

ALARM MUTE Indicator/Button Illuminates green to indicate normal operation and flashes red to indicate an alarm condition. Press to mute an audible alarm.

J

Information Screen The backlit screen provides a visual display of the elapsed inflation time and pressure of the cuff(s) during a procedure.

K

PRINT Button If the optional report printer is connected, press to print a summary report of tourniquet activity including cuff pressure and cuff application time during a procedure.

L

IVRA (Intravenous Regional Anesthesia) Control Button Press to lock or unlock the control. When locked, this control prevents the accidental deflation of an active cuff associated with a Bier Block procedure or the management of two cuffs involved in a bilateral procedure.

M

AC Power Receptacle Using a power cord, allows connection of facility AC power source to the pump.

N

Battery Charge Indicator Displays the charge status of the internal battery. The pump has an automatic internal battery switch-over feature to allow AC-free use and provide a backup if AC power is lost.

O

AC Power Indicator Illuminates green to indicate facility AC power is connected to the pump.

P

Fill Line Connector (each cuff channel) Using a fill line, allows the connection of a cuff to the selected cuff channel.

Q

Fill Line When connected to the pump, the fill line provides the inflation pressure pathway to a connected cuff. NOTE: The fill line and cuff are considered to be Defibrillation Proof BF Type Applied Parts. See the For Use With and Specififcations sections.

R

Mounting Knob Turn to install and remove the pump from the rolling stand.

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Features (continued)

A

B D

E C

F

Information Screen Layout

A

TIME Value Area (two) Displays an elapsed time value that indicates how long a cuff has been inflated. Two formats are available [H:MM and MINUTES].

B

System Status Area Displays READY icon when the pump is ready for use.

C

PRESSURE Gauge and Value Area (two) Displays the real-time, actual pressure value of an inflated cuff in millimeters of mercury and a graphical pressure gauge icon.

D

CUFF 1 and CUFF 2 Channel Areas Displays the elapsed procedure time and inflation pressure of the cuff connected to the corresponding channel fill line connector. Each channel is controlled and operated independently by the corresponding control buttons located on the sides of the pump.

E

Intravenous Regional Anesthesia (IVRA) Status Area Displays the IVRA lock or unlock status [shown unlocked].

F

Battery Status Area Displays the charge status or power level of the internal battery.

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Definitions Information Screen Icons Icon

Name

Definition

Ready

The pump is operating normally and ready for use.

Default Display

The time and pressure values displayed are the set default target values.

Service Required

An error condition has occurred and service is required. Record the code number displayed. See the Troubleshooting section.

Audible Alarm Active

An alarm condition has occurred and the audible tone is active. See the Troubleshooting section.

Audible Alarm Muted

An alarm condition has occurred and the audible tone is muted. See the Troubleshooting section.

Caution

An error or alarm condition has occurred and action is required. See the Troubleshooting section.

Under Pressure Gauge

The actual pressure value of the selected cuff is less than the set target pressure value.

Target Pressure Gauge

The actual pressure value of the selected cuff has reached the set target pressure value.

Over Pressure Gauge

The actual pressure value of the selected cuff is greater than the set target pressure value.

IVRA Lock

The Intravenous Regional Anesthesia (IVRA) control is locked.

IVRA Unlock

The IVRA control is unlocked.

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Definitions (continued) Information Screen Icons Icon

Name

Definition

Battery Power Status

The amount of battery power if the battery is in use.

Battery Charge Status

The battery is charging, as shown by band segments illuminating sequentially.

Cuff Deflate

The selected cuff is either deflating or deflated.

Pressure Value

The pressure value of the selected cuff.

Time, Date, and Year Control

The time, date, and year values when adjusting the internal clock settings. The clock does not adjust for daylight savings time changes automatically.

Time Value

The time value of the selected cuff.

Hours and Minutes

A display format option for the selected cuff time value.

Minutes

A display format option for the selected cuff time value.

Audible Event Indicators Type

Description

Event

Button Feedback

One beep

Power on button press Power off button press Normal button press Incorrect button press

Task Completion

Three beeps in rapid succession

Confirms cuff has reached target pressure value

Two beeps in rapid succession

Confirms change to pressure, time or display default values Confirms change to IVRA status, lock or unlock

Action Required

One long beep, about 1.5 seconds

Audio volume setting

Continuous, repeating beep, about one beep per second

Indicates system failure

Six beeps, about one beep per second, followed by a six second pause (silent), then repeated

Indicates the cuff time value has exceeded its limit

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Indicates the cuff pressure value is either high or low

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Definitions Battery Charge Indicators Indication

Status

GREEN (steady state)

Battery is fully charged, in trickle or slow charge mode. Information screen displays power status.

YELLOW (blinking)

Battery is in fast charge mode and may require one hour to reach an 80% charge level. Information screen power status.

NO ILLUMINATION

Battery is not charging. Ensure AC power is connected to the pump. If AC power is connected, see the Troubleshooting section.

Symbols The symbols located on the equipment and/or labeling are defined in this section or in the Symbol Definition Chart. See the Symbol Definition Chart supplied with the equipment.

On/Off (Stand-by)

AC Power Alternating Current (AC)

Battery Power

Alarm Mute

Set and Save

Inflate

Deflate

Cuff One Connector

Cuff Two Connector

Fill Line Connection Only

Default Display

Cuff One Channel

Cuff Two Channel

Print Report

Printer Port

IVRA Lock/ UnLock Control

Increase

Decrease

Refer to Instruction Manual/ Booklet

General Warning Sign

Protective Earth Ground

Direct Current (DC)

Consult Instructions for Use

Fuse

Defibrillation Proof Type BF Applied Part

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Time Control Adjustment

Pressure Control Adjustment

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Instructions To Prepare the Pump for Use (Figure 1) WARNINGS: • ALWAYS secure and position the tourniquet pump outside of the sterile field in accordance with your hospital guidelines and local regulations. If no hospital guidelines exist, follow the procedure for mounting the tourniquet pump provided in these instructions. • TIPPING HAZARD - DO NOT use the rolling stand REF 5920-013-000 with any other equipment, unless otherwise specified. • ALWAYS place the power cord away from personnel traffic areas to eliminate a trip hazard. ALWAYS place the power cord away from water or liquids to prevent a shock hazard. To Mount the Pump to Rolling Stand REF 5920-013-000 1. Make sure the rolling stand is assembled properly and the casters are locked. See the instructions for use supplied with the rolling stand. 2. Gently install the pump onto the post assembly of the rolling stand. 3. Turn the pump’s mounting knob to fasten the pump to the post assembly securely. 4. Loosen the rolling stand’s height adjustment knob and position the pump at a height that facilitates access to the controls and provides a clear view of the display. 5. Tighten the rolling stand’s height adjustment knob. 6. If available, install the optional report printer kit components on the rolling stand. See the instructions for use supplied with the report printer. 7. Connect the power cord between the pump and facility power. 8. Make sure the internal battery is fully charged. See the To Charge the Battery section.

EN

9. Press and release the ON/OFF (STANDBY) button to turn ON the pump. An audible tone will occur to indicate power is applied. See the Audible Event Indicators section. NOTE: The software version number will appear briefly in the lower left corner of the information screen during power up. Make sure the version number matches the software version number printed on the cover of the manual. To Charge the Battery NOTE: During the automatic self-test, internal systems are checked for proper operation. If an error occurs, a service code will be displayed. See the Troubleshooting section if required. 1. Connect the power cord to the pump and facility power. 2. Press the ON/OFF (STANDBY) button to turn ON the pump and initiate an automatic selftest. The software version will appear briefly on the information screen. 3. Press and hold the ON/OFF (STANDBY) button for 1.5 seconds to turn OFF the pump. 4. Keep the pump connected to facility power for six hours to allow the pump’s internal battery to fully charge. To Set the System Time and Date Values (Figures 2 and 3) NOTE: The pump has a real-time clock, powered by an internal battery, which tracks time and date information. The clock does not adjust for daylight savings time changes automatically. To Initiate Setting the Values 1. Ensure the READY icon is displayed on the screen and the cuffs are not inflated. 2. Press and hold the SET/SAVE button and the TIME INCREASE button of cuff channel one simultaneously for four seconds. 3. Release both buttons. Locate the time value (HH:MM, 24-hour format) on the information screen and observe the hour value is blinking. To Set the Hour Value 1. Press the TIME INCREASE or DECREASE buttons of cuff channel one to set the hour value. 2. Press the SET/SAVE button to save the new value. Observe the minute value is blinking.

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Instructions

Figure 1 To Prepare the Pump for Use To Set the Minute Value 1. Press the TIME INCREASE or DECREASE buttons of cuff channel one to set the minute value. 2. Press the SET/SAVE button to save the new value. Locate the date value (MN.DY, 12.06 format) on the information screen and observe the month value is blinking. To Set the Month Value 1. Press the TIME INCREASE or DECREASE buttons of cuff channel one to set the month value. 2. Press SET/SAVE button to save the new value. Observe the day value is blinking.

Figure 2 To Initiate Setting the Values

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Instructions (continued)

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NOTE: The time display format will remain the constant until the format is changed again.

To Set the System Time and Date Values (continued) To Set the Day Value 1. Press the TIME INCREASE or DECREASE buttons of cuff channel one to set the day value. 2. Press SET/SAVE button to save the new value. Observe the year value is blinking. To Set the Year Value 1. Press the TIME INCREASE or DECREASE buttons of cuff channel one to set the year value. 2. Press SET/SAVE button to save the new time and date values. 3. Ensure the DEFAULT DISPLAY icon appears on the information screen.

Figure 3 To Set the Time and Date Values To Change the Time Display Format (Figure 4) 1. Ensure both cuffs are deflated and each cuff channel is not active. 2. Ensure the READY icon is displayed on the information screen. NOTE: The time display format cannot be changed during an active cuff procedure. 3. Press the INCREASE button on the TIME control of both cuff channels simultaneously. 4. Observe the current time format on the information screen change automatically, for example, from H:MM to MINUTES.

Figure 4 To Change the Time Display Format To Change the Default Time and/or Target Pressure Values 1. Press the SET/SAVE button to initiate the adjustment mode. NOTE: Observe the corresponding time and pressure values blink on the information screen. 2. Press the TIME INCREASE or DECREASE buttons to increase or decrease the time value, respectively. Observe the time value change accordingly. NOTE: Each button press will change the value by 5-minute increments for the 15 to 240 minute time range. The value will change by one-minute increments for the 1 to 15 minute time range. 3. Press the PRESSURE INCREASE or DECREASE buttons to increase or decrease the pressure value, respectively. Observe the pressure value change accordingly.

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Instructions To Change the Default Time and/or Target Pressure Values (continued) NOTE: Each button press will change the pressure value by 5-mmHg increments for the 100 to 475 mmHg pressure range. 4. After the desired values are selected, press the DEFAULT DISPLAY button to save the new values. NOTES: • The time and pressure values will stop blinking on the information screen. A doublebeep will indicate the new values have been saved. The READY icon and DEFAULT DISPLAY icon will appear on the information screen. • If the DEFAULT DISPLAY button is not pressed within five minutes of starting the adjustment mode, the mode will be cancelled without changing the default settings. To Adjust Alarm Volume (Figure 5) 1. Press and hold the ALARM MUTE indicator/ button. 2. Press the TIME INCREASE or DECREASE buttons of cuff channel one to increase or decrease, respectively, the alarm volume to a desired level. NOTE: The alarm volume may be adjusted in the active or READY mode.

Figure 5 To Adjust Alarm Value

To Minimize the Display of Screen Values (Figure 6) NOTES: • The information screen displays the time and pressure values of both cuff channels as a factory default setting. • If single cuff procedures are used more often, the display of values may be changed to appear for one cuff channel only. • When the display of values is minimized to one cuff channel, the values of the selected cuff will be displayed only. 1. Ensure the READY icon is displayed on the information screen and no cuffs are inflated. 2. Press and hold the ALARM MUTE indicator/ button, then press the DEFAULT DISPLAY button. 3. Ensure the display cycles twice by blinking on one channel and then the other channel to confirm the selection of the minimization mode. NOTES: • To view the default settings when the display has been minimized, you may press the DEFAULT DISPLAY button, the IVRA Lock button to LOCK, or the INFLATE button located on the channel where the setting display is minimized. • To restore the continuous display of default settings for both cuff channels, repeat steps one and two. Both channel display setting values will blink to confirm de-selection of the minimization mode.

Figure 6 To Minimize the Display of Screen Values

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Instructions (continued) WARNINGS:

To Connect a Cuff 1. Ensure the READY icon and DEFAULT DISPLAY icon appear on the information screen. 2. If the default time and pressure settings are acceptable, connect a fill line to the pump. If the time and pressure settings need to be changed, see the To Change the Procedure Time and Target Pressure Values section. 3. Position the cuff on the patient’s limb. WARNING: Connect the fill line connector of the pump to the tourniquet cuff only. Fill line extension tubing and/or an adapter may be used between the fill line connector of the pump and the tourniquet cuff. See the Definitions - Symbols section. 4. Connect the cuff to the fill line connector. 5. Inflate and deflate the cuff as required. See the To Inflate a Cuff section.

To Inflate a Cuff WARNINGS: • ALWAYS operate the equipment within the specified environmental condition values. See the Specifications section. • Verify the tourniquet pump is connected to the tourniquet cuff only. • ALWAYS monitor the cuff pressure and application time throughout a surgical procedure. DO NOT apply excessive cuff pressure. DO NOT use a cuff for an excessive amount of time. Failure to comply may result in patient injury, including vascular complications, neuromuscular or neurological injuries, tourniquet pain, ischemia, venous emboli or thromboembolism, blood vessel trauma, reperfusion problems and arterial occlusion, mild, aching pain in the limb, stiffness, weakness, reactive hyperemia, and skin discoloration. • NEVER turn OFF the pump while the cuff(s) are inflated. Failure to comply will cause the cuffs to deflate and may result in patient injury.

• Pay particular attention to excessive sound associated with frequent pump activity. Any pressure loss will cause the system to compensate for the decreased pressure. However, the system may eventually fail to maintain cuff pressure if the pressure loss begins to increase significantly. See the Troubleshooting section. • ALWAYS resolve an alarm condition before continuing to use the pump. An alert triangle, a flashing time or pressure value, or a wrench icon with a service code indicates an alarm condition. See the Troubleshooting section. • If a pump malfunction occurs due to a loss of both AC power and internal battery power, an inflated cuff will remain inflated. Deflate the cuff by manually disconnecting the cuff. 1. Press the INFLATE button to inflate the selected cuff. 2. Ensure the selected cuff inflates to the target pressure value and the time value accumulates the elapsed time of cuff inflation. 3. Monitor and manage the pressure and elapsed time settings. See the To Change the Procedure Time and Target Pressure Values section as required. NOTE: If a cuff cannot reach or maintain the target pressure value during initial inflation, discontinue using the cuff. See the To Switch (or Backup) a Single Cuff section. 4. When the target elapsed cuff time is reached, perform one of the options: • Option 1 - Press the DEFLATE button to deflate the selected cuff. See the To Deflate a Cuff section for details. NOTES: • If necessary, you may then press the INFLATE button to re-inflate the cuff to the highest pressure used during the procedure. The elapsed cuff time will start again and continue to accumulate elapsed cuff time. • The pump will not deflate the cuff automatically when the target time is reached. You must press the DEFLATE button to deflate the selected cuff.

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Instructions • Option 2 - Press the ALARM MUTE indicator/ button to mute the audible alarm for 15 minutes. NOTE: The ALARM MUTE indicator/button will remain red and flash. The pump will continue to monitor and display the total elapsed time value of cuff inflation. • Option 3 - Add more time as required. See the To Change the Procedure Time and Target Pressure Values section.

To Switch (or Backup) a Single Cuff NOTES: • If cuff channel one or two become inoperative, a cuff may be switched to the functional channel. • Use this procedure only when an inflated, active cuff is at risk or an alarm condition cannot be resolved and no alternative cuff is available. • Adapt this procedure to current local protocol as required. 1. Ensure the cuff and all pneumatic connections are leak-free and secure. 2. Clamp and close off the fill line of the inflated cuff to retain cuff pressure. 3. Disconnect the fill line from the pump. 4. Press the DEFLATE button of the inoperative channel to clear the alarm condition. 5. Move the clamped fill line cuff to the operative channel and connect the fill line to the pump. 6. Press the INFLATE button and release the clamp to allow the pump to take control of cuff pressure. NOTE: A momentary pressure alarm condition may occur as the pump takes control of cuff pressure. 7. Adjust the cuff time and target pressure values as required. See the To Change the Procedure Time and Target Pressure Values section.

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To Change the Procedure Time and Target Pressure Values NOTES: • Time and pressure values may be changed when the pump is in the READY mode or during active cuff inflation. • Time and pressure values will remain constant unless: (a) the values are changed as described in this procedure, (b) the DEFAULT DISPLAY button is pressed after deflation or, (c) the pump is turned off and turned on again. • An error beep will occur if the button press sequence is incorrect. For example, an error beep will occur if the TIME INCREASE or TIME DECREASE buttons are pressed before pressing the SET/SAVE button to initiate a change. • Each TIME INCREASE or DECREASE button press will change the time value by 5-minute increments for the 15 to 240 minute time range. The value will change by one-minute increments for the 1 to 15 minute time range. • Each PRESSURE INCREASE or DECREASE button press will change the pressure value by 5-mmHg increments for the 100 to 475 mmHg pressure range. 1. Press the SET/SAVE button to initiate changing a time or pressure value. NOTE: Observe the corresponding time and pressure values blinking on the information screen. 2. Press the TIME INCREASE or DECREASE buttons to increase or decrease the time value, respectively. Observe the time value change accordingly. 3. Press the PRESSURE INCREASE or DECREASE buttons to increase or decrease the pressure value, respectively. Observe the pressure value change accordingly. 4. When the desired values are selected, press the SET/SAVE button to save the new values. NOTES: • The time and pressure values will stop blinking on the information screen. A doublebeep will indicate the new values have been saved. • If a cuff is not inflated, the READY icon will appear on the information screen. If a cuff is inflated, the time and pressure values will appear as actual, real-time values.

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5920-011-700 Rev-L

Instructions To Deflate a Cuff WARNINGS: • ALWAYS disconnect and remove the deflated cuff from the tourniquet system after the procedure is complete. • ALWAYS remove the sleeve and other underlying materials after the procedure is complete. NOTE: A cuff may be deflated at any time during a procedure. 1. Press the DEFLATE button for the selected cuff for 1.5 seconds. 2. Ensure the pressure value and pressure gauge icon on the information screen indicate a pressure decrease. 3. If the optional report printer is attached, a procedure summary report may be printed. See the To Print the Procedure Summary Report (optional) section for details. 4. Press the DEFAULT DISPLAY button to clear the procedure’s pressure and time values. NOTES: • When the cuff pressure value reaches zero, the pressure value and pressure gauge icon are not present on the information screen. The total elapsed cuff time remains on the information screen. • In the deflated (inactive) state, the pump will continue to monitor ambient air pressure. The pump will exhaust any ambient pressure due to cuff or patient movement, automatically, before cuff removal. • The IVRA LOCK/UNLOCK CONTROL button may be used to prevent accidental cuff deflation during a Bier Block procedure or the management of two cuffs involved in a bilateral procedure. See the To Perform a Bier Block Procedure section for details.

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To Print the Procedure Summary Report (optional) NOTES: • Procedure summary information is saved and retained in the pump even if power is removed or the internal battery is fully discharged. • Each time a new procedure is initiated, the previous summary information is replaced by the new information. • Previous summary information may be replaced as follows: (1) pressing the DEFAULT DISPLAY button followed by pressing the INFLATE button and (2) turning the pump OFF and ON followed by pressing the INFLATE button. 1. Make sure the optional report printer is connected to the pump. See the instructions for use supplied with the report printer. 2. Make sure the report printer is loaded with the proper self-adhesive labels and ready for use. See the instruction for use supplied with the report printer. 3. Press the PRINT button on the pump. 4. Apply the self-adhesive label to the patient record or chart according to current local guidelines.

To Perform a Bier Block Procedure WARNINGS: • ALWAYS follow current hospital protocol governing the safe and effective use of a Bier Block procedure. • DO NOT apply excessive cuff pressure or apply the cuff(s) for an excessive amount of time during a Bier Block procedure. Failure to comply may result in patient injury or death.

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Print Date: Aug 31, 2015 05:54:27 PM 0000012899, Rev. L Effective Date: Dec 16, 2014 9:17:33 AM

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5920-011-700 Rev-L

Instructions To Perform a Bier Block Procedure (continued)

To Switch (or Backup) a Bier Block Cuff

NOTES: • The pump will support the connection of a Bier Block cuff to either cuff channel one or two. • Pressing the INFLATE button will interrupt a cuff deflation instantly or return cuff pressure to the highest value used during the preceding procedure. • The IVRA LOCK/UNLOCK CONTROL button may be activated (locked) either before or after inflation. 1. Press the IVRA LOCK/UNLOCK CONTROL button to lock the IVRA control and prevent the accidental deflation of the cuff. Ensure the IVRA LOCK icon is displayed on the information screen. NOTE: If a cuff cannot reach or maintain the target pressure value during initial inflation, discontinue using the cuff. See the To Switch (or Backup) a Bier Block Cuff section. 2. Sequence the inflation and deflation of the Bier block cuffs according to current local guidelines governing the performance of a Bier Block procedure. 3. After the sequencing is complete, deflate the Bier Block cuffs using one of the options: • Option 1 - Press the IVRA LOCK/UNLOCK CONTROL button to unlock the IVRA control and allow the deflation of the cuff. • Option 2 - Deflate the cuff pressure incrementally. See the To Change the Procedure Time and Target Pressure Values section. After incremental deflation of the cuff is complete, press the IVRA LOCK/ UNLOCK CONTROL button to unlock the control and allow full deflation of the cuff.

NOTES: • If the primary cuff cannot reach or maintain the target pressure value during initial inflation and before anesthetic injection, discontinue using the cuff. • If, before deflation of the primary cuff, the secondary cuff cannot reach or maintain the target pressure value, use this procedure to backup the primary cuff. 1. Ensure the cuff and all pneumatic connections are leak-free and secure. 2. Clamp and close the fill line of the inflated primary cuff to retain cuff pressure. 3. Disconnect the fill line of the primary cuff from the pump. NOTE: A pressure alarm condition will occur. 4. Connect the fill line of the secondary cuff to the fill line connector of the primary cuff. 5. After confirming the second cuff reaches the target pressure value, release the clamped primary cuff. 6. Adjust the cuff time and target pressure values as required. See the To Change the Procedure Time and Target Pressure Values section.

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Print Date: Aug 31, 2015 05:54:27 PM 0000012899, Rev. L Effective Date: Dec 16, 2014 9:17:33 AM

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