SmartPump Tourniquet System Instructions for Use Rev AI April 2022

5920-011-700 Rev-AI

Contents Introduction... 4 Conventions... 4

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To Adjust the Audible Alert Volume... 17 To Remove Display of Cuff Two Channel Values... 17

Contact Information... 4

To Restore Display of Cuff Two Channel Values... 18

Indications For Use... 4

During Use... 18

Contraindications... 4

To Connect a Cuff... 18

Safety Directives... 5

To Inflate a Cuff... 20

General Safety... 5

To Switch (or Backup) a Single Cuff... 21

Electrical Safety... 5 Magnetic Resonance (MR) Safety... 5

To Change the Procedure Time and Target Pressure Values... 21

System Overview... 6

To Deflate a Cuff... 22

For Use With... 7

To Perform a Bier Block Procedure... 22

Features... 8

To Switch (or Backup) a Bier Block Cuff . . . 23

Hardware Interface... 8

After Use... 23

Button and Indicator Panel... 9

To Remove Components... 23

Information Screen... 10

To Turn OFF Tourniquet Pump and Disconnect Facility Power... 24

Definitions... 10 Information Screen Icons... 10 Audible Event Indicators... 11 Battery Charge Indicators... 11 Colors... 12 Symbols... 12 Product Marking(s)... 12

Cleaning and Disinfection... 25 Recommended Equipment and Materials... 25 To Wipe Down Equipment... 25 Inspection and Testing... 26 Storage and Handling... 26 Service... 26 Fuse Replacement... 27

BS EN ISO 7010 Graphical Symbols Safety colors and safety signs Registered Safety Signs... 12

Disposal/Recycle... 27

IEC 60417 Graphical symbols for use on equipment... 12

Physiological Alert Conditions... 28

Instructions... 13 Before Use... 13 To Mount the Tourniquet Pump... 13 To Connect Facility Power and Charge Internal Battery... 13 To Turn ON Power... 14 To Set the System Time and Date Values . . . 14 To Set and Save Custom Default Time and/or Pressure Values... 16

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Troubleshooting... 28 Technical Alert Conditions... 29 Error Code Conditions... 30 Electrical Interference Conditions... 31 Specifications... 31 Power Cord Specifications (general)... 33 Power Cord Requirements (specific)... 33 China RoHS Disclosure Report... 33 Electromagnetic Compatibility... 34 Software License Notice... 38

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Introduction

Indications For Use

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 service life of the product.

The Stryker SmartPump Dual Channel Tourniquet Pump System (tourniquet 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:

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.

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A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage.

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A NOTE supplements and/or clarifies procedural information.

Contact Information For additional information, including safety information, inservice training, or current literature, contact your Stryker sales representative or call Stryker customer service at 1-800-253-3210. Outside the US, contact your nearest Stryker subsidiary. NOTE: The user and/or patient should report any serious product-related incident to both the manufacturer and the Competent Authority of the European Member State where the user and/or patient is established.

▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪

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: ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪

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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.

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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Safety Directives WARNINGS:

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Electrical Safety ▪

Take special precautions regarding electromagnetic compatibility (EMC) when using the tourniquet pump and system components. Install and place this medical electrical equipment into service according to the EMC information contained in this manual. Portable and mobile radiofrequency (RF) equipment and high frequency (HF) surgical equipment can affect the function of this medical electrical equipment.

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DO NOT stack or place equipment adjacent to this medical electrical equipment. If such a configuration is necessary, observe the configuration to make sure that electromagnetic interference does not degrade performance and equipment operation is normal. See Electromagnetic Compatibility.

General Safety ▪

Before using this equipment, or any component or accessory compatible with this equipment, read and understand the instructions for use. Pay particular attention to safety information. Become familiar with the equipment before use.

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Equipment is limited to professional healthcare use within a healthcare environment. Healthcare environments include hospital operating rooms, hospital outpatient operating rooms, ambulatory surgical centers, operating theatres, and physician clinics.

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Only healthcare professionals trained and experienced in the use of this medical device should operate this equipment.

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Healthcare professionals shall be thoroughly familiar with the instructions for use, handling characteristics, and the indicated and intended uses of this equipment.

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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 or technique.

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DO NOT use this equipment in areas in which flammable anesthetics or flammable agents are mixed with air, oxygen or nitrous oxide.

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Magnetic Resonance (MR) Safety WARNING: MR UNSAFE - The tourniquet pump is MR unsafe. DO NOT use the system in an MR environment. Operating the system outside the specified environmental conditions could result in death or serious injury.

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System Overview The tourniquet pump system consists of reusable and disposable components. The tourniquet pump, mounting stand, and specific tourniquet cuffs are reusable. Disposable components include fill lines, extension tubing, protective sleeves, adapters, and specific tourniquet cuffs. The tourniquet pump is designed to be mounted on a stand and connected to facility power (Figure 1). The internal battery of the tourniquet pump has a switchover capability to provide an automatic power backup if facility power is lost. The internal battery must be fully charged before use. A real-time clock inside the tourniquet pump, powered by the internal battery, tracks time and date information. The clock does not adjust automatically for daylight savings time changes. The tourniquet pump allows for the connection and control of two tourniquet cuffs. Two separate cuff channel control areas with control buttons allow independent adjustment and setting of pressure and time values for each cuff. The pressure value and elapsed inflation time value of each cuff are displayed and monitored on the information screen. Pressure fluctuations are compensated for by the tourniquet pump and adjusted to the set target pressure value automatically.

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If both facility power and internal battery power are lost, an inflated cuff will remain inflated. The Intravenous Regional Anesthesia (IVRA) control prevents the accidental deflation of an active cuff during a Bier Block procedure and aides in the management of two cuffs during a bilateral procedure. After a procedure is complete, the Default Display (DD) function is used to clear the most recent procedure time and pressure values and reset the tourniquet pump for the next procedure. This function is also used to save new default time and pressure setting values. Mounting Stand

Facility Power

Dual Channel Tourniquet Pump

Speaker

Default Display

Alert Indicator

Internal Battery

Information Screen

Internal Clock

Cuff Channel 1 Controls

Cuff Channel 2 Controls

IVRA Control

Cuff pressure conditions determined to be outside normal operating parameters will trigger an audible (speaker) and visual alert (information screen) requiring action. Tourniquet Cuff 1

Tourniquet Cuff 2

Figure 1 – System Block Diagram

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For Use With WARNINGS: ▪

Use only Stryker-approved electronic components and accessories. Failure to comply may result in degraded performance, increased electromagnetic emissions or decreased electromagnetic immunity of the system. See Electromagnetic Compatibility.

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Use only Stryker-approved components and accessories, unless otherwise specified. Failure to comply may result in injury or equipment incompatibility. DESCRIPTION REF Tourniquet Pump - required Dual Channel Tourniquet Pump 5920-011-000 Mounting Stand - required Rolling Stand with wire basket 5920-013-000 Fill Line(s) - required (applied part) Disposable Fill Line, Single or Set 5920-000-20X series Tourniquet Cuff(s) - required (applied part) Disposable Cuffs 5921-XXX-XXX series Reusable Cuffs 5922-XXX-XXX series Accessories/Replacement Parts Disposable Extension Tubing 5920-000-00X series Disposable Protective Sleeves 5920-000-10X (stockinettes) series Disposable Non-sterile Adapters 5920-000-30X series Power Cord (tourniquet pump) 5920-010-054, 0590-100-002; see Power Cord Specifications (general).

NOTE: ▪

Fill lines, extension tubing, and tourniquet cuffs are considered to be Defibrillation Proof Type BF Applied Parts. See Features and Specifications.

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For a complete list of components, accessories, and replacement parts or ordering and market availability information, contact your Stryker sales representative or customer service. See Contact Information.

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Features Hardware Interface E I J

H

D

K

C

L

G

M N

B A

G

Identification Label Contains the product name and part number.

F

A

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

B

Connector Release When pressed, the release allows for the disconnection of a fill line.

C

E

Air Embolism Hazard Warning and Defibrillation-proof type BF Label (Left/Right)

Pole Clamp Secures the tourniquet pump to the rolling stand. See To Mount the Tourniquet Pump.

J

Tipping Hazard Warning Label See To Mount the Tourniquet Pump.

K

Specification Label Contains the serial number, date of manufacture, and facility power/fuse specifications. See Specifications.

L

Equipotential Grounding Lug Provides for the connection of an equipotential ground. The lug shall not be used as a protective earth connection. See To Connect Facility Power and Charge Internal Battery.

M

Handle Facilitates relocation and height adjustment of the tourniquet pump.

F

I

Button and Indicator Panel The panel contains buttons and indicators that allow the user to interact with the tourniquet pump. See Button and Indicator Panel.

Mounting Knob Turn to install and remove the tourniquet pump from the rolling stand. See To Mount the Tourniquet Pump.

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

D

H

Fuse Receptacle Allows for the installation of fuses. See Specifications and Fuse Replacement.

N

Power Cord Receptacle Allows for the installation of the power cord. See Power Cord Specifications (general).

See To Connect a Cuff. Cuff.

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Button and Indicator Panel

E

Press the button to initiate the EDIT mode and allow editing of the TIME or PRESSURE values for the selected cuff channel. After editing, press the button again to confirm (save) the new values. See To Set and Save Custom Default Time and/or Pressure Values.

G F F E

H I

B

J

A K

A

B

D

H

PRESSURE Control Adjustment Buttons (each cuff channel)

IVRA CONTROL Button Press the button to lock or unlock the control. See To Perform a Bier Block Procedure.

I

ON/OFF (STANDBY) Button Press and release the button to start tourniquet pump operation. Press and hold the button for 1.5 seconds to stop tourniquet pump operation. See To Turn ON Power.

DEFAULT DISPLAY (DD) Button Press the button to clear the most recent procedure time and pressure values and reset the tourniquet pump to the default time and pressure values. Press the button to save new default time and pressure setting values. See To Change the Default Time and/or Target Pressure Values.

ALERT MUTE Indicator/Button Illuminates green to indicate normal operation and flashes red to indicate an alert condition. Press the button to mute the audible alert. See To Adjust the Audible Alert Volume.

INFLATE Button (each cuff channel) Press the button to inflate the cuff of the selected channel to the target pressure. See To Inflate a Cuff.

C

G

DEFLATE Button (each cuff channel) Press and hold the button for 1.5 seconds to deflate the cuff of the selected channel. See To Deflate a Cuff.

TIME Control Adjustment Buttons (each cuff channel) When in the EDIT mode, press the INCREASE or DECREASE buttons to edit 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 one (1) to 15 minute time range, each button press will change the time value by one-minute increments. The numeric time value will change accordingly. See To Set and Save Custom Default Time and/or Pressure Values.

D C

EDIT/CONFIRM Button (each cuff channel)

J

Battery Charge Indicator Displays the charge status of the internal battery. See Battery Charge Indicators.

K

AC Power Indicator Illuminates green to indicate facility AC power is connected to the tourniquet pump. See To Connect Facility Power and Charge Internal Battery.

When in the EDIT mode, press the INCREASE or DECREASE buttons to edit 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. See To Set and Save Custom Default Time and/or Pressure Values.

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Definitions

Information Screen

Information Screen Icons ICON B

NAME Alert

C

Audible Alert Mute A

Battery Charge Status

G

A

F

E

D

PRESSURE Status Area (two channel areas) Displays the real-time, actual pressure value of an inflated cuff in millimeters of mercury and a graphical pressure gauge icon. Also used to indicate a deflation condition and an alert condition.

B

Cuff Deflate

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

C

Battery Power Status

Cuff One Cuff Two Default Display

Alert Mute Status Area Indicates a muted alert condition.

D

IVRA Status Area Indicates the status (locked/unlocked) of the IVRA CONTROL.

E

Battery Charge Status Area Indicates the charge or power status of the internal battery. See Battery Charge Indicators.

F

Default Display (DD) Status Area Indicates default values are displayed and the tourniquet pump is ready for use.

G

Pressure Gauge Over

TIME DATE YEAR / Service CODE Status Area Displays the time, date, and year values. Also used to indicate whether service is required.

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IVRA (Intravenous Regional Anesthesia) CONTROL Locked IVRA CONTROL Unlocked

Pressure Gauge Target

DEFINITION Indicates an alert condition. See Troubleshooting. Indicates an alert condition audible tone is muted. See Troubleshooting. Indicates the internal battery is charging (blinking). See Battery Charge Indicators. Indicates internal battery is in use and fully charged (no blinking). See Specifications. Indicates the selected cuff is either deflating or deflated. See To Deflate a Cuff. Identifies the cuff channel display area. Indicates the time and pressure values are default values. The tourniquet pump is ready for use. Indicates the IVRA CONTROL is locked. Indicates the IVRA CONTROL is unlocked. Indicates the actual pressure value of the selected cuff is greater than the set target pressure value. Indicates the actual pressure value of the selected cuff has reached the set target pressure value.

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ICON

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NAME Pressure Gauge Under

DEFINITION Indicates the actual pressure value of the selected cuff is less than the set target pressure value. Pressure Value Indicates the pressure value of the selected cuff. Service Required Indicates service is required. Record the code number displayed. See Troubleshooting. Time, Date, and Year Indicates the time, Control date, and year values when adjusting the internal clock settings. See To Set the System Time and Date Values. Time Value Indicates the elapsed time value of the selected cuff. Hours and Minutes Indicates the time format of the Minutes selected cuff time values.

Audible Event Indicators TYPE Action Required (errors and alerts)

Button Feedback

DESCRIPTION Continuous, repeat beep, one beep per second Six beeps, one beep per second, followed by a six second pause; then repeated One beep

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TYPE DESCRIPTION Task Three beeps Completion in rapid succession Two beeps in rapid succession

One long beep, about 1.5 seconds

EVENT Confirms cuff has reached target pressure value Confirms change to pressure, time or display default values Confirms change to IVRA CONTROL status, locked or unlock Audio volume setting

Battery Charge Indicators INDICATION Blinking State (orange)

None (no illumination)

Steady State (green)

STATUS Battery is in fast charge mode and may require one hour to reach an 80% charge level. Information screen displays power status. Battery is not charging. Make sure AC power is connected to the tourniquet pump. If AC power is connected, see Troubleshooting. Battery is fully charged, in trickle or slow charge mode. Information screen displays power status.

EVENT Indicates system failure Indicates the cuff pressure value is either high or low Indicates the cuff time value has exceeded its limit

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

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Colors COLOR

WARNING: Air Embolism Hazard Label DEFINITION

IVRA CONTROL Button

Alert Condition (yellow) Cuff One (1) Channel/Fill Line Connector, Battery Fast Charge Mode (orange) Cuff Two (2) Channel/Fill Line Connector (blue) AC Facility Power Indicator (green)

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.

Product Marking(s) Alternating Current (AC) Facility Power Indicator (LED) Audible Alert Indicator/Button Battery Charge Indicator (LED) Intertek ETL certification mark for United States and Canada. These products were tested and meet medical electrical equipment certification requirements. The Dual Channel Smart Pump has been found in compliance to the following product safety standards: IEC 606011-6+A1, IEC 62366+A1, IEC 62366-1, IEC60601-8+A1, IEC 62304+A1, IEC 60601-1-2 (4th Ed.), AIM 7351731, IEC 60601-1:1988+A1+A2, IEC 60601-1-4. Cuff One Channel/Fill Line Connector Identification Cuff Two Channel/Connector Identification Decrease Button (time/pressure) Default Display Button Deflate Cuff Button

BS EN ISO 7010 Graphical Symbols - Safety colors and safety signs - Registered Safety Signs Refer to instruction manual/booklet (M002): indicates the instruction manual/booklet must be read. General warning sign (W001): indicates a general warning.

IEC 60417 Graphical symbols for use on equipment [ON/OFF] Stand-by (5009): identifies the switch by means of which part of the equipment is switched on in order to bring it into the stand-by condition, and identifies the control to shift to or to indicate the state of low power consumption. Fuse (5016): identifies fuse boxes or their location Equipotentiality (5021): identifies the terminals which, when connected together, bring the various parts of an equipment or of a system to the same potential, not necessarily being the earth (ground) potential, for example, for local bonding. For additional information, refer to IEC 60601-1 for medical electrical systems. Defibrillation-proof type BF [body, floating] applied part (5334): indicates a defibrillation-proof type BF part complying with IEC 60601-1. The tourniquet cuff, as a defibrillationproof type BF applied part, can remain on a patient’s limb while the patient is subject to external defibrillation.

Edit/Confirm Button

Increase Button (time/pressure) Inflate Cuff Button

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Instructions Before Use To Mount the Tourniquet Pump

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3. Turn the tourniquet pump’s mounting knob to fasten the tourniquet pump to the post securely. 4. Grasping the handle, loosen the height adjustment knob. Position the tourniquet pump at a height that provides access to the controls and provides a clear view of the display (Figure 3). Tighten the height adjustment knob. See Tipping Hazard Warning.

WARNINGS: ▪

Upon initial receipt and before each use, inspect the equipment for damage. See Inspection and Testing. DO NOT use the equipment if damage is apparent.

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DO NOT use the rolling stand (REF 5920-013-000) with any other equipment, unless otherwise specified.

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TIPPING HAZARD - The arrow must be below the top of the mounting pole after installation (Figure 3).

NOTE: The tourniquet pump is not intended to be used on a tabletop. The tourniquet pump was designed to be mounted on the rolling stand post. 1. Make sure the rolling stand is assembled correctly and the casters are locked. See the instructions for use supplied with the rolling stand. 2. Using the handle, install the tourniquet pump onto the post of the rolling stand (Figure 2).

Figure 3 – To Adjust Tourniquet Pump Height NOTE: The height of the rolling stand post may be adjusted to optimize the final height of the mounted tourniquet pump. See the instructions for use supplied with the rolling stand.

To Connect Facility Power and Charge Internal Battery WARNINGS: ▪

To avoid the risk of electric shock, ALWAYS connect this equipment to a hospital-grade, facility power receptacle with protective earth.

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ALWAYS place the power cord away from personnel traffic areas to eliminate a trip hazard.

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ALWAYS place the power cord away from water or liquids to prevent a shock hazard.

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ALWAYS position the equipment so that the power cord may be easily disconnected as required.

NOTES: ▪ Figure 2 – To Mount the Tourniquet Pump

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The power cord should remain connected to facility power at all times during use. The tourniquet pump’s internal battery is intended to provide electrical energy only if facility power is momentarily lost. Facility power must be restored before the internal battery loses its power. The tourniquet pump should always remain grounded during operation.

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If equipotential grounding is used, connect one end of the bonding cable to the equipotential lug on the tourniquet pump. See Hardware Interface. Connect the other end of the bonding cable to the facility grounding bus bar. The software version number appears 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 this manual.

To Turn ON Power 1. Make sure the tourniquet pump is connected to facility power. 2. Press the ON/OFF (STANDBY) button to turn ON the tourniquet pump (Figure 6).

1. Connect the power cord between the tourniquet pump and facility power (Figure 4).

Figure 6 – To Turn Power ON NOTES: ▪

An audible tone will indicate power is applied. See Audible Event Indicators.

▪

An automatic self-test will check internal systems for proper operation. If an error occurs, a service code will appear on the information screen. Record the code and see Troubleshooting.

To Set the System Time and Date Values To Initiate Setting the Values 1. Make sure the tourniquet pump is ready for use and no cuffs are inflated. Figure 4 – To Connect Tourniquet Pump Power 2. Keep the tourniquet pump connected to facility power for six hours to fully charge the internal battery. Observe BATTERY CHARGE INDICATOR flashes (Figure 5).

2. Press and hold the EDIT/CONFIRM button and the TIME INCREASE button of the cuff one channel simultaneously for four seconds (Figure 7). 3. Release both buttons. Locate the time value (HH:MM, 24-hour format) on the information screen and observe the hour value is blinking.

6h

Figure 5 – To Charge Internal Battery

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To Set the Minute Value 1. Press the TIME INCREASE button or TIME DECREASE button of the cuff one channel to set the minute value (Figure 8).

4s

2. Press the EDIT/CONFIRM button to save the new value. Locate the DATE value (MM.DD format, 12.31 format) on the information screen and observe the month value is blinking. To Set the Month Value 1. Press the TIME INCREASE button or TIME DECREASE button of the cuff one channel to set the month value (Figure 8).

Figure 7 – To Initiate Setting the Values To Set the Hour Value 1. Press the TIME INCREASE button or TIME DECREASE button of the cuff one channel to set the hour value (Figure 8). 2. Press the EDIT/CONFIRM button to save the new value. Observe the minute value is blinking.

2. Press EDIT/CONFIRM button to save the new value. Observe the day value is blinking. To Set the Day Value 1. Press the TIME INCREASE button or TIME DECREASE button of the cuff one channel to set the day value (Figure 8). 2. Press EDIT/CONFIRM button to save the new value. Observe the year value is blinking. To Set the Year Value 1. Press the TIME INCREASE button or TIME DECREASE button of the cuff one channel to set the year value (Figure 8). 2. Press EDIT/CONFIRM button to save the new time and date values. 3. Make sure the DEFAULT DISPLAY (DD) icon appears on the information screen.

Figure 8 – To Set the Time and Date Values

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To Change the Time Display Format (H:MM - MMM) 1. Make sure both cuffs are deflated and each cuff channel is not active. NOTE: The time display format cannot be changed during an active cuff procedure. 2. Press the TIME INCREASE buttons on both cuff channels simultaneously (Figure 9). 3. Observe the current time format (H:MM - MMM) on the information screen changes automatically. NOTE: The time display format will remain constant until the format is changed again.

Figure 10 – To Save Custom Values NOTE: Observe the corresponding time and pressure values blink on the information screen. 2. Press the TIME INCREASE button or TIME DECREASE button 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 one (1) to 15 minute time range. Figure 9 – To Change the Time Display Format

To Set and Save Custom Default Time and/or Pressure Values NOTES: ▪

The factory default time and pressure values may be changed and saved as new custom default values using this procedure.

▪

See the Specifications section for the original factory default values for time and pressure.

3. Press the PRESSURE INCREASE button or PRESSURE DECREASE button to increase or decrease the pressure value, respectively. Observe the pressure value change accordingly. NOTE: Each button press will change the value by 5-mmHg increments for the 100 to 475 mmHg pressure range. 4. After entering the new custom values, press the DEFAULT DISPLAY (DD) button to save the values (Figure 11).

1. Press the EDIT/CONFIRM button to initiate the edit mode (Figure 10).

Figure 11 – To Save Custom Default Values

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NOTES: ▪

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The time and pressure values stop blinking and a double-beep indicates the new custom default values are saved. The DEFAULT DISPLAY (DD) icon will appear on the information screen. If the DEFAULT DISPLAY (DD) button is not pressed within five minutes, the changes will be cancelled.

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To Remove Display of Cuff Two Channel Values NOTES: ▪

The information screen displays the time and pressure values of both cuff channels as a factory default setting.

▪

Cuff two channel values may be removed from the information screen using this procedure. Removal may be helpful if a single cuff procedure is used often.

▪

When the display of values is minimized, only cuff one channel values are present.

To Adjust the Audible Alert Volume 1. While pressing and holding the ALERT MUTE indicator/ button, press the TIME INCREASE button or TIME DECREASE button of the cuff one channel to increase or decrease, respectively (Figure 12). 2. Adjust the audible alert volume to the desired level.

1. Make sure no cuffs are inflated and the tourniquet pump is ready for use.

NOTE: The audible alert volume may be adjusted during tourniquet pump use.

2. Press and hold the ALERT MUTE indicator/button, then press the DEFAULT DISPLAY (DD) button (Figure 13).

Figure 12 – To Adjust Alert Volume

Figure 13 – To Remove Cuff Two Channel Values 3. Make sure the screen values blink on both channels. 4. The tourniquet pump is now ready for use. When cuff one is inflated, only the values on the cuff one channel will appear. See During Use.

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NOTE: To view the default settings of the cuff one channel, press the DEFAULT DISPLAY (DD) button (Figure 14).

During Use WARNINGS: ▪

ALWAYS operate the tourniquet pump within the specified environmental limitation values. See Specifications.

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ALWAYS position the tourniquet pump outside of the sterile field.

▪

ALWAYS monitor pneumatic connections during use, including the cuff(s) and cuff connector(s) with O-ring, the quick-lock connectors, and the fill line(s) and connectors. If leakage or damage is apparent, see Troubleshooting.

To Connect a Cuff Figure 14 – To View Default Settings

To Restore Display of Cuff Two Channel Values

1. Make sure the DEFAULT DISPLAY (DD) icon appears on the information screen. 2. Connect a fill line to the fill line connector on the tourniquet pump (Figure 16).

1. Press and hold the ALERT MUTE indicator/button, then press the DEFAULT DISPLAY (DD) button (Figure 13). 2. Make sure the screen values blink on both channels. 3. The tourniquet pump is now ready for use. When a cuff is inflated, the values on both cuff channels will appear (Figure 15). See During Use.

Figure 16 – To Connect Fill Line Figure 15 – To Restore Cuff Two Channel Values

NOTE: If the time and pressure settings need to be changed, see To Change the Procedure Time and Target Pressure Values. 3. Position the cuff on the patient’s limb.

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WARNING: AIR EMBOLISM HAZARD - Use the tourniquet pump fill line connection to inflate a tourniquet cuff only. NEVER connect the tourniquet pump fill line connection to a patient intravenous (IV) connection. NOTE: An extension tube may be used between the fill line and tourniquet cuff. See For Use With. 4. Connect the cuff to the fill line (Figure 17). 5. The tourniquet pump system is ready for use (Figure 18). Inflate the cuff as required. See To Inflate a Cuff.

Figure 17 – To Connect a Cuff

Figure 18 – Tourniquet System Ready for Use

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To Inflate a Cuff WARNINGS: ▪

Make sure the tourniquet pump is connected to the tourniquet cuff only. NEVER connect the tourniquet pump fill line connection to a patient intravenous (IV) connection.

▪

ALWAYS follow current hospital protocol governing the safe and effective use of a tourniquet system.

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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.

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NEVER turn OFF the tourniquet 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 tourniquet 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 Troubleshooting.

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ALWAYS respond to an alert condition before continuing to use the tourniquet pump. An ALERT symbol, a flashing time or pressure value, or a service code will appear to indicate an alert condition. See Troubleshooting.

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If a tourniquet 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.

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1. Press the INFLATE button to inflate the selected cuff. 2. Observe 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 To Change the Procedure Time and Target Pressure Values as required. NOTE: If a cuff does not reach or maintain the target pressure value during initial inflation, discontinue using the cuff. See To Switch (or Backup) a Single Cuff. 4. When the target elapsed cuff time is reached, perform one of the following options: OPTION 1 - Press the DEFLATE button to deflate the selected cuff. See To Deflate a Cuff. NOTES: ▪

If necessary, you may press the INFLATE button to reinflate the cuff to the highest pressure used during the procedure. The elapsed cuff time will start again and continue to accumulate elapsed cuff time.

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The tourniquet pump will not deflate the cuff automatically when the target time is reached. Press the DEFLATE button to deflate the selected cuff.

OPTION 2 - Press the ALERT MUTE indicator/button to mute the audible alert for 15 minutes. NOTE: The ALERT MUTE indicator/button will remain red and flash. The tourniquet pump will continue to monitor and display the total elapsed time value of cuff inflation. OPTION 3 - Add more time if necessary. See To Change the Procedure Time and Target Pressure Values.

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To Switch (or Backup) a Single Cuff

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Each TIME INCREASE button or TIME DECREASE button press will change the time value by 5-minute increments for the 15 to 240 minute time value range. The value will change by one-minute increments for the one [1] to 15 minute time value range.

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Each PRESSURE INCREASE or DECREASE button press will change the pressure value by 5-mmHg increments for the 100 to 475 mmHg pressure value range.

NOTES: ▪

Use this procedure only if an inflated, active cuff is at risk or an alert condition cannot be resolved and no alternative cuff is available.

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If a cuff channel does not function, you may move the active cuff to a functional cuff channel.

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Use current local hospital protocol when using this procedure.

1. Press the EDIT/CONFIRM button to initiate changing a time or pressure value.

1. Make sure the cuff and all fill line connections are leak-free and secure.

NOTE: Observe the corresponding time and pressure values blinking on the information screen.

2. Use a clamp to close off the fill line of the inflated cuff to retain cuff pressure.

2. Press the TIME INCREASE button or TIME DECREASE button to adjust the time value. Observe the time value change.

3. Disconnect the fill line from the tourniquet pump. 4. Press the DEFLATE button of the inoperative cuff channel to clear the alert condition. 5. Move the clamped fill line cuff to the operative cuff channel and connect the fill line to the tourniquet pump. 6. Press the INFLATE button and release the clamp to allow the tourniquet pump to take control of cuff pressure. NOTE: A momentary pressure alert condition may occur as the tourniquet pump takes control of cuff pressure. 7. Adjust the cuff time and target pressure values as required. See To Change the Procedure Time and Target Pressure Values.

3. Press the PRESSURE INCREASE button or PRESSURE DECREASE button to adjust the pressure value. Observe the pressure value change. 4. When the desired values are selected, press the EDIT/ CONFIRM button to save the new values. NOTES: ▪

The time and pressure values stop blinking on the information screen. A double-beep indicates the new values have been saved.

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If a cuff is not inflated, the DEFAULT DISPLAY icon will appear on the information screen. If a cuff is inflated, the time and pressure values appear as actual, realtime values.

To Change the Procedure Time and Target Pressure Values NOTES: ▪

Time and pressure values may be changed during active cuff inflation.

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Time and pressure values will remain constant unless: (a) the values are changed as described in this procedure, (b) the DEFAULT DISPLAY (DD) button is pressed after deflation or, (c) the tourniquet pump is turned off and turned on again.

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An error beep will occur if the button press sequence is incorrect. For example, an error beep will occur if the TIME INCREASE button or TIME DECREASE button are pressed before pressing the EDIT/CONFIRM button to initiate a change.

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