Smartpump Dual Channel Quick Reference Guide Rev None

Getting Started

Display Screen

Cuff 2

changing Settings

Cuff 1

Default Settings: Inflation Timer: Indicating elapsed time: 50 minutes

Time: 1 hour Pressure: 250 mmHg

Pressure Gauge: Indicating cuff and target pressure

System Ready Indicator IVRA Lock Status: Unlocked

bier block procedure

Active Cuff Pressure 220 mmHg

battery Power

(Time displayed in hours and minutes format)

Battery Charge Indicator

alarms & Service codes

The SmartPump dual channel surgical tourniquet inflation system is designed for use by qualified medical personnel to temporarily impede blood flow in a patient’s extremity. Its dual channel design supports, single cuff, bilateral, & Bier Block procedures and allows for simultaneous surgery of both an upper and lower limb. Each cuff’s unique pressure and time settings are displayed, controlled and monitored independently, in real-time. The system uses single port cuffs.

system backup

The unit’s internal nickel metal hydride (NiMH) backup battery is automatically charged whenever the system is plugged into an AC power outlet. The fully charged internal battery provides up to 5 hours of AC-free operation as a safety backup. The battery is recharged to approximately 80% level within 45 minutes. When the system is “Off” and unplugged it automatically conserves its internal battery for up to 30 days by shifting to a power conservation mode.

usage



Getting Started

Getting Started 1. Turn On

The system’s primary power source is AC power. In addition its internal battery can provide power as a safety backup. See page 5 for details on the unit’s internal backup battery.

On/Off

Press On/Off Standby. The system performs a self-test and calibration. When completed, default Time and Pressure settings are displayed.

2. Change the Time and Pressure Set/Save 1. Press Set/Save on the side requiring change. The corresponding Time and Pressure values will blink. + TIME

–

2. Change the procedure Timer using the increase (+) and decrease (-) buttons. Each press adjusts the time in 5 min. increments (1 min. in the 1 to 15 min. range).

3. Change cuff target Pressure using the the increase (+) and decrease (-) buttons. Each press adjusts the pressure in 5 mmHg increments. + PRESSUE 4. Press Set/Save again to implement the new settings. The display stops blinking, and a double beep confirms that the – new values are enabled.

NOTE: Settings changed using this technique do not change the default settings. To change default settings, see page 4.

3. Inflate the Cuff Inflate Press Inflate on the selected side.

The cuff remains inflated until Deflate is pressed.

4. Deflate the Cuff Deflate Press and hold Deflate for 1.5 seconds to begin deflation. Tourniquet monitor will display total inflated “cuff time”. The deflated cuff icon will appear.

NOTE: To instantly interrupt deflation, press Inflate. Re-inflation commences immediately. The timer is restarted, accumulating additional total elapsed “cuff time”.

CAUTION: Disconnect cuff from fill-line after deflation, remove cuff(s) from limb(s).

5. Prepare for the Next Procedure DEFAULT DISPLAY

Press Default Display after deflation to clear the previous procedures data and return to the default settings. 

Changing Settings When the Target Time is Reached changing Settings

NOTE: The cuff will NOT automatically deflate.

The Alarm Mute button flashes red, the Time setting blinks once per second, and an audible alarm chimes 6 times over 6 seconds. The chime then pauses 6 seconds and repeats. This will continue indefinitely until: (a) Alarm Mute is pressed (b) additional time is added to the timer or (c) the cuff is deflated When Alarm Mute is pressed, the audible chime is silenced for 15 minutes. The Time value will continue to blink once per second. Deflating the cuff stops the Timer. Elapsed Time is cleared when the Default Display is pressed.

Changing the Default Settings Set/Save

1. Press Set/Save on the side requiring change. The corresponding Time and Pressure values will blink.

+ 2. Use the time increase (+) and decrease (-) buttons to change the procedure timer. Time is adjusted in 5 minute TIME – increments (1 minute increments in the 1 to 15 minute range).

+

3. Use the pressure increase (+) and decrease (-) buttons to change the pressure. Pressure is adjusted in PRESSUE 5 mmHg increments. – DEFAULT 4. When the desired values are displayed, press Default Display to store the new values as the new default settings. DISPLAY The display stops blinking, and a double beep confirms the new values have been stored.

Time Display Format Change the Time Display format by pressing both Time (+) buttons simultaneously while the unit is in “Ready” mode,

100 100 60 60 TIME

TIME

TIME

HOURS

HOURS

MINUTES MINUTES

TIME

with both cuffs deflated (not active). It is not possible to change the time format if a procedure is started. If it is currently displaying H:MM (hours & minutes) it will automatically shift to Minutes and vice versa. A Time Display format change remains in effect permanently until changed again.

Changing Display Preferences, Printing & Time/Date Setup Consult the Dual Channel Instructions for Use or the Tourniquet Report Printer Instructions for Use for detailed descriptions and instructions. 

Battery Power Internal Battery The SmartPump’s internal battery automatically provides back-up power if AC battery power is interrupted. The internal battery when fully charged supports up to five hours of operation. If, at initial start-up, the SmartPump is not plugged into AC power, the following occurs: • “No AC” is displayed on the lower left of the LCD • The Alarm Indicator Mute button flashes red. battery Power

Pressing the Alarm Indicator Mute button within 30 seconds of initial start-up will apply power to the SmartPump using its internal battery. In this mode, the Alarm Indicator Mute button will return to green, the “No AC” indicator will remain illuminated and the battery symbol will indicate the amount of battery charge. NOTE: If, at initial start-up, there is no AC present and Alarm Indicator Mute button is not pressed within 30 seconds, the SmartPump will automatically return to its ‘OFF (standby)’ mode automatically. This feature prevents the SmartPump from unintentionally being used in a (back up) battery mode and prevents accidental battery discharge during transport and storage. If AC power is interrupted during normal use, the SmartPump will use its internal battery automatically. Press the Alarm Indicator Mute button to acknowledge the change in power source. The Alarm Indicator Mute button returns to green. When AC power is restored, the SmartPump will return to its normal AC operation automatically. When the SmartPump is unplugged and turned ‘OFF (standby),’ it converses its internal battery automatically using a power conservation mode. If fully charged, the internal battery is kept charged for up to 750 hours.

Low Battery Power Alarms

In “Low Battery” alarm conditions, connect the system to AC power as soon as possible. Should AC power be unavailable and the battery becomes fully discharged, the system will close all valves to maintain cuff pressure. Manual cuff deflation is required. • 30 minutes of battery runtime remaining will trigger an audible alarm; the Alarm Mute button flashes red and the battery “fuel gauge” blinks. The alarm may be muted for 15 minutes. • 15 minutes of battery runtime remaining triggers the alarm sequence (above). Alarm Mute is 1 minute, indicating the battery is “minutes” from full discharge.



Bier Block Procedure Follow your institution’s standard for Bier Block procedures. The Dual Channel will support a Bier Block cuff with its Cuff 1 and Cuff 2 tourniquet controls.

• Use of the IVRA Lock prevents accidental deflation of a cuff (tourniquet).

• To engage the IVRA Lock, press IVRA Lock after the cuff is inflated. The IVRA padlock icon will move to the locked position.

1. Begin the procedure by sequencing the inflation and deflation of the Bier Block cuff bladders according to your institution’s standard practice. Press the IVRA Lock once the cuffs have been inflated. 2. When the procedure is complete, unlock the IVRA Lock to deflate the remaining cuff bladder, or bier block procedure

3. Reduce the cuff bladder pressure in stages. Follow standard Set/Save pressure adjustment steps (page 3). 4. When the incremental deflation sequence is complete, unlock the IVRA Lock and fully deflate the cuff bladder.

NOTE: Press Inflate to instantly interrupt a cuff deflation or to return a cuff to its original higher pressure setting. CAUTION: During a Bier Block or dual cuff procedure, confirm status of the primary cuff (bladder) before initiating a deflation.



Alarms & Service Codes Responding to Alarms When an Alarm event occurs, the following happens: • The Alarm Mute button flashes red. • An audible alarm sounds. • The associated graphic or numeric will flash. • When the target procedure time has been reached, the Time display blinks.

Press Alarm Mute to silence the alarm. The audible Time alarm will remain muted for 15 minutes. Pressure alarms may be muted for 30 seconds or 1 minute depending on their severity. Once the alarm is muted, the audible Alarm indicator is illuminated with a slash. Correcting the condition causing the alarm will automatically clear and reset the alarm system.

alarms & Service codes

Common alarms are typically corrected by: (a) eliminating a leaking pneumatic connection or replacing a leaking cuff (b) adding time to the procedure Timer or (c) connecting to AC power

Service Codes

Service codes are summarized in the Service Code section of the Instructions for Use. When the system detects a condition that requires service, a service code with a wrench is displayed and the unit will alarm. Note the code and call the Stryker Customer Service Department for support and troubleshooting assistance: 800-253-3210.



System Backup Using the System’s Backup Capability Should one side (Cuff 1 or Cuff 2) become inoperable, the user may switch sides and continue operation. The following steps summarize the techniques used to “switch” a cuff from one side of the tourniquet to the other as “backup” when an active cuff is at risk and no alternative system is available. This procedure should be used only when absolutely necessary. Adapt these guidelines as necessary to reflect your institution’s protocols. Always confirm all pneumatic connections and cuffs are leak-free prior to any action. Single Cuff

• During initial inflation (after confirming all connections are secure), if the tourniquet cannot reach or maintain target cuff pressure, discontinue use. • After inflation, if cuff pressure is at risk and/or tourniquet alarms cannot be resolved:

1. Clamp off the inflated cuff’s fill-line and remove it from the unit’s cuff connector. Note: This action will cause the unit to alarm.

2. Press Deflate on the failed side to clear its alarm state.

3. Move the clamped fill-line to the other side and insert it into cuff connector.

4. Press Inflate and release clamp as the system takes control. This action may cause a momentary pressure alarm.

5. Adjust Pressure and Cuff Timer as necessary.

Bier Block Cuff

• During initial inflation, if the primary cuff cannot reach or maintain target cuff pressure (prior to anesthetic injection) discontinue use. • If prior to deflation of the primary cuff (bladder) the second cuff (bladder) cannot reach or maintain target pressure, do the following: 1. Clamp off primary cuff (to retain pressure) and disconnect its fill-line. Note: This action will cause the unit to alarm.

2. Clamp off the second cuff’s fill-line and connect to the primary cuff’s connector.

3. The system will inflate the second cuff to target pressure.

4. After confirming the second cuff (bladder) is at target pressure, the clamped primary cuff may be released.

5. Adjust Pressure and Cuff Timer as necessary.

WARNING: In the unlikely event of a complete unit failure, such as simultaneous loss of AC and battery power, the unit is designed to close and lock its internal valves in order to protect an inflated cuff from unintended deflation. Deflate by manually disconnecting cuff.

system backup



Usage Indications A tourniquet is indicated when it is necessary to reduce blood flow and/or when greater visualization of the operating field is imperative or desired. It is designed to temporarily occlude or decrease blood flow in a patient’s extremities during surgical procedures of those extremities and is not a substitute for proper homeostasis. Typical procedures include: • Arthroscopy • Total wrist joint repair • Finger joint replacement • Bone grafts

• Tendon repair • Knee joint replacement • Nerve repair • Other surgeries of the extremities identified by your institution requiring temporary occlusion of blood flow

Contraindications A tourniquet is not suitable for ligatures or cauterization to stop hemorrhages and should never be applied without consideration of the local anatomy. The Stryker SmartPump dual channel and associated tourniquet is contraindicated for use on the human torso. Tourniquets are contraindicated for use on 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. Current medical literature lists the following as possible contraindications: • Compromised vascular circulation • Mellitus • Post traumatic lengthy reconstruction • Elbow surgery (associated with excessive swelling) • Skin grafts in which bleeding must be readily distinguished.

• Severe scar tissue in cuff zone • Open leg fractures • Severe crushing injuries • Severe hypertension • Presence of sickle cell disease or clotting disorder

All final decisions regarding use of a tourniquet are the responsibility of the attending physician.

Possible Adverse Effects Excessive pressure or prolonged application potentially cause: • Blood vessel trauma • Reperfusion problems and arterial occlusion • Mild, aching pain may develop in the limb • Stiffness, weakness, reactive hyperemia, and skin discoloration • Death, specific to the Bier Block procedure



usage

• Vascular complications • Neuromuscular or neurological injuries • Tourniquet pain • Ischemia • Venous emboli or thromboembolism

Getting Started

Tourniquet Cuffs Getting Started Color Cuff Sterile Disposable Tourniquet Cuffs Color Cuff sterile disposable tourniquets eliminate the risk of cuff-bone cross contamination. Color Cuff combines its low profile, roll resistance and contour compliance to deliver uniform tourniquet pressure. Single & dual port configurations as well as Quick Connect and Luer Lock connectors are available. Color Cuff Cylindrical Tourniquets – Latex Free with 40” tubing

Single Bladder

Single Port

Dual Port

SIZE COLOR

QUICK CONNECT LUER LOCK

QUICK CONNECT LUER LOCK

9” x 1.75”

Light Blue

5921-109-135

5921-109-136

5921-109-235

5921-109-236

9” x 2.75”

Light Blue

5921-209-135

5921-209-136

5921-209-235

5921-209-236

12” x 2”

Purple

5921-112-135

5921-112-136

5921-112-235

5921-112-236

12” x 3.5”

Purple

5921-212-135

5921-212-136

5921-212-235

5921-212-236

15” x 2.5”

Pink

5921-115-135

5921-115-136

5921-115-235

5921-115-236

18” x 3”

Red

5921-018-135

5921-018-136

5921-018-235

5921-018-236

18” x 4”

Red

5921-218-135

5921-218-136

5921-218-235

5921-218-236

24” x 4”

Yellow

5921-024-135

5921-024-136

5921-024-235

5921-024-236

30” x 4”

Royal Blue

5921-030-135

5921-030-136

5921-030-235

5921-030-236

34” x 4”

Purple

5921-034-135

5921-034-136

5921-034-235

5921-034-236

44” x 4”

Navy Blue

5921-044-135

5921-044-136

5921-044-235

5921-044-236

Dual Bladder

Single Port

Dual Port

SIZE COLOR

QUICK CONNECT LUER LOCK

QUICK CONNECT LUER LOCK

18” x 5.5”

Royal Blue

5921-018-145

5921-018-146

5921-018-245

5921-018-246

24” x 5.5”

Navy Blue

5921-024-145

5921-024-146

5921-024-245

5921-024-246

Color Cuff Sterile Disposable Tourniquets are packaged 10/case. 10

The information presented in this brochure is intended to demonstrate the breadth of Stryker product offerings. Always refer to the package insert, product label and/or user instructions before using any Stryker product. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets.

Contact your Stryker representative for more information or a hands-on demonstration. www.stryker.com | 800.253.3210

4100 East Milham Avenue Kalamazoo, MI 49001 USA t: 269-323-7700 f: 800-999-3811 toll free: 800-253-3210

Literature Number: 9100-001-113 Rev None DDM/PS

Products referenced with TM designation are trademarks of Stryker. Products referenced with ® designation are registered trademarks of Stryker.

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