Stryker SmartPump Rx User manual

US Patents 6,051,016; 6,475,228; 6,605,103
Additional US and foreign patents pending Software Version
1.3x
2007/04 5920-011-700 Rev - www.stryker.com
SmartPump®Tourniquet System
Dual Channel Tourniquet Pump
REF 5920-011-000
Instructions For Use

ii
Table of Contents PAGE
User/Patient Safety 5
Indications 5
Contraindications 6
Possible Adverse Effects 6
Precautions for Use 7
Environment and Placement 7
1 Introduction 8
System Overview 8
Features 9
Convenient Preparation 9
Ease of Operation 9
Continuous, Real-time Monitoring 9
Accessory Information* 9
Power Options 10
AC Power 10
Internal Battery 10
Low Battery Power Alarms 11
Maintaining Internal Battery Charge 11
2 Control Panel and Display 12
Control Buttons 13
Display Screen 15
Display Indicators 16
Status Indicators 16
Alarm Indicators 16

iii
3 Preparing for Use 17
Mounting the SmartPump 17
Power Requirements 18
Initial Set-up 18
Default Parameters 19
Procedure Timer 19
Target Pressure 19
Changing Default Time and Pressure Settings 20
4 General Use Procedure 21
Connect the Cuff To Fill Line Connector 21
Turn On the SmartPump 22
Setting Timer and Target Pressure 23
Time Display Format 24
Alarm Volume Adjustment 24
Default Display Viewing Preferences 24
Setting Time and Date 26
Cuff Inflation 28
Intravenous Regional Anesthesia (IVRA) Lock 28
To Inflate a Cuff 28
Cuff Pressure Gauge 29
Monitor Time and Pressure 29
Cuff Deflation 33
Tourniquet Report Printer 34
Bier Block Procedure 35
Responding to Alarms and Service Codes 36
Service Codes 36
Using the SmartPump’s Backup Capability 37

iv
5 Cleaning and Maintenance 39
Cleaning Recommendations 39
Periodic Maintenance 40
Annual Maintenance Checklist 43
6 Service Code Summary 46
7Specifications 47

User/Patient Safety 5
User/Patient Safety
WARNINGS:
This manual explains how to use the Stryker SmartPump®tourniquet system. Failure to
follow the conditions of use set forth below shall absolve Stryker from any responsibility
for the safety, reliability, and performance of this equipment:
♦Federal law restricts the sale of this device. It may be sold only by or on the
order of a physician.
♦Only qualified medical personnel may use the SmartPump.
♦SmartPump users should read the Instructions For Use prior to operation.
♦To reduce the risk of electrical shock, DO NOT open the enclosure. Refer
service to qualified service personnel.
♦Only personnel trained and/or authorized by Stryker may perform adjustments,
modifications, or repairs to this equipment.
♦The SmartPump must be used, maintained and cleaned in accordance with
these Instructions For Use.
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 hemostasis. Typical procedures include:
♦Arthroscopy
♦Tendon repair
♦Total wrist joint repair
♦Knee joint replacement
♦Finger joint replacement
♦Nerve repair
♦Bone grafts
And other surgeries of the extremities identified by your institution
requiring temporary occlusion of blood flow.

User/Patient Safety 6
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 and associated tourniquet cuff is
contraindicated for use on the 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
♦Severe scar tissue in 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
All final decisions regarding use of a tourniquet are the responsibility of
the attending physician.
Possible Adverse Effects
WARNING:Excessive pressure or prolonged application could
potentially cause:
♦Vascular complications
♦Neuromuscular or neurological injuries
♦Tourniquet pain
♦Ischemia
♦Venous emboli or thromboembolism
♦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

User/Patient Safety 7
Precautions for Use
Extreme care must be taken when using tourniquets. Minimum cuff pressure
and application time should be used. Monitor time and pressure throughout the
procedure as injury may occur.
WARNINGS:
•Disconnect the deflated cuff from the fill line connector when a procedure
is completed. Disconnecting a deflated cuff manages potential risks by:
(1) eliminating the risk of injury should a user unintentionally re-inflate a
deflated, unmonitored cuff and (2) providing confirmation that the cuff
deflation sequence has been implemented and completed. Failure to
comply may result in patient injury.
•At the end of a procedure, as soon as the tourniquet pressure is released,
remove the cuff, sleeve and other underlying materials, as the slightest
impedance of venous return may lead to congestion and pooling of blood
in the operative field. Failure to comply may result in patient injury.
Follow guidelines developed by your institution regarding standards of practice
for tourniquet use. Failure to follow instructions could result in possible
medical complications.
Published tourniquet guidelines and training programs developed by the Association of
periOperative Registered Nurses (AORN) provide valuable references and resources to establish
and update guidelines.
The AORN Recommended Practices for Use of The Pneumatic Tourniquet is available online.
Originally published in the AORN Journal and revised in December 1998, it is included in the AORN
2000 Standards, Recommended Practices, and Guidelines.
AORN’s web address is www.aorn.org. The AORN mailing address is 2170 South Parker Rd, Suite
300, Denver, CO 80231.
Environment and Placement
WARNINGS:
♦The SmartPump is designed for use in a non-sterile zone of a surgical operating room. The
SmartPump must be placed outside the patient zone, 6 feet [1.83 m] horizontally 8 feet
[2.5 m] vertically.
♦For optimal use, the SmartPump, including the roll stand with pole, must be positioned and
installed according to the instructions herein.
♦Use only hospital grade line cord connected to a hospital grade grounded receptacle.
♦Ensure power cord is away from personnel traffic and areas of water or liquids.
♦DO NOT place the SmartPump on an unstable cart, stand, or table. Recommend using the
Stryker Roll Stand with pole REF 5920-013-000.
♦DO NOT use this equipment in the presence of a mixture consisting of flammable
anesthetic and air or oxygen or nitrous oxide.

Control Panel and Display 8
1 Introduction
System Overview
The SmartPump is a dual channel
tourniquet pump. It is designed for use
by qualified medical personnel to
temporarily impede blood flow in a
patient’s extremity in order to create a
blood-free surgical zone.
Its dual channel design supports single
cuff, bilateral and 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. The
SmartPump uses single port cuffs.
The built-in serial interface port supports
its optional Stryker Tourniquet Report
Printer and enables Clinical Information
System (CIS) connectivity.
The two channels are identified on
the SmartPump’s display as ‘Cuff 1’
and ’Cuff 2.’ The cuff connection
ports are identified similarly.
Cuff 1 may be referred to as the
‘Main Cuff’ and Cuff 2 as the
‘Second Cuff.’
The SmartPump is shown with the recommended Stryker roll stand and cuff basket. The optional
printer, printer tray and power cord organizer mounted below the basket are also shown.

Control Panel and Display 9
Features
Convenient Preparation
♦The internal battery is charged automatically whenever the SmartPump is plugged into
an AC power source. The internal battery is recharged to approximately 80% level within
one hour.
♦The fully charged internal battery provides five hours of uninterrupted power. However,
internal battery power is a safety feature and is to be used as a back up only. Always
connect the SmartPump to an AC power source for normal operation.
♦Battery ‘saver’ technology keeps the internal battery charged. If the SmartPump is fully
charged, then left ‘OFF(standby)’ and unplugged, the internal battery is kept charged for
up to 30 days.
♦The SmartPump is center mounted to its recommended Stryker roll stand with pole.
♦Fill lines are attached to the positive locking connectors located at the bottom corners of
the SmartPump.
♦At start-up, the SmartPump performs a self-test automatically and tests the pneumatic,
pressure, display, battery, and processor systems. The SmartPump will alert the user via
alarms, indicators and the display of error codes to assist in troubleshooting.
Ease of Operation
♦The procedure timer and cuff target pressure may be set using simple, intuitive steps.
Control buttons are clearly identified.
♦Inflation is initiated by pressing the Inflate button.
♦Deflation is initiated by pressing and holding the Deflate button for 1.5 seconds.
Continuous, Real-time Monitoring
♦The large, bright, backlit LCD display shows total elapsed cuff inflation time and cuff
pressure (mmHg). The displayed time format is user selectable: minutes or hours and
minutes.
♦Audible control alarms and flashing graphical symbols identify conditions requiring
attention.
Accessory Information*
Description REF
Roll Stand with Pole …..…….………………………….…………..5920-013-000
Tubing, Stockinettes, Fill Lines, and Adapters .………………..5920-xxx-xxx Series
Disposable Tourniquet Cuffs ………………………..….…………5921-xxx-xxx Series
Non-sterile Reusable Tourniquet Cuffs…..…………….………..5922-xxx-xxx Series
*Contact your Stryker sales representative for a complete list of accessories.

Control Panel and Display 10
Power Options
AC Power
The Smart Pump’s primary power source is AC power. As a safety
feature, the SmartPump’s internal battery provides an alterative (back
up) power source if AC power is lost.
Always connect the SmartPump to an AC power source for normal
operation.
Internal Battery
The SmartPump’s internal battery automatically provides back-up
power if AC 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.
Pressing the Alarm Indicator Mute button within 30 seconds of initial
start-up will cancel the alarm. 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 the Alarm
Indicator Mute button is not pressed within 30 seconds, the
SmartPump will 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
conserves its internal battery automatically using a power conservation
mode. If fully charged, the internal battery is kept charged for up to
750 hours.

Control Panel and Display 11
Low Battery Power Alarms
If a ‘low battery’ alarm condition occurs, connect the SmartPump to AC
power as soon as possible. If AC power is unavailable and the internal
battery becomes fully discharged, the SmartPump will maintain cuff
pressure. Manual cuff deflation is required.
•If 30 minutes of internal battery operating time remain, the
following will occur: an audible alarm, the Alarm Indicator Mute
button will flash red and the battery charge icon will blink. The
alarm may be muted for 15 minutes.
•If 15 minutes of internal battery operating time remain, an audible
alarm will occur. The alarm may be muted for one minute,
indicating the battery is ‘minutes’ from full discharge.
Maintaining Internal Battery Charge
When the SmartPump is plugged into AC power, its internal battery is
charging automatically.
The SmartPump control panel indicates battery-charging status as
follows:
Battery Charging Symbol: The segments of this symbol illuminates sequentially
and repetitively while the internal battery is being charged. This occurs when the
SmartPump is connected to an AC power source. Once the internal battery is
fully charged, all of the segments are lit.
Battery Power Symbol: The segments of the battery power symbol are lit to
indicate the level of battery charge during internal battery operation. For
example, three segments lit indicate a charge level of approximately 80%.
AC Power LED Indicator: Illuminated green whenever AC power is applied to the
unit.
Battery Charge LED Indicator: Indicates battery charge status. The indicator
operates when connected to AC power and the SmartPump is on or off.
♦Green (steady): internal battery is fully charged, in trickle or slow charge
mode.
♦Yellow (blink): internal battery is in fast charge mode and may require one
hour to reach an 80% charge level.
♦No Light: internal battery is not charging; AC power may not be present. if
AC power is present, there may be battery charge circuit failure or internal
battery failure.

Control Panel and Display 12
2 Control Panel and Display
This section reviews the SmartPump’s interfaces, control panel layout,
display screen functions, and icons.
The control panel is the user’s interface to control, adjust, and set the
following: Procedure Timer and Cuff Pressure, Inflation, Deflation, and
Default Display. Cuff pressure and elapsed cuff time are displayed in
real-time.
LCD
Display Screen
Time display:
User Selectable:
Minutes or
Hours and Minutes
Pressure display:
mmHg
IVRA Lock
Alarm Indicator
Mute button
Default Display
button
On/Off (standby)
AC and Battery
Indicators
Cuff 1 Cuff 2
Fill line Fill line
Connector Connector
Serial Interface
Port (not shown)
Cuff Control
Buttons
Inflate Button
Deflate Button
Time and
Pressure
Adjustments
Print Button
Cuff I Cuff 2

Control Panel and Display 13
Control Buttons
Button Explanation
♦Turn ON by pressing, then releasing the ON/OFF (standby)
button.
♦Turn OFF by pressing and holding the ON/OFF (standby)
button for 1.5 seconds (safety pause).
WARNING: Turning OFF the SmartPump while cuffs are inflated
will deflate the cuffs and total elapsed time information will be
lost.
SET/SAVE
SET/SAVE
1. Press the Set/Save button to initiate a change of the TIME
and/or target PRESSURE for the corresponding cuff. The display will
blink after the Set/Save button is pressed.
2. Press the Set/Save button again to save new time or pressure
values.
+
TIME
-
TIME Increase/Decrease (located above the Set/Save button)
After pressing the Set/Save button, press these buttons to
increase (+) or decrease (-) the inflation time for the selected
cuff. Each button press changes the time value in 5-minute
increments (1-minute increments within the 1 to 15 minute time
range). The numeric display changes accordingly.
+
PRESSURE
-
PRESSURE Increase/Decrease (located below the Set/Save button)
After pressing Set/Save button, press these buttons to increase
(+) or decrease (-) the inflation pressure for the selected cuff.
Each button press changes the pressure value in 5 mmHg
increments. The numeric display changes accordingly.
INFLATE
INFLATE
Press the INFLATE button of the corresponding cuff to inflate the
cuff to its target pressure. If a cuff is deflated during a procedure,
press the Inflate button to return to the set pressure. The Timer
stops during the period of a deflation and resumes accumulating
total ‘cuff time’ upon reinflation.

Control Panel and Display 14
DEFLATE
INFLATE
Press and hold the Deflate button for 1.5 seconds (safety pause)
to initiate deflation. When deflation begins and after it is
completed, the Deflation icon appears next to the cuff pressure
gauge.
The tourniquet time monitor will stop accumulating time and
display the total inflated ‘cuff time.’
NOTE:To interrupt a deflation instantly, press the Inflate button.
Re-inflation will commence immediately. The timer is restarted to
accumulate additional elapsed ‘cuff time.’
DEFAULT
DISPLAY
At the end of a procedure and after deflation has occurred, press
the Default Display button to clear and reset the SmartPump to its
default time and pressure settings.
The Default Display button is also used to set new default time
and pressure settings for preferred practice settings. See
Changing Default Time and Pressure Settings.
ALARM INDICATOR MUTE BUTTON
Indicator button illuminates green when the SmartPump is
operating normally.
Indicator button flashes red when the SmartPump is in an alarm
condition. Press the Alarm Indicator Mute button to mute the
audible alarm. Correct the alarm condition to restore the indicator
button to green.

Control Panel and Display 15
Display Screen
Areas of the SmartPump display screen are illustrated below.
See Display Indicators.
Battery Charge
Indicator
Actual Cuff
Pressure
220 mmHg
Pressure Gauge:
Indicating cuff at
target pressure
System Ready
Indicator
IVRA Lock
Status: Unlocked
Inflation Timer:
Indicating elapsed
time: 50 minutes
(Time displayed in
hours and minutes
format)
Active Cuff
Cuff 1
Ready Cuff
Cuff 2
Default Settings:
Time: 1 hour
Pressure: 250 mmHg

Control Panel and Display 16
Display Indicators
Status Indicators
Default Display: Illuminated when the time and pressure are set for
the default target values.
Ready: All components are functioning normally and the unit is ready
to use.
Battery Charge Status: Indicates if battery is charging (bars light
sequentially) or battery charge level (when running from battery).
IVRA Lock: Indicates whether IVRA is locked or unlocked. This control
provides accidental cuff/bladder deflation protection.
H: MM or MINUTES: Indicates time format in use.
Deflation: Indicates corresponding cuff is deflating or deflated.
Alarm Indicators
Service Required: When the SmartPump detects a condition that
requires service, a service code with a wrench is displayed on the LCD
and an audible alarm will occur. Note the code and call Stryker for
assistance: 1-800-253-3210.
Caution: When an alarm is detected, the ‘Alert’ triangle is displayed,
and either the time or pressure value will blink. DO NOT proceed until
the alarm condition is resolved. Failure to comply may result in patient
injury.
Audible Alarm: Indicates when the SmartPump is in an alarm
condition and the audible alarm has been triggered.
Alarm Muted: Indicates when the SmartPump is in an alarm condition
and the audible alarm has been muted.

Preparing for Use 17
3 Preparing for Use
Mounting the SmartPump
WARNING: Ensure the SmartPump is mounted on the roll stand pole
securely. Failure to comply may result in user/patient injury.
1. Assemble roll stand. See instructions for use supplied with roll
stand.
2. Gently lower the SmartPump onto the roll stand pole. Adjust the
height of the SmartPump using the adjustment knob to facilitate
access to the display and controls.
3. Tighten the knob to secure the SmartPump to the roll stand pole.
Roll Stand Pole
Cuff 2

Preparing for Use 18
Power Requirements
The hospital-grade power cord shipped with the SmartPump is UL
listed and configured for North American power sources. The
SmartPump is configured for use with 120V, 10A, 60 Hz AC power.
Initial Set-up
The SmartPump is shipped with a fully charged battery, which provides
a safety back up power source.
1. Mount the SmartPump onto the roll stand with pole.
WARNING: DO NOT connect any other electrical device into the
power receptacle of the power cord organizer, except the SmartPump
and Tourniquet Report Printer. Failure to comply may result in
user/patient injury.
2. Connect the power cord between the SmartPump and the power
cord organizer with power receptacle or a hospital-grade AC
receptacle.
Press and release the ON/OFF (standby) button to initiate system
power on and self-test. The self-test checks the pneumatic system,
pressure, display, battery, and processors. Self-test errors are reported
via service codes on the LCD display. See Service Code Summary
section.
Upon successful completion of the system self-test, including battery
charge level voltage test, the Ready indicator appears in the center of
the display.
The Battery Charging indicator on the bottom right corner of the front
enclosure indicates battery charge status. The system automatically
begins charging the battery whenever it is connected to AC power.
The Battery Charge indicator segments on the lower right of the LCD
illuminate sequentially when the battery is charging.
If the battery is not charged adequately, the alarm sounds and the
Battery charge icon indicates low charge level.
Press and hold the ON/OFF (standby) button for 1.5 seconds to turn
the unit off. Allow more charging time.
NOTE: The NiMH battery will attain approximately 80% of its rated capacity
within one hour of charging.

Preparing for Use 19
Default Parameters
SmartPump factory preset default time and pressure settings are:
1. Elapsed Procedure Time: One hour
(Displayed as: 1:00)
2. Target Cuff Pressure: 250 mmHg
(Displayed as: 250)
Procedure Timer
The timer display shows elapsed procedure time.
The timer may be set to the desired cuff inflation time from a minimum
of one minute. Timer adjustment may be made in one-minute
increments from 1 to 15 minutes, and five minute increments from 15
to 240 minutes.
The Cuff time alarm is preset at the factory for one hour. This means
that, if unchanged, the time setting for the Cuff is one hour. The
Timer’s alert will sound, the Alarm Indicator Mute button will flash red
and the corresponding time display will flash when the preset total
elapsed inflated cuff time has been reached.
NOTE: The SmartPump does NOT automatically deflate the cuff when
the target time is reached. It maintains inflation until the Deflate button
is pressed or the SmartPump is turned off.
Target Pressure
The default target pressure is preset to 250 mmHg at the factory. The
default pressure may be adjusted and set between an operating range
of 100 to 475 mmHg, in 5 mmHg increments.

Preparing for Use 20
Changing Default Time and Pressure Settings
To change the Default Time and/or Target Pressure:
1. If the unit is turned off, press the ON/OFF (standby) button to
turn it on. Following self-test, it will enter the ‘Ready’ state.
2. Press the Set/Save button on the side requiring change.
The corresponding time and pressure values will blink.
3. To change the default time, use the increase (+) or decrease (-) buttons. Each press adjusts the time in 5-minute increments
(one-minute increments in the 1 to 15 minute time range). The
numeric time display changes accordingly.
4. To change the default pressure, use the increase (+) or decrease (-) buttons. Each press adjusts the pressure in 5
mmHg increments, numeric pressure values change accordingly.
5. When the desired values are displayed, press the Default
Display button to store the new values as the new default
settings. The display stops blinking and the double-beep
indicates the new values have been stored.
The Ready indicator reappears in the center of the display.
The Default Display indicator appears near the bottom of the display
indicating that the default settings are being used.
NOTE:If the Default Display button is not pressed within five minutes
of starting the adjustment process, the Set Mode is cancelled without
changing the settings.