Stryker SmartPump User manual

SmartPump® Tourniquet System

Dual Channel Tourniquet Pump

REF 5920-011-000

Instructions For Use

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

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

ii

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

iii

5 Cleaning and Maintenance 39

Cleaning Recommendations 39
Periodic Maintenance 40
Annual Maintenance Checklist 43

6 Service Code Summary 46

7 Specifications 47

iv

User/Patient Safety

WARNINGS:

This manual explains how to use the Stryker SmartPump
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.

®

tourniquet system. Failure to

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 5

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 6

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.

User/Patient Safety 7

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 8

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 9

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 10

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 11

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.

Alarm Indicator
Mute button

Cuff Control
Buttons

Time and
Pressure
Adjustments

Print Button

Inflate Button
Deflate Button

Cuff 1 Cuff 2
Fill line Fill line
Connector Connector

LCD
Display Screen

Time display:
User Selectable:

Minutes or
Hours and Minutes

Pressure display:
mmHg

IVRA Lock

Default Display
button

Cuff I

Cuff 2

On/Off (standby)
AC and Battery

Indicators

Serial Interface
Port (not shown)

Control Panel and Display 12

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

1. Press the Set/Save button to initiate a change of the

SET/SAVE

+

TIME

-

+

PRESSURE

-

INFLATE

and/or target
blink after the Set/Save button is pressed.

2. Press the Set/Save button again to save new time or pressure
values.

T

IME 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.

P

RESSURE 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.

I

NFLATE

Press 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.

TIME

PRESSURE for the corresponding cuff. The display will

INFLATE button of the corresponding cuff to inflate the

Control Panel and Display 13

DEFLATE

INFLATE

DEFAULT

DISPLAY

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.’

OTE: To interrupt a deflation instantly, press the Inflate button.

N

Re-inflation will commence immediately. The timer is restarted to
accumulate additional elapsed ‘cuff time.’

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.

LARM INDICATOR MUTE BUTTON

A

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 14

Display Screen

Areas of the SmartPump display screen are illustrated below.

Inflation Timer:
Indicating elapsed
time: 50 minutes

(Time displayed in
hours and minutes
format)

Pressure Gauge:
Indicating cuff at
target pressure

Actual Cuff
Pressure

220 mmHg

See Display Indicators.

Active Cuff

Cuff 1

Ready Cuff

Cuff 2

Default Settings:

Time: 1 hour
Pressure: 250 mmHg

System Ready
Indicator

IVRA Lock
Status: Unlocked

Battery Charge
Indicator

Control Panel and Display 15

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.

Control Panel and Display 16

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.

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.

Cuff 2

Roll Stand Pole

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.

Preparing for Use 17