UAP-7 Analog Pelvic Floor Pump User Manual Ver 2.0 March 2005

LABORIE MEDICAL TECHNOLOGIES

UAP-7 User Manual

Table of Contents 1

INTRODUCTION ... 4

2

WARNINGS AND PRECAUTIONS ... 5 2.1 2.2 2.3 2.4 2.5

WARNINGS ... 5 CAUTIONS ... 5 INTENDED USE ... 5 TARGET POPULATION ... 6 CONTRAINDICATIONS ... 6

3

UNPACKING ... 7

4

CONNECTING AND POWERING ON THE PUMP ... 9 4.1 4.2

CONNECTING THE PUMP ... 9 POWERING ON THE PUMP ... 9

5

MOUNTING AND REMOVING THE PUMP HEAD ... 11

6

SETTING UP THE PUMP TUBING ... 12

7

PUMP MENU ITEMS ... 14 7.1 CONFIGURE PUMP... 15 7.1.1 Auto Pump Option ... 16 7.1.2 Auto Pump Event ... 16 7.1.3 Pump Speeds... 16 7.1.4 Configuring the Control Panel to Control the Pump ... 17 7.1.5 The Pressure/Volume Limit ... 18 7.1.6 Volume Warning Limit ... 18 7.2 CALIBRATING THE PUMP ... 19 7.3 PRIMING THE PUMP ... 21 7.4 SLOW FILL... 21 7.5 MEDIUM FILL ... 21 7.6 FAST FILL ... 21 7.7 STOP PUMP ... 21

8

CONTROLLING THE PUMP... 22 8.1 8.2 8.3

9

STARTING THE PUMP ... 22 STOPPING THE PUMP ... 22 STOPPING THE TEST AND THE PUMP SIMULTANEOUSLY ... 22

CLEANING AND MAINTENANCE ... 23 9.1

PHOTO SENSOR SAFETY FEATURE ... 24

10

RECOMMENDED SPEED RANGES WITH CATHETERS AND TUBING ... 25

11

TROUBLESHOOTING GUIDE... 26

12

TECHNICAL SPECIFICATIONS... 28 Page 2 of 30

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13

UAP-7 User Manual

SYMBOLS USED... 29

Copyright © 2005 by LABORIE MEDICAL TECHNOLOGIES

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1 Introduction The UAP-7 Analog Pelvic Floor Pump is intended for use with a Laborie Urodynamic Analyzer to deliver saline or radio-opaque contrast into the bladder for urodynamic procedures. This device can also be used to fill a rectal balloon that is inserted inside the rectum during Anorectal-manometry studies. Urodynamics is used to verify or disprove patient symptoms via scientific methodology. It is a prerequisite for the user of this equipment to understand the basic measuring principles and techniques of urodynamic analysis.

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2 Warnings and Precautions 2.1 Warnings 1.

Read the instruction manual provided with the UAP-7 Analog Pelvic Floor Pump before using the device.

2.

DO NOT USE in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

EXPLOSION HAZARD 3.

Do not use the UAP-7 Analog Pelvic Floor Pump in the same room as an operating magnetic resonance imaging device (MRI.) The strong magnetic field produced during MRI may cause disruption of the system.

4.

Use single use disposable tubing and catheters designed for urodynamic measurements. Do not reuse disposable equipment. Note: Pump accuracy is not guaranteed if the Pump head tubing is used more than once.

5.

Only use the UAP-7 Analog Pelvic Floor Pump with the LABORIE MEDICAL TECHNOLOGIES Urodynamic system.

6.

LABORIE equipment is licensed by Governments and Safety Agencies to work with LABORIE accessories ONLY.

7.

LABORIE equipment is warranted to work with LABORIE accessories ONLY.

8.

LABORIE accessories are warranted to work with LABORIE equipment ONLY.

2.2 Cautions UNITED STATES FEDERAL LAW RESTRICTS THIS DEVICE TO SALE OR USE BY OR ON THE ORDER OF A LICENSED PHYSICIAN.

2.3 Intended Use The Pump is intended to infuse saline or a radio-opaque contrast, into the bladder or rectum (in a catheter) for urodynamic or anorectal-manometry procedures. Page 5 of 30

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2.4 Target Population The main application of urodynamics is the diagnosis of uncontrolled loss of urine (incontinence), abnormal urinary retention, or neurological causes of micturition disorders.

2.5 Contraindications The UAP-7 Analog Pelvic Floor Pump is contraindicated for any patient who is not a candidate for urodynamic testing. Catheters should not be used on patients who suffer from: • •

Bladder infections Strictures in the urethra

All catheters provided by Laborie Medical Technologies are sterile. Printed in Canada. No reproduction permitted without the prior written permission of the company.

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3 Unpacking Before setting up the UAP-7 Analog Pelvic Floor Pump, please verify that all ordered equipment and accessories have been received. Please contact LABORIE MEDICAL TECHNOGLIES should there be any discrepancies between ordered and received equipment. Inspect the equipment for any visible signs of damage or mishandling. Notify the carrier immediately if damage has been found.

Standard Equipment Component

Part Number

1 - Pump 1 - Pump Head 1 - Pump Instruction Manual 1 - Pump Cable 5 - Pump Tubing Set 1 - Pump Stand with 5 Castor Base

UAP-7 UAP-7H UAP7-IM UDP-5H UAP-5S

Power indicator Light

Power Switch

Tubing Priming Button

Pump Head

Figure 1A: UAP-7 Analog Pelvic Floor Pump

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Figure 1B: The Pelvic Floor Pump (back view) (Stand-alone model)

Figure 2: Pump Stand

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4 Connecting and Powering On the Pump Before using the UAP-7 Analog Pelvic Floor Pump, it must be properly connected and calibrated.

4.1 Connecting the Pump 1. Connect the metal connector of the pump cable to the 9-pin connector (DB9) on the back panel of the pump. (Refer to Fig 1B). 2. Connect the green end of the pump interface cable to the port labeled PUMP/BUBBLE on your Laborie Urodynamic System. Response: The pump is connected and ready to be powered on.

4.2 Powering On the Pump 1. Flip the power switch from the down “OFF” position to the up “On” position. 2. Power on your Laborie Urodynamic System. 3. If the pump has never been used on your particular system, a pump calibration must be performed. (The pump was calibrated with the standard tubing UDP-5H before is was shipped.) 4. Select the cystometry test that you require. Note: Choose a pre-configured test or configure your own test. Verify that the procedure is setup to use the pump. For additional information on selecting a test, please refer to the software sections of the urodynamic system instruction manual. Important: The test you select should include the following channels: • • •

IH20 VH20 A pressure channel (Pves)

5. Set up the tubing. For additional information on setting up the tubing, refer to the chapter, Setting up the Pump Tubing. 6. Verify that the selected test is configured to run the pump and that the necessary transducers are plugged into the UDS system (Uroflow Volume, Flow, Pves, Pabd, etc.) and calibrated.

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NOTE: In addition to the two month regular calibration schedule, a pump calibration must be completed for the following situations: • • • •

the UDS system has not previously been used with a UAP-7 pump the UAP-7 is replacing an older pump model on the same UDS system the UDP-5T tubing has been replaced after each change of a different size catheter

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5 Mounting and Removing the Pump Head To mount the pump head: 1. To mount the pump head onto the drive unit, align the drive coupling to the slot in the pump head. Align the pump head with the notches in the mounting plate and twist the pump head clockwise to snap it into place.

To remove the pump head: 1. To remove the pump head, push in the release lever and twist the pump head anti-clockwise while pulling out the pump head.

Fig 3: Pump Head Removal

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6 Setting Up the Pump Tubing Caution: Only Laborie approved tubing can be used with the UAP-7 pump. Any other tubing may be incompatible with the pump and may cause damage to the unit. Refer to Figure 1 to become familiar with the parts of the pump. To set up the tubing: 1. Stop the pump using the software program and switch off the pump before setting up and changing the pump tubing. 2. Unpack the pump tubing set and a urodynamic catheter. 3. Open the pump head by flipping up the pump head lever. (Refer to Figure 4A.) 4. Insert the pump head tubing in the pump head. 5. Flip the pump head lever down to close the pump head. (Refer to Figure 4B.) 6. Secure the pump head tubing by adjusting the tube clamps on both sides of the pump head. The tube clamp on the left side of the pump (tubing from the I.V. bag) should be set at 4.8 mm for Laborie approved pump head tubing. The tube clamp on the right side of the pump (tubing to catheter) should be set at a higher number than 4.8mm in order to accommodate a larger size tubing. (Refer to Figure 4C.) Note: Ensure that the tubing is seated correctly and it is not twisted or pinched by the tube clamp. 7. Connect the male luer lock end of the 3-way stopcock to the filling port of a urodynamic catheter. Note: Refer to your specific urodynamic system instruction manual for additional information on setting up a pressure transducer. 8. Insert the administration set spike into the infusion bag. 9. Switch on the pump. Response: The pump is ready to be used.

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Flow Direction

Flow Direction

Figure 4A: Pump Head Lever Open

Figure 4B: Pump Head Lever Closed

Pump Head Lever

Tubing Size Ranges

Size Selector Dial

Tubing Size Indicator Arrow

Figure 4C: Pump Head Tubing Retainers

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7 Pump Menu Items The pump is controlled by the Laborie Urodynamic processor and software. The pump menu can be found on the UDS Client screen. Clicking on the Pump menu drops down the following menu items: • • • • • • •

Configure Pump Pump Calibrate Prime Pump Slow Fill Medium Fill Fast Fill Stop Pump

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7.1 Configure Pump To configure the Pump: 1. Click Pump from the menu bar. 2. Select Configure Pump. Response: The Configure Pump dialog box appears. (Refer to Figure 5.)

5 1 6

2

7

Pressure Limit: Do not exceed the volume of 150 cm H20. Volume Limit: Do not exceed the volume of 750 ml.

3 4

8

Figure 5: Configure Pump Dialog Box Number

Feature

Function

1 2 3

Pump Mode Bubble Detector Auto Pump Option

4

Auto Pump Event

5 6 7

Volume/Pressure Channel Flow rate speeds Pressure/Volume Limit

8

Volume Warning Limit

Infuses at a constant pre-set flow rate N/A The option to run the pump at the selected pump speed at the start of the test. Records events automatically when the pump runs or stops. Specifies the channel used for feedback information Determines the speed of the flow rate settings Pressure Limit: Stop the pump if the pressure channel exceeds this limit. Volume Limit: Stop the pump if the volume channel exceeds this limit. Indicates a warning when the pump infuses the minimal acceptable total bladder capacity (MATBC). Used for Pediatrics only.

The following sections in this chapter explain each feature in detail.

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7.1.1 Auto Pump Option The Auto Pump Option starts the pump automatically when the procedure is running. To change the Auto pump option: 1. Click on the Auto Pump Option combo box. 2. Select the speed you want the pump to run. Choose Stop if you don’t want to use this option. 3. Click OK. Response: The Configure Pump dialog box closes. 4. Click the Run button when you are ready to start the test. Response: The test and the pump start at the same time.

7.1.2 Auto Pump Event The Auto Pump Event feature automatically marks a change in pump status as an event. Example: When the pump is started or stopped, the change appears on the test as an event. This feature is turned on by default. To turn off the Auto Pump Event: 1. Click in the Auto Pump Event check box. Response: The test will not indicate a change in pump status.

7.1.3 Pump Speeds The default pump speed rates are: Slow Medium Fast Prime

25 ml/min 50 ml/min 100 ml/min *150 ml/min

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To change the rate of the pump speeds, refer to the following table: To change the… Slow speed: Medium speed: Fast speed: Prime speed:

Click in the… Slow check box and enter the speed you want the rate to be Medium check box and enter the speed you want the rate to be Fast check box and enter the speed you want the rate to be Prime check box and enter the speed you want the rate to be

* Caution: Laborie Medical Technologies strongly recommends that the range of speed to be used in pediatric mode is 1 - 40 ml/min.

7.1.4 Configuring the Control Panel to Control the Pump You can configure the control panel buttons of your UDS software to control the pump. To set the control panel buttons to control the pump speed, speed increment, and prime the pump tubing: 1. Click Options from the menu bar. 2. Select Control Panel Definition. Response: The Command box appears. 3. Follow the example below. In the Label column, type:

In the Definition column, type:

*Slow *Medium *Fast *Prime *Speed *Increase *Decrease

sf mf ff pp Sp=100 Sp+25 (means increase speed by 25) Sp-30 (means decrease speed by 30)

In the third column, change the status of the function button by scrolling down to: Pump Command Pump Command Pump Command Pump Command Pump Command Pump Command Pump Command

* Note: These label names and values are merely examples. You can enter any label name in the label column or numerical value in the definition column.

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7.1.5 The Pressure/Volume Limit The Pressure Limit and Volume Limit stops the pump when the channel limits are exceeded. The default values for these limits are: Pressure Limit Volume Limit

200 cm H20 750 ml

** Laborie Medical Technologies does not recommend changing these values unless there is a need for it. One example would be for pediatric patients. To change these default values: 1. Click in the Pressure/Volume Limit check box. 2. Enter the new value. Response: The limit is changed. Warning! For safety reasons, do not exceed: • •

Pressure of 200 H2O Volume of 750 ml

7.1.6 Volume Warning Limit The Volume Warning Limit is used in the pediatric “Uro Mode” which applies to patients under 16 years of age. This limit is the maximum amount of fluid that can be infused into the patient. The Volume Warning Limit is determined by Minimal Acceptable Total Bladder Capacity (MATBC.) MATBC = 16 * (age) + 70 ml. The pump receives the information to calculate the MATBC from the data entered in the Patient Information dialog box. If the infused volume exceeds the limit specified in the Volume Warning Limit box, a message appears. Important: After the warning appears, the pump does not stop automatically. It must be stopped manually.

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Note: The MATBC is calculated automatically and cannot be changed.

7.2 Calibrating the Pump The UAP-7 pump is initially calibrated at the factory before it is shipped out. It is recommended that when you first receive your pump, you perform calibration with the type of tubing and catheter you plan to use during studies. If different sizes of catheters are to be used, perform a calibration after each change of catheter size. Laborie Medical Technologies recommends that pump calibration be verified at least every 2 months or whenever the user feels that flow measurements might be inaccurate or whenever a different size or type of catheter is used. Note: Calibration should be performed only if readings are off or if the user changes the type or size of catheter used in a procedure. Warning: Tubing is single use only and must be discarded after each procedure.

To calibrate the pump: 1. Verify that the pump tubing is properly connected to the fluid source and the catheter. Ensure that the catheter is placed in an empty beaker that has been placed on the uroflow transducer. 2. Close the UDS Client window. In the UDS Server window, click Options. 3. Choose Transducer Calibration. Response: The Transducer Calibration window appears. 4. Select Pump in the Transducer Calibration window. Note: The slow rate, fast rate, beaker volume and fluid density values are preset. If you are using saline with a radio-opaque contrast, please consult the supplier for the correct fluid density value. For further information, contact your local Laborie Medical Technologies representative. If you are using very low pump flow rates (2 to 9 ml/min) for slow speeds: Use a larger beaker volume to make calibration more accurate (i.e 300 ml) for the lower speed range. 5. Press Apply. Response: A message appears saying, “Please ensure that the tubing is connected to a fluid source and catheter. Prime the tubing now?”

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6. Click NO (cancel). Warning: Do not prime the pump using the “software” priming option. Refer to the section, Priming the Pump for details. Note: If you realize that you have made a mistake in the calibration procedure (ie: the uroflow transducer is bumped into or the catheter falls out of the beaker) click Abort and begin the calibration again. 7. When the calibration is complete, one of two messages will appear: If message says… Calibration is complete Calibration change is greater than XXX%

Then… Click OK. Repeat calibration process

When the calibration of the Pump is finished, select Exit in the calibration menu window. The unit will then download the settings. Potential Calibration Error Messages: If the message reads… “Please ensure that the tubing is connected to a fluid source and catheter.”

“Volume not changed, infusion bag may be empty or uroflow transducer not present.” “Calibration failed! Replace tubing.”

Then make sure that the… • Tubing is primed • Tubing is properly connected • Catheter is sitting on an empty beaker which is sitting on the uroflow transducer • Catheter is sitting on an empty beaker which is sitting on the uroflow transducer which is connected to the UDS equipment • Tubing is properly connected • Tubing is not being reused

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