Models SA0972AW & SA0972AC Uroflow Transducer Operators Manual Rev A

Table of Contents Introduction ... 3 General Description ... 3 Formatting Conventions Used in this Manual... 3 Contact Information... 3 Precautions ... 4 Illustrations in this Manual ... 4 Safety... 4 Environment... 5 Environmental Protection... 5 Service ... 6 Meaning of Symbols ... 6 Specifications... 7 Interface Cables... 7 Unpacking the Components ... 8 Overview of Uroflow Transducer Components... 8 Installation and System Interface... 9 Connecting the SA0972AC Uroflow Transducer to the M30/M30P Urodynamic Module ... 9 Disconnecting the SA0972AC Uroflow Transducer from the M30/M30P Urodynamic Module... 10 Connecting the SA0972AW Uroflow Transducer to a Patient Unit... 11 Disconnecting the SA0972AW Uroflow Transducer from a Patient Unit ... 12 Using the Uroflow Transducer... 13 Preparation ... 13 Operation ... 13 Maintenance and Repair... 14 Product Return Information... 15 Uroflow Transducer Troubleshooting Guide... 16 Maintenance of the Uroflow Transducer... 16 Cleaning & Disinfection... 17 Declaration of Conformity ... 19 Index ... 21

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Table of Figures Figure 1 – Uroflow Transducer Components ... 8 Figure 2 – Connect the SA0972AC Uroflow Transducer(s) to the M30/M30P Urodynamic Module ... 9 Figure 3 – Connecting a Circular Plug ... 10 Figure 4 – Disconnecting a Circular Plug ... 10 Figure 5 – Connect the SA0972AW Uroflow Transducer(s) to a Patient Unit... 11 Figure 6 – Preparing the Uroflow Transducer for Use ... 13 Figure 7 – Cleaning & Disinfection of the Uroflow Transducer ... 18

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Introduction General Description

The Model SA0972AW and SA0972AC Uroflow Transducers measure the weight increase as fluid enters a graduated beaker placed on top of the transducer. The Uroflow Transducer is calibrated to produce an output that is proportional to the change in volume. The unit does not incorporate a display of the signal output. Rather, the signal output is displayed on a digital channel of the recording device to which the transducer is connected.

Please read this manual and follow its instructions carefully. Throughout the manual, Formatting Conventions you will see paragraphs with the following headings: Used in this WARNING Manual CAUTION

 NOTE Carefully review the paragraph associated with any of these headings to ensure the safe and effective operation of this product. WARNING: A WARNING indicates that the personal safety of the patient or equipment operator may be involved. Disregarding a WARNING could result in injury to the patient or operator of the equipment. CAUTION: A CAUTION indicates that particular service procedures or precautions must be followed to avoid possible damage to the product.

 NOTE: A NOTE indicates special information to improve the ease of maintaining or using the product, or to clarify important information.

Contact Information

Mailing Address: ...Life-Tech, Inc. ...PO Box 1849 ...Stafford, Texas 77497-1849 ...United States of America Telephone...(281) 491-6600 or (800) 231-9841 FAX: Administrative / Financial...(281) 491-6646 Sales / Customer Service ...(281) 491-7197 Technical and Clinical Support ...(281) 491-6852 International Sales...(281) 491-6852 Internet...http://www.life-tech.com

The Life-Tech representative for the European Community is: FBI Fred Berninger Importe Bergstrasse 12 82024 Taufkirchen, GERMANY Tel: +49 89 61 453 453 Fax: +49 89 61 453 455 Email: [email protected]

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Introduction, Continued Precautions

WARNING: Read this instruction manual thoroughly and be familiar with its contents prior to using this equipment. Read the entire instruction manual before assembling or connecting the equipment. Take special care to follow the warnings shown on the Uroflow Transducer itself, as well as any safety suggestions in this manual. CAUTION: Previous generations of Life-Tech Uroflow Transducers required removal of the transducer (top) platter for cleaning and storage. This new model of transducer does not require this practice. DO NOT remove the transducer platter by pulling it off, as you will damage the transducer and void its warranty.

Illustrations in this Manual

Some of the illustrations contained in this manual may not represent the exact construction details of the user’s specific equipment model. The illustrations in this manual are provided as general information to aid in showing possible features and components.

Safety

Please read these safety instructions carefully before using this instrument. Before using the instrument it is imperative that you be acquainted with how it operates and is controlled. 1.

WARNING: Do NOT touch the pins of the connectors marked with the symbol without following the Electrostatic Discharge (ESD) precautionary procedures detailed on page 9 of this manual. Staff that could touch the pins of the connectors identified with the ESD warning symbol should receive precautionary explanation and training. This includes clinical / biomedical engineering and healthcare staff. Electrostatic Discharge training should include an introduction to the physics of electrostatic charge, the voltage levels that can occur in normal practice and the damage that can be done to electronic components if they are touched by an operator who is electrostatically charged. Further, an explanation should be given of methods to prevent build-up of electrostatic charge, and how and why to discharge one’s body to an earth ground or to the frame of the equipment, or bond oneself by means of a wrist strap to the equipment or to an earth ground prior to making a connection.

2.

WARNING: There is a risk of an explosion if the equipment is used in the presence of flammable anesthetics.

3.

WARNING: To reduce the risk of electrical shock, do NOT open the instrument’s inner housing. Refer servicing to qualified personnel only.

4.

Disassembly of equipment by unauthorized personnel will void the instrument’s warranty.

5.

Power Source: The Model SA0972AC Uroflow Transducer is powered via its connection to the M30/M30P Urodynamic Module. The Model SA0972AW Uroflow Transducer is powered via its connection to the following Patient Units: M22J; M22; M20, and M42; and Microflow 2001 and Spectrum 2200A. Continued on next page...

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Introduction, Continued Safety (Cont.)

Environment

6.

WARNING: Take care to keep the transducer where it cannot be stepped on or kicked, which will damage the unit and present a tripping hazard for persons in the area.

7.

The Uroflow Transducer is placed on the floor directly beneath the uroflow chair or table as shown in Figure 6 – Preparing the Uroflow Transducer for Use on page 13.

1.

Water and Moisture: Do NOT immerse the instrument in any fluid. This instrument has an IP 21 rating.

2.

Magnetism: Position the instrument away from equipment or devices that generate strong magnetic fields.

3.

Storage / Shipping Conditions: Humidity: 10 to 90% (non-condensing) Temperature: -4° to 140°F (-20° to 60°C) Atmospheric Pressure: 50kPa to 106kPa

4.

Operating Conditions: Humidity: 30 to 75% (non-condensing) Temperature: 50° to 104°F (10° to 40°C) CAUTION: Allow adequate air circulation to prevent internal heat build-up. Do NOT install the unit in a location near heat sources such as radiators or air ducts, or in a place subject to direct sunlight, excessive dust or humidity, or mechanical vibration or shock. To avoid moisture condensation, do not install the unit in a location where the temperature may rise rapidly.

5.

Electromagnetic Compatibility: The Model SA0972AC Uroflow Transducer, used in conjunction with a M30/M30P Urodynamic System, has been tested and found to comply with the EMC limits for the Medical Device Directive 93/42 EEC (EN 55011 Class A and EN 60601-1-2:2001). Refer to the LifeTech M30/M30P Operator’s Manual for more information on EMC compliance. WARNING: It is prudent to separate all electrical equipment that is very close in distance to the Uroflow Transducer. If it is essential to use the Uroflow Transducer very close to other electrical equipment, it is prudent to determine, by observation, if the performance of either product is affected by unintended electromagnetic coupling.

Environmental Protection

At the end of its useful life, you may return hardware components to Life-Tech for disposal. If you choose not to return items, follow your local governing ordinances and recycling plans regarding disposal or recycling of device components.

Continued on next page...

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Introduction, Continued Service

1.

Damage Requiring Service: The instrument should be serviced by qualified service personnel when: • • • •

2.

Any cable, cord, or plug has been damaged. The instrument does not appear to operate normally or exhibits a marked change in performance. The instrument has been dropped, or the casing is damaged. Fluid has been spilled on the instrument, or it has been immersed, and it appears that fluid has entered the casing.

Service: The user should not attempt to service the instrument beyond that described in this operator’s manual unless directed by Life-Tech Service personnel. Refer all other servicing to qualified service personnel. Circuit diagrams, itemized parts listings, descriptions, and other items of available documentation can be ordered by suitably qualified user personnel duly authorized by Life-Tech for their use in repairing those components of the instrument that have been designated by Life-Tech as repairable. Supply of such technical documentation relating to the equipment shall not be construed as constituting Life-Tech’s authorization of user’s personnel, regardless of their levels of technical training, to open or repair the instrument. Explicitly exempted here are those maintenance and repair operations described in this manual.

Meaning of Symbols

REF

Reference (model) number

SN

Serial number

Continued on next page...

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Introduction, Continued Specifications

Unit Size:

13.5 cm Diameter x 7.5 cm Height (5.3” x 2.9”)

Weight:

510 Gm (1.15 lbs)

Volume Accuracy

± 2% of full scale

Volume Range

0 – 1000 ml

Safety

When used in conjunction with the M30/M30P Urodynamic Module, the Model SA0972AC Uroflow Transducer complies with: IEC/EN60601-1 (International/Europe) C22.2 No.60601.1-M90 (Canada) UL Std. No. 60601-1 (USA) Product Classification: Type BF Applied Parts Class I equipment Mode of operation: Continuous This equipment is NOT suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or with nitrous oxide. Ingress rating: IP21.

Interface Cables

• •

The SA0972AC Uroflow Transducer connects to the M30/M30P Urodynamic Module via an interface cable terminating in a circular connector. The SA0972AW Uroflow Transducer connects to the M22J, M22, M20 or M42 Patient Unit via an interface cable terminating in a modular plug.

Continued on next page...

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Introduction, Continued Unpacking the Components

Unpack and identify the Uroflow Transducer before you are ready to begin using the system. As you do so, examine it for obvious damage. If you find any damage, observe anything unusual, or if any parts are missing notify Life-Tech’s Technical Service Department at 800-231-9841 or 281-4916600 before attempting to use the instrument.

Overview of Uroflow Transducer Components

The SA0972AC and SA0972AW Uroflow Transducers are a two-piece assembly consisting of a transducer platter, screwed onto the transducer body. The transducer body incorporates a hardwired interface cable, terminating in a circular connector (SA0972AC) or a modular plug (SA0972AW). The components of the Model SA0972AC are illustrated and described below:

Figure 1 – Uroflow Transducer Components

Component

Description

X Transducer Platter

Screws onto the top of the body and holds a graduated beaker.

o Body Z Transducer Cable &

Houses the uroflow transducer circuitry. •

Plug •

The SA0972AC Uroflow Transducer connects into the input jack on the bottom panel of the M30/M30P Urodynamic Module via an interface cable terminating in a circular connector. The SA0972AW Uroflow Transducer connects to the input jack on the bottom panel of M22J, M22, M20 or M42 Patient Unit via an interface cable terminating in a modular plug.

CAUTION: The transducer platter on Uroflow Transducer Models SA0972AC or SA0972AW should never need to be removed. If you must remove it, unscrew it counterclockwise until it comes free of the transducer body. Pulling the transducer platter off instead of unscrewing it will cause damage to both components, which will void the unit’s warranty.

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Installation and System Interface Connecting the SA0972AC Uroflow Transducer to the M30/M30P Urodynamic Module

The Model SA0972AC Uroflow Transducer is interfaced to the M30/M30P Urodynamic Module. WARNING: Do NOT touch the pins of the connectors marked with the symbol without following ESD precautionary procedures, which include: •

Methods to prevent build-up of electrostatic charge (e.g., air conditioning, humidification, conductive floor coverings, and non-synthetic clothing). • Discharging one’s body to the frame of the equipment or to an earth ground, or a large metal object. • Bonding oneself, by means of a wrist strap, to the equipment or to an earth ground. For more information, see Precautions on page 4.

Figure 2 – Connect the SA0972AC Uroflow Transducer(s) to the M30/M30P Urodynamic Module

Continued on next page…

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Installation and System Interface, Continued Connecting the SA0972AC Uroflow Transducer to the M30/M30P Urodynamic Module (cont.)

„ To connect the SA0972AC Uroflow Transducer to the M30/M30P Urodynamic Module: 1.

Confirm that the system computer, M30/M30P Urodynamic Module and all accessory components are powered OFF.

2.

Connect the circular plug on the end of the Uroflow Transducer cable into the input jack labeled Uroflow1 on the bottom panel of the M30/M30P Urodynamic Module.

To connect a circular plug: a. Orient the interface cable plug with the receptacle, so that the “keyed” (notched) insulator faces align. b. Push the plug into the receptacle until the locking tabs snap into the undercuts. Figure 3 – Connecting a Circular Plug

Disconnecting the SA0972AC Uroflow Transducer from the M30/M30P Urodynamic Module

3.

If your system purchase included a second SA0972AC transducer and the Uroflow2 software option, connect the circular plug on the end of the cable of the second transducer to the input jack labeled Uroflow2 on the bottom panel of the M30/M30P Urodynamic Module.

4.

The SA0972AC is ready for use.

„ To disconnect the SA0972AC Uroflow Transducer from the M30/M30P Urodynamic Module: 1. Confirm that all system hardware is powered OFF. 2. Squeeze the circular plug on the Uroflow Transducer cable at the finger grips to flex the plastic coupling area. The locking tabs will deflect outward and unlock. 3. Pull back on the plug until it is fully disengaged. Figure 4 – Disconnecting a Circular Plug

Continued on next page...

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Installation and System Interface, Continued Connecting the SA0972AW Uroflow Transducer to a Patient Unit

The Model SA0972AW Uroflow Transducer is interfaced to the Life-Tech Urodynamic System via the following Patient Units: M22J, M22, M20, M42, and Microflow 2001, Spectrum 2200A.

„ To connect the SA0972AW Uroflow Transducer to a Patient Unit: 1.

Confirm that the system computer and all accessory components are powered OFF.

2.

Connect the modular plug end of the transducer cable into the Uroflow input jack on the bottom panel of the Patient Unit.

3.

Insert the modular plug into the Uroflow connector until the latch clicks and secures the cable in place.

Figure 5 – Connect the SA0972AW Uroflow Transducer(s) to a Patient Unit Continued on next page… 11

Installation and System Interface, Continued Connecting the SA0972AW Uroflow Transducer to a Patient Unit (cont.)

 NOTE: Labeling and availability of multiple Uroflow input jacks varies with Patient Unit models. If using the Model…

Then…

M22J Patient Unit…

a. Connect the Uroflow Transducer to the input jack labeled Uroflow1 on the bottom panel of the patient unit. b. If your system purchase included a second SA0972AW transducer and the Uroflow2 software option, connect the second transducer to the input jack labeled Uroflow2 on the bottom panel of the patient unit.

M22, M20 or M42 Patient Unit…

¾ Connect the Uroflow Transducer to the input jack labeled Uroflow on the bottom panel of the patient unit.

The SA0972AW transducer is ready for use.

Disconnecting the SA0972AW Uroflow Transducer from a Patient Unit

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„ To disconnect the SA0972AW Uroflow Transducer from a Patient Unit: 1. Confirm that all system hardware is powered OFF. 2. Release the locking mechanism on the modular plug. 3. Pull back on the modular plug until it is fully disengaged.

Using the Uroflow Transducer Preparation

„ To prepare the Uroflow Transducer for use: WARNING: Take care to keep the transducer where it cannot be stepped on or kicked, which will damage the unit and present a tripping hazard for persons in the area.

 Note Refer to page 17 for instructions on cleaning and disinfection of the Uroflow Transducer. 1.

Power the attached urodynamic system components ON.

2.

Place the Uroflow Transducer on the floor, centered directly beneath the opening of the funnel in the Uroflow chair.

3.

Place an empty graduated beaker inside the recessed rim on the Uroflow Transducer platter.

 NOTE: It is important that you position the graduated beaker before starting an urodynamic procedure, so that the automatic zeroing function in the system software will set the voided volume and flow rate channel / displays at zero, compensating for the weight of the empty graduated beaker. 4. Figure 6 – Preparing the Uroflow Transducer for Use

Operation

The transducer is now ready for use.

 NOTE: Refer to the Life-Tech Urodynamic System Operator’s Manual for further instruction on procedure setup.

„ To operate the Uroflow Transducer: ¾

The SA0972AC and SA0972AW Uroflow Transducers have no useroperated mechanical or electronic parts. Once connected to the M30/M30P Urodynamic Module or patient unit, the transducer is ready for operation.

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Maintenance and Repair Introduction

Problems with the Model SA0972AC or SA0972AW Uroflow Transducer typically fall into the following categories: 1.

Operating error during urodynamic procedures (software or hardware setup).

2.

Interface cable is damaged or disconnected.

3.

Need for routine calibration / maintenance.

4.

Instrument component failure.

If you experience a problem, please refer to the Uroflow Transducer Troubleshooting Guide on page 16. If you are able to identify the cause of the problem, try the suggested actions. For troubleshooting assistance, contact Life-Tech Technical Service at 800-231-9841 or 281-491-6600. For assistance outside the USA, contact your local Life-Tech authorized dealer, or FAX us at 281-491-6646. You can also contact us through our web site: http://www.life-tech.com, or email our service department at [email protected]. The Life-Tech representative for the European Community is: FBI Fred Berninger Importe Bergstrasse 12 82024 Taufkirchen, GERMANY Tel: +49 89 61 453 453 Fax: +49 89 61 453 455 Email: [email protected]

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Maintenance and Repair, Continued Product Return Information

If your system components must be returned to Life-Tech for service or calibration, follow this procedure: 1.

Call Life-Tech Technical Service and request a return authorization (RMA) number.

2.

Clean, disinfect, and dry the instrument before placing it in packaging. For cleaning instructions, see the Cleaning & Disinfection section of this manual starting on page 17.

3.

Place the transducer in its original packaging, or in a sturdy container, well padded with soft packing material.

4

In the mailing container, place a written list of the following information: • • • • •

5.



A detailed description of why you are returning the Volume Transducer. Your name and address. The name and telephone number of a contact person who is a user of the equipment. A purchase order number (for non-warranty repairs / calibration). Return shipping address and return shipping instructions.

Label the outside of the box with your return address, the return authorization number and Life-Tech’s mailing address: Life-Tech, Inc. 4235 Greenbriar Drive Attn: Technical Service Stafford, TX 77477-3995 NOTE: For fastest service, use prepaid airfreight. Insure the shipment and keep the name of the carrier and freight waybill number to trace the shipment if necessary. Continued on next page...

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Maintenance and Repair, Continued Uroflow Transducer Troubleshooting Guide

The troubleshooting tips in this table will help you identify the possible causes of problems you may encounter when using the Uroflow Transducer.

If…

Then…

The amount of fluid in the graduated beaker and the reported voided volume don’t match.

•

•

•

Maintenance of the Uroflow Transducer

If the volume discrepancy exceeds ± 20 ml, the Uroflow Transducer may have been damaged and require recalibration. Contact Technical Service to make arrangements to return the unit for service. Consider the possibility that the patient kicked the graduated beaker with sufficient force to simulate the onset of flow. This would have started recording and, if the patient did not begin voiding before the recorder’s Post Void Delay timeout, the unit would have ended recording and printed before fluid entered the graduated beaker. This is usually seen as a sharp spike on the Uroflow waveform, followed by no further activity. Refer to the recording system’s operator’s manual for more information. The patient may have voided intermittently with long pauses. If a pause is longer than the Post Void Delay setting in the urodynamic recorder software, the unit ends recording, analyzes and prints. Refer to the recording system’s operator’s manual for more information. WARNING: Disconnect mains AC power to the system before conducting any regular maintenance.

To maintain your Uroflow Transducer in optimum operating condition, do the following: 1.

Have the instrument tested and calibrated to the factory specifications shown on page 7, every 12 months.

2.

Protect the instrument from fluid spills and keep it free of dust and particulate residue from infusion solutions, body fluids, etc. This is particularly important when using contrast medium. Contrast leaves a sticky, thick, corrosive residue and must be cleaned immediately. The procedures for cleaning and disinfecting equipment follow.

3.

Protect the Uroflow Transducer from physical damage such as getting stepped on or kicked during use, or damaged during floor cleaning. CAUTION: The transducer platter on Uroflow Transducer Models SA0972AC or SA0972AW should never need to be removed. If you must remove it, unscrew it counterclockwise until it comes free of the transducer body. Pulling the transducer platter off instead of unscrewing it will cause damage to both components, which will void the unit’s warranty.

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Cleaning & Disinfection Introduction

In this section, you will find instructions for cleaning and disinfection of the Uroflow Transducer and cable.

 NOTE: Life-Tech, Inc. makes no claims of the efficacy of disinfection when this procedure is used. The cleaning and disinfecting solutions recommended herein have been tested only for materials compatibility with the Uroflow Transducer. Refer to published guidelines1,2,3 or solution manufacturers’ recommendations for additional information on disinfection of medical equipment. The Uroflow Transducer should be cleaned: • Anytime it has been or is suspected to have been contaminated by biologically active materials. • Before using it on a patient if its condition warrants (e.g. if there is an accumulation of dust or other visible debris or contamination). • Immediately after spillage of infusion medium since contrast is particularly corrosive. The solutions shown in the table below were selected from the Association for Professionals in Infection Control and Epidemiology (APIC) guidelines (1996)1 and CDC2 recommendations for disinfection of noncritical items and are approved for use on system components. Solution

Concentration

Alcohol (ethyl or isopropyl)

70%

Sodium hypochlorite

1 part household bleach to 10 parts water3

Aqueous quaternary ammonium compounds

0.1 – 0.2 % (e.g. Buckeye® Sani-Care Quat-256)

WARNING: Disconnect mains AC power to the system before applying any cleaning or disinfecting solutions to hardware.

Cleaning & Disinfection Procedure

Supplies: • Cleaning and disinfecting solution(s) • Clean, soft cotton cleaning cloths CAUTION: Do NOT spray or pour solutions directly into the Uroflow Transducer, nor submerge the instrument, system hardware, interface cables, and power cords in any solution. Wipe the hardware with a clean cloth dampened with cleaning and disinfecting solution. The cloth should be damp, not dripping, to ensure that solution does not enter the component cases. Continued on next page…

1

Dix, K. Choosing Surface Disinfectants, Infection Control Today, 9/1/2002. Available online @ http://www.infectioncontroltoday.com/articles/291clean.html

2

Sterilization or Disinfection of Patient-Care Equipment: HIV Related. Available online @ http://www.cdc.gov/ncidod/hip/sterile/hivsteri.htm

3

OSHA & CDC Current Issues, New OSHA Inspection Guidelines. Medical Environment. http://www.medicalenvironment.com/subscribers/osha.html Buckeye is a registered trademark of Buckeye International, Inc.

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Cleaning & Disinfection, Continued Cleaning & Disinfection Procedure (cont.)

CAUTION: The transducer platter on Uroflow Transducer Models SA0972AC or SA0972AW should never need to be removed. If you must remove it, unscrew it counterclockwise until it comes free of the transducer body. Pulling the transducer platter off instead of unscrewing it will cause damage to both components, which will void the unit’s warranty.

To order replacement graduated beakers contact the LifeTech Customer Service department.

Figure 7 – Cleaning & Disinfection of the Uroflow Transducer

„ To clean and disinfect the Uroflow Transducer and/or cable:  NOTE: Efficacy of the disinfection process is NOT guaranteed herein, as it is dependent upon user adherence to published clinical guidelines or solution manufacturer’s instructions for use. 1.

Turn the system computer and all mains AC powered accessory equipment OFF and disconnect the power cords from the mains AC power source.

2.

Apply cleaning or disinfecting solution to a clean cloth and use the cloth to wipe the outside casing of the transducer to remove visible contaminants. CAUTION: Cloth should be damp, not dripping, to ensure that the solution does not enter the Uroflow Transducer, hardware casing, or cable connections.

3.

If using…

Then…

Alcohol or chlorine bleach solution…

Allow the item to air dry up to 10 minutes. Wipe with a clean dry cloth after that time to remove any residual.

Using a commercial germicidal detergent solution

Follow the manufacturer’s recommendations.

When the cleaned components are confirmed completely dry, reconnect power cables to the mains AC power source. WARNING: Do NOT reconnect the equipment to the mains AC power supply, or turn power ON until all components are completely dry (e.g., all the alcohol vapors have dispersed). An electrical spark could ignite the vapors and cause a fire.

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Declaration of Conformity

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