Owners Manual Amendments
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Amendments to Caution & Warnings Section listed within current released version of LABORIE Product Owner’s Manuals and Instructions for Use S TATEMENTS LISTED IN THIS AMENDMENT WILL BE ADDED TO NEX T RELEASED VERSION OF OWNER ’ S MANUALS AND / OR INSTRUCTIONS FOR USE 1. UPDATED STATEMENT FOR ALL DISPOSABLES THAT ARE MARKED AS STERILE AND SINGLE-USE:
Re-use, reprocessing or resterilization of disposables could lead to device failure and create a risk of cross-infection and/or cross transmission of infectious disease(s) from one patient to another. Result of sterilization failure could lead to cross infection and/or cross-transmission of infectious disease from one patient to another. To be added to next version of: AQTT-UM01: Aquarius TT Owner’s Manual AQS-UM01: Aquarius XT/CT/LT Owner’s Manual DELA-UM01: Delphis Owner’s Manual DELIP-UM01: Delphis IP Owner’s Manual DELKT-UM01: Delphis KT Owner’s Manual DORKT-UM01: Dorado KT Owner’s Manual GOBYKT-UM01: Goby KT Owner’s Manual GOBY-UM01: Goby Quick Start Guide GOBY-UM02: Goby Owner’s Manual TRI-UM01: Triton Owner’s Manual UC3-UM01: Urocap III Owner’s Manual UC4-UM01: Urocap IV Standalone Owner’s Manual UC4-UM02: Urocap IV Standalone Quick Start Guide 2. UPDATED STATEMENTS FOR INJETAK ADJUSTABLE TIP NEEDLES
Re-use, reprocessing or resterilization could lead to device failure and create a risk of cross-infection and/or cross transmission of infectious disease(s) from one patient to another. Result of sterilization failure could lead to cross infection and/or cross-transmission of infectious disease from one patient to another. The injeTAK Adjustable Tip Needles are identified as single-use only and cannot be reused or re-sterilized. Reuse, reprocessing or re-sterilization could lead to failure of the devices and create a risk of cross-infection and/or crosstransmission of infectious disease(s) from one patient to another. Re-use, re-processing or re-sterilization may compromise the structural integrity of the needle and/or lead to device failure. It may also lead to a decrease in sharpness of the needle, which can result in increased pain to the patient during insertion. If the injeTAK needles are re-used, re-processed and/or re-sterilized, it may lead to slow material degradation of the needle cannula (i.e. stainless steel) and insulation. To be added to next version of: INJ-UM01: injeTAK Adjustable Tip Needles Instructions for Use
Laborie Medical Technologies Canada ULC
Document#: LMT-UM01 Version#: 1.0 January 2014
3. UPDATED STATEMENTS FOR URODYNAMIC MEASUREMENT TUBING, LABORIE DISPOSABLE URODYNAMIC TUBING & STOPCOCKS
Re-use, reprocessing or resterilization could lead to device failure and create a risk of cross-infection and/or cross transmission of infectious disease(s) from one patient to another. Result of sterilization failure could lead to cross infection and/or cross-transmission of infectious disease from one patient to another. The Urodynamic Measurement Tubing, Laborie Disposable Urodynamic Tubings & Stopcocks are sterile and single use only and cannot be reused or resterilized. Reuse, reprocessing or resterilization could lead to failure of the devices and create a risk of cross-infection and/or cross-transmission of infectious disease(s) from one patient to another. If reprocessed or resterilized, there might be a loss of structural integrity in the Urodynamic Measurement Tubings, Laborie disposable urodynamic tubings and stopcocks. Material degradation of the tubings can occur as well which could cause the tubing to burst if there is pressure build up. To be added to next version of: DIS130-UM01: Pressure Transducer Cartridge Instructions for Use TUB101-UM01: Urodynamics Measurement Tubing Set Instructions for Use TUB500-UM01: Pump Tubing Infusion Line Instructions for Use 4. UPDATED STATEMENTS FOR URODYNAMIC CATHETERS
Re-use, reprocessing or resterilization could lead to device failure and create a risk of cross-infection and/or cross transmission of infectious disease(s) from one patient to another. Result of sterilization failure could lead to cross infection and/or cross-transmission of infectious disease from one patient to another. The Urodynamic Catheters are sterile and single use only and cannot be reused or resterilized. Reuse, reprocessing or resterilization could lead to failure of the devices and create a risk of cross-infection and/or cross-transmission of infectious disease(s) from one patient to another. If reprocessed or resterilized, there might be a loss of structural integrity in the Urodynamic Catheter. Material degradation can also occur which could cause leakage and connection failure. To be added to next version of: C001-UM01: Urodynamic Rectal Balloon Catheter CAT411, CAT412, CAT506, CAT507, CAT509, CAT511 (International) Instructions for Use C001-UM02: Urodynamic Rectal Balloon Catheter 410, 510, & 508 Instructions for Use C002-UM01: Urodynamic Rectal Balloon Catheter CAT411, 509, 506, 412, 511, & 507 Instructions for Use C003-UM01: Cystometry and Urethrocystometry Catheter Instructions for Use DIS-IFU-ERPC9: ERPC9 Instructions for Use DIS-IFU-RPC9/9P: RPC9-RPC9P Instructions for Use DIS-IFU-RPCPT: RPC-PT Instructions for Use UDS-UM02: Quick Start Guide for Air-Charged Catheters UDS-UM03: Quick Start Guide for Electronic Catheters UDS-UM04: Quick Start Guide for Fluid-Filled Catheters
Laborie Medical Technologies Canada ULC
Document#: LMT-UM01 Version#: 1.0 January 2014
5. UPDATED STATEMENTS FOR ST. MARK’S ELECTRODE
Re-use, reprocessing or resterilization could lead to device failure and create a risk of cross-infection and/or cross transmission of infectious disease(s) from one patient to another. Result of sterilization failure could lead to cross infection and/or cross-transmission of infectious disease from one patient to another. There are appropriate guidelines for using the St. Mark’s Electrode in the patient (e.g.: not indicated for infected patients, etc.) that control the proper indications for applying the electrode for a PNTML procedure. If the situation is contra-indicated, then the PNTML test should not be performed and thus the device is not involved. If the contaminated set is re-used, there is risk of infection. Moreover, if the patient’s set is re-used in a future procedure on another patient, then there is additional risk of cross-infection. The instructions for use as well as device labels and packaging must state that the devices are single use only and cannot be reused or resterilized. Re-use, reprocessing or resterilization could lead to device failure and create a risk of cross-infection and/or cross transmission of infectious disease(s) from one patient to another. To be added to next version of: EVOX-UM01: EVOX Owner’s Manual EVOX-UM02: EVOX Quick Start Guide 6. UPDATED STATEMENTS FOR WIRE EMG ELECTRODES
Re-use, reprocessing or resterilization could lead to device failure and create a risk of cross-infection and/or cross transmission of infectious disease(s) from one patient to another. Result of sterilization failure could lead to cross infection and/or cross-transmission of infectious disease from one patient to another. The devices are identified as single use only and cannot be reused or re-sterilized. Reuse, reprocessing or resterilization could lead to failure of the devices and create a risk of cross-infection and/or cross-transmission of infectious disease(s) from one patient to another. The Wire EMG Electrodes are identified as single-use only and cannot be reused. Reuse could lead to a risk of crossinfection and/or cross-transmission of infectious disease(s) from one patient to another. Re-use can lead to a decrease in sharpness of the EMG Wire electrode needle, which can result in increased pain to the patient during insertion. If the EMG Wire Electrode needles are re-used on multiple patients, processed and/or sterilized, it may lead to slow material degradation of the wire gauge (i.e. stainless steel) and insulation (i.e. Heavy Polyimide). To be added to next version of: DISIFU1512A-F-M: Wire EMG Electrode Set Instructions for Use
Laborie Medical Technologies Canada ULC
Document#: LMT-UM01 Version#: 1.0 January 2014
7. UPDATED STATEMENTS FOR BIOFEEDBACK & MANOMETRY PROBES
Re-use, reprocessing or resterilization could lead to device failure and create a risk of cross-infection and/or cross transmission of infectious disease(s) from one patient to another. Result of sterilization failure could lead to cross infection and/or cross-transmission of infectious disease from one patient to another. The Biofeedback & Manometry probes are not sterile but are single-patient use only. Reusing the probes on multiple patients could result in a risk of cross-infection and/or cross-transmission of infectious disease(s) from one patient to another. To be added to next version of: PERI-UM01: Peritron Owner's Manual PFX-UM01: PFX2/PFXA Handbook UST-UM01: Urostym Owner’s Manual UST-UM02: Urostym Quick Start Guide
Laborie Medical Technologies Canada ULC
Document#: LMT-UM01 Version#: 1.0 January 2014