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Cardinal Health™ Negative Pressure Wound Therapy PRO/PRO TO GO Patient User Manual...
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Things you need to know about your PRO/PRO to GO • Do not allow the PRO/PRO to GO to get wet. Clamp the tubing and disconnect from the canister if you take a bath or shower. • Keep the PRO/PRO to GO plugged in whenever possible to keep the battery fully charged. Always take the A.C.
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This Cardinal Health™ NPWT PRO/PRO to GO Patient User Manual is not a guarantee or warranty. It is intended only as an operational guide. For additional information and questions, please contact Cardinal Health Customer Service at 1.866.484.6798. In order for the PRO/PRO to GO to provide safe, reliable, and proper performance, the following conditions must be met.
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CAUTION: Use the PRO/PRO to GO only as described in this user manual. Do not interconnect the PRO/PRO to GO with other devices not included in this user manual. Failure to comply could result in improper therapy and could result in damage to the PRO/PRO to GO.
1.1 Indications ..............................6 1.2 Contraindications ............................6 1.3 Precautions ..............................6 1.4 Safety Tips ...............................7 2. Getting to Know the PRO/PRO to GO ....................8 2.1 Getting to Know the PRO/PRO to GO .......................8 2.2 Charging the Battery ............................9 2.3 Changing the Canister ...........................10 2.4 Disconnecting from the PRO/PRO to GO ......................11...
• Magnetic Resonance Imaging (MRI): The PRO/PRO to GO is not MRI-compatible and cannot be used in the presence of strong magnetic fields. Do not take the PRO/PRO to GO into the MRI area or any area of high magnetic fields.
The PRO/PRO to GO should be operated at least 22 hours out of every 24-hour period. Contact your healthcare professional if negative pressure wound therapy stops or if the PRO/PRO to GO is OFF for more than 2 hours in a 24-hour period. Your dressing must be changed by your healthcare professional.
2.1 Getting to Know the PRO/PRO to GO You may not need to use many of the buttons on the PRO/PRO to GO, but it is important that you are familiar with what they are and their location (Figure 1).
(Figure 2). If the battery is charging, the yellow light next to the Battery Charging symbol comes on. Once the battery is fully charged, the light goes off. NOTE: If the PRO/PRO to GO is plugged in and the green light does not turn on, check to make sure the outlet is working properly.
6. To install a new canister, hold the new unused canister at the bottom and slide upwards into the holder. 7. Line up the two ports on the canister with the two ports on the PRO/PRO to GO. Press the canister up and into the PRO/PRO to GO until it clicks and locks into place.
2.4 Disconnecting from the PRO/PRO to GO You may disconnect the PRO/PRO to GO from your dressing for short amounts of time for activities such as bathing or showering. Ask your healthcare professional about care of your dressing during bathing or showering.
1. Press the ON Button. All lights on the PRO/PRO to GO will sequentially light up during the power-on self-test. 2. Each time the PRO/PRO to GO is turned on, it goes through self-test and the Alert Display shows a series of numbers and/or letters.
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• Press the canister release button above the Two-tone beep. canister and slide the full canister out. Cap and If the PRO/PRO to GO are placed on their fronts, fluid dispose of properly. Slide new canister in, align entering the canisters will cause a false canister full the short ports and click into place.
Clean the PRO/PRO to GO with a damp soft cloth and a mild soap and water solution. Do not saturate the PRO/PRO to GO with liquid or allow liquid to pool on the PRO/PRO to GO. This can present a potential hazard for you and/or your healthcare professional.
5. Symbols Glossary Symbols Recognized by Standard/Law Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference ISO 13225-1, Medical devices - Symbols to be used Manufacturer Indicates the medical Clause 5.1.1 with medical device labels, labeling and device manufacturer. information to be supplied ISO 7000-3082 Graphical symbols for use on equipment...
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Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference ISO 15223-1, Medical devices - Symbols to be used In Vitro Diagnostic Indicates that a medical Clause 5.5.1 with medical device labels, labeling and Medical Device device is intended to be information to be supplied used as an in vitro diagnostic medical device.
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Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference ISO 15223-1, Medical devices - Symbols to be used Sterile Indicates a medical device Clause 5.2.1 with medical device labels, labeling and that has been subjected to information to be supplied a sterilization process.
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Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference ISO 15223-1, Medical devices - Symbols to be used Consult Instructions Indicates user needs to Clause 5.4.3 with medical device labels, labeling and for Use consult instructions for use. information to be supplied ISO 7000-1641 Graphical symbols for use on equipment...
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Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference IS EN- Symbol for use in the labeling of medical Contains Presence of Indicates presence of Bis 15986:2011 devices. Requirements for labeling of Phthalates (2-ethylexyl) phthalate medical devices containing phthalates. (DEHP).
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Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference IEC 60601-1, Medical electrical equipment - Part 1: Type B Applied Part Identifies a type B applied Table D.1, Symbol General requirements for basic safety part complying with IEC and essential performance 60601-1.
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Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference 21 CFR Part Labeling - Medical devices; prominence Prescription Use Only Requires prescription for 801.1(c)(1)(i)F of required label statements sale in the United States and is used in place of the statement below: CAUTION: Federal law restricts this device to sale...
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Standard/Law Symbol Title/ Symbol Standard/Law Title Explanatory Text Reference Text Reference ISO 7000-5546 Battery check Battery Check To identify the battery condition indicator. ISO 7000-0623 This way up This Way Up To indicate correct upright position of the transport package. Symbols Not Recognized by Standard/Law Symbol Guidance...
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Symbol Guidance Guidance Symbol Title Explanatory Text This glove has been tested for permeation of various chemicals per ASTM F739, "Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact." 1 Pair of Gloves Contains a pair of gloves.
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Symbol Guidance Guidance Symbol Title Explanatory Text Device Plugged into Indicates that device is an Outlet connected to an external power source. Battery Charging Device is plugged into an outlet and the internal battery is charging.
Relative Humidity Range ......................60 +/-25% (35% to 85%) Atmospheric Pressure Range ........................80kPa to 110kPa PRO Therapy Time ............................... 1,000 hours PRO to GO Therapy Time .............................10 days CAUTION: Federal law restricts this device to sale by, or on the order of, a physician.
RF communications equipment and the PRO. The PRO is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the PRO can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the PRO as recommended below, according to the maximum output power of the communications equipment.
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To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the PRO is used exceeds the applicable RF compliance level above, the PRO should be observed to verify normal operation.
7. Questions & Information For questions or additional information on the Cardinal Health™ PRO/PRO to GO, please contact your local Cardinal Health representative, or: Call Customer Service at 1.866.484.6798 Cardinal Health Waukegan, IL 60085 www.cardinalhealth.com Always consult a physician and product instructions for use prior to application.
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