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DeRoyal Prospera PRO Series, User Manual

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SAFETY US-CA

E355754

USER MANUAL

DeRoyal

®

 Prospera

®

 PRO Series

Negative Pressure Wound Therapy System

PRO-II

®

 and PRO-III

®

AS TO ELECTRICAL SHOCK, 
FIRE AND MECHANICAL HAZARDS 
ONLY IN ACCORDANCE WITH 
ANSI/AAMI ES60601-1 (2005),
CAN/CSA-C22.2 No. 60601-1 
(2008)

Summary of Contents for Prospera PRO Series

Page 1: ...ER MANUAL DeRoyal Prospera PRO Series Negative Pressure Wound Therapy System PRO II and PRO III AS TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI AAMI ES60601 1 2005 CAN CSA C22 2 No 60601 1 2008 ...

Page 2: ......

Page 3: ...ouble filter system for PRO III Device 16 2 2 6 Battery 16 2 2 7 Pressure settings 17 2 3 Warranty 17 3 1 Set Up and Startup 19 3 1 1 Startup 19 3 1 2 Connecting the PRO II and PRO III Devices 19 3 1 3 Positioning of the PRO II Devices 20 3 1 4 Connecting the disposable exudate canister of the PRO II Device 20 3 1 5 Positioning of the PRO III Device 20 3 1 6 Connecting the DeRoyal disposable exuda...

Page 4: ...rvice 31 4 3 Testing the PRO II or PRO III Devices 31 5 1 Function Test 32 5 2 Troubleshooting 32 5 3 Error Messages 33 6 1 Decontamination prior to shipment 35 6 2 Storage 35 6 3 Disposal 35 7 1 PRO II Device 36 7 2 PRO III Device 37 7 3 EMC Information 38 8 1 PRO II Device 43 8 2 PRO III Device 43 ...

Page 5: ...se call 1 800 251 9864 internationally please call 1 865 938 7828 1 2 Icons 1 2 1 General Symbols Symbol Meaning Symbol Meaning CAUTION Warning of possible bodily injury or health risk WARNING Warning of severe bodily injury or resulting death ATTENTION Warning of possible property damage NOTE Note containing useful information and tips Radiofrequency RF MRI Unsafe 1 2 2 Device and Packaging Symbo...

Page 6: ...ly during operation and can be canceled by simultaneously pressing the Up and Down buttons Filter run time elapsed replacement of the internal filter by an authorized DeRoyal service technician is required Alarm display settings X Represents Sensitivity of System closed alarms Y Represents Sensitivity of Check dressing seal alarms 1 3 Symbol Convention Symbol Meaning Enumeration 1 2 3 Perform the ...

Page 7: ...Class The Protection Class defines the degree of protection of the device against contact and ingress of liquids The PRO II and PRO III are protected against finger access and falling water drops at an inclination of up to 15 O Overflow Overflow means that wound exudate is sucked into the interior of the device W Wound exudate The term wound exudate denotes all liquids and particles collected that...

Page 8: ...ticoagulants and have active bleeding Patients with complicated wound hemostasis Use of the device in direct proximity to blood vessels organs muscles and fascias Irradiated vessels and tissues Bone fragments Non compliant non responsive patients Untreated malnutrition Paralysis associated with the affected area or spinal cord injuries Circumferential dressing application Take extreme caution when...

Page 9: ...ace of the dressing which indicates an occlusive environment thus maintaining proper suction 1 5 4 Restrictions on use In medical rooms where potential equalization is necessary e g heart surgery In hazardous areas When patients use the device outside or outdoors advise to not drop overly shake or permit the device to get wet or be exposed to other elements 1 6 Basic Safety Instructions CAUTION He...

Page 10: ...and spare parts ATTENTION Damage to the device by intake exposure of liquids Do not use the device near splashing water Do not use the device in damp rooms or while bathing showering Do not allow the power supply unit plug and display film to get wet Never submerge the device in water or other liquids ATTENTION Damage to the device by heat Do not cover the power supply unit Keep the device as well...

Page 11: ...evice Training should be repeated on a regular basis or at least every 24 months 1 8 Information on Product Liability The liability for the operation of the device is channeled to the operator in the following cases the device is used outside its intended use the device is not used in accordance with the instruction for use the device is opened by unauthorized personnel installation settings enhan...

Page 12: ... device 2 x disposable exudate canister 250 cc with integrated bacterial filter carbon filter solidifier and suction tube power supply unit instruction for use multilingual charging instructions instructions for safe handling of battery packs DeRoyal warranty statement optional accessories depending on the order A separate Quick Reference Guide for use of the PRO II device for in home care is avai...

Page 13: ...anister system comprising the external canister holder for external canister connecting tube power supply unit instruction for use multilingual charging instructions instructions for safe handling of battery packs DeRoyal warranty statement optional accessories depending on the order A separate Quick Reference Guide for use of the PRO III device for in home care is available for download via the i...

Page 14: ...tegrated overflow protection system and stops the pump The PRO II and PRO III devices must only be operated with DeRoyal supplied disposable exudate canisters The expected lifetime of a PRO II and or PRO III device is 36 months The provided disposable exudate canister for the PRO II device as well as the disposable canister and tubing for the PRO III device are intended for single use 2 2 1 Dispos...

Page 15: ...ctively reduced Service life and reuse The carbon filter is not intended for reuse To ensure consistent performance the carbon filter must be replaced during maintenance or after 2 years of use approximately 8 000 hours The carbon filter must be replaced by DeRoyal or an authorized service partner of DeRoyal 2 2 4 Disposable exudate canister system for PRO III Device The disposable exudate caniste...

Page 16: ... ion battery which unlike traditional types of rechargeable batteries have a low self discharge rate The PRO II and PRO III devices should ideally be stored and charged at room temperature in accordance with the ambient conditions specified in the technical data Never store the device incl battery in a discharged state Fully recharge the battery if the device is not operated for a longer period of...

Page 17: ...elines this includes using any non DeRoyal provided accessories kits canisters etc 3 the special tamper proof seal is missing or broken or 4 the unit has been rendered inoperable due to physical damage inclusive of drops or falls of the device Any maintenance or service repair that is not covered by the warranty may be performed by DeRoyal at a cost of 75 per hour A minimum of 75 may be charged an...

Page 18: ...toring intervals must be dependent on the wound situation the health of the patient and the settings of the alarm sensitivities WARNING Hazard of persons due to decreasing the alarm sensitivities When greatly decreasing alarm sensitivities it is possible that a blockage or leakage in the wound and tube system may not be detected and thus no alarm will be triggered The PRO II and PRO III devices ar...

Page 19: ...I and PRO III device It is important to avoid kinking when connecting the tubing Ensure prior to switching on the unit that the disposable exudate canister and all tubing are properly connected Fully charge the battery prior to initial startup Perform a function test Please refer to chapter 5 1 3 1 2 Connecting the PRO II and PRO III Devices Use the socket for power supply unit of the PRO II devic...

Page 20: ...tube B Locking mechanism for canister C Aspiration port D PRO II device E Guiding rail 1 Remove the disposable exudate canister fig 5 A from the packaging 2 Slide the canister on the guiding rails fig 5 E of the PRO II device until the disposable exudate canister clicks into place in the locking mechanism fig 5 B 3 To remove from the device after use press the Press Here button on the top of the c...

Page 21: ...anister and the connecting tube with external filter 3 1 7 Connecting a wound drainage system Connect the suction tube to the wound drainage system such as the DeRoyal TopDraw Medium Black foam Kit with Triple Release Transeal NP 0501 For a complete listing of approved DeRoyal wound draining kits please visit www deroyal com npwt The suction tube must never come into direct contact with the aspira...

Page 22: ...inuous Mode set to 80mmHg 3 Use the arrow buttons to select the Language menu 4 Use the button to confirm your choice 5 Use the arrow buttons to select the desired language 6 Use the button to confirm your choice 7 Select the prescribed operating mode in the Setup menu 8 Use the button to confirm your choice 9 Perform the desired treatment please refer to chapter 3 2 2 or 3 2 3 10 Switch off the P...

Page 23: ...he arrow buttons to select the Continuous menu 4 Use the button to confirm your choice The following screen is displayed 5 Use the arrow buttons to set the prescribed vacuum value 6 Confirm the setting by pressing the button The following overview screen is displayed 7 Press the button to start the therapy Default target value 80 mmHg 8 The following screen is displayed for one minute after the th...

Page 24: ...for high or low vacuum can be set separately from 2 to 10 minutes in increments of 0 5 minutes The low vacuum can be set in a range from 20 mmHg to 100 mmHg in increments of 5 mmHg The high vacuum can be set in a range from 30 mmHg to 200 mmHg in increments of 5 mmHg The setting of the low vacuum cannot be set higher than the setting of the high vacuum The following values are preset High Vacuum 8...

Page 25: ...ttons to set the prescribed time value for the high vacuum 10 Confirm the setting by pressing the button 11 Use the arrow buttons to set the prescribed time value for the low vacuum 12 Confirm the setting by pressing the button 13 The display shows the set parameters in an overview again 14 Press the button to start the therapy A timing bar will appear to visually display the amount of time remain...

Page 26: ... The following start screen is displayed for 5 seconds 2 While the start screen is displayed simultaneously press the arrow buttons The menu Setup is displayed 3 Use the arrow buttons to select the Language menu 4 Use the button to confirm your choice 5 Use the arrow buttons to select the desired language 6 Use the button to confirm your choice 3 2 5 Alarm delay at startup At startup of the PRO II...

Page 27: ...elect the other digits of the code with the arrow button and confirm them with the button as well The authorization code may only be passed to specially trained personnel You will get the training and the authorization code by DeRoyal or an authorized distribution partner of DeRoyal Passwords must be treated as confidential information to prevent misuse 4 After the authorization the sensitivity se...

Page 28: ... due to incorrect settings Prior to using the PRO II or PRO III device on a new patient it must be verified that the currently set alarm sensitivities are appropriate for this patient It is important to adapt the alarm system and sensitivities to the particular wound and situation of the patient The adjustment of alarm sensitivities may only be carried out by qualified and authorized healthcare pe...

Page 29: ...ube to the wound drainage system 8 Switch on the PRO II device 9 Loosen the tubing clamp at the wound drainage system 3 4 2 Replacement of the disposable canister of the PRO III Device 1 Close the tubing clamp at the patient tubing fig 3 and at the wound drainage system TopDraw tubing to maintain the vacuum in the wound 2 Turn off the PRO III device 3 Separate the patient tubing from the wound dra...

Page 30: ...ll and then disconnect the power supply from the unit of the PRO II or PRO III device ATTENTION Risk of damage to the device due to improper cleaning agents Do not use disinfectants that contain acetone These may damage or disfigure the housing components and the accessories Follow the instruction for use provided by the manufacturers of the utilized disinfectants particularly with respect to mate...

Page 31: ...formed by DeRoyal or by authorized professionals of DeRoyal in compliance with the service documentation specified by the manufacturer as well as with technical and hygienic precautionary measures The device may be sent back for repair to DeRoyal directly or via the specialty dealer from which the device was purchased Clean and disinfect all accessories prior to returning the device The device its...

Page 32: ...m System closed must be displayed after no more than 5 seconds If the alarm is not displayed even after repeating the test have the device inspected by a service partner 5 2 Troubleshooting Malfunction Probable causes Remedy Device cannot be switched on Battery is empty Connect the power supply unit Therapy does not start Tubing clamp is closed Overflow protection system is blocked disposable exud...

Page 33: ...perly connected disposable exudate canister is connected but the tube is opened Check for proper connection Start pump Pump off Discontinuation of the current operating mode Disposable exudate canister is full Switch off the device Replace the disposable exudate canister Exudate flow obstructed tubing is kinked or stenosis in the tubing Check the tubing If the alarm is displayed even if the canist...

Page 34: ...r Current operating mode continues to run in the background Low battery charge level Connect the power supply unit soon Alarm after 15 minutes Current operating mode continues to run in the background The therapy was not initiated Start therapy The device was not switched off Switch off the device Contact DeRoyal or your service partner if the malfunction cannot be corrected by the described measu...

Page 35: ...l Data chapter 7 The battery of the PRO II or PRO III device must be charged prior to storage of the device This ensures that the device is operational at all times Fully recharge the battery if the PRO II or PRO III device is not used for a longer period of time approx 10 months 6 3 Disposal The components of the device must be disposed of in a proper manner at the end of the product s service li...

Page 36: ...tion IP code as per IEC 60529 IP22 UL marking Sound emission Operation 35 dB A High priority alarm 52 dB A Low priority alarm 49 dB A Ambient conditions Transport Storage 25 C to 60 C humidity of max 93 non condensing Operation 5 C to 40 C humidity 15 to 93 non condensing Air Pressure 700 hPa to 1060 hPa Battery rechargeable 7 4 V 4 4 Ah Lithium ions Charging time if battery is empty Charging time...

Page 37: ...P22 UL marking Sound emission Operation 35 dB A High priority alarm 53 dB A Low priority alarm 51 dB A Ambient conditions Transport Storage 25 C to 60 C humidity of max 93 non condensing Operation 5 C to 40 C humidity 15 to 93 non condensing Air Pressure 700 hPa to 1060 hPa Battery rechargeable 7 4 V 4 4 Ah Lithium ions Charging time if battery is empty Charging time if battery is approx 50 full 6...

Page 38: ...mproper use is not covered by warranty in any case Only use original DeRoyal accessories and spare parts CAUTION Use of the recommended accessories and spare parts incl transformers and cables in devices other than the PRO II and PRO III devices may increase the emission of electromagnetic interference or reduce the electromagnetic immunity Damage caused by using recommended accessories and spare ...

Page 39: ...rsuant to IEC 61000 3 2 Class A Voltage fluctuations Flicker emissions pursuant to IEC 61000 3 3 Complies Table 2 Guidance and Manufacturer s Declaration Electromagnetic Immunity The PRO II and PRO III devices are intended for operation in the electromagnetic environment specified below The customer or user of the PRO II or PRO III device must ensure that it is used in such an environment Immunity...

Page 40: ...riods 5 UT 95 dip of UT for 5s 5 UT 95 dip of UT for period 40 UT 60 dip of UT for 5 periods 70 UT 30 dip of UT for 25 periods 5 UT 95 dip of UT for 5s Main supply voltage should be of the same quality as in a typical commercial living or hospital environment If the user of the PRO II or PRO III device requires continued operation during mains power outages it is recommended to power the device fr...

Page 41: ... and mobile RF communications equipment should be used no closer to any part of the PRO II and PRO III devices incl cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P d 1 2 P for 80 MHz to 800 MHz d 2 3 P for 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitt...

Page 42: ... the PRO II and PRO III devices The PRO II and PRO III devices are intended for operation in an electromagnetic environment in which the radiated RF disturbances are controlled The customer or the user of the PRO II or PRO III device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the PRO II or...

Page 43: ... integrated tubing no NP 0450N Disposable exudate canister 400 ml with integrated tubing without solidifier no NP 2001 Carrying bag for DeRoyal PRO II Device no NP 170 Bed Holder for DeRoyal PRO II Device no 8 2 PRO III Device Item number Description Included with purchase of new Pro 2 NP 3000 PRO III Stationary Negative Pressure Device yes NP 1006 Disposable exudate canister 800 ml with tubing fi...

Page 44: ... II and PRO III Transeal and TopDraw are trademarks or registered trademarks of DeRoyal Industries Inc DeRoyal UL and the UL logo are registered trademarks of UL LLC Incidin is a trademark of Drager Inc The safety of the PRO II and PRO III complies with the acknowledged rules of technology and meets the requirements of the German Medical Devices Act The PRO II and PRO III have been tested in accor...

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