User Manual - US . Home/Self Use
Contents
1. medical Instructions for use Alarm unit amp Sensor patch 02 Warnings and Precautions About the Redsense alarm system The Redsense device is intended to monitor for Redsense is a system for monitoring the vein needle potential blood loss from the hemodialysis access site during hemodialysis Redsense consists of an alarm unit in hemodialysis patients undergoing hemodialysis and a sensor patch see Fig 1 Once the sensor patch treatment up to 5 hours at home or in the clinical has been placed over the vein needle it detects blood setting that comes into contact with the sensor patch This can occur if the needle has been accidentally pulled out or if The device includes a blood sensor incorporated into there is a blood loss during dialysis an adhesive dressing The sensor monitors potential blood leakage from the needle puncture via an infrared light and will alarm if needle dislodgement or blood leakage is detected All use must be administrated under physician s one prescription and the patient using the device at home 000 must be considered to be competent in the use of this device by the prescribing physician All use must be observed by a trained and qualified person considered to be competent in the use of this device by the prescribing physician Before use a test must be performed to make sure the patient and the observing person can clearly hear the alarm signal The test is further described at page 6 under p2. arm with the clip It is also possible to fasten the alarm unit onto the lower arm and turn it to face in the opposite direction Fig 3 shows the alarm unit fastened onto the upper arm using the Velcro strip Do not tighten the Velcro strip too hard due to possible compression of access vessels It is also possible to fasten the alarm unit to your shirt pocket 1 Fasten the Velcro strip to your upper or lower arm if the Velcro strip is being used 2 Remove the sensor patch from its pack Fig 4 The sensor patch must be labelled Redsense Ensure that the sensor patch is not mechanically damaged 4 Completely clean the area around the needle so that any fluid blood residual cleaning fluid lotion etc is fully removed gt Apply the sensor patch to the skin over the needle with the absorbent part of the patch centered over the puncture Fig 5 Make certain that the sticky part of the patch does not cover the wings Fig 6 shows how the sensor should be placed in position 5 Fasten the needles in place in the normal way by using tape or something equivalent Connect the sensor patch cable to the alarm unit by pressing the connector into the socket until a click is heard Fig 7 amp Fig 8 For use with upper arm fistula see Fig 9 7 Fasten the alarm unit with the clip Fig 10 For use with upper arm fistula see Fig 11 8 If necessary tape can be used to stick the sensor patch and or the sensor cable down
3. into contact with the alarm unit the unit must be cleaned carefully to avoid biohazards DO NOT use Alcalic detergents as they may damage the plastic shell of the alarm unit If using the Velcro strip the Velcro strip is personal and must only be used by you Printable surface If any kind of information needs to be written on the alarm unit Fig 16 shows the surface intended for this purpose Use a marker or similar If the written information needs to be removed or changed it can be wiped off using a damp cloth dipped in alcohol Charging the battery The battery should only be charged when the alarm unit is not in use and is not attached to your arm A fully charged battery lasts 15 20 hours meaning that it is advisable to charge the battery after each dialysis treatment depen ding on the duration of the treatment 1 Connect the charger to the alarm unit using the cable The charger must be labeled Redsense Note that the sensor should not be connected at the same time Fig 17 2 Plug the charger into a socket outlet 100 240 V 3 The yellow light blinks while charging is in progress 4 When the green light is illuminated the battery is fully charged This can take up to 6 hours Changing the battery In order to change the battery the alarm unit must be opened up and therefore this should only be done when the unit is being serviced Service must be performed by personnel authorized by Redsense Med
4. Fig 12 13 show how the fibre optic cables of the sensor patch can be fastened to your arm Press the on button once to start the test of the alarm signal and the 4 LED Fig 14 15 Confirm that all 4 LED are lit and clearly can be indicated Confirm that the patient and the observing person can clearly hear the alarm signal The observing person must be sure that the alarm signal can be heard from other rooms or while there is noise in the house The observing person must be situated at places where the alarm signal can be heard during the entire dialysis treatment The alarm signal test will continue until the button is pressed again 10 To stop the test of the LED and alarm signal press the Start button once again The green light starts to blink for a few seconds before becoming completely lit When the green light is completely lit the alarm is operational the monitoring is functioning in the correct way and the dialysis can begin The green light blinking indicates that the alarm unit is performing a test During this test there are three conditions that may need to be addressed These are shown by the following lights and symbols being illuminated The yellow light marked by the battery symbol denotes that the battery does not have sufficient capacity left for a 5 hours dialysis session and should be recharged See the later section on maintenance about charging the battery The yellow light marked by a warning symbol sig
5. ce between the device and the patient does not conduct electricity The alarm unit is covered by the WEEE directive therefore it must be recycled Alarm unit Last date for use of the sensor In this example year 2008 month 9 Sensor patch The sensor has been sterilized using Ethylene Oxide Sensor patch Instructions for use Alarm unit amp Sensor patch 09
6. e has come into contact with the sensor The sensor has come loose or broken down Instructions for use Alarm unit amp Sensor patch 04 While dialysis is in progress cont Switch off the alarm by holding the button pressed in and continue the dialysis without monitoring the needle or change to a new sensor patch and start again All LEDs blinking accompanied by an intermittent alarm signal indicates an internal software error please contact Redsense Medical for further support Switch off the alarm unit by holding the button pressed in and continue the dialysis without monitoring the needle please contact Redsense Medical for further support After the dialysis is complete 1 Hold the button pressed down for one second in order to switch off the alarm 2 Remove the sensor patch from your arm 3 Remove the alarm unit 4 Disconnect the sensor patch from the alarm unit and dispose it along with the other waste material from the dialysis 5 Clean the alarm unit according to the maintenance instructions Note The alarm can also be switched off at any time during an ongoing dialysis Maintenance Cleaning The sensor patch itself is disposable and must not be cleaned forre tse _ W _ The alarm unit should be wiped off with appropriate disinfectant after every use Either an alcohol based disinfectant using a slightly damp cloth or pads saturated with alcohol based disinfectant can be used If blood has come
7. ical Internal memory Redsense alarm unit has an internal memory that stores data on the last treatments The internal memory is accessed using the communications port The internal memory must only be accessed by personnel authorized by Redsense Medical Instructions for use Alarm unit amp Sensor patch 05 Setting up Redsense Fig 2 7 FIG 5 Setting up Redsense Fig 8 13 FIG 13 I Setting up Redsense Fig 14 17 FIG 14 FIG 15 FIG 16 Printable surface Symbols amp terms The following symbols and terms are used in this manual and on the product Red light and alarm symbol On off button Communications port Yellow light and battery symbol Green light and working symbol Yellow light and warning symbol Socket for the sensor fiber optic cable Socket for battery charger Other symbols displayed on the product and its accessories indicate the following CE Redsense Medical AB Halmstad Sweden 2 The product fulfills the requirements in 93 42 EEC Medical Device Directive Consult Instructions for use Manufactured by Redsense Medical AB Sweden Only for single use Sensor patch Serial number including year of manufacture Alarm unit LOT z EXP 2008 09 STERILE Eo Lot number including year of manufacture Sensor patch User part Type BF Body Floating the surfa
8. medical 6 REDSENSE HOME SELF USE _ User Manual 1 amp Sensor patch ee 31 1 i 0 E teal Instructions for use e Alarm unit amp Sensor patch Instructions for use US English version 2010 Redsense Medical AB Warnings and Precautions 3 PO Box 287 yS About the Redsense alarm system 3 www redsensemedical com Setting Up Redsense 4 Redsense Medical INC While dialysis is in progress 4 150 N Michigan Avenue Suite 1950 D ei a After the dialysis is complete 5 Fax 1 312 276 8606 Cleaning 5 RM 1 RM129 July 2010 Charging the battery 5 Changing the battery 5 Figures 2 6 Caution 9 Federal US law restricts this Figures 8 13 device to sale by or on the Figures 14 17 8 order of a licensed practitioner Symbols and terms 9 Intended use The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodialysis treatment up to 5 hours at home or in the clinical setting The device includes a blood sensor incorporated into an adhesive dressing The sensor monitors potential blood leakage from the needle puncture via an infrared light and will alarm if needle dislodgement or blood leakage is detected All use must be administrated under physician s prescription and must be observed by a trained and qualified person considered to be competent in the use of this device by the prescribing physician REDSENSE
9. nifies one of the following situations There is moisture on the sensor The sensor is not correctly connected The sensor is defect If all LEDs are blinking this means that an internal software error has been detected please contact Redsense Medical for further support Any problems should be dealt with before a new attempt is made to start the alarm unit If blood or moisture has come into contact with the sensor it must be replaced by a new one If any other technical problem appears do not use the Redsense unit please contact Redsense Medical for further support While dialysis is in progress During operation the green light is completely lit and you may observe the following The red light accompanied by a continuous two toned alarm signal indicates that blood has dripped onto the sensor either because the needle has been pulled out or there has been a leakage In this event firstly deal with the reason for the leakage and then switch off the alarm by holding the button pressed in for one second The yellow battery warning light accompanied by an intermittent alarm signal signifies that the battery capacity has become too low meaning that the monitoring can no longer be performed correctly In this case switch off the alarm unit by pressing and holding in the button and then replace it with a fully charged unit The yellow warning light accompanied by an intermit tent alarm signal indicates one of the following Moistur
10. oint 9 Redsense must be used only for its intended purpose and in accordance with these instructions All other use is not allowed The device must only be attached to the patient as shown in instruction for use and the user manual Read and follow all instructions for use carefully Sensor patch Redsense has been tested and is approved in accor dance with the IEC 60601 1 2 2007 and IEC 61000 6 1 2007 standard concerning electromagnetic compa tibility EMC Redsense requires special precautions regarding EMC and consequently has to be employed in conformance with the EMC information detailed in these instructions Portable and mobile RF communi cations equipment may affect Redsense as This device should not be relied upon as the sole monitor for blood loss needle disconnection at the vascular access site Warnings and Precautions Redsense is not for nocturnal use Instructions for use Alarm unit amp Sensor patch 03 Setting up Redsense Redsense should be placed on your arm after the insertion of the needles and prior to the start of dialysis Redsense must be switched on for the entire duration of the dialysis The alarm unit can be fasten as follows Fasten the alarm unit with the clip at a maximum distance of 25 cm from the needle with the sockets turned towards the sensor patch You can also fasten the alarm unit with a Velcro strip which is optional Fig 2 shows the alarm unit fastened onto the upper
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