User`s Manual
Contents
1. of intracompartmental pressure User s Manual Table of Contents Introduction Compartmental Pressure Monitoring System 2 Indications 4 Instructions Operating Instructions a Care and Maintenance 8 Sterilization 11 System Messages and Troubleshooting 12 Checking the Number of Remaining Measurements t3 Changing the Battery 14 Product Information Set List 15 Synthes Compartmental Pressure Monitoring System Monitor 530 411 Liquid crystal display LCD Standard 9 V battery 6LR61 Measures from 0 to 200 mm Hg Displays pressure in 1 mm Hg increments Weight including battery 235 gm Operating temperature 10 C 40 C 50 F 104 F Storage temperature 10 C 55 C 50 F 131 F Protection class BF body floating protection against electrical shock Connector Monitor turns on automatically by plugging in the probe or the probe extension cable assembly This device complies with the following standards UL 94VO housing EN 60601 1 EN 60601 1 1 EN 60601 1 2 Fi Compartmental Pressure Monitor Daniaid iry SYNTHES usa Abridged Instructions for use 1 Prepare lhe puncture sile 2 Connect a sterile probe to the monitor 4 Obierve tho display until iA indicates T00 mm Hg 4 Insert a 14 gaupe cannula into the compartment and remove the needie 5 Insert the probe 530 412 inio the compar2. Synthes 7 Care and Maintenance Cleaning the monitor To clean the monitor wipe with a soft cloth and a mild detergent Important Do not use solvents to disinfect the monitor Do not place under water or immerse into liquids The connector must not contact water or solvent Danger of short circuiting Do not sterilize the monitor 8 Synthes Compartmental Pressure Monitoring System User s Manual Cleaning the pressure measuring probe Important Failure to follow the cleaning instructions properly may render the probe unusable Always clean and sterilize the probe before the first surgical use and immediately after each subsequent use Never immerse the connector in water or cleaning solution Always place the silicone cap over the connector prior to cleaning and sterilizing the probe Do not use ultrasonic baths to clean the probe Do not use brushes wires needles sharp objects or other mechanical aids to clean the probe Do not attempt to dislodge objects or dried blood from the sensor window using sharp objects pickups or by rubbing with fingernails Use only lukewarm water and a paper towel Do not use hydrogen peroxide sodium hypochlorite or solvents to clean the pressure measuring probe 1 Run water over probe tip Manually remove blood and body fluids by running lukewarm maximum 65 C 149 F water over the tip of the probe If the probe cannot be clea
3. Pressure Monitoring System CPMS Version XX X Measurements Available Xx 3 Disconnect probe Immediately disconnect the probe from the hand held monitor Disconnecting the probe at this point ensures that the probe s counter has not been decreased Important The probe should be disconnected after the number of measurements available is displayed The probe s counter will be decreased 3 seconds after the first display of the number of measurements available Following the 3 seconds the message Measurements Available XX will be displayed again showing that the counter has now been decreased by one measurement Synthes 13 Changing the Battery The monitor uses a standard 9 V battery type 6LR61 The battery is housed within the battery compartment on the back of the hand held monitor To open the battery compartment use a Synthes 2 5 mm hexagonal screwdriver The battery compartment lid can be opened without completely removing the screws When replacing the battery match the polarity indicated in the battery compartment Reversing the polarity when inserting the battery may damage the unit Once the battery has been secured in the battery compartment position the battery compartment lid and tighten the screws The screws should not be over tightened as this may damage the screw threads or the battery compartment lid 14 Synthes Compartmental Pressure Monitoring System User s M
4. meter 6 5 foot sterilizable cable Preserves the sterile field when measuring compartmental pressure in the operating room Convenient for indwelling continuous pressure monitoring To check the number of measurements left without decreasing the counter refer to page 13 Synthes 3 Indications The Synthes Compartmental Pressure Monitoring System Is intended for the immediate or continuous measurement of intracompartmental pressures The system includes a hand held monitor with a liquid crystal display a probe and an optional extension cable Pressure detected by the unicrystalline piezoelectric semiconductor embedded at the end of the probe creates an electric signal that is sent to the hand held monitor and displayed 4 Synthes Compartmental Pressure Monitoring System User s Manual Operating Instructions Important The probe and extension cable are provided nonsterile They must be cleaned and sterilized prior to first use and between uses following the cleaning and sterilization instructions provided in this manual 1 Prepare puncture site Prepare the puncture site according to hospital guidelines and inject local anesthetic if necessary 2 Connect sterile probe Connect a sterile probe or the probe extension cable assembly to the monitor 3 Observe display Observe the display until the message SYSTEM READY appears followed by 000 mmHg Refer to the Sys
5. anual Compartmental Pressure Monitoring System 150 001 306 001 Carrying Case 530 411 Monitor 530 412 Probe 530 413 Extension Cable Synthes 15 SYNTHES 2000 Synthes Inc or its affiliates All rights reserved Synthes USA Synthes Canada Ltd 1302 Wrights Lane East 2566 Meadowpine Boulevard West Chester PA 19380 Mississauga Ontario L5N 6P9 Telephone 610 719 5000 Telephone 905 567 0440 To order 800 523 0322 To order 800 668 1119 Fax 610 251 9056 Fax 905 567 3185 www synthes com Synthes is a trademark of Synthes Inc or its affiliates Printed in U S A 2 10 J4990 C
6. be measured using the 14 gauge cannnula Battery low The battery Is low Keep using the hand held monitor until the Battery Empty message is displayed Change the battery before next use Battery empty change battery The battery is drained Do not unplug the probe from the monitor Do not remove the probe from the compartment Replace the battery with a new 9V 6LR61 battery The system will reinitialize without decreasing the probe s counter Wrong probe The hand held monitor does not recognize the probe Use a Synthes Probe 530 412 only Probe overheated during sterilization The probe was sterilized at a temperature higher than 134 C Replace the probe No measurements available change probe The probe has been used 25 times Replace the probe Probe malfunction The probe is damaged Replace the probe System malfunction The probe is damaged Replace the probe 12 Synthes Compartmental Pressure Monitoring System User s Manual Checking the Number of Remaining Measurements The Compartmental Pressure Monitoring System allows the user to verify the number of measurements left on a probe without decreasing the probe s counter To check the number of remaining measurements 1 Connect probe to monitor Connect the probe to the hand held monitor 2 Observe display Observe the display attentively for the following messages Synthes Compartmental
7. iment through the cannula 6 Retract the cannula completely or refer to the Users Manual for alternate teahn gue T Read the measurement B Determine palkent risk using ihi pressure displayed or calculata AF For detailed tachnimus care arsi ani rrianint ani boutieihogling pasa misr jm thp Comparimenia Prirast Maiitoring Ayata User s Mamin Battery compartment Houses a 9 V battery LCD display Displays system messages pressure measurements and probe usages remaining 530 411 Monitor ior Gomparimental Saral Nwmbar Pressure Monitoring System SYNTHES Usa nismos Synths UGA MADE iN GERMANY 10i Symhes Ave Monument CO Apia Protecheg pinsi siecincal shock AOC Sa aeT OF Bod Flosiing a weg 2 Synthes Compartmental Pressure Monitoring System User s Manual Probe 530 412 Converts pressure to an electrical signal Powers system on when connected to the monitor eee j Built in usage counter is decreased during the initialization i phase each time the probe is connected to the monitor Sterilizable and reusable 25 times after which the probe EAA PEN no longer functions and the hand held monitor displays the message NO MEASUREMENTS AVAILABLE CHANGE PROBE Size 4 French Total length 64 cm Requires a 14 gauge intravenous cannula for insertion into the compartments Extension Cable 530 413 May be used to connect a probe to the monitor 2
8. ned immediately after use place the probe tip in a bowl of water to ensure that the blood does not dry on it Do not place the connector in the water 2 Wipe probe Carefully wipe the probe with a paper towel Avoid applying excessive pressure on the sensor window 3 Rinse with water Rinse the probe with distilled water 4 Wipe with disinfectant Wipe the connector with a 70 alcohol disinfectant Do not immerse the connector Synthes 9 Care and Maintenance continued Disinfecting the pressure measuring probe Always follow the instructions of the manufacturer of the disintecting solution when disinfecting the probe Care should be taken never to immerse the connector in disinfecting solution The probe should be rinsed with distilled water and allowed to dry prior to sterilization Cleaning the extension cable Important Do not immerse the connectors Wipe the cable and connectors with a 70 alcohol disinfectant If blood has dried on the cable soak the cable in a bowl of lukewarm water to dissolve the blood Do not immerse the connectors 10 Synthes Compartmental Pressure Monitoring System User s Manual Sterilization Steam autoclave temperature should not exceed 134 C Temperatures in excess of 134 C will damage the probe The silicone cap prevents steam from entering the connector to protect the electronic circuitry in the probe The inside of the connector is therefore n
9. ot sterile and precautions should be taken to ensure that sterile personnel do not touch the inside of the connector while plugging it into the sterile extension cable or nonsterile monitor Synthes recommends a 10 minute drying cycle and a 30 minute cooling time after the probe has been removed trom the autoclave prior to use These parameters are validated to sterilize only these devices The autoclave must be properly installed maintained and calibrated Important Do not sterilize the hand held monitor The probe and extension cable should be steam sterilized in accordance with the following guidelines Minimum Time Temperature Exposure Wrapped Prevacuum 132 134 C 4 minutes 270 273 F Unwrapped Prevacuum 132 134 C 4 minutes 270 273 F Synthes 11 System Messages and Troubleshooting The hand held monitor displays messages referring to the status of the system If the display does not come on when the probe is connected replace the battery If suggested solutions are unsuccessful call the Synthes Service Department at 1 800 288 6698 for servicing information Message Description Action Required Measurements available XX Number of measurements available None tor the probe plugged into the monitor System ready The system is operational and ready None to be used 000 mmHg The system is ready to measure Insert the probe in the the pressure compartment to
10. tem Messages and Troubleshooting section page 11 for all messages displayed Synthes 5 Operating Instructions continued 4 Insert cannula Insert a 14 gauge intravenous cannula into the muscle compartment Remove the trocar carefully making sure the cannula remains in place 5 Insert probe Insert the probe into the muscle compartment through the cannula 6 Retract cannula Retract the cannula completely If repeated measurements through the same site are planned make sure to retract the cannula at least one centimeter from the tip of the probe to expose the sensor 6 Synthes Compartmental Pressure Monitoring System User s Manual 7 Read pressure Read the compartment pressure displayed on the monitor 8 Determine risk Determine patient risk using the pressure displayed or calculate AP diastolic pressure minus pressure displayed Caution To avoid false high readings care should be taken to insert the needle and probe parallel to the muscle fibers The measurement is an indication of the pressure at the insertion site If the needle is inserted into the intramuscular tendon or if crosswise tensed muscle fibers press on the measuring window a false high reading may be obtained The surgeon should exercise clinical judgment and use other available information including symptoms when diagnosing compartment syndrome EFESE u i i ia E iT Sure ee
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