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OPERATOR AND MAINTENANCE MANUAL
DELFI PTS ii PORTABLE TOURNIQUET SYSTEM
U.S. PATENTS 6,213,939; 5,931,853; 5,649,954 PAT. PEND. and FOREIGN PATENTS
REF 9‐2200‐001X
Delfi
Delfi Medical Innovations Inc.
Vancouver BC, Canada
800‐933‐3022 (US & Canada)
604‐742‐0600 (Global)
Fax. 604‐742‐3800
www.delfimedical.com
medical
innovations inc.
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Summary of Contents for Delfi PTS ii
- Page 1 OPERATOR AND MAINTENANCE MANUAL DELFI PTS ii PORTABLE TOURNIQUET SYSTEM REF 9‐2200‐001X U.S. PATENTS 6,213,939; 5,931,853; 5,649,954 PAT. PEND. and FOREIGN PATENTS Delfi medical innovations inc. Delfi Medical Innovations Inc. Vancouver BC, Canada 800‐933‐3022 (US & Canada) 604‐742‐0600 (Global) Fax. 604‐742‐3800 www.delfimedical.com ...
- Page 2 LIMITED TWO YEAR WARRANTY (North America. only) SCOPE OF WARRANTY Delfi Medical Innovations Inc. (‘Delfi’) warrants the PTS ii Portable Tourniquet System (‘product’) for two years from date of purchase. During the warranty period, Delfi will repair or replace, at its option, any product which is defective in materials or workmanship or which fails to meet the published specification for that model. This Limited Warranty is made only to the original purchaser of the product and is non‐transferable. The remedies described in the Limited Warranty are the exclusive remedies for breach of warranty. THIS WARRANTY SHALL NOT APPLY TO ANY PRODUCT WHICH HAS BEEN ALTERED, MODIFIED, DISASSEMBLED OR SERVICED BY ANYONE OTHER THAN DELFI STAFF IN ANY WAY, OR WHICH HAS BEEN SUBJECTED TO MISUSE OR ABUSE. DISCLAIMER OF IMPLIED WARRANTIES The foregoing Express Limited Warranty is given in lieu of any and all other express or implied warranties. DELFI MAKES NO OTHER WARRANTIES INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. LIMITATION OF REMEDIES In no case shall Delfi Medical Innovations Inc. be liable for any special incidental or consequential damages whether based on breach of warranty or other legal theory. Some states do not allow limitations on warranties or on remedies for breach in certain transactions. In such states, the limits in this paragraph and the preceding paragraph do not apply. WARRANTY CLAIMS In the event of a warranty claim within the warranty period please take the following steps: 1. Notify Customer Service Department, Delfi Medical Innovations Inc. at 800‐933‐3022. Please provide details about the nature of the problem and include the product serial number. Upon receipt of this information, Delfi will provide a date for service or a return shipping authorization. 2. Upon receipt of the shipping authorization, forward the equipment, freight prepaid, to the location specified in the shipping authorization. Your compliance with these steps will help assure that you receive prompt warranty service for your product. WARRANTY (OUTSIDE North America) Please contact Delfi for warranty information. Unit Serial Number _________________ AC Power Supply Serial Number _________________ ...
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Page 3: Table Of Contents
TABLE OF CONTENTS Delfi PTS ii TOURNIQUET SYSTEM SECTION TITLE PAGE SECTION 1.0 GENERAL INFORMATION .................... 3 SPECIFICATIONS........................3 INTENDED USE........................4 CONTRAINDICATIONS......................4 PRECAUTIONS IN USE ......................4 ... -
Page 4: Section 1.0
Guidance and manufacturer's declaration - electromagnetic emissions Pressure Regulation: The PTS ii tourniquet system is intended for use in the electromagnetic environment +/‐ 6 mmHg of set point (10‐second average under non specified below. The user of the PTS ii tourniquet system should assure that is used in such an environment. transient conditions without external leaks) Emissions Test... -
Page 5: Intended Use
1.4 PRECAUTIONS IN USE 1.2 INTENDED USE The tourniquet system must be kept well calibrated The Delfi PTS ii Portable Tourniquet System is intended to and in operable condition. Accessories should be be used by qualified medical professionals to temporarily checked regularly for leaks and other defects. occlude blood flow in a patient's extremity during surgical The tourniquet cuff must never be punctured; procedures on that extremity. Tourniquets are generally therefore towel clips used near the system must be ... -
Page 6: Adverse Effects
Whenever IVRA (Bier Block anesthesia) is used, it is guination before tourniquet application may be done without the use of an elastic bandage by elevating recommended that the tourniquet remain inflated for the limb for 3 to 5 minutes. at least 20 minutes from the time of injection. In case of failure, the tourniquet cuff must be fully 1.5 ADVERSE EFFECTS deflated and the limb exsanguinated again before A ... -
Page 7: Section 2.0
If the unit is damaged, notify the carrier and Delfi immediately. If the initial inspection results are satisfactory, a functional and calibration check should be Icon Function performed after an 10 hour charge. The attention label ... - Page 8 AC Power Supply The red alarm indicator light is illuminated when any An AC power supply adapter is supplied with every PTS ii alarm condition exists. The alarm indicator will remain unit. It is a sealed unit designed specifically for the PTS ii. illuminated until the alarm condition is corrected, as long Contact Delfi if your power supply needs service or as sufficient power is available. replacement. Plug the connector on the AC power supply 8. Battery Indicator Symbol cord into the AC power receptacle on the PTS ii unit (see The battery indicator symbol in the center of the color ...
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Page 9: Figure 2.1: Pts Ii Controls, Indicators, Displays, And Connectors
Figure 2.1: PTS ii Controls, Indicators, Displays, and Connectors ... -
Page 10: Figure 2.2: Pts Ii Single System Mounting Bracket (7-2200-008)
Figure 2.2: PTS ii Single system mounting bracket (7‐2200‐008) Figure 2.3: PTS ii Twin system mounting bracket (7‐2200‐009) ... -
Page 11: Initial Setup
AC power is connected it remains on constantly. WARNING: Use only a Delfi REF 7‐2200‐020 or 7‐2200‐021 AC power supply and cord assembly Figure 2.2 Welcome Screen supplied with your PTS ii. Do not use any other AC ... - Page 12 Calibration‐check is displayed (Figure 2.4). Locking Connector to Luer adapter supplied with During this time, the unit is checking its calibration your PTS ii unit to connect the end of the PTS ii at zero pressure. hose to the reference gauge. b) Power up the unit by pressing the ‘ON/STANDBY’ Figure 2.4 button. Calibration Check c) Enter the pressure adjustment mode by pressing the pressure adjustment button. ...
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Page 13: Pressure Set Point Adjustment
2.5 PRESSURE SET POINT ADJUSTMENT Figure 2.7 Extended Pressure Mode a) At the main screen (Figure 2.5), momentarily press the pressure adjustment button. The PTS ii will display the pressure adjustment screen (Figure 2.6). A pressure gauge icon is displayed and the pressure set point is highlighted to indicate that the set point is being adjusted. b) Use the increment and decrement buttons to modify the pressure set‐point value. ... -
Page 14: Tourniquet Time Reset
Figure 2.10 2.7. TOURNIQUET TIME RESET System Settings and Special Features The elapsed tourniquet time may be reset to zero at any time after the cuff has been inflated. a) At the time limit set point adjustment screen (Figure 2.7) momentarily press the TIME RESET button. The reset confirmation screen will be shown (Figure 2.9). Press the OK button to reset the ... -
Page 15: Set Default Pressure
Figure 2.12 2.10 SET DEFAULT PRESSURE Leak In Progress The pressure set point will be set to the default pressure when the system is powered on. a) At the main screen (Figure 2.5) press the settings button to enter the settings menu (Figure 2.10). b) To adjust the default pressure set point, move the highlighting box to the pressure gauge icon and press the OK button. c) Use the increment / decrement buttons to adjust the ... -
Page 16: Printer Label Size
(Figure 2.10). The PTS ii may be used with an optional industry standard thermal label printer (Delfi REF 9‐2200‐150 ). b) To adjust the alarm volume, move the highlighting The printer is supplied from Delfi with an appropriate box to the speaker icon and press the OK button. interface cable for use with either a single PTS ii system c) Use the increment / decrement buttons to adjust or with two PTS ii systems in a Twin configuration. ... -
Page 17: Operation
Follow the instructions included with the printer to setup and connect the printer to the PTS ii system(s). Figure 2.21 Printed Event Record (two labels) Note: When using a printer with two PTS ii systems in a Twin configuration both PTS ii systems must be powered on in order to print. During a surgical procedure the PTS ii maintains a record ... - Page 18 For each patient, tourniquet pressure required to on the patient's anatomy, age, and absence of occlude blood flow to the operative site should be vascular disease. In many operating rooms, it is set to the minimum effective pressure. The customary to prominently note the time of minimum effective pressure depends on many inflation, ...
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Page 19: Alarm Conditions
is held (in the absence of leaks). It is also likely that a 2.17 ALARM CONDITIONS tone will sound under these conditions. The ‘safe There are a number of conditions for which the PTS ii state’ mode helps prevent unexpected loss of occlusion will produce visual and audible alarms. Those during a procedure if a sudden failure occurs. conditions, indications and appropriate actions are shown in Table 2.1. The appropriate actions indicated Although it is very unlikely, internal hardware failures are based on the most probable causes and should only ... - Page 20 Table 2.1: Alarms and Warnings Condition Appropriate action / Remarks TEST FOR LEAKS This warning is only given when the cuff is deflated. The unit has detected leakage from the cuff, hose, or If during the time that a cuff is inflated connectors during the time the the PTS ii detects minor leakage from the cuff was inflated. cuff, hose, or connectors this warning is given. Press the OK button to clear the warning message Inspect the cuff, hose, and connectors for damage. Perform a leak test (see 2.X). CUFF PRESSURE HIGH Normally caused by transient conditions such as patient movement, regulator The unit has detected high overshoot, or hose occlusion. This pressure in the cuff. High condition, for an extended period, would pressure is defined as pressure indicate a hardware failure and the PTS ii ...
- Page 21 CUFF LEAK Connections, hose, and cuff should be checked and the leak repaired The unit has detected a large leak in the cuff, hose or OR connectors which is defined as Reduce pressure set point until unit can the cuff failing to reach the maintain pressure pressure set point in a reasonable time, or the pump OR running excessively while Press and hold ‘DEFLATE’ for 2 seconds to regulating the pressure and the deflate the cuff pressure set point is not being adjusted. Alarm message alternates with cuff pressure display CUFF PRESURIZED DURING The system assumes that a procedure is POWER UP in progress and adopts the sensed pressure as the new set point. The The unit has detected an operator should immediately check the approximate pressure of ...
- Page 22 LOW BATTERY Plug unit in. If the unit is not plugged in, a battery failure condition will occur and The battery voltage has dropped the unit will shut down in a fail safe to a level indicating that the unit mode closing all valves. While running should be plugged into AC with a Low Battery Voltage Alarm power for continued use, and to Condition other alarm conditions can charge the battery. not be guaranteed. OR Press ‘ON/STANDBY’ to shut unit down. Alarm message alternates with elapsed time display CUFF NOT FULLY DEFLATED Disconnect hose to cuff to exhaust pressure The unit has detected pressure in the cuff greater than 15mmHg, 30 seconds after the cuff has been deflated. Alarm message alternates with cuff pressure display ...
- Page 23 CHECK PRINTER Check that the printer is not out of labels; the labels are correctly installed; and the The unit has detected that the printer door is fully closed. printer is not ready to print. Alarm message alternates with elapsed time display NO PRINTER The unit was unable to communicate with the optional printer. Check to make The unit can not communicate sure the printer is correctly connected to with the optional printer. the PTS ii, and powered on. Alarm message alternates with elapsed time display BATTERY FAIL Press ‘ON/STANDBY’ to shut unit down. When cuff deflation is required, The battery voltage has dropped disconnect hose to cuff. Ensure that the below the threshold of safe ...
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Page 24: Section 3.0
Delfi staff poses a risk of electric performed as described in this section to ensure continual shock, damage to the unit, and injury to the patient and safe and effective operation. This section also serves as a will void all warranties. Internal parts in the PTS ii can guide to troubleshooting and expediting unscheduled only be serviced at the factory by Delfi staff. Please maintenance. The maintenance intervals listed below are contact Delfi if you have problems with your PTS ii unit provided as a guideline; refer also to the policies in your that cannot be resolved by following the maintenance practice setting for general tourniquet maintenance ... -
Page 25: Periodic Maintenance
3.2 PERIODIC MAINTENANCE signal from the pressure transducers during normal operation. The calibration factors are stored in memory. 3.2.1 CLEANING EQUIPMENT REQUIRED: The exterior of the unit may be cleaned as often as Calibrated 0 to 650 mmHg pressure gauge. required with a cloth that has been dampened (not Adjustable 0 to 650 mmHg pressure source. dripping) with a mild detergent. The exterior of the ... -
Page 26: Battery Testing And Replacement
The PTS ii features automatic battery charging and c) Install the new battery pack supplied by Delfi by monitoring functions and attempts to charge the aligning the keyed plug and pushing the connector battery whenever the unit is connected to AC power, ... -
Page 27: Internal Hardware Servicing
Internal parts in calibration, and troubleshooting procedures described the PTS ii can only be serviced at the factory by Delfi above do not restore normal operation, contact Delfi staff. Please contact Delfi if you have problems with ... - Page 28 Green AC indicator light does not AC power supply assembly not Ensure wall socket is working, of the illuminate when unit is plugged in plugged in to suitable wall outlet. correct voltage, and that the plug is all the to AC power. way in. AC power supply assembly not plugged in to PTS ii unit. Ensure connector is fully engaged. Incorrect AC power supply assembly. Ensure AC power adapter is the one supplied with the PTS ii unit. AC power supply not working Contact Delfi. AC indicator light not working. Contact Delfi. Red Alarm indicator light does not Alarm indicator light not working. Confirm that alarm indicator light illuminate during alarm conditions. illuminates during self‐check upon power‐ up. Contact Delfi. No cuff pressure and/or tourniquet Faulty pressure/time display. Confirm that all segments of the display time reading. illuminate during self‐check upon power‐ up. Internal hardware failure. Contact Delfi. Pump runs continuously. External leak (cuff or hose). Correct leak to clear leak alarm. Internal leak. ...
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Page 29: Figure 3.1: Labels
ST O RE AT ROO M TEMPERATURE OR CO OLER. REF 7-2200-021 O NLY. DO NOT INCINERATE. Delfi Me d ic a l Innova tions Inc . REC YC LE / DISPOSE AT PROPER FAC ILITY Delfi Va nc ouver BC Ca na d a 800-933-3022 ... - Page 30 Delfi medical innovations inc. Delfi Medical Innovations Inc. Vancouver BC, Canada 800‐933‐3022 (US & Canada) 604‐742‐0600 (Global) Fax. 604‐742‐3800 www.delfimedical.com © 2009 Delfi Medical Innovations Inc. Abatis Medical Technologies Limited Ballybrohan, Killaloe Printed in Canada 0197 County Claire, Ireland (Eire) 4‐2200‐025 Rev. 2 ...