Related Manuals for Delfi PTS ii
Summary of Contents for Delfi PTS ii
- Page 1 ENGLISH PTS ii Personalized Tourniquet System® Operator & Maintenance Manual 9-2200-001B/R delfimedical.com Pat.:www.delfimedical.com/patents...
- Page 3 Delfi Medical Innovations Inc. (‘Delfi’) warrants the components of the PTS ii Personalized Tourniquet System (‘product’) from date of purchase as follows: PTS ii instrument and accessories (2 years), and rechargeable battery (90 days). 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.
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Page 4: Table Of Contents
CONTENTS GENERAL INFORMATION ........4 INTENDED USE ............. 4 CONTRAINDICATIONS ........... 4 WARNINGS ............4 PRECAUTIONS IN USE ........... 5 ADVERSE EFFECTS..........7 SPECIFICATIONS ........... 7 EN 60601-1 CLASSIFICATION ......... 9 EMISSIONS/IMMUNITY ........9 OPERATING INSTRUCTIONS ......11 INITIAL INSPECTION ..........11 FEATURES............ - Page 5 CONTENTS PERIODIC MAINTENANCE ........46 CALIBRATION ............. 47 LEAK TESTING .............. 50 BATTERY TESTING AND REPLACEMENT ....50 BATTERY TESTING ............51 BATTERY PACK REPLACEMENT ........51 INTERNAL HARDWARE SERVICING ...... 52 TROUBLE SHOOTING GUIDE ....... 52 TROUBLESHOOTING ............ 52 ACCESSORIES AND REPLACEMENT PARTS ...
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Page 6: General Information
INTENDED USE The Delfi PTS ii Portable Tourniquet System is intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Tourniquets are generally used for operations lasting less than 90 minutes. -
Page 7: Precautions In Use
• History of pain or weakness in muscles or bones in extremities • Increased intracranial pressure. Delfi recommends that users regularly review published medical literature for other factors that warrant careful consideration before use of a tourniquet during surgical procedures. - Page 8 Tourniquet users must be familiar with the inflation / deflation sequence when using two tourniquet cuffs and two PTS ii units together for IVRA (Bier Block anesthesia), so that the wrong tourniquet will not be released accidentally, which could cause severe injury to the patient or death.
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Page 9: Adverse Effects
Reperfusion injury may occur to the limb and produce systemic effects if the tourniquet inflation is prolonged • Hematoma Delfi recommends that users regularly review published medical literature for other adverse effects that warrant careful consideration before use of a tourniquet during surgical procedures. SPECIFICATIONS... - Page 10 GENERAL INFORMATION Line Current 175 mA RMS @ 120V ~ (AC) typical, Delfi (REF 7-2200-020) Input Power 100 watts maximum (REF 7-2200-020) AC Power Plug (North America) Hospital grade, 3 prong straight blade, 15 amp Power Cord Medical grade NEMA 5-15P, type SJT, AWG 18, 2.45 m (8 ft)
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Page 11: En 60601-1 Classification
EMISSIONS/IMMUNITY The Delfi PTS ii complies with EMC criteria set forth in EN 60601-1-2. The user of this device should be aware that precautions should be taken in regards to EMC. The device should be installed and used according to the EMC information provided in the instructions for use. - Page 12 GENERAL INFORMATION Cable Maximum length 2.45 m (8 ft) ~ AC Power Mains power cord WARNING: use of an ~ AC Power Mains power cord with a length other than those specified may result in increased emissions and decreased immunity GENERAL INFORMATION...
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Page 13: Operating Instructions
OPERATING INSTRUCTIONS INITIAL INSPECTION Unpack the PTS ii upon receipt and inspect the unit for any obvious damage that may have occurred during shipment. We recommend that this inspection be performed by a qualified biomedical engineer or other person thoroughly familiar with electronic medical devices. - Page 14 OPERATING INSTRUCTIONS BACK To Instrument OPERATING INSTRUCTIONS...
- Page 15 OPERATING INSTRUCTIONS MAIN SCREEN – DEFLATED Power Status Indicator PRESSURE Button / Indicator TIME Button / Indicator INFLATE SETTINGS Button Button OPERATING INSTRUCTIONS...
- Page 16 OPERATING INSTRUCTIONS MAIN SCREEN – INFLATED Power Status Indicator PRESSURE Button / Indicator TIME Button / Indicator DEFLATE Button / Slider OPERATING INSTRUCTIONS...
- Page 17 A PTS ii hose assembly is supplied with each PTS ii. The male connector on the hose plugs into the female Positive Locking Connector on the PTS ii (see above). The other end of the hose has a female Positive Locking Connector that plugs into cuffs with female Positive Locking Connectors.
- Page 18 Power Receptacle The power receptacle is located on the left of the battery compartment from a rear view of the PTS ii. The PTS ii is designed for use with the supplied AC power supply (see below) only; do not use any other type of connection to AC power An AC power supply adapter is supplied with every PTS ii.
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Page 19: Touchscreen Buttons And Icons
OPERATING INSTRUCTIONS TOUCHSCREEN BUTTONS AND ICONS Various colored buttons and icons are used in the PTS ii and described below. Button/Indicator Title Description Warning Indicator Indicates a warning condition or system failure Alarm Paused Indicator Indicates an alarm is paused... - Page 20 OPERATING INSTRUCTIONS Button/Indicator Title Description PRESSURE Indicates the current cuff pressure in the center of Button / Indicator the PRESSURE indicator The scale of the PRESSURE indicator is indicated by the orange lower scale and upper scale markers The pressure set-point is indicated by the green marker NOTE: If a pressure alarm is present, a pressure...
- Page 21 OPERATING INSTRUCTIONS Button/Indicator Title Description Touch and slide the DEFLATE button to the left side DEFLATE Button / Slider of the DEFLATE slider and hold for ~1 second to deflate cuff STOP Button Touch to stop leak test INCREMENT Button Touch to increment selected parameter DECREMENT Button Touch to decrement selected parameter...
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Page 22: Initial Setup
WARNING: Use only a Delfi (REF 7-2200-007) NiMh battery pack with your PTS ii. Do not use any other battery pack. Use of an improper battery pack may cause irregular operation that could be hazardous to the patient and/or user, and may... -
Page 23: Automatic Diagnostic And Calibration Checks
These automatic checks verify certain System Functions through diagnostics and calibration to system standards. Connect the power supply to the PTS ii, then connect the AC power plug to a compatible grounded power source. Refer to Specifications under Section 1 General Information. Observe that the Status indicator... - Page 24 OPERATING INSTRUCTIONS After the startup routine is completed, the Main Screen appears • “0 mmHg” is indicated in the PRESSURE indicator • If a number other than zero is indicated in the PRESSURE indicator, the unit should be calibrated by a qualified technician.
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Page 25: Manual Tests And Checks
OPERATING INSTRUCTIONS MANUAL TESTS AND CHECKS These manual tests and checks verify certain System Functions and include Pressure and Time set-point tests and Calibration and Low-Pressure Alarm checks. Pressure Set-Point Adjustment Test: • Enter the pressure adjustment mode by touching the PRESSURE button •... - Page 26 OPERATING INSTRUCTIONS • Touch the DECREMENT button to decrease the pressure set-point to 250 mmHg NOTE: If the pressure set-point is below 400, the instrument will automatically return to the normal pressure range (up to 400 mmHg) • Touch the PRESSURE button, or wait approximately 10 seconds to return to the Main Screen Time Set-Point Adjustment Test: •...
- Page 27 OPERATING INSTRUCTIONS Low Pressure Alarm Test: • Connect the PTS ii hose assembly and a cuff to the PTS ii • Touch the INFLATE button to inflate the cuff • Create a leak by partially detaching the hose from the unit while the cuff is inflated •...
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Page 28: Operation
Checks under Section 2 Operating Instructions • Successful completion of the self-check and calibration check indicates that the unit is ready for use • Connect the PTS ii hose assembly and a Delfi cuff or a tourniquet cuff with Positive Locking connector OPERATING INSTRUCTIONS... - Page 29 OPERATING INSTRUCTIONS to the unit at the hose connector WARNING: Do not allow foreign objects from entering the PTS ii, the hose assembly, or the cuff. This could damage/affect the performance of the PTS ii system Selecting a Pressure Set-Point: •...
- Page 30 OPERATING INSTRUCTIONS Inflating the Cuff: • When instructed by the physician, touch the INFLATE button to inflate the cuff to the pressure set-point (top image) • The DEFLATE button and slider will appear after the INFLATE button is touched (bottom image). OPERATING INSTRUCTIONS...
- Page 31 OPERATING INSTRUCTIONS Deflating the Cuff: • When instructed by the physician, deflate the cuff as follows: Touch and hold the DEFLATE button NOTE: An animation of a red arrow pointing towards a grey circle at the left of the DEFLATE slider will appear while the DEFLATE button is pressed Drag the DEFLATE button to the left of the DEFLATE slider...
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Page 32: Settings
Settings Menu is not accessible while the cuff is inflated LEAK TEST The PTS ii includes an automatic test feature to check for leakage from an attached cuff, hose and connectors. To perform a leak test, follow the instructions below: Setting Up for a Leak Test: •... - Page 33 OPERATING INSTRUCTIONS Initiating a Leak Test: • Press the INFLATE button to initiate a leak test • During a leak test, the cuff will inflate to approximately 250 mmHg and a 30 second leak test will commence. At the end of the test, the cuff will automatically deflate, and the test result will be displayed WARNING: Do not start a leak test (press the INFLATE button)
- Page 34 NOTE: This indicates that there is a leak in either the test cuff, hose, connection points or in the PTS ii internal pneumatics. Repeat the test with a variety of different cuffs and hose assemblies. If the unit continues to fail, the...
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Page 35: System Defaults Menu
The PTS ii has nine volume levels ranging from approximately 65 dB to a minimum of 75 dB when measured at 1 meter from the center of the touch screen. -
Page 36: Alarm And Warning Conditions
ALARM AND WARNING CONDITIONS There are a number of conditions for which the PTS ii will produce a visual and audible alarm. The appropriate actions indicated are based on the most probable causes and should only be used as a guide. Other causes of alarm and warning conditions may indicate a need for other actions. -
Page 37: Alarm And Warning Condition, And Error Code Tables
OPERATING INSTRUCTIONS VISUAL AND AUDITORY ALARM PRIORITY STATUS Indicator Light Auditory Priority Tone Auditory Pulse Pattern Comments Constant Red Technical 1 tone pulse per burst Indicates technical failure. Flashing Red High 10 tone pulses per burst Indicates immediate operator response is required. - Page 38 Test for Leaks This warning is only given when the cuff is deflated • If during the time that a cuff is inflated, the PTS ii detects minor leakage from the cuff, hose, or connectors, this warning is given. •...
- Page 39 1 second • Check lines and connections. If this condition persists without apparent cause, the PTS ii may require servicing • Alarm will stop automatically whenever the unit can regulate the cuff to within 15 mmHg of the pressure set-point •...
- Page 40 OPERATING INSTRUCTIONS Conditions Status Auditory Remarks and Appropriate Indicator Light Priority Tone Actions • Power switch was activated with cuff Flashing Yellow Medium Cuff pressure greater than not deflated zero when ON/STANDBY button pressed. The system assumes that a procedure is in progress and prevents activation of STANDBY mode...
- Page 41 OPERATING INSTRUCTIONS Conditions Status Auditory Remarks and Appropriate Indicator Light Priority Tone Actions • Time up Flashing Yellow Medium The unit’s elapsed timer, which advances when the cuff is inflated, has reached the time set-point and caused the time alarm to activate •...
- Page 42 ‘safe state’ mode* • Disconnect the hose and press the ON/STANDBY button twice to restart the unit • If this problem persists, the PTS ii requires calibration service. Refer to Calibration under Section 3 Maintenance OPERATING INSTRUCTIONS...
- Page 43 E0000 to E0008 Internal The unit detected a failure related to the internal electronics • electronics Physically separate ESU, ESU pencil and ESU cable from the PTS ii and PTS ii E0012 to E0014 failures power adapter (E0004) • Restart the unit by pressing the ON/STANDBY button twice.
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Page 44: Electromagnetic Compatibility (Emc) Guidance Tables
Note error code and the accompanied numeric code (if any) and contact Delfi ELECTROMAGNETIC COMPATIBILITY (EMC) GUIDANCE TABLES The following tables provide guidance on needs and installation of the PTS ii regarding electromagnetic compatibility. EMC GUIDANCE AND DECLARATION - EM EMISSIONS Guidance and Manufacturer's Declaration - Electromagnetic Emissions The PTS ii Personalized Tourniquet System is intended for use in the electromagnetic environment specified below. - Page 45 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The PTS ii Personalized Tourniquet System is intended for use in the electromagnetic environment specified below. The customer or the user of the PTS ii should ensure that it is used in such an environment. Electromagnetic Environment –...
- Page 46 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The PTS ii Personalized Tourniquet System is intended for use in the electromagnetic environment specified below. The customer or the user of the PTS ii should ensure that it is used in such an environment. IEC 60601 Electromagnetic Environment –...
- Page 47 OPERATING INSTRUCTIONS should be considered. If the measured field strength in the location in which the PTS ii Personalized Tourniquet System is used exceeds the applicable RF compliance level above, the PTS ii Personalized Tourniquet System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the PTS ii Personalized Tourniquet System.
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Page 48: Maintenance
Delfi staff poses a risk of electric shock, damage to the unit, and injury to the patient and will void all warranties. Internal parts in the PTS ii can only be serviced at the factory by Delfi staff. Please contact Delfi if you have problems with your... -
Page 49: Calibration
• Suitable pneumatic hoses and connectors. Note: A calibration hose set Delfi (REF 9-2200-612) can be purchased from Delfi to connect the end of the PTS ii hose to a pressure source and a reference pressure gauge CAUTION: The following steps must be taken in the exact order to calibrate the unit. Failure to do so may result in... - Page 50 Once the zero point is calibrated, press the SCROLL RIGHT button to advance the unit to the next pressure level. The display will now show “100 mmHg” • Connect the PTS ii to the pressure source and a reference pressure gauge • Apply a calibrated reference pressure of 100 ± 1 mmHg to the cuff port •...
- Page 51 Setting Up the Calibration Check: • Connect the PTS ii hose assembly to the PTS ii, then connect the hose to a reference pressure gauge known to be accurate (e.g. manometer or calibrated gauge) •...
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Page 52: Leak Testing
A new battery pack is designed to run the PTS ii without AC power for up to 10 hours of typical use on a full charge; however, this charge life will vary greatly depending on the conditions of use. The life and performance of the battery pack also depend on the conditions of use and storage. -
Page 53: Battery Testing
It is recommended that the battery in the PTS ii be tested as described below every 3 months and replaced annually. Even when the PTS ii is used on AC power, the battery pack must be in good condition to provide backup power in the... -
Page 54: Internal Hardware Servicing
Delfi staff poses a risk of electric shock, damage to the unit, and injury to the patient and will void all warranties. Internal parts in the PTS ii can only be serviced at the factory by Delfi staff. Please contact Delfi if you have problems with your... - Page 55 External leak (cuff or hose) Correct leak to clear leak alarm Internal leak Test for leaks. Refer to Leak Testing under Section 3 Maintenance Disconnect PTS ii from cuff to Internal hardware failure deflate cuff if required. Contact Delfi BATTERY FAILURE alarm...
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Page 56: Accessories And Replacement Parts
Mail Telephone Website Delfi Medical Innovations Inc. 800.933.3022 (US & Canada) www.delfimedical.com 106 - 1099 West 8th Avenue 604.742.0600 (Global) Vancouver BC Canada V6H 1C3 NOTE: We strongly recommend that all repairs be done by Delfi or authorized personnel MAINTENANCE... -
Page 57: Warnings, Cautions & Symbology
WARNINGS, CAUTIONS & SYMBOLOGY WARNINGS, CAUTIONS & SYMBOLOGY WARNINGS, CAUTIONS & SYMBOLOGY Below are graphical warning, caution and other symbols indicated on the PTS ii and within this manual: Graphic Description Type B Medical Equipment Refer to instruction manual / booklet ... - Page 58 WARNINGS, CAUTIONS & SYMBOLOGY Graphic Description Indicates manufacturer and is accompanied by the name and address of the manufacturer cTUVus: Medical Equipment with respect to electrical shock, fire and mechanical hazards and electromagnetic compatibility only. In accordance with CAN/CSA – C22.2 No. 60601:14, ANSI/AAMI ES60601-1:2005 and A2 (R)2012 and A1.
- Page 60 Delfi Medical Innovations Inc. 106 - 1099 West 8 Avenue Vancouver BC V6H 1C3 Canada 800.933.3022 (US & Canada) 604.742.0600 (Global Tel) delfimedical.com ©2022 Delfi Medical Innovations Inc. Printed in Canada 4-2200-025 Rev 7 2022-08-22...