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GE Healthcare

TuffSat

Pulse Oximeter

User’s Guide and Service Manual

Summary of Contents for TuffSat

Page 1: ...GE Healthcare TuffSat Pulse Oximeter User s Guide and Service Manual ...

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Page 3: ...ut printing data see the appendix Printer Features and Use PIr button Press to display the PIr pulsatile value Press again to cancel the PIr display Sensor connector Connect a Datex Ohmeda sensor or sensor cable approved for use with the TuffSat Pleth bar Segments flash to match pulse rate Number of flashing segments indicates pulse strength Backlight button Press to power on the backlight Press a...

Page 4: ...es must be performed by authorized service personnel Repair this device or its parts only in accordance with instructions provided by the manufacturer To order replacement parts or for assistance contact an authorized service office When shipping the monitor for repair clean the monitor allow it to dry completely and pack it for shipment in the original shipping container if possible Trademarks Tu...

Page 5: ...fety oximeter 1 7 Patient safety sensors 1 7 Cleaning 1 7 Maintenance and repair 1 8 Disposal 1 8 2 Oximeter Features and Use Product information labels 2 1 Oximeter features and controls 2 2 PIr pulsatile value display 2 3 Top view 2 3 Checking normal operation 2 4 Using the oximeter 2 5 Data validity and signal strength 2 6 Pleth bar pulse rate and strength indicator 2 6 3 Maintenance Troublesho...

Page 6: ...ronment 4 4 Dimensions and weight 4 4 A Printer Features and Use Functions and features A 1 How the TuffSat stores data A 1 Printer components A 2 Using the printer A 2 Powering the printer A 2 Positioning the oximeter and printer A 3 Printing data A 3 Sample printouts A 4 Real time printout and Trend 1 printout A 4 Trend 2 printout A 5 Troubleshooting A 5 Printer maintenance A 6 Replacing printer...

Page 7: ...o the optional Hewlett Packard Infrared Printer HP 82240B For information on ordering and using this printer with the TuffSat see the appendix Printer Features and Use Important Only OxyTip sensors can be used with this monitor Clinical use The TuffSat is designed specifically for spot checking arterial oxygen saturation SpO2 and pulse rate This easy to use oximeter is ideal for use in the environ...

Page 8: ...system provides reliable readings during times of low perfusion motion or electrical interference The TuffSat oximeter employs an analog digital A D converter and maximized digital signal processing techniques to produce samples for the TruTrak system to process The result is a highly reliable level of oximetry performance Theory of operation The TuffSat oximeter uses a two wavelength pulsatile sy...

Page 9: ...on of light energy due to arterial blood flow Absorption Time Figure 1 2 Comparative light absorption The sensor s photodetector collects and converts the light into an electronic signal Since O2Hb and HHb allow different amounts of light to reach the photodetector at the selected wavelengths the electronic signal varies according to which light source is on red or infrared and the oxygenation of ...

Page 10: ...ill differ in situations where a patient s COHb or MetHb are increased Increased patient COHb leads to falsely increased SpO2 in all pulse oximeters Assumptions The calculation of SpO2 assumes 1 6 carboxyhemoglobin COHb 0 4 methemoglobin MetHb and no other pigments These values are based on the Datex Ohmeda Pulse Oximeter Empirical Calibration Study Appreciable variation from these values will inf...

Page 11: ...ustrated below Figure 1 4 Circuit board block diagram Power on off control reset control Infrared IR wireless transmitter Keys Ambient light detection Backlight LED Processor Code memory and Data memory Watchdog timer Alphanumeric LCD and LCD driver Sensor LED drive Sensor Analog front end Timing Analog Signal Path A D converter Power supply ...

Page 12: ...fore always verify unusual data by performing a formal patient assessment Warning Do not use the oximeter if it fails to function as described or if the validity of data is questionable Refer to the appropriate sections of this manual to identify and correct the malfunction Data validity Warning To prevent erroneous readings do not use an inflated blood pressure cuff or arterial blood pressure mea...

Page 13: ...blistering skin discoloration ischemic skin necrosis and skin erosion may warrant changing the site frequently or using a different style of sensor Warning Discard a damaged sensor immediately Do not repair a damaged sensor or use a sensor repaired by others Warning To prevent patient injury or equipment damage use only Datex Ohmeda sensors approved for use with this oximeter For complete informat...

Page 14: ...ho are trained in the repair of this equipment Caution Internal electronic components are susceptible to damage by electrostatic discharge To avoid damage when disassembling the oximeter observe the standard precautions and procedures for handling static sensitive components Disposal Caution When the oximeter has reached the end of its useful life dispose of it in accordance with local procedures ...

Page 15: ...r Instructions for using the oximeter Information to help you determine the validity of the SpO2 and pulse rate values you see on the oximeter Product information labels Labels on the TuffSat oximeter provide product information Agency and regulatory symbols are described in chapter 4 SpO2 Not for continuous monitoring The TuffSat has no alarms audible or visual It is to be used only for spot chec...

Page 16: ...are erased from memory when the oximeter is powered off Backlight button Press to power on the backlight Press again to power it off PI I I Ir r r r button Press to display the PIr pulsatile value Press again to cancel the PIr display Oxygen saturation SpO2 Pulse rate in beats per minute Low battery and print icons Flashes on and off until the batteries are replaced or until no power remains Indic...

Page 17: ...is number represents the relative perfusion blood flow at the sensor site Indicates that the PIr pulsatile value is being displayed Infrared IR transmitter port Port through which real time and trend data are transmitted from the oximeter to the optional printer Sensor connector Receptacle for connecting a Datex Ohmeda sensor refer to the instructions for the sensor ...

Page 18: ...es its self test verify the following The backlight illuminates All display elements including the printer and battery screen icons illuminate briefly then all turn off The backlight remains on until dashes are displayed for the SpO2 and pulse rate values NOTE If the low battery icon flashes on and off continuously change the batteries as instructed in chapter 3 3 Place a sensor on your finger and...

Page 19: ...inical evaluation of the patient See Data validity and signal strength later in this chapter If the oximeter fails to function as described refer to Troubleshooting in chapter 3 WARNING Patient safety When the display indicates an error condition or the oximeter appears to be operating abnormally disconnect the sensor immediately Patient conditions such as reddening blistering skin discoloration i...

Page 20: ...y If possible remove sources of electrical interference such as electrosurgical and electrical electronic devices Pleth bar pulse rate and strength indicator The pleth bar a column of seven segments represents the plethysmographic waveform During monitoring the lowest segment is always on the other segments pulsate flash on and off The rate at which the segments pulsate represents the pulse rate T...

Page 21: ...y and equipment damage from leaking batteries remove the batteries when the oximeter is not to be used for some time Replacing oximeter batteries WARNING Fire explosion hazard Use only AA batteries in the oximeter WARNING Operator safety Do not handle hot or leaking batteries 1 Power off the oximeter 2 Use a flat blade screwdriver or coin to loosen the screw that secures the battery door to the ba...

Page 22: ... or solutions containing acetone freon or harsh solvents to clean the oximeter These substances may damage the oximeter and cause a malfunction Cleaning agents Mild detergent solution 3 4 glutaraldehyde Cidex Plus Quaternary germicides Virex 70 isopropyl alcohol 1 6 phenol Sporicidin 0 5 sodium hypochlorite bleach 1 Power off the oximeter 2 Wipe the display lens with a cotton swab moistened with a...

Page 23: ...splay is blank and the backlight is on there has been a software failure Replace the circuit board The unit failed the power on self test and or an internal component malfunctioned Power off then on again If the message reappears replace the circuit board The sensor is not properly applied to the patient or not connected to the oximeter Loss of signal quality Low perfusion an electrosurgery device...

Page 24: ...sensor connector assembly and the circuit board Disconnect the sensor and pour shake the liquid out of the sensor connector Replace the sensor connector assembly If the message reappears replace the circuit board Flashing on off The battery power is low 10 to 60 minutes remain for alkaline batteries the time remaining for nonalkaline batteries is not predictable Install new batteries Unexpected re...

Page 25: ...meter for damage or debris Inspect all parts for damage Remove debris and replace visibly damaged parts NOTE All parts are shown in Assembly drawing later in this chapter 1 Power off the oximeter and disconnect the sensor 2 Turn the oximeter face down and loosen the screw that secures the battery door Remove the door and the batteries 3 Remove the 3 screws that secure the back case to the front ca...

Page 26: ...ed 4 Position the circuit board in the front case Carefully bend the cable to position the sensor connector over its slot in the case Slide it into the slot Adjust the bumper around the sensor connector to ensure a snug fit 5 Align the notches on the back case with the bumper Be sure that the 2 battery contacts on the circuit board slip into the 2 slots in the battery compartment Press down on the...

Page 27: ...g and Service 3 7 Assembly drawing Battery door Battery door screw with washer Screw 3 Back case Bumper Sensor connector assembly Circuit board Battery contacts Button cover Lens Front case Lens gasket IR window Battery contacts ...

Page 28: ...6050 0005 566 Service kit circuit board 6050 0006 539 Service kit TuffSat yellow case 6050 0006 652 Includes Yellow back case and battery door yellow front case with installed lens lens gasket and IR window button cover blank label battery door screw with washer Phillips screws 3 Service kit TuffSat blue case 6050 0006 647 Includes Blue back case and battery door blue front case with installed len...

Page 29: ...006 077 Dutch 6050 0006 079 English 6050 0006 075 Finnish 6050 0006 081 French 6050 0006 083 German 6050 0006 085 Hungarian 6050 0007 250 Italian 6050 0006 087 Japanese 6050 0006 089 Norwegian 6050 0007 334 Polish 6050 0006 091 Portuguese 6050 0006 093 Russian 6050 0007 252 Spanish 6050 0006 095 Swedish 6050 0006 097 ...

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Page 31: ...ty requirements The oximeter complies with the requirements of EN 60601 1 Part 1 General requirements for safety of medical electrical equipment Type BF applied part Type of protection against electric shock Internally powered equipment Degree of protection against ingress of liquids EN 60529 Ordinary IPX0 Mode of operation without exceeding temperature limits Continuous The oximeter also complies...

Page 32: ...s in the pulse strength indicator that do not correlate to the physiological condition of the patient Dashed messages that are not resolved by the instructions found in this manual when a valid physiological signal is present This interference may be intermittent and careful correlation between the effect and its possible source is important Indications of interference should not occur if the moni...

Page 33: ...tructions for the sensor First reading full accuracy 12 seconds Resolution 1 Interfering substances Carboxyhemoglobin may erroneously increase readings in all pulse oximeters The level of increase is approximately equal to the amount of carboxyhemoglobin present Cigarette smokers and victims of smoke inhalation often have increased levels of carboxyhemoglobin Dyes that change usual arterial pigmen...

Page 34: ...bon lithium etc Low battery indicator screen icon Flashes on off when battery power is low and fresh batteries are needed The icon continues to flash on off until 1 the batteries are replaced 2 no power is left to power the oximeter or 3 the oximeter is powered off The first time the icon flashes on off 10 to 60 minutes of battery life remains for alkaline batteries when the oximeter has been oper...

Page 35: ...le monitoring a patient the printout is for archival or record keeping purposes only Print stored trend data after monitoring one or more patients How the TuffSat stores data The TuffSat automatically stores SpO2 and pulse rate trend data starting 15 seconds after you begin monitoring a patient then every 2 minutes The oximeter can store up to 32 data points approximately 64 minutes of monitoring ...

Page 36: ...hat it is the correct adapter for your local line voltage Then connect the adapter Plug the AC adapter into the port on the back of the printer left of the paper roll door Connect the adapter to the AC mains power supply 3 To power on the printer move the O slider to the right the on position Contrast selector Slide left for low contrast slide right for high contrast Power on indicator Illuminates...

Page 37: ...t 1 To start printing press the PIr button and the button simultaneously Release both buttons when the print indicator is displayed Real time data print if you are monitoring a patient a sensor is on the patient and is connected to the oximeter Stored trend data print if you are not monitoring a patient a sensor is connected to the oximeter 2 Do not move the oximeter or printer until printing stop...

Page 38: ...MM 3 Real time SpO2 and pulse rate PR values print every 15 seconds Trend The first data point was stored 15 seconds after monitoring began then every 2 minutes 4 The average Avg and minimum Min SpO2 data points for each patient 5 Real time A new heading prints if you stop then restart printing Trend A new ID indicates monitoring stopped for at least 15 seconds 6 Dashes indicate the finger was rem...

Page 39: ...ponent malfunction No action required Connect a sensor to the oximeter Install batteries check the AC adapter connections and or turn on the printer See Powering the printer Reposition the printer and oximeter for infrared transmission See Positioning the oximeter and printer Replace the printer If the condition persists replace the A D board is printed Printer is too close to oximeter or too low ...

Page 40: ...n the paper through to the end of the roll Datex Ohmeda paper is not attached 2 Tear or cut the end of the paper evenly Do not use paper with folds or uneven edges 3 Open the paper roll door and remove the used paper roll core 4 Position the new paper roll in the door NOTE The paper spools from the bottom of the roll Verify that the printer mechanism is not obstructed 5 Hold down the button and ge...

Page 41: ... may damage the printer and cause a malfunction 1 Power off the printer and disconnect it from AC mains power 2 Moisten a lint free cloth with water or a mild cleaning solution such as 70 isopropyl alcohol and wipe the surface of the printer 3 Allow the printer to dry thoroughly Ordering the printer and printer accessories The HP printer is not a serviceable part Replace the printer when it fails ...

Page 42: ...r trend data stored in memory The printer will not print correctly under the most severe test levels of IEC EN 61000 4 2 and 61000 4 4 however no permanent damage occurs Print indicator screen icon Appears on the screen while printing Power AC adapter with four 1 5 V AA batteries in printer Voltage 9 to 12 V ac or dc Current 500 to 1500 mAmps Environment Parameter Operating Storage Temperature 0 t...

Page 43: ...of the failure Limitation GE Healthcare may at any time discharge its warranty obligation by repairing and returning the product to original factory performance This may be accomplished by installing new or remanufactured assemblies or by other repairs deemed appropriate by GE Healthcare The choice of repair or replacement by GE Healthcare shall be the sole remedy of the buyer or user Conditions T...

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