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B–1

B.

 

WARRANTY

The TruSat pulse oximeter (the Product) is sold by GE Healthcare (the Company) only under
the warranties set forth in the following paragraphs. Such warranties are extended only
with respect to the purchase of the Product directly from the Company’s Authorized Dealers
as new merchandise and are extended to the first buyer thereof, other than for resale. The
Company warrants that the Product meets the published specifications at the time of
shipment from the factory.

Products not under warranty

The following items are not covered under this warranty:  disposable items, accessories,
service kits, and replacement parts. These items may be covered under a separate warranty.
Consult the Company for details.

Duration

The Product is warranted against defects in materials and workmanship for a period of
three (3) years from the date of delivery to the user (in no event for a period of more than four
[4] years from the date of original delivery by the Company to an Authorized Dealer). The
internal battery is warranted against defects in materials and workmanship for a period of
one (1) year from the date of delivery to the user.

If any part of the Product proves defective under proper and normal use within the warranty
period, as the purchaser's exclusive remedy, the Company will repair or replace, at its sole
discretion, the Product or any defective part provided it is returned to an authorized Service
Center within 30 days of the failure.

Limitation

The Company 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 the
Company. The choice of repair or replacement by the Company shall be the sole remedy of
the buyer or user.

This  warranty  is  valid  only  when  qualified  personnel  have  performed  installation  and
service on the Product and when all recommended planned maintenance procedures have
been completed during the warranty period. Damage caused by the abuse or misuse of the
Product is not covered by this warranty. The Company shall not be liable for damage
resulting from the improper installation or the misuse of the Product.

Exclusion of warranties

Oral statements about the Product do not constitute warranties, shall not be relied on by
the buyer or user, and are not part of any warranty extended by the Company.

Except as set forth in this limited warranty, the Company makes no warranties, expressed or
implied,  including  the  implied  warranty  of  merchantability  and  the  implied  warranty  of
fitness for a particular purpose. Except for the obligations under this limited warranty, the
Company  shall  not  have  any  obligation  or  liability  for  any  incidental  or  consequential
damages (including those from commercial loss) or other loss, damage, or injury resulting
directly  or  indirectly  from  the  Product.

Summary of Contents for TruSat

Page 1: ...GE Healthcare TruSat Pulse Oximeter User s Guide...

Page 2: ......

Page 3: ...GE Healthcare TruSat Pulse Oximeter User s Guide 6050 0006 815 March 2005...

Page 4: ...ence Manual Service and repair Service and repair procedures must be performed by authorized service personnel Repair this device or its parts only in accordance with instructions provided by the manu...

Page 5: ...label and symbols 2 2 Buttons and indicators 2 3 Power button and power LED 2 3 Alarm Silence button and indicator 2 3 Alarm LED 2 3 Battery indicator 2 4 On screen controls 2 4 Using the monitor 2 5...

Page 6: ...s 3 5 Supplies and accessories 3 6 Sensors 3 6 TruSat pulse oximeters 3 6 Miscellaneous 3 6 Trend Download option 3 7 TruSat manuals 3 7 4 Compliance and Specifications Compliance 4 1 Specifications 4...

Page 7: ...nter A 3 Connecting the printer A 3 Printing summary statistics for one or more patients A 4 Sample printout Summary statistics A 4 Printing real time data A 5 Sample printout Real time data A 5 Trend...

Page 8: ......

Page 9: ...e monitor also contains on screen controls for changing monitor settings such as alarm limits volume and the backlight A lock function when activated protects against unintended changes to settings Th...

Page 10: ...rent sites on a patient in order to locate the best site for the sensor the site with the strongest pulse signal Measurement characteristics The pulse oximetry measurement uses a two wavelength pulsat...

Page 11: ...tion The level of increase is approximately equal to the amount of carboxyhemoglobin present Methemoglobin from certain therapies dyes that change arterial pigmentation and substances at the sensor si...

Page 12: ...nterference with the measurement or result in increased emissions decreased immunity or damage to the equipment or system This monitor does not measure respiration and should never be used as a substi...

Page 13: ...onitor features 1 Oxygen saturation SpO2 measurement value 2 SpO2 high and low alarm limit settings adjustable 3 Pulse rate measurement value 4 Pulse rate high and low alarm limit settings adjustable...

Page 14: ...underside of the monitor contains the model number serial number date of manufacture and other information about the monitor The following symbols also appear on this label and or on the packaging for...

Page 15: ...LED is lit yellow while alarms are silenced Press the Alarm Silence button once to silence all alarms for two minutes Press it three times rapidly to silence all alarms indefinitely The alarm silence...

Page 16: ...OFF Monitor can be powered by the battery only 10 to 60 minutes longer Connect the monitor to AC power to continue monitoring Important When the battery is completely depleted monitoring stops A conti...

Page 17: ...k the line power filter setting shown in the high pulse rate alarm area 50 Hz or 60 Hz If the setting matches your local line power frequency go to the next step If it is different go to Changing the...

Page 18: ...nger or toe Used to minimize the effects of motion at the sensor site Adhesive sensor with integrated cable The sensor is positioned inside tape that is wrapped around the site to secure the sensor Us...

Page 19: ...contact with the patient Each time you monitor a patient Verify that the signal strength is adequate and that the displayed values agree with your clinical evaluation of the patient Routinely check s...

Page 20: ...the ComWheel to move the pointer to the next setting Setting alarm limits WARNING To avoid rendering the alarm system useless always set reasonable alarm limits based on the clinical condition of the...

Page 21: ...N the backlight symbol remains visible for several seconds Locking unlocking monitor settings You can lock the monitor to protect against unwanted changes to settings You can set then lock alarm limit...

Page 22: ...w perfusion performance set the line power filter to match the line power frequency of your local AC power source The software line power filter will then eliminate potential interference when you use...

Page 23: ...depleted battery a faulty sensor or an internal malfunction Alarm priorities Alarms are prioritized according to the severity and urgency of the alarm condition This allows you to identify and respon...

Page 24: ...Yellow flashing ON OFF Three beeps beep beep beep with falling tone every 20 seconds Battery is low Battery indicator flashes ON OFF Signals for multiple alarms During multiple alarm conditions the v...

Page 25: ...emove debris from the sensor detector and light source If the site is thick select a site where there is less distance between the light source and the detector Ear Gently massage the sensor site to i...

Page 26: ...s did not sound during startup Alarm system failure or internal malfunction Power OFF then ON again If the tones do not sound DO NOT use the monitor Contact authorized service personnel Display is bla...

Page 27: ...ilize the monitor Do not immerse the monitor in liquid or allow liquid to enter the interior CAUTION Abrasive materials or harsh chemicals may damage the surface of the monitor Do not use petroleum ba...

Page 28: ...yellow 6051 0000 190 TruSat white 6051 0000 192 TruSat with Trend Download option yellow 6051 0000 191 TruSat with Trend Download option white 6051 0000 193 Miscellaneous Pole mount 6050 0007 197 Carr...

Page 29: ...ial printer and instructions Cable TruSat serial printer Printer paper 1 roll Printer battery pack Printer power supply US Europe or Japan Printer paper 5 rolls 6002 0000 200 Printer battery pack 6002...

Page 30: ......

Page 31: ...pe BF applied part Degree of protection against ingress of water EN 60529 IPX2 Not suitable for use in the presence of flammable anesthetic mixtures Mode of operation Continuous EN 60601 1 2 2nd Editi...

Page 32: ...n 70 to 100 3 digits during clinical motion 2 70 to 100 2 digits during clinical low perfusion Below 70 unspecified SpO2 measurement accuracy is based on deep hypoxia studies using OxyTip sensors on v...

Page 33: ...flashing ON OFF Visibility operator positioned in front of monitor 4 m 13 ft at 30 angle in any direction NOTE When an SpO2 or pulse rate alarm limit is violated the related measurement flashes ON OFF...

Page 34: ...ity 3 5 hours typical Battery indicator 4 segment symbol shaded segments represent battery charge 0 shaded low or depleted 4 shaded fully charged Automatic power OFF to conserve battery 20 minutes aft...

Page 35: ...ored A data point is stored every 4 seconds Patient identification number When you power ON the monitor a patient number P01 P02 P99 is displayed for one second The patient number is stored with the t...

Page 36: ...included on printouts and with data downloaded to a PC Clock settings are stored indefinitely unless battery power is lost Important Set the clock before you begin monitoring to ensure that all patie...

Page 37: ...ith the printer WARNING When you connect equipment to the monitor you are configuring a medical system and are responsible for ensuring that the system complies with IEC 60601 1 1 and with local requi...

Page 38: ...layed approximately 1 minute for every 24 hours of data The monitor may appear to be inactive however printing will begin when the calculation is completed Sample printout Summary statistics Trends mo...

Page 39: ...top printing The print symbol is displayed during printing Sample printout Real time data Current patient data General information Patient number and lines for adding information Legend for symbols in...

Page 40: ...uctions pdf TruSat PC RS 232 cable NOTE The Trend Download PC program interface menus messages etc is in English PC requirements Microsoft Windows 2000 and XP Intel Pentium 90 MHz processor minimum 32...

Page 41: ...puter and monitor 3 To launch the program on the PC select the Trend Download program or screen icon 4 After using the Trend Download program to download data or change monitor settings power OFF the...

Page 42: ......

Page 43: ...ective part provided it is returned to an authorized Service Center within 30 days of the failure Limitation The Company may at any time discharge its warranty obligation by repairing and returning th...

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