USER MANUAL - Precision Medical
Contents
1. 12 Effects Of 13 SEE i mna 13 Effect Of 5 14 Effects of Anesthetic Gases 14 ALARMS odes 15 TO Set 15 Alarm Situation eiiieaenii eninin aaibaar iaaa 16 GLEANIN G 16 16 SENSOR 16 Battery 16 17 DISPOSALINSTRUC TIONS 17 TROUBLESHOOTING 17 REPLACEMENT PARTS 2 19 ACCESSORIES 19 20 LIMITED WARRANTY 21 DECLARATION CONFORMITY 22 OXYGEN MONITOR 1 RECEIVING INSPECTION Remove the Precision Medical Oxygen Monitor from the packaging and inspect for damage If there is any damage DO NOT USE and contact your Provider INTENDED USE Precision Medical Inc Oxygen Monitor provides continuous direct monitoring of oxygen mixtures in a wide variety of medical applications suchas anesthesiology2. anesthesia machines respiratory devices e g respirators ventilators pediatric incubators and oxygen therapy e g oxygen tents OPERATOR PROFILE The oxygen monitor is to be used by trained healthcare professionals under the supervision or on the order of a physician in a hospital or other clinical setting The Precision Medical Inc Oxygen Monitor is not intended for transport use This device is not an oxygen supply source READ ALL INSTRUCTIONS BEFORE USING This manual instructs a Professional to install and operate the Oxygen Monitor This is provided for your safety and to prevent damage to the Oxygen Monitor If you do not understand this manual DO NOT USE the Oxygen Monitor and contact your Provider SAFETY INFORMATION WARNINGS AND CAUTIONS Indicates an imminently hazardous situation which if not avoided will result in death or serious injury AWARNING Indicates a potentially hazardous situation which if not avoided could result in death or serious injury ACAUTION Indicates a potentially hazardous situation which if not avoided may result in minor or moderate injury Used without the safety alert symbol indicates a CAUTION potentially hazardous situation which if not avoided may result in property damage 15 CONSULT ACCOMPANYING DOCUMENTS ts Direct current Symbol indicates the device complies with the 0197 requirements of Directive 93 42 EEC concerning medical devic
3. USER MANUAL OxyGEN MONITOR Model PM5900 SAVE THESE INSTRUCTIONS ACAUTION Federal USA law restricts this device to sale by or on the order of a physician PRECISION MEDICAL 300 Held Drive Tel 001 610 262 6090 Northampton PA 18067 USA Fax 001 610 262 6080 www precisionmedical com CONTENTS RECEIVING INSPECTION 2 INTENDED OSE ties ete ace 2 OPERATOR PRO FIVE aa a aea 2 READ ALL INSTRUCTIONS BEFORE 2 SAFETY INFORMATION WARNINGS AND CAUTIONS 2 SPECIFICATIONS ei ci 4 SPECIFICATIONS ARE SUBJECT TO CHANGE WITHOUT PRIOR IN OTE 4 COMPONENT DESCRIP THON rrenaren eaea eninin erias 5 Oxygen Monitor IDENTIFICATION 5 Oxygen Monitor LCD Display IDENTIFICATION 8 Oxygen Sensor Component Identification 9 BATTERY INSTALLATION 0 cccccceceeceeceeeeeceeeeeeneeeseaeeeeneeeseneeeseeeseneees 10 Battery Installation 10 OPERATING INSTRUCTIONS 0 cccccccecececeeeeeeeeeeeeeeeeseeeeeneeeseneeeeeees 10 QUICK SETUP 11 SENSOR INSTALLATION 11 CARRA O N
4. 90 of final value in less than 12 seconds at 77 F 25 C Warm up Time None required Low Battery Indication LO BATTERY message displayed on graphics screen and audible alarm Alarm System Alarm Accuracy Low Alarm Range High Alarm Range High Alarm De Activation Setting High Low alarms flashing red LEDs and graphics and nominal 68 db audible alarm 1 meter displayed value 0 1 18 99 Oxygen 19 100 Oxygen Above 100 will appear Sensor Specifications Sensor Type Expected Sensor Life Drift Galvanic Oxygen Sensor fuel cell Precision Medical Part Number 504877 gt 1 000 000 O2 Hours lt 1 volume month air Specifications are subject to change without prior notice OXYGEN Moniror COMPONENT DESCRIPTION ACAUTION Missing or illegible labels must be replaced contact Precision Medical Inc OXYGEN MONITOR IDENTIFICATION 1 High Alarm 2 t Up amp 7 High Alarm LED 8 LCD Display 3 Low Alarm 4 Power 9 Low Alarm LED 10 Alarm Silence Key 11 Sensor Cable Connector Unlock Key s 12 Calibration Key 6 Serial NOmber Label OXYGEN Moniror 5 NO ITEM NAME DESCRIPTION High Alarm Set Key Pressing the key when the keypad is unlocked the high alarm set point will flash The high alarm setting can be adjusted w
5. Please Recycle Problem Probable Cause Remedy A Low Battery 1 Battery voltage 1 Replace with 4 NEW Indicator is too low AA alkaline batteries displayed with a 30 second chirp alarm B Check Sensor 1 Cable 1 Make sure cable appears on connections are connections are display with not secure secure and locking a continuing pulsing alarm 2 Oxygen Sensor not functioning 3 Using Oxygen Sensor other than Precision Medical Oxygen Sensor 2 3 rings are tight Replace with New Precision Medical Oxygen Sensor Attach New Precision Medical Oxygen Sensor OXYGEN Moniror 17 Problem Probable Cause Remedy C New Oxygen 1 Oxygen Sensor 1 Wait approximately Sensor has NOT 20 minutes for temperature Oxygen Sensor to responds lt A slowly or stabilized stabilize with the seems to drift environment and then recalibrate the Oxygen Monitor D Oxygen Sensor does not react 1 Condensation on the Oxygen Sensor Remove Condensation aas 2 Non functioning 2 Replace with New yg Oxygen Sensor Precision Medical E Triple Pulse 1 Oxygen readings 1 Adjust the High Low Alarm and are outside the Alarm setting to be flashing LED High Low Alarm above below the limits oxygen value being displayed 2 Loss of Air or 2 Reconnect the Air or Oxygen Supply Oxygen Supply F Keys inoperable 1 keypadis 1 Unlock the Power ON heeled ra keypad
6. G No Display 1 Dead Batteries 1 Check and replace LCD screen with 4 New AA will not power alkaline batteries ON 2 Battery installed 2 Check that batteries incorrectly are installed in the proper position H SERVICE NEED 1 Electronic 1 Oxygen Monitor appears on the malfunction must be serviced display 1 CAL FAIL 1 Improper or 1 Recalibrate the appears on the wrong Oxygen Oxygen Monitor display Sensor 2 Improper Air 2 Check the Air Oxygen source Oxygen source functioning 3 Replace with New Oxygen Sensor Precision Medical Oxygen Sensor OXYGEN 18 Monitor REPLACEMENT PARTS Description Part User Manual 505127 Precision Medical Oxygen Sensor 504877 with Diverter Tee Adaptor 505126 Extendible Cable 504937 AA Alkaline Battery 4 Pack 505124 4 Rubber Feet 4 5051 22 4 Battery Cover 504909 V Block 505010 Diverter 505344 Circuit Board Assembly 505145 Key Pad 504926 Display 505125 Case Assembly Front 504907 Case Assembly Back 504908 ACCESSORIES Description Part Monitor Wall Mount Bracket 505189 Monitor Vertical Pole Mount Clamp 505013 Monitor Horizontal Pole Mount Clamp 505014 Dove tail Bracket 505012 Dove tail Bracket Screw 505712 NOTE Orders for replacement parts should include the part number if available and the model and serial number of the instrument for which the parts are in
7. ONLY AA Alkaline Batteries 1 N Press down the center top edge of the battery cover and slide down Remove old batteries if applicable Install 4 AA Alkaline Batteries and follow the diagram stamped in the bottom of the battery compartment Slide the battery cover back into position until the cover snaps on to the Monitor BATTERY INSTALLATION DIAGRAM Alarm Grill Mounting Battery Cover Block Battery Compartment 4 AA Alkaline Batteries OPERATING INSTRUCTIONS CAUTION Inspect the Oxygen Monitor Sensor and Cable for visual damage before use DO NOT USE if damaged AWARNING Read this User Manual before installing or operating the Oxygen Monitor OXYGEN 10 MonirorR QUICK SETUP GUIDE 1 Install 4 AA Alkaline Batteries 2 Connect the Oxygen Sensor and Diverter Fitting 3 Connect the Coiled Cable 4 Calibrate the Oxygen Monitor 5 Set the High Low Alarms SENSOR INSTALLATION ACAUTION Inspect the Oxygen Sensor and Diverter Fitting for visual damage or electrolyte leakage before use DO NOT USE if damaged Use ONLY an Oxygen Sensor specified by Precision Medical Inc The Oxygen Sensor should not be used in the presence of flammable anesthetics such as Diethyl Ether or Cyclopropane AWARNING DO NOT attempt to open or repair the Oxygen Sensor The Sensor electrolyte is corrosive and contains lead DO NOT let i
8. be monitored EFFECTS OF ANESTHETIC GASES ANESTHETIC TEST Oxygen AGENT CONCENTRATION Helium 50 Balance Oxygen 0 Nitrous Oxide 80 Balance Oxygen 0 Carbon Dioxide 10 Balance Oxygen 0 Halothane 4 lt 1 5 Oxygen Enflurane 5 lt 1 5 Oxygen Isoflurane 5 lt 1 5 Oxygen Sevoflurane 5 lt 1 5 Oxygen Desflurane 15 lt 1 5 Oxygen Test mixture 30 Oz balance 70 NzO except where noted Errors may vary based on concentrations and exposure times These results meet or exceed the requirements of ISO 7767 and DIN EN 12598 ACAUTION The Oxygen Sensor should not be used in the presence of flammable anesthetics such as Diethyl Ether or Cyclopropane OXYGEN 14 Moniror ALARMS The Precision Medical Oxygen Monitor will store the HIGH LOW alarm settings in memory after the Oxygen Monitor is turned OFF The Oxygen Monitor is designed to prevent crossing of the HIGH LOW alarm settings The LOW alarm cannot be set above the HIGH alarm and the High alarm cannot be set below than the LOW alarm on D OXYGEN TO SET ALARM With the Power key Press the 8 LOCK UNLOCK key To set the HIGH Alarm Press the HIGH ALARM SET key once Press the MW UP and DOWN arrow keys until the desired value is displayed next to the Up arrow in the upper right corner of the display Continuously pressing the arrow keys wil
9. liquid DO NOT use any strong solvent or abrasive cleaners DO NOT allow any liquid to enter the Oxygen Monitor or the Oxygen Sensor this will damage the Oxygen Monitor or Oxygen Sensor and will void the Warranty 1 Disconnect all connections before cleaning 2 Clean exterior surfaces of the Oxygen Monitor and Coiled Cable with a cloth dampened with mild detergent and water 3 Wipe dry with a clean cloth MAINTENANCE SENSOR REPLACEMENT Reference SENSOR INSTALLATION on page 11 ACAUTION Sensor Replacement must be performed by a Qualified Medical Personnel BATTERY REPLACEMENT Replace batteries when LO BATTERY is displayed Reference BATTERY INSTALLATION on page 10 OXYGEN 16 Moniror RETURNS Returned products require a Returned Goods Authorization RGA number contact Precision Medical Inc All returns must be packaged in sealed containers to prevent damage Precision Medical Inc will not be responsible for goods damaged in transit Refer to Precision Medical Inc Return Policy available on the Internet www precisionmedical com DISPOSAL INSTRUCTIONS The Oxygen Sensor contains lead Dispose of the Oxygen Monitor batteries and its components in accordance with the local regulations TROUBLESHOOTING If the Oxygen Monitor fails to function consult the Troubleshooting Guide If the problem cannot be solved by using Troubleshooting Guide consult your Provider
10. 14 Message CHK SENSOR Indicator CAL AIR CAL 100 CAL FAIL DONE SERVICE NEED 15 Low Battery Indicates when the batteries shall be Indicator replaced 16 Low Alarm The Low Alarm set point value Set Point 17 Lock Unlock indicates if the keypad is Locked a Inalcator Unlocked m 18 Oxygen Unit of measure 19 High Alarm Indicates High Alarm Indicator 20 Oxygen Displays percentage of Oxygen Concentration Concentration 21 Low Alarm Indicates Low Alarm Indicator 22 Alarm Silence AUDIO PAUSED Indicates Alarm Indicator Silence Mode OXYGEN 8 Monitor OXYGEN SENSOR COMPONENT IDENTIFICATION 23 Coiled Cable 24 Locking Ring B 25 Oxygen Sensor lt 26 Diverter Fitting Tee Adaptor NO ITEM NAME DESCRIPTION 23 Coiled Cable The Coiled Cable allows the Sensor to with Male Plugs be positioned up to 10 ft from the side of the Oxygen Monitor There are Male Plugs at each end of the Coiled Cable 24 Locking Ring Male Plug has a Locking Ring and must be engaged when in use 25 Oxygen Sensor Galvanic Oxygen Sensor 26 Diverter Fitting _ Fitting used to connect to the Oxygen Source 27 Tee Adaptor The Tee Adaptor is used to connect the Oxygen Sensor and Diverter Fitting to a oxygen pathway circuit OXYGEN Monitor 9 BATTERY INSTALLATION ACAUTION Use
11. 80 BS EN 1041 ISO 9899 EN ISO 14971 EN ISO 15001 EN ISO 21647 Notified Body T V Rheinland Products Safety GmbH 0197 EC Certificate No HD 60019110 0001 OXYGEN 22 Monitor PRECISION MEDICAL Precision Medical Inc 300 Held Drive Northampton PA 18067 USA Toll Free Tel 800 272 7285 Toll Free Fax 800 353 1240 Tel 001 610 262 6090 Fax 001 610 262 6080 www precisionmedical com ISO 13485 Certified Te 505127 Rev7 11 24 10 in USA
12. contaminants are present on or around this Oxygen Monitor or connecting devices e DO NOT smoke in an area where oxygen is being administered e DO NOT clean with aromatic hydrocarbons e DO NOT steam autoclave e DO NOT gas sterilize with Ethylene Oxide e DO NOT immerse Oxygen Monitor or Sensor in liquid OXYGEN Moniror 3 SPECIFICATIONS Base Unit Specifications Dimensions Monitor without Cable and Sensor attached Length 1 72 in 4 36 cm Width 3 56 in 9 04 cm Height 5 44 in 13 82 cm Cable Length Fully extended 199 305 Weight Oxygen Monitor Sensor Batteries and Cable Weight 1 11 lbs 0 50 kg Shipping Weight 1 64 lbs 0 75 kg Operating Conditions Temperature 50 F to 113 F 10 45 C Altitude Sea Level to 8 000 ft 2438 m Storage Conditions Temperature 5 F to 122 F 15 C to 50 C Humidity 0 95 Noncondensing Power Requirements 4 AA Alkaline Batteries 4 x 1 5 6 Volts Battery Life Approximately 2 000 hours continuous use non alarm condition Diverter Fitting 15 mm T adapter Measurement Range 0 0 100 Oxygen Resolution 0 1 increments Accuracy amp Linearity 1 of full scale at constant temperature relative humidity and pressure when calibrated at full scale Total Accuracy 3 actual oxygen level over full operating temperature range Response Time
13. d confirm that the display reads between 19 22 Oxygen in room air EFFECTS OF TEMPERATURE To minimize temperature effects 1 In a breathing circuit place the Oxygen Sensor upstream of the heater 2 Allow time for the Oxygen Sensor to stabilize to its new room temperature 3 Perform the calibration procedure at a temperature close to or similar to your clinical application EFFECTS OF HUMIDITY High Moisture levels will dilute the oxygen concentration decreasing the concentration of oxygen being monitored by the Oxygen Sensor High humidity can cause condensation to collect on the Oxygen Sensor obstructing the passages and reducing the effectiveness of the Oxygen Sensor CAUTION To reduce the effects of humidity on the Sensor e DO NOT USE the Oxygen Sensor in environments with greater than 95 humidity e Place the Oxygen Sensor upstream from the humidifier in a breathing circuit OXYGEN Moniror 13 EFFECT OF PRESSURE When the Oxygen Sensor is placed in a breathing circuit the alternating breathing pressure cycles will be sensed as an increase in oxygen concentration The concentration is not actually changing but it appears to be due to the change in pressure The following recommendation is provided to reduce the chances of pressure causing false readings Calibrate the Precision Medical Oxygen Monitor using 100 Oxygen or room air at the same pressure and flow as the gas to
14. es and all applicable International Standards On CE marked Devices ONLY PM5900 WITH RESPECT TO ELECTRICAL SHOCK S FIRE AND MECHANICAL HAZARDS ONLY IN 0 ACCORDANCE WITH UL60601 1 IEC60601 1 62NA CAN CSA C22 2 No 601 1 OXYGEN 2 Moniror ADANGER This product is not intended as a life sustaining or life supporting device AWARNING Only trained qualified medical personnel under the direct supervision of a licensed physician should operate the Oxygen Monitor Use this Oxygen Monitor only for its intended use as described in this manual Medical Oxygen should meet the requirements of USP Always follow ANSI and CGA standards for Medical Gas Products Flowmeters and Oxygen Handling The Oxygen Monitor should be serviced by a qualified hospital dealer service technician or by Precision Medical Inc DO NOT obstruct the alarm grill on the back of the Oxygen Monitor DO NOT use near any type of flame or flammable explosive substances vapors or atmosphere DO NOT allow an excess length of cable near the patient s head or neck this could result in strangulation Secure excess Cable to bed rail or suitable object DO NOT use Oxygen Monitor with a cable that appears worn cracked or has damaged insulation ACAUTION The Oxygen Monitor contains magnetic ferrous material that may affect the results of an MRI Store the Oxygen Monitor in a clean dry area when not in use DO NOT use if dirt or
15. ey must be pressed to unlock the Oxygen Monitor before being powered OFF 5 Lock Unlock Pressing the key will Unlock Key the keypad so changes in the stored settings can be made When pressing the key to Lock W the Oxygen Monitor disables the key pad and no changes can be made 6 Serial Number REF PM5900 YYYY ote Label SN XXXXXXXX m CE Wis 02 Power 6V 0 151 7 High Alarm During a High Alarm condition the red LED LED will flash accompanied by the triple pulse audible alarm 8 LCD Display Graphic Display with backlight 9 Low Alarm LED During a Low Alarm condition the red LED will flash accompanied by the triple pulse audible alarm 10 Alarm Silence In alarm condition pressing the Key Key will deactivate the audible alarm for 120 seconds The visual alarm will continue to display 11 Sensor Cable Cable Interface connection between Connector Oxygen Monitor and Oxygen Sensor Cable 12 Calibration Key Pressing the key calibrates the Oxygen Monitor with air or oxygen CAL OXYGEN Monitor 7 OXYGEN MONITOR LCD DISPLAY IDENTIFICATION 13 High Alarm Set Point 14 Message Indicator 15 Low Battery Indicator 16 Low Alarm Set Point 17 Lock Unlock Indicator 18 Oxygen 19 High Alarm Indicator 20 Oxygen Concentration 21 Low Alarm Indicator 22 Alarm Silence Indicator 13 High Alarm The High Alarm set point value Set Point
16. ged defect along with return of the sensor at the customer s expense and substantiation that the sensor has been stored installed maintained and operated in accordance with Precision Medical Inc s instructions and standard industry practice and that no modifications substitutions or alterations have been made to the sensor correct such defect by repair or replacement at Precision Medical Inc s option at its own expense Should a sensor require repair or replacement due to said defects the sensor is warranted only for the remainder of the original sensor warranty period A sensor shall not be considered defective for failure to function beyond its normal estimated consumption capacity rates and this warranty does not cover normal wear due to consumption beyond the sensor s estimated 02 hours ORAL STATEMENTS DO NOT CONSTITUTE WARRANTIES The representatives of Precision Medical Inc or any retailers are not authorized to make oral warranties about the merchandise described in this warranty and any such statements shall not be relied upon and are not part of the contract for sale Thus this writing is a final complete and exclusive statement of the terms of the warranty for the products covered by the applicable contract THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ANY WARRANTY OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE OR OTHER WARRANTY OF QUALITY WHETHER EXPRESS OR IMPLIED Precision Medical Inc shall not under an
17. ith the UP DOWN keys When the high alarm value is changed pressing the H key will save the setting The Oxygen Monitor will also save the setting and revert to normal operation if no keys are pressed within 10 seconds The High Alarm Set is adjustable up to 100 Oxygen To disable the HIGH Alarm raise the HIGH Alarm setting above 100 Dashes will be displayed next to the UP key on the LCD display NOTE When the High alarm is disabled dashes will appear next to the UP key on the LCD display the Low alarm will still function NOTE Factory Preset 50 Oxygen Up and Down Keys The tl keys are used in conjunction with the alarm set keys Pressing either of these keys will change the alarms set points by 1 increments or 5 if held down continuously Low Alarm Set Key Pressing 4 key when the keypad is unlocked the Low Alarm set point will flash The Low Alarm setting can be adjusted with the UP DOWN keys When the Low Alarm value is changed pressing the W key will save the setting The Oxygen Monitor will also save the setting and revert to normal operation if no keys are pressed within 10 seconds The Low Alarm Set is adjustable down to 18 Oxygen NOTE Factory Preset 18 Oxygen OXYGEN 6 Monitor NO ITEM NAME DESCRIPTION 4 Power Key The key turns the Oxygen Monitor ON and OFF The LOCK UNLOCK k
18. l move the value in increments of 5 Press the HIGH ALARM SET key to save the setting Flashing Number indicates the Number can be changed If no keys are pressed for 10 seconds the setting will be saved and the Oxygen Monitor will revert to locked mode To set the LOW Alarm Press the LOW ALARM SET key once Press the UP and DOWN arrow keys until the desired value is displayed next to the Down arrow in the lower right corner of the display Continuously pressing the arrow keys will move the value in increments of 5 Press the LOW ALARM SET key to save the setting Flashing Number indicates the Number can be changed If no keys are pressed for 10 seconds the setting will be saved and the Oxygen Monitor will revert to locked mode Lock the display by pressing the 8 LOCK UNLOCK key To disable the HIGH Alarm raise the HIGH Alarm setting above 100 will be displayed next to the Up arrow on the display The LOW alarm will still function while the HIGH alarm is disabled Moniror 15 ALARM SITUATION During a HIGH or LOW alarm 1 Triple pulse alarm sounds 2 LED will flash 3 Alarm Low High set point will flash 4 UP or DOWN Arrow will turn dark Pressing the Alarm Silent key will deactivate the audible alarm for 120 seconds If the alarm exists after 120 seconds the alarm will sound again CLEANING CAUTION DO NOT steam autoclave DO NOT immerse the Oxygen Monitor into any
19. s not recommended unless the Sensor can be exposed to a known source of clean air Hospital room air is often enriched with excess oxygen Calibrate the Oxygen Monitor at a pressure and flow similar to your clinical application Before calibrating the Oxygen Monitor the oxygen concentration readout should be stable and not drifting more than 0 2 DO NOT calibrate the Oxygen Monitor in humidified gas as water vapor makes the oxygen concentration appear lower than the actual value CALIBRATION 1 Place the Sensor with Diverter and Plastic Tee attached into the gas stream of 100 USP Oxygen or room air The highest accuracy is achieved when using 100 USP Oxygen at a constant pressure and flow Wait at least 20 seconds or more for the oxygen to purge the line Turn the Oxygen Monitor ON by pressing the POWER key 4 Let the oxygen concentration display stabilize the readout should not drift more than 0 2 5 Press the 8 key to UNLOCK the keys OXYGEN 12 Monitor 6 Press the CAL key The display will show CAL Air or CAL 100 oxygen When DONE appears the calibration is complete The Oxygen Concentration will be displayed in a gas percent value Press 8 LOCK UNLOCK to save the calibration data If no keys are pressed within 3 seconds the setting will be saved and the keypad will be locked 7 Remove the Oxygen Sensor from the oxygen supply an
20. t come in contact with the skin If it does flush affected area with water Check the Sensor regularly for leaks Ifthe Sensor is leaking replace with NEW Sensor Leaking or used Sensors should be handled and disposed ofin accordance with local regulations An MSDS is available from Precision Medical Inc If the Oxygen Sensor is used in breathing circuits the Diverter must be attached to the Sensor and must be used with the Tee Adapter The Oxygen Sensor must be installed before the Oxygen Monitor can be operated 1 Screw the Diverter to the bottom of the Oxygen Sensor tighten until snug 2 If using the Tee Adapter attach to the Diverter 3 Insert the one end of the Coiled Cable into the top of the Sensor and secure by tightening the Locking Ring until snug OXYGEN Moniror 11 4 Insert the other end of the Coiled Cable into the Sensor Cable Connection located on the right side of the Oxygen Monitor Secure it in place by tightening the Locking Ring until snug Wait approximately 20 minutes for the NEW Sensor to stabilize to the environment 6 Calibrate the Oxygen Monitor with the NEW Sensor ACAUTION Calibrate the Oxygen Monitor before each use and when replacing the Oxygen Sensor or the batteries The Precision Medical Oxygen Monitor can only be calibrated accurately using 100 Oxygen or 20 9 Oxygen Room Air Using any other concentration will result in a inaccurate readings Air calibration i
21. tended OXYGEN MONITOR 19 NOTES DEVICE SERIAL IN SERVICE DATE Zj m OXYGEN 20 Monitor AND LIMITATION OF LIABILITY Precision Medical Inc warrants that the Oxygen Monitor the Product will be free of defects in workmanship and or material for the following period Two 2 years from shipment Should any failure to conform to this warranty appear within the applicable period Precision Medical Inc shall upon written notification thereof received by Precision Medical Inc within 30 days of the customer s discovery of the alleged defect along with return of the Product at the customer s expense and substantiation that the goods have been stored installed maintained and operated in accordance with Precision Medical Inc s instructions and standard industry practice and that no modifications substitutions or alterations have been made to the goods correct such defect by repair or replacement at Precision Medical Inc s option at its own expense Precision Medical Inc warrants the 504877 Oxygen Sensor included with the PM5900 Oxygen Monitor to be free from defects in material and workmanship for a period of sixteen 16 months from date of shipment Should any failure to conform to this warranty appear within the applicable period Precision Medical Inc shall upon written notification thereof received by Precision Medical Inc within 30 days of the customer s discovery of the alle
22. y circumstances be liable for special incidental or consequential damages including but not limited to lost profits lost sales or injury to person or property Correction of non conformities as provided above shall constitute fulfillment of all liabilities of Precision Medical Inc whether ased on contract negligence strict tort or otherwise Precision Medical Inc eserves the right to discontinue manufacture of any product or change product materials designs or specifications without notice Precision Medical Inc reserves the right to correct clerical or typographical errors ZS SSS LSS 5 ESS SS MINIS OXYGEN Moniror 21 DECLARATION OF CONFORMITY Manufacturer Precision Medical Inc 300 Held Drive Northampton PA 18067 USA CONTACT Quality Manager Phone 610 262 6090 Authorized European Representative Emergo Europe European Office Molenstraat 15 2513 BH The Hague The Netherlands Phone 31 0 70 345 8570 Fax 31 0 70 346 7299 Product Oxygen Monitor Model s PM5900 MDD Class IIb Classification criteria Clause 3 2 Rule 11 of Annex IX of MDD As delivered the object of the declaration described above is in conformity with the requirements of MDD 93 42 EEC Annex 11 3 Directive 2007 47 EC of The European Parliament and the following documents EN 60601 1 EN 60601 1 2 EN 60601 1 4 BS EN 60601 1 8 IEC TR 60878 BS EN 60068 2 27 BS EN 60068 2 6 BS EN 60068 2 64 EN 9
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