- Frank`s Hospital Workshop
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1. Welch Allyn Part Number 701627 Service Documentation This documentation provides only technical information technical data calibration instruction general information and regulations for medical products The function of the thermometer is described in the Operating Instructions Welch Allyn P N 701622 Technical data Welch Allyn Display Display resolution Displayed temperature range Work place temperature range Work place humidity In the range between the accuracy of allowable tolerance with probe cover is Outside the range from the accuracy of allowable tolerance with probe cover is Probe tip Power supply Smart plug Base station Rechargeable Battery life Rechargeable battery capacity Rechargeable battery charging Rechargeable battery charging time Base station function indications Electronic anti theft Automatic turn off Manual turn off LCD Display 0 1 C F 20 0 C 42 2 68 0 F 108 0 F 10 0 C 40 0 50 0 F 104 0 F up to 95 35 5 C 42 0 95 9 F 107 6 F 0 2 C 0 4 F 35 5 C 42 0 C 95 9 F 107 6 F 0 3 C 0 5 F heated up to approximately 37 C rechargeable Braun battery pack with base station and smart plug or 2 1 5 V type AA LR 6 batteries 100 240 V input 12 V output 12 V input approx 2 4 V output 3 years 1000 charging cycles 12. in a test protocol If similar regulations should apply for your country please contact your Welch Allyn Service Center for details on necessary equipment and procedures Please note that the above described test procedure with the BB 3200 is not sufficient for this purpose The 9600 PLUS Calibration device should be used to verify these parameters The PRO 4000 can t be calibrated in the field By using the Black Body device you can verify accuracy of the unit only 701627 REV J Page 8 of 9 Welch Service Documentation Allyn Part Number 701627 Rev J Authorized Welch Allyn The following is a listing of authorized Welch Allyn Service Centers and Customer Service contact numbers United States Service Center Welch Allyn North Dock 4619 Jordan Road Skaneateles Falls NY 13153 Customer Service 800 535 6663 Service Fax 315 685 3361 Canada Service Center Welch Allyn Canada 160 Matheson Blvd E Unit 2 Mississauga ON L4Z 1V4 Customer Service 905 890 0004 Service Fax 905 890 0008 Australia Service Center Welch Allyn Australia The Metro Centre Unit 5 38 46 South Street Rydalmere NSW 2116 Customer Service 61 2 9638 3000 Service Fax 61 2 9638 3500 EMEA Service Center Welch Allyn GMBH Product Service Center Zollerstrasse 2 4 Jungingen 72417 Germany Customer Service 011 49 7477 9271 0 Fax 011 49 7477 9271 90 South Africa Welch Allyn South Africa 39
3. month standby 500 measuring cycles Thermometer stored in basis station 14 hours 1 LED green for power connection 1 LED yellow for charging indication for Pro 4000 appliances only and with the base station in use If no button is pressed within 60 seconds the appliance will turn off automatically Push button for gt 3 seconds 701627 REV J Page 1 of 9 Welch Service Documentation Allyn Part Number 701627 General hints Production code Near the battery storage LOT 4042 4 Year 042 Day Attention Do not dispose of empty batteries or defective rechargeable batteries in household waste Disposal can take place at appropriate collection sites provided in your country Hint Type BF equipment R This appliance conforms to the following standards DIN EN 60601 1 lt lt Medical electrical equipment gt gt Part 1 General requirements for safety Hint This product conforms to the provisions of the EC directive 93 42 EEC Medical Device Directive 0297 Labour Group 03 Welch Allyn 701627 REV J Page 2 of 9 Welch Allyn Part Number 701627 Special tools Welch Allyn Service Documentation Rev J The accuracy of infrared thermometers can only be tested with a blackbody device BB 3200 Series no longer available for purchase or the 9600 PLUS Calibration Tester The Model 9600 PLUS Calibration Tester can be ordered through Welch Allyn Custo
4. section customer complaints Products sent in by consumers as defective must be checked thoroughly for any technical deficiencies If there is any doubt about the performance of the unit it must be exchanged A repair except cleaning is not possible and strictly forbidden If the result of the check shows that the product is working within specifications it will be sent back to the consumer In this case it is important to include information on the condition of the unit that was initially received as defective and to give guidance for the correct use of the appliance The checking should always start with a visual inspection of the unit for any external damage Especially the probe tip and probe cover should be examined for any dirt earwax which could adversely affect the measuring accuracy After pressing the On button the unit performs a self test and all segments of the unit should show up For any error messages refer to technical data and troubleshooting sections or to use instructions The measuring accuracy can only be tested with a blackbody BB 3200 or 9600 PLUS which has a precisely defined temperature 701627 REV J Page 4 of 9 Welch Allyn Part Number 701627 Calibration general Welch Allyn Service Documentation Rev J Checking the measuring accuracy with blackbody BB 3200 or 9600 PLUS NOTE It is recommended that the PRO 4000 have an Operational Verification p
5. 4 Surrey Ave Ferndale Randburg GP 2194 Customer Service 011 2711 777 7509 Welch Allyn 701627 REV J Page 9 of 9
6. 6 of 9 Welch Allyn Part Number 701627 Calibration Advanced Display High resolution LS lo mI IIo E H iedo Welch Allyn zE Service Documentation Follow the operating instructions for the BB 3200 or 9600 PLUS closely The measured value must be within 39 7 C to 40 1 C 103 5 F to 104 3 F NOTE The measured temperature will vary with ambient temperature Calibration mode must be activated the display is flashing and showing CAL and alternately One temperature measuring with probe cover must be done Push once the 97 button short time High resolution mode the display is flashing and showing hr and measured temperature e g 736 37 36 hundredth C alternately The first digit will be not showing Push once again the button short time Ambient temperature mode the display is flashing and showing AT and ambient temperature e g 23 6 C alternately Push once again the button short time Probe tip temperature mode the display is flashing and showing ST and probe tip temperature e g 37 0 C alternately Push once again the button short time for reset to the first display CAL and For leaving the CAL mode wait approx 4 minutes the appliance will turn off automatically or push button for gt 3 seconds 701627 REV J Page 7 of 9 Welch Allyn Part Number 701627 Customer complaints Yearl
7. ented according to Welch Allyn Quality procedures stating the date of measurement the serial number of the unit the measured values and the final decision All data will be documented via SAP or current data collection system 701627 REV J Page 5 of 9 Welch Service Documentation Allyn Part Number 701627 Calibration Mode To enter the calibration mode perform the following steps Use anew probe cover for calibration check Turn the product on by push the button Following symbols and functions will be shown on the display Automatic self check After few seconds a beep signal is audible the display shows these symbols e Push the 497 button again and keep it pressed for the following steps After approximately 3 seconds the OFF symbol is flashing on the display After approximately 5 more seconds a beep signal is audible now release thei2 button immediately The product is now in calibration check mode the display is flashing and showing CAL and alternately The probe tip is heated up to the correct temperature After each measurement the display is flashing and showing CAL and only two alternately the probe tip is not heated up No measurement is possible Push the start button for new heating up of the probe tip The appliance will show again CAL and It is now ready for a new measurement Welch Allyn 701627 REV J Page
8. erformed annually using the 9600 Plus Blackbody device e Testing must only be done in Calibration mode see page 6 Use a new probe cover for calibration check transparent protection cap Make sure that The ambient temperature is within the range 20 25 C and is stable no drafts The appliances to be checked have had time to adapt to ambient temperature i e they have been placed unpacked in the room for at least half an hour prior to the test After reaching the calibration mode CAL wait for 1 minute insert the appliance into the black body and wait for 3 seconds again to start the measuring Wait about 1 minute before taking repeat measurements during waiting the unit should be put down and not kept in hand A series of 3 measurements should be taken All three measurements should be with in the specific range e Due to the design of this black body its emission factor is only 0 99 Since PRO IRT 4000 models are calibrated on a blackbody with emission factor 1 00 in the factory a correction has to be made for the black body effective temperature This correction is 0 1 C for PRO IRT 4000 Due to the heated probe tip this value is different compared to PRO IRT 3000 Appliances with readings outside the permissible range where the probe tip is contaminated can be cleaned carefully with a cloth soaked with alcohol After cleaning wait at least 5 minutes before retest e All measured values must be docum
9. mer Service see page 8 for Welch Allyn contact information Model Welch Allyn P N Braun P N 9600 PLUS Calibration Tester 01802 110 N A The following additional data will be necessary Bill to address Ship to address Quantity Billing contact person with fon fax extension Shipping contact person with fon fax extension Shipping method Purchase Order Credit Card The blackbody has to be calibrated every 12 months by the manufacturer Contact Welch Allyn Customer Service to get a Return Material Authorization number to have your unit calibrated Refer to Customer Service Listing see page 8 for Welch Allyn contact information Please direct all requirements and questions concerning blackbodies directly to the Welch Allyn Service Center Refer to Customer Service Listing see page 8 for Welch Allyn contact information 701627 REV J Page 3 of 9 Welch Allyn Part Number 701627 General Initial inspection Welch Allyn Service Documentation Rev J Braun ThermoScan infrared thermometers are classified as medical devices This implies that the manufacturer the distributor and all service functions have to fulfil certain legal requirements Special care has to be taken to ensure that only products are handed back to the consumer which are safe and perform according to its specifications Furthermore you are obliged to notify Braun Corporate Quality of any unusual defects of the appliance see also
10. y Calibration of Professional units Welch Allyn Service Documentation Welch Allyn encourages all service centers to report customer complaints This information is valuable for the improvements of products All complaints where it is alleged that our product has caused or contributed to a death or a serious deterioration in the state of health of a patient user or other person must be reported immediately to your local Welch Allyn Organization A serious deterioration in the state of health can include a life threatening illness or a condition necessitating medical intervention to prevent permanent damage Also all cases should be reported where the circumstances indicate that the incident was such that if it occurred again it may lead to death or serious deterioration in health NOTE It is recommended the PRO 4000 device have an Operational verification performed annually using the Model 9600 Plus Blackbody device In general the accuracy for the PRO 4000 unit should be checked any time you suspect the unit is not reading correctly Some countries e g Germany require by legislation a regular check of the measuring accuracy for all medical devices used by professionals For infrared thermometers this check must be done yearly and it is required to verify the measuring accuracy for the full temperature range This implies to test at three different temperatures the correct reading and to document the results
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