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Appendix A: Regulatory Supplement

Reporting Health or Safety Related Issues or Concerns

Should the need arise to report any safety or health related issues or concerns regarding the use of 

Gammex products, contact Gammex directly.

Modifications to Equipment

WARNING:  No modifications may be made to this unit without the 

expressed written consent of Gammex. Unauthorized changes may 

present a risk to user or patients and will void the warranty.

Содержание 163-DIG

Страница 1: ...i Title LJLWDO RPSUHVVLRQ 6FDOH 0RGHO...

Страница 2: ...selling or otherwise distributing any part of this manual without the prior writ ten consent of Gammex Inc is prohibited Gammex Inc reserves the right to make periodic modifications to this manual wit...

Страница 3: ...uence 4 Zero Tare 4 Hold Pause 4 Overload Warning 4 Energy Saver 4 Detachable Display Panel 5 Scale Specifications 6 Using the 163 DIG 7 General Operation 7 Standard Setup 0 degree 7 Prone Stereotacti...

Страница 4: ...type of batteries to use A display of Lo or the battery symbol on the 163 DIG readout indicates low batteries and replacements are required To install batteries in the 163 DIG 1 On the bottom of the 1...

Страница 5: ...t potentially lead to voiding product warranty Independent Failure Mode Warning Do not use results from the 163 DIG to make changes to your system do use the results to perform additional system check...

Страница 6: ...n over time You can freeze the display of the maximum force reading by pressing the Pause Hold button Press the Zero button to reset Components Figure 2 1 Model 163 DIG Diagram Table 2 1 Parts and Acc...

Страница 7: ...ved the Scale will read a negative value Press Zero Tare to re zero the 163 DIG Hold Pause Hold Pause allows users to freeze the display on the Scale Press it again to cancel or use Zero Tare Overload...

Страница 8: ...1 On the bottom push the release tab with arrow indicting direction 2 Wriggle and slide the Display Panel upwards in the direction of the Platform while holding the release tab 3 The separated Displa...

Страница 9: ...g 0 1 kg 0 01 kg 1 25 kg Display Units g lb oz kg lb oz Scale Dimensions 8 9 x 8 2 x 2 9 in 225 x 208 x 73 mm Platform Dimensions 7 87 x 6 22 in 200 x 158 mm Foam Compression Block Dimensions 7 25 x 4...

Страница 10: ...mpression paddle Optionally place the Foam Compression Block on top of the 163 DIG Platform which is also useful for testing curved paddles 3 Power On the 163 DIG Scale and wait for Initialization to...

Страница 11: ...lat and stable surface 2 Rotate the 163 DIG onto its narrow side on a flat and stable surface and zero the scale 3 Bring the 163 DIG to the Mammography system and very carefully apply pressure to clam...

Страница 12: ...mponents are subject to wear Calibration Process Required equipment 10 kg certified weight or combination of certified weights Process 1 While the 163 DIG is off press and hold the Unit button while h...

Страница 13: ...ter use with a damp cloth if necessary Contacting Gammex Support Technical support is available from Gammex Inc Contact the Support department By telephone 1 321 259 6862 option 3 then 3 By email Glob...

Страница 14: ...21 CFR 820 Gammex Quality Management System is certified to 13485 by SGS Operator Responsibility The instructions in this manual are intended for trained personnel The operator is solely responsible f...

Страница 15: ...any safety or health related issues or concerns regarding the use of Gammex products contact Gammex directly Modifications to Equipment WARNING No modifications may be made to this unit without the e...

Страница 16: ...RUSRUDWH HDGTXDUWHUV LVFRYHU ULYH 0LGGOHWRQ 86 VXQQXFOHDU FRP...

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