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Contents
1. lt NewPersonm Flt LOST Patient LOST Patient New Person Basic e t c Basic SAVE2. 1 E gt Export AyY EI yy LET 21 Mega Electronics Ltd 2004 FemiScan PC Software User s Manual 5 2 l Esport Import Source path and file Available training programa Importable training programs 5 1 2 3
3. PC Preferance Device COM PORT PC HMTR ICTRA PC COM PORT PC
4. 2 Home CHinic CHinic Home amp ClinicD Preferance Device OFF Line Home amp Clinic Clinic 1 Al
5. 15 Mega Electronics Ltd 2004 FemiScan PC Software User s Manual 0 3 4 u V 1 3 2 6 Relax 3H H Cu V 2
6. 50 17 1 3 17 2 Te 17 2 1Home Trainer
7. 1 3 0 1 1 1 5
8. CAUTION 33 Mega Electronics Ltd 2004 FemiScan PC Software User s Manual r Glutaraldehyde2 5 17 2 3Cover
9. ROAD 1 BACK Reportl Mega Electronics Ltd 2004 20 Order code 800304 Rev 2 1 a 5 Import Export 5 1 Export Import Target path D Femis can ADATABASEN File name _EXPORT DB Available training programs 4 Exportable training programs ForHT CS pat HTA proto KEYSIN test 12 1 QO LL EXPORTLDB
10. 1 2 1 35 Mega Electronics Ltd 2004 FemiScan PC Software User s Manual http www nihonmedix CO jD A A At Be E A ON SEE EESHA ETHE a HORT BESRA FRSA Se PT SR UG TRARA PAHAN le tS eT Ter 1 0065 T2 0 1444 T349 0135 7564 0044 7811 1311 T890 0056 7465 0054 TSBU UB3B Te25 0019 To20 0024 T950 2004 T600 8320 7651 0077 T702 8031 Tf 33 0001 7761 8071 Mega Electronics Ltd 2004 SA ee aT 15 1 TSR 2 She ee see1157 i PU Aa 20 20 ARR Ae Ae 12 18 ee Sr eM 1 8 2 ARSAEARNS MENA
11. PC Download Upload E S Downloads Care period 1 13 12 2001 EE Home training 13 12 2 13 12 2001 period 1 13 12 2001 10 6 2002 i 14 12 2001 E 15 12 2001 7 6 2002 forHTCS B 16 12 2001 10 6 2002 very 17 12 2001 18 12 2001 19 12 2001 B 20 12 2001 4 9 4 A 11 Mega Electronics Ltd 2004 FemiScan PC Software User s Manual
12. 1 2V 1 3 V Mega Electronics Ltd 2004 34 Order code 800304 Rev 2 1 11 OA YT FOAL VP ica en Ca 6
13. Savgl Hile tool Bar gt Show Show Mega Electronics Ltd 2004 26 Order code 800304 Rev 2 1 _ 15 2 Home Trainer fi gt v gt 1 2 3 gt 1 2
14. Change password Oowrh WN FH 9 Mega Electronics Ltd 2004 FemiScan PC Software User s Manual 2 2 1 HTCS HMTR Maximum Response settings 9 1 Define Maximum
15. Tmstruction Guide 10 1 1 Home Trainer Instruction Guide Home Trainer Set Mega Electronics Ltd 2004 32 Order code 800304 Rev 2 1 mm 17 1 2
16. 17 2 4 6 0 17 2 5PC 17 2 6
17. PC Mega Electronics Ltd 2004 10 Order code 800304 Rev 2 1 Ue Serial number HU1rEg Voltage 1 AD S Change batten when lt 1 2 2 2 ie Home Trainer Download Upload Device Device type HameTrainer grey HTCS Serial number Device v Change battery when lt 1 2 Download a 9 3 PC Download
18. Gf Care period 4 24 6 2002 24 6 200 Care period 5 24 6 2002 24 6 200 Training measurement 24 6 200 x 24 6 2002 H E Care period 6 27 6 2002 27 6 200 E E Care period 7 27 6 2002 16 7 200 H E Training measurement 27 6 200 Training measurement 27 6 200 H E Home training 14 1 2002 13 2 1 Compare Compare by Act uv v Training measurement 25 6 2002 EE Left sm Left LU Improyement eft Right ae bsolute bw 3 86 4 44 26 34 29 43 Delete Eolowap Show Report Close 1 0 3 REPORT Mega Electronics Ltd 2004 18 3 5 Order code 800304 Rev 2 1 ee Follow UP 0 tYl1
19. Backup 4 OR UJ 23 Mega Electronics Ltd 2004 FemiScan PC Software User s Manual 6 2 l Restore FemiScan Restore Restore from C Program Files FemiScan ADATABASESB ackuph 1 3 2 Restore 2 Restore LET 4 OR UI Mega Electronics Ltd 2004 24 Order code 800304 Rev 2 1 7 ear ee san Restar Exception message access violation at address asadas Read of address Fs Fas Fl Press Restart to restart the program Close to close the program without restart Ignore to continue with the esceptior Restart Close I nnrg 25 Mega Electronics Ltd 2004 FemiScan PC Software User s Manual 8 8 1
20. Tools Preferences 3 gt 1 n JER 1 2 Tools Preferences gt On line measurement gt gt 8 2 PS
21. oe 1 RRR 4 V 3 2 2 Peak uV 0 3 0 3
22. 1 Femi Scan 2 Tools Preferences Device tab lem avy TUL Att Clinic system Unit ICTRCA X ls Multi Trainer MTR X 5 X Tb EEE Figure 2 15 Preferences Device tab online offline PC COM Save preferences Femi Scan Chapter i ni E Program Files FemiScan 2 DATABASE m 7 Figure 2 16 Preferences General tab 1 Language drop down 2 WaV l Mega Electronics Ltd 2004 O Order code 800304 Rev 2 1 1 2 3 Database Path 1 Tools
23. RAM OS R AM eg Terminate And Stay Resident Programs 27 Mega Electronics Ltd 2004 FemiScan PC Software User s Manual 9 FemiScan PC Software VALID FROM July 7 2004 Classification General unless otherwise specified below MDD Classification Compliance with USA only FDA 510 k N o Regulatory class Compliance with Canada only MDD Classification Compliance with Overall system Measuring range vaginal EMG abdominal EMG Measurement accuracy vaginal EMG abdominal EMG Measurement repeatability vaginal EMG abdominal EMG PC requirements Minimum processor Free space on Hard Disk Ports CD ROM Display Sounds Operating systems Compatible with Mega Electronics Ltd 2004 SUBJECT TO CHANGE WITHOUT NOTICE Class Ila MDD 93 42 EEC EN60601 1 1998 EN60601 1 4 1999 A1 K993411 Class II 21 CFR 884 1425 Procode 85HIR 21 CFR 876 5320 Procode 78KPI 21 CFR Part 820 EN60601 1 1998 EN60601 1 4 1999 A1 Class Ila MDD 93 42 EEC EN60601 1 1998 EN60601 1 4 1999 A1 CAN CSA C22 2 No 601 1 M90 0 4095 uV FS ICTRA default range 50uV 0 255 uV FS HTCS default range 50uV
24. Freedom TO move FemiScan PC Software User s Manual E WARNING Mega Electronics Ltd 2004 Order code 800304 Rev 2 1 eee HE 9 52 9 1 52 92 53 10 55 10 1 13 10 1 1 55 10 1 2 55 10 1 3 56 10 2 57 10 2 1 Act 15 10 2 2 15 10 2 3 57 10 2 4 15 10 2 5 15 10 2 6 HK 16 10 2 7 58 10 3 58 10 3 1 16 10 3 2
25. 2 Follow up Act fp First Result 9 1 2002 Last Result 15 2 2002 Left Right Home Trainer Left 91 2002 17 1 2002 21 1 2002 251 2002 291 2002 2 2 2002 6 2 2002 10 2 2002 15 2 2002 E Right Curves Improvement mamma LL ioe oo y AME Relative 2 elete Eompare SHOV 7 Report Close 10 4
26. Bleed Mega Electronics Ltd 2004 12 Order code 800304 Rev 2 1 a o l N gt 3 Resuts Results Care Period Free Measurement Free Measurement Trining Measurement Trining Measurement Home Training Home Training 1 Home Training 2 10 1 3 1 1 UU i Show 3 1 2
27. u V IBackI IReporII 19 Mega Electronics Ltd 2004 FemiScan PC Software User s Manual Results A A Queries FemiQueries Results FemiOueries l 2 IloW_up Incontinence differentiation points Degree of incontinence disability Show Degree of incontinence disability Degree of incontinence 7 0 L 11 1 2002 13 2 2002 Curves D Absolute Degree of incontinence disability 40 Incontinence differentiation points 1 1 1 O
28. 3 2 7 33 1 Reputition 1 Training Series 1 Training Part 3 3 1 1 markerl 2 34 Note A TOK 3 3 2 10 3 2 1
29. 1 S bol 4 INPORT oa Mega Electronics Ltd 2004 Order code 800304 Rev 2 1 I 6 1 Back Up Kestore 6 1 l Back Up Femiscan Backup Perform backup to ae C Program Files FemiScan SDA TABASE Backup 13 1 2
30. Preferences Device tab 2 12 2 Database path 3 BAe FemiScanroot gt 1 2 4 g 1 Tools gt Preferences gt General 2 Basics 2 4 4 1
31. Clinic System FS ICTRA USB 2 3 2 1 HTCS 2 1 2 HTIFO RS 232 COM1 COM2 etc 3 Is Figure 2 13 Attaching the Serial interface between Home Trainer and PC 2 3 2 1 FS ICTRA FS MEIFS COMI COM etc 1 x PC wd e a Si St HF a Mega Electronics Ltd 2004 6 Order code 800304 Rev 2 1 Figure 2 14 Attaching the Serial interface between Clinic System unit and PC 7 Mega Electronics Ltd 2004 FemiScan PC Software User s Manual 1 2 1 2 1 COM
32. 16 10 4 18 10 5 FOLLOW UP 19 11 62 121 63 12 1 63 12 2 64 13 6 13 1 65 13 2 66 14 67 Mega Electronics Ltd 2004 FemiScan PC Software User s Manual 15 15 1 15 2 HOME TRAINER 15 3 16 FEMISCANIM PC SOFTWARE FEMISCANIM COVER 7 ker O Veny 171 17 1 1 Home Trainer 17 1 2 Cover 17 1 3 Headphones 17 2 17 2 1 Home Trainer 17 2 2 Cover 17 2 3 17 24 PC 1 2 5 18 Mega Electronics Ltd 2004 68 68 27 69 70 28 31 32 74 32 74 75 75 33 34 76 34 76 35 Order code 800304 Rev 2 1
33. 2 3 Femi Scan Femi Scan aco D po ate 2 2 ICTRA Clinic System Unit ICTRA HMTR Home Trainer HTCS grey 5 Mega Electronics Ltd 2004 FemiScan PC Software User s Manual 1 1 1 1 1 U SB HTCS 2 USB HTIFO 4 USB PC 2 2 USB USB USB NN Figure 2 12 USB interface for Home Trainer and Multi Trainer 1 1 2 RS 232
34. O Numeric results Curve Repetition Part Series Report LET Mega Electronics Ltd 2004 14 Order code 800304 Rev 2 1 in tl 3 2 3 2 1 Act V 0 5
35. Repetition Series Part 1 Repetition Series Part 2 Mega Electronics Ltd 2004 16 Order code 800304 Rev 2 1 Repetition Series Part 1 Repetition Series Part 2 10 3 2 1 2 10 3 2 1 S AV
36. View 13 Mega Electronics Ltd 2004 FemiScan PC Software User s Manual HTCS Free Training Training Measurement Home HTCS MTIR 3 1 3 V scale Calculated results Display Show Device type Training Program 16 act Ic Singe Dual E Clinic system Unit ICTRIAJ HTCS Training 300 0 350 0 400 0 450 0 150 0 200 0 250 0 a Result Level Curve ba Marker 6 Numeric results 4 Repo Save 10 2 DQ D Curve Ae lel Cal eee 7 eee Ce a
37. 0 4095 uV default range 120uV 2 or 2 uV whichever greater 2 or 2 uV whichever greater 1 uV l uV Intel PentiumJI 550 MHz power management must be switched off 40 MB for FemiScan PC Software and database USB port not in Windows NT Serial port if used with FS ICTRA buffered serial chip 16550AFN or compatible one CD ROM drive Display card and driver driver with small fonts installed minimum resolution SVGA 800 600 and 16 bit colors Sound card and driver Windows 98 NT service pack 6 ME Windows 2000 or Windows XP minimum RAM 128 MB minimum RAM 256 MB for Windows XP 28 Order code 800304 Rev 2 1 mm Compatibility with FemiScan Clinic System Clinic System FS ICTRA From revision FS ICTRA 2 onwards From revision FS CTR 0 onwards Clinic System Interface FS MEIFS serial port From revision HTIFO 4B onwards USB FemiScan HomeTrainer Set Home Trainer Set FS HTCS From revision FS HTCS 2 onwards Multi Trainer Set FS MTR From revision FS MTR 1 onwards FemiScan Clinic Set Clinic Set Interface HTIFO Revisions HTIFO 2 and HTIFO 3 serial port From revision HTIFO 4 onwards USB Classification Revisions FS HTCS 2 I10EN and FemiScan MultiTrainer FS MTR 1 10EN MDD Classification Class Ila Type EN60601 1 Type BF Compliance with MDD 93 42 EEC EN60601 1 1998 EN60601 1 2 1993 EN60601 2 40 1998 CAN CSA C22 2 No 601 1 M90 FDA 510 k N o K993411 for F
38. 0 3 3 2 3 Speed uw V s 4u V 1 3 2 4 Work Vs 1 3 2 5 Reaction
39. EEI 1 FES F S F S F S Training measurement Ae Training measurement 24 6 2002 BY 24 6 2002 1 Show Show fei oa e Use as default User result FSreut H 17 Mega Electronics Ltd 2004 FemiScan PC Software User s Manual 3 4 2 Ctr 1 2
40. Response manually or choose previous Maximum Response from the table Previous Maximum Response Training Program HTCS Training P Common Show All nd Jv Auto W Maximum Response C Separately Training Parts Maximum Response Target Target Level Part 1 Contract gt 2 W 80 Part 2 Contract 80 Part 3 Contract 80 9 2 Auto Check Box AUTO OK
41. 2 40 1998 Overall system Reorder code REF 900028 Type Aseptic electrode for vaginal EMG biofeedback SINGLE USE at clinic use SINGLE PATIENT USE at home use Operating temperature 10 40 C Storage temperature 0 40 C Relative humidity lt 90 Ambient pressure 500 1060 hPa Manufacturing method In controlled clean room environment Class 2 R 100000 Single package Sealed plastic bubble Delivery package 50 pieces in cardboard box with sealed double plastic bag Validity period 2 years from checking Compatibility with FemiScan products FemiScan Clinic System Clinic System FS ICTRA From revision FS ICTRA 2 onwards IncoTrainer ICTR From revision FS ICTR 1 onwards Clinic Trainer From revision ICPR 0 onwards FemiScan HomeTrainer Set and FemiScan MultiTrainer Home Trainer Set FS HTCS From revision FS HTCS 2 onwards Home Trainer Set FS HMTR From revision FS HMTR 1 onwards MultiTrainer with PassiveProbe From revision FS MTR 1 onwards FemiScan Clinic Set Clinic Set FS CTS From revision FS CTS 1 onwards Home Trainer Set FS HTCS From revision FS HTCS 2 onwards MultiTrainer with PassiveProbe From revision FS MTR 1 onwards Technical details Electrode contacts 6 longitudinal 45 4 mm each Dimensions 9 45 74 mm diameter max 27 mm Weight 16 g without package Cleaning Cleaning and disinfection Allowed only at home use under supervision of health care personnel See appropri
42. 704 1617 FAX 0263 29 0863 FAX 011 787 1183 FAX 022 288 2956 FAX 019 684 2445 FAX 048 766 0199 FAX 047 360 3750 FAX 03 5689 4615 FAX 0422 70 5723 FAS 045 912 2481 FAX 076 222 3815 FAX 025 230 3641 FAX 075 353 4833 FAX 078 252 2518 FAX 086 902 5412 FAX 082 238 7987 FAX O87 668 4338
43. FemiScan MultiTrainer FS MTR 1 Dimensions Weight Enclosure class Headphone options 8 bit CMOS 2 0 MHz 0 154 MHz Analog full wave rectification and low pass filtering 8 bits 10 samples sec Total 12890 1 uV 1 uV 11 530 Hz 3dB points Typ 100 dB lt 2 uV in the measuring band 100 45 74 mm with Cover installed on 75 g with Cover installed on IP67 103 54 24 mm without cables 84 g without cables IP20 Headphone dual earphone with bail code VPO0187 System box Type Cable length Weight Type Dimensions Weight PC Software compatibility Cover Options 2 channel monophone with volume control 1 30 m 76g Cardboard 235 175 62 mm 135g See FemiScan PC software User s Manual chapter TECHNICAL SPECIFICATIONS See separate TECHNICAL SPECIFICATIONS for FemiScan Cover after these pages Set of replacement System boxes includes unfolded System boxes with internal parts and foams Standard accessories Mega Electronics Ltd 2004 30 Order code 800304 Rev 2 1 mm FemiScan Cover Classification MDD Classification Class Ila Compliance with MDD 93 42 EEC EN60601 1 1998 EN60601 2 40 1998 CAN CSA C22 2 No 601 1 M90 EN 980 1996 A1 ISO 780 1997 E ISO 10993 5 and ISO 10993 10 FDA 510 k N o K993411 Regulatory class Class II 21 CFR 884 1425 Procode 85HIR 21 CFR 876 5320 Procode 78KPI Compliance with 21 CFR Part 820 EN60601 1 1998 EN60601
44. T 27 G2 12 101 1 201 10 1 SCR Et ike 5 6 2 SSeS esl 1 A ab 20 20 TERA HREM 15 1 2 10 6 PRE LSF gt 5 13 33 ARRIRA AREN 2AS 221 KONDO IL 1B 15 134B 2 81 40B 3 3 e mail LUST 21 1F 2 13 14 WAEL BRT 299 5 36 ssp nihonmedix co jp TEL O47 368 87117 0 TEL O4 7193 3333 10 TEL O48 766 2669 TL TEL 06 6369 1201 2 TEL 092 57 1 8258 18 TEL 099 286 1081 TEL 052 704 1616 14 TEL 0263 29 0862 14 TEL O11 787 1182 1 TEL 022 2868 2955 10 TEL 019 699 1201 Hi TEL 048 767 1681 4 TEL 047 703 1750 8 TEL 03 5689 4611 2 TEL 0422 70 5721 2 TEL 045 911 8421 2 TEL O76 222 3811 2 TEL 025 230 3655 2 TEL O75 353 4822 i TEL O78 252 2336 1 TEL 086 902 5411 4 TEL O82 236 7588 tE TEL O87 B68 43923 FAX 047 368 1535 FAX O4 7193 3311 FAX 048 766 2264 FAX 06 6369 2088 FAX 092 571 8259 FAX 099 286 1082 FAX 052
45. ate FemiScan product User s Manuals Cleaning temperature Max 50 C 31 Mega Electronics Ltd 2004 FemiScan PC Software User s Manual 10 2 18 1 18 2 1 1 17 1
46. emiScan HomeTrainer Regulatory class Class II 21 CFR 884 1425 Procode 85HIR 21 CFR 876 5320 Procode 78KPI Compliance with 21 CFR Part 820 Overall system Measuring range vaginal EMG 0 220 uV during home measurements for clinic use see FemiScan Clinic Set specifications Measurement accuracy vaginal EMG 6 or 3uV whichever greater accuracy not specified at range gt 220LV Measurement repeatability vaginal EMG 2uV Operating temperature 10 40 C Storage temperature 0 40 C Relative humidity lt 90 Ambient pressure 500 1060 hPa Weight 75 g Home Trainer with Cover 84 g MultiTrainer without cables Subsystems Home Trainer and MultiTrainer Channels 2 vaginal EMG channels EMG type Averaged surface EMG Measuring modes Averaged off line to internal memory Averaged on line to PC Software with FemiScan Clinic Set Internal memory 32 KB Recording times Typically 60 100 training sessions Power source Alkaline battery non chargeable type AAA LRO3 1 5V Typical running time gt 20 hours starting with full and fresh battery Current consumption Typically 30 mA 29 Mega Electronics Ltd 2004 FemiScan PC Software User s Manual Microprocessor Crystal freq Clock freq Signal processing AD conversion Sampling rate Amplification Sensitivity Resolution Filtering band CMRR Noise Physical information FemiScan HomeTrainer FS HTCS 2 Dimensions Weight Enclosure class
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