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ALMAG+

ACCEPTANCE CERTIFICATE

ALMAG+ Magnetotherapy Device incl. accessories, S/N _______________ com-

plies with GIKS.941519.114 TU speci

ca ons and is classi

ed as

t for opera on.

So ware version: GIKS.21-0101.

Date of manufacture: ___________________

Stamp here

_____________________________________

(Full name and signature of the person responsible for acceptance)

ALMAG+ Magnetotherapy Device incl. accessories has been packaged in compli-

ance with the requirements of the design documenta on.

Packing date __________________________

Stamp here

Packaged by __________________________

(Full name and signature)

Содержание ALMAG+

Страница 1: ...ique product capabili es on the treatment and preven on of a wide range of diseases either under medical facility environ ment where the physiotherapy department is present or by pa ents themselves at...

Страница 2: ...ith reinforced insula on no protec ve earthing is required Opera on Manual Please read the Opera on Manual carefully Control Unit of the product provides the ingress protec on against items over 1 mm...

Страница 3: ...TS 10 PREPARATION FOR USE 11 OPERATION PROCEDURES 12 Visual Display 12 Treatment Modes 13 Detailed Procedures 15 DEVICE USER MANUAL 21 Age specific dosage prescrip ons 22 Inductors applica on to deliv...

Страница 4: ...n case its housing or cable is damaged Store and use the device in a dry room Keep control unit and emi er away from humidity when trea ng sur faces with disinfectant solu on s Keep the device in dry...

Страница 5: ...environmental protec on Dispose of the device at the end of its lifecycle as electronic waste at dedicated disposal loca ons Disclaimer of liability The manufacturer will not be liable for damages re...

Страница 6: ...The device consists of the control unit current pulse generator and an emi er comprising four interconnected inductor coils used to provide exposure to individ ual parts of the body The device is desi...

Страница 7: ...ductor coils fastener is omi ed for clarity Inductor coils are combined into two groups of two coils per group The groups may be configured in the form of 2x2 matrix and or spline composed of four ind...

Страница 8: ...ve humidity up to 98 at a temperature of 25 The device is transportable using any mode of transport within temperate and cold macroclima c areas at ambient temperatures of 50 to 50 During opera on a e...

Страница 9: ...disease of the I and II degree Dystonia vegetovascular dystonia Complica ons of diabetes mellitus Type I and II Atherosclerosis Vein and lymph vascular disease including varicosity and its complica o...

Страница 10: ...in bone ssue is not a contraindica on to adminis tra on of the device in therapeu c doses Metal dental crowns if present in mouth cavity is not a contraindica on to ad ministra on of the device in th...

Страница 11: ...or use in medical prac ce to protect the plas c and metal items from dermatomycosis infec on Keep interval between wipings accord ing to the direc ons for use of disinfectant solu on Keep control unit...

Страница 12: ...ce is powered on the Start Stop bu on LED starts blink ing to indicate that the device is on and in wai ng mode The device changes the mode into normal opera on mode upon brief pressing any bu on The...

Страница 13: ...e mains frequency 20 6 Basic mode of opera on 2 traveling 6 25 1 8 of the mains frequency 8 2 Pediatric mode with reduced magne c field density 3 sta onary 100 doubled mains frequency 6 2 Therapeu c m...

Страница 14: ...d signal and non flashing glow of the START STOP bu on LED indicator The operability of the device with the treatment mode switched on can be fur ther checked with magne c field indicator applying it...

Страница 15: ...links o and the START STOP bu on starts blinking The device provides work for 8 hours in the recursive short me mode The ex posure me is 20 minutes for all the modes followed by 10 minutes idle period...

Страница 16: ...sed magne c field is to be directed from the 1st inductor coil to the 4th inductor coil when spline emi er configura on is used namely The coil directly connected to the control unit is referred to as...

Страница 17: ...ON MANUAL Unzip the fastener and open the velcros located inside the fastener Take the 3rd and 4th inductor coils of the device and fix them with velcros in the fastener at the 3rd and 4th coils conne...

Страница 18: ...18 ALMAG Place the rest 1st and 2nd inductor coils into the fastener and fix them with velcros Zip up the fastener Four inductor coils are now arranged in the form of spline...

Страница 19: ...19 OPERATION MANUAL Use the accessory straps delivered with the device to fix the spline to the extremi es Locate the straps over the zipper and fix them with velcros...

Страница 20: ...nductor coil configura on is recommended the following emi er arrangement op on should be used no spline fastener is required the emi ers are placed pairwise directly to the exposure areas according t...

Страница 21: ...ent and rehabilita on using the device please consult with your local physiotherapist 4 In case the treatment is administered by the doctor the doctor can modify the procedure based on the personal ch...

Страница 22: ...t on Days 3 4 the dura on of treatment will be reduced to 7 minutes for 2 days and then the dura on of treatment will increase up to 15 to 20 minutes A er the first 6 day course of treatment make a br...

Страница 23: ...ng the first 6 days of treatment Mode 1 apply Mode 2 during the next 3 days of treatment From that me onwards resume Mode 1 treatment In case the exposure results in the blood pressure increase or dec...

Страница 24: ...3 3 2 Dura on min 3 4 3 4 3 4 3 4 3 4 Treatment day 6 7 8 9 10 Mode 2 2 2 2 2 Dura on min 3 4 3 4 3 4 3 4 3 4 Table 3 Course treatment procedure for pa ents at the age of 4 weeks to 1 year old 1 to 3...

Страница 25: ...2 Dura on min 7 8 7 8 7 8 7 8 7 8 Table 5 Course treatment procedure for pa ents 3 to 7 years old 7 to 15 years old Treatment day 1 2 3 4 5 Mode 3 3 3 3 2 Dura on min 10 12 10 12 10 12 10 12 10 12 Tr...

Страница 26: ...thri s apply the spline of four inductor coils helically around the joint engaging the surrounding ssues For pa ents with two joints a ected apply the first pair of inductor coils to the first joint a...

Страница 27: ...y bone spur treatment OSTEOCHONDROSIS VERTEBRALIS INCLUDING HERNIATED NUCLEUS PULPO SUS OR SCOLIOSIS Locate the inductor coils pairwise in parallel along the spine over the long back muscles in such a...

Страница 28: ...erve and expose the second area See Figure 5 for the exemplary treat ment of a pa ent with lumbar osteochon drosis and nerve root syndrome OSTEOPOROSIS Apply the spline of four inductor coils along th...

Страница 29: ...For pa ents with dystonia apply the spline of four inductor coils to the collar zone The exposure me shall comply with the age specific dosage prescrip ons Complica ons of diabetes mellitus When trea...

Страница 30: ...both the extremi es a ected expose both the legs once a day If one leg is a ected expose twice a day when trea ng at home See Figure 9 for the exemplary leg atherosclerosis treat ment Vein diseases ch...

Страница 31: ...o areas in parallel with the spline over interscapular region Following the interscapular region exposure as per age specific dosage prescrip ons join two inductor coils pairs into the spline and appl...

Страница 32: ...le cerebral palsy and associated pareses or hypertonia apply the inductor coils to the a ected plexus and along the a ected nerve according to the age specific dosage prescrip ons Adjust the number of...

Страница 33: ...uctor coils along the pro jec on of the a ected area The treatment through the gauze or plaster bandage is al lowed The number of inductor coils will depend on the surface area of the injured region S...

Страница 34: ...me is set automa cally on program selec on During opera on the device is resistant to clima c factors at ambient temper atures of 10 to 35 and a rated value of rela ve humidity of 80 at 25 During tran...

Страница 35: ...signal indica ng the intermediate exposure me intervals will be gen erated every 5 minutes 5 from the treatment start me and on The me delay before switching to standby mode a er the comple on of the...

Страница 36: ...the use of products The standard specifies the levels of immunity to electro magne c interference as well as the maximum levels of electromagne c emis sion as applicable to medical equipment This dev...

Страница 37: ...enance of the device does not require special skills and it will be conduct ed by representa ves of the healthcare ins tu on where the device is operated or by the user himself herself at home Mainten...

Страница 38: ...ed contact the manufacturer or its representa ve Data displayed by Control Unit Malfunc on Sound signal and Mode 2 LED blinking Emi er cable wire is broken Sound signal and Mode 3 LED blinking Inducto...

Страница 39: ...Group 1 The device uses radio frequency energy only to perform internal functions The emission level of the radio frequency interference is low and might not lead to disturbances in the functioning o...

Страница 40: ...IEC 61000 4 5 1 kV when applying wire to wire interference 2 kV when applying wire to ground interference Complies Power quality in mains must be provided in accordance with the typical conditions of...

Страница 41: ...nce between the mobile radiotelephone communica on systems used and any element of the device including the cables should not be less than the recommended separa on distance which is calcu lated in ac...

Страница 42: ...exceed the applicable levels of compliance the opera on of the device should be monitored to verify their normal func oning If a devia on from normal func oning is detected during the observa on proc...

Страница 43: ...nsmitter P W Separation distance d m depending on the frequency of the transmitter d 1 2 P in band from 150 kHz to 80 MHz d 1 2 P in band from 80 to 800 MHz d 2 3 P in band from 800 MHz to 2 5 GHz 0 0...

Страница 44: ...21 0101 Date of manufacture ___________________ Stamp here _____________________________________ Full name and signature of the person responsible for acceptance ALMAG Magnetotherapy Device incl acce...

Страница 45: ...disposed of separately in dedicated centers in accordance with local legisla on Do not dispose of these components with household waste Proper disposal of the waste product will help in preven ng the...

Страница 46: ...nents free of charge upon presenta on of the warranty card 2 Terms of warranty The warranty does not cover the following cases If the unit has signs of extraneous interference or a emptedrepair in an...

Страница 47: ...r Date __________________ City ______________________________________ Released after repairs _______________________________________________ Stamp here Head of the repair facility ___________________...

Страница 48: ...48 ALMAG...

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