T250. Manufactured by:

Transcription

1 Manufactured by JOHARI DIGITAL HEALTHCARE LTD. G , EPIP, Boranada, Jodhpur Rajasthan, India Te Apr2016

2 Precautionary instructions The precautionary instructions found in this section and throughout this manua are indicated by specific symbos. Understand these symbos and their definitions before operating this equipment. The definitions of these symbos are as foows CAUTION WARNING DANGER Text with a CAUTION indicator wi expain possibe Safety infractions that coud have the potentia to cause minor to moderate injury or damage to equipment. Text with a WARNING indicator wi expain possibe Safety infractions that wi potentiay cause serious injury and equipment damage. Text with a DANGER indicator wi expain possibe safety infractions that are imminenty hazardous situations that woud resut in death or serious injury. NOTE Throughout this manua, NOTE may be found. These Notes are hepfu information to aid in the particuar area or function being described INSTRUCTIONS FOR THE USER OF ELECTROTHERAPY 1.1 Warnings 1.2 Danger 1.3 Indications for use 1.4 Contraindications 1.5 Precautions 1.6 Adverse reaction INTRODUCTION DESCRIPTION ACCESSORIES SPECIFICATIONS 7 6. CONTROLS AND FUNCTIONS 9 7. HOW TO OPERATE 10 Nomencature The foowing are the symbos used in manua and sticker 8. ELECTRODE CARE AND SELECTION 11 Hardware symbos 9. CONNECTING THE DEVICE 12 Eectrica Type, Type BF BATTERY INFORMATION CLEANING THE DEVICE CLASS II symbo MAINTENANCE TROUBLESHOOTING DC Input Symbo SUGGESTED ELECTRODE PLACEMENT CHART WARRANTY 17 18

3 1. INSTRUCTIONS FOR THE USER OF ELECTROTHERAPY Pease read this instruction manua carefuy before using because it is unsafe to start using the device before reading the whoe manua. The instructions on the foowing pages wi show you how to use and care for your in a genera manner. You shoud be particuary famiiar with the prescription information and precautions before proceeding. CAUTION This device must be used ony under the continued supervision of a physician or icensed practitioner in the state he/she practices. DO NOT operate this unit in an environment where other devices are being used that intentionay radiates eectromagnetic energy in an unshieded manner. This unit shoud be operated in temperatures between 15 C and 45 C, transported and stored in temperatures between 5 C and 55 C, with Reative Humidity ranges from 30% to 60%. Inspect connectors before each use. The system is not designated to prevent the ingress of water or iquids. Ingress of water or iquids coud cause mafunction of interna components of the system and therefore create a risk of injury to the patient. 1.1 Warnings The ong-term effects of chronic eectrica stimuation are unknown. Stimuation shoud not be appied over the carotid sinus nerves, particuar in patient with known sensitivity to the carotid' sinus refex. The TENS eectrode shoud not be appied over the neck or mouth, or anywhere ese on the head. If TENS stimuation is appied over the neck or mouth especiay, severe spasm of the aryngea and pharyngea musce may occur and the contraction may be strong enough to cose the airway or cause difficuty in breathing. Inspect connectors before each use. The system is not designated to prevent the ingress of water or iquids. Ingress of water or iquids coud cause mafunction of interna components of the system and therefore create a risk of injury to the patient. Stimuation shoud not be appied transthoracicay in that the introduction of eectrica current into the heart may cause cardiac arrhythmias. Stimuation shoud not be appied over swoen, infected, or infamed areas or skin eruption, e.g. phebitis, thrombophebitis, varicose veins, etc. Stimuation shoud not be appied over, or in proximity to, cancerous esion. This device shoud not be appied on the anterior aspect of the chest (i.e. thorax) To be used under doctor prescription and contro (not suggestion but obigation). If system persist, contact doctor. To be used excusivey on not injured skin. To be used excusivey with adaptor from manufacturer. To be used excusivey with eectrodes from manufacturer. The eectro stimuator is not abe to act on the origin of the pain. 1.2 Danger Improper handing or use of this device may resut in a high risk of death or serious injury. Stimuus deivered by the TENS waveforms of this device, in certain configurations, wi deiver a charge of 25 micro couombs (µc) or

4 greater per puse and may be sufficient to cause eectrocution. Eectrica current of this magnitude must not fow through the thorax because it may cause cardiac arrhythmia. Patients with an impanted Neurostimuation device must not be treated with or be in cose proximity to any shortwave diathermy, microwave, diathermy, therapeutic utrasound diathermy, or aser diathermy anywhere on their body. Energy from diathermy (shortwave, microwave, utrasound and aser) can be transferred through the impanted Neurostimuation system, can cause tissue damage, and can resut in severe injury or death. Injury, damage, or death can occur during diathermy therapy even if the impanted Neurostimuation system is turned "off'. Hande cean, and dispose of components and accessories that have come in contact with bodiy fuids according to Nationa, Loca and Faciity rues, reguations and procedures. In the event of battery ce rupture or eakage, hande battery wearing neoprene or natura rubber goves. Contents of a ruptured or eaking battery can cause respiratory irritation. Hypersensitivity to nicke can cause aergic pumonary asthma. Contents of ce coming in content with skin can cause skin irritation and/or chemica burns. Never, under any circumstances, open the battery or ces. Shoud an individua ce from a battery become disassembed, spontaneous combustion of the negative eectrode is possibe. There can be a deay between exposure to the air and spontaneous combustion. Change the battery according to the instructions found in this manua. Do not reverse the poarity of the battery. Doing so can increase the individua ce temperature and cause eakage or ce rupture. Never dispose of battery in the fire. Never short circuit the battery. The battery may expode, ignite, eak or get hot causing serious persona injury. Dispose of batteries according to nationa, state and oca codes and reguations. 1.3 Indication for Use is indicated to be used for Symptomatic reief and management of chronic intractabe pain and/or as an adjunctive treatment in the management of post-traumatic and post-surgica acute pain. 1.4 Contraindications must not be used by Pregnant Woman, Patients with Metaic Prosthesis / Impantabe Devices & Patients with Cardiac Probems. must not be used near the Eyes, Genitas and Transcerebra Area. 1.5 Precautions Caution shoud be used for patients with suspected or diagnosed heart probems. The may be susceptibe to interference originating from shortwave diathermy units operating in cose proximity to it (aprrox 3m). Avoid operating the adjacent to and simutaneousy with operating short-wave devices. Caution shoud be used for patients with suspected or diagnosed epiepsy. Caution shoud be used in presences of foowing When there is a tendency of hemorrhage foowing acute trauma or fracture. Foowing recent surgica procedures when musce contraction may disrupt the heaing process. Over the menstruating or uterus. Over area of the skin which ack norma sensation. Some patients may experience skin irritation or

5 hypersensitivity due to the eectrica stimuation. The irritation can usuay be reduced by using an aternate eectrode pacement. TENS eectrode pacement shoud be based on the guidance of the prescribing physician. shoud be kept out of the reach of chidren. The shoud be used ony with the eads and eectrodes recommended for use by the manufacturer. The shoud not be used whie driving, operating machinery, or during any activity in which invountary musce contraction may put the user at undue risk of injury. 1.6 Adverse Reaction Skin irritation and sight burns beneath the eectrodes have been reported with use of TENS devices. 2. INTRODUCTION is a microcomputer controed two channe portabe unit. has been designed by engineers with years of expertise and knowedge in the medica device industry, specificay eectrica stimuation. is the resut of extensive research in the area of eectric musce stimuation therapy. 4. ACCESSORIES comes compete with a the necessary accessories and beow is a ist of items that are incuded S. No. Particuars Quantity 1. Lead Wire (2 poe) 02 Length 1 mtr. 2. Sef Adhesive Eectrodes 04 (Size 2 X 2 ) 3. 9V Battery Instruction Manua 5. Adaptor 01 Carry Bag DESCRIPTION is portabe transcutaneous eectrica nerve stimuation device. It has three modes viz. (i) TENS Burst (ii) TENS Norma (Conventiona) and (iii) TENS Moduation. It provides easy mode seection through the Mode Seector switch and the user can seect any one of the avaiabe modes through it.

6 5. SPECIFICATIONS WAVEFORM SPECIFICATIONS SYSTEM SPECIFICATIONS Unit Length Width Height Standard Weight Power (unit) Battery Input 9.3cm (3.70 ) 6.4cm (2.54 ) 3.3cm (1.3 ) Approx 220 gms. (0.5 bs) +9 Vots Battery / 9 Vot DC Adaptor Channes Two Waveform Asymmetrica biphasic Square Puse Rate Seectabe from 2 to 150 Hz Puse Width Seectabe from 40 to 260 µs Output Votages 500Ω Resistive Load Output Current Ω Resistive Load Modes Seectabe(B- Burst, N-Norma and M-Moduation) Treatment Time Seectabe 30,C, 60 Minutes NOTE A the parameters have± 10% toerance. Eectrica Type Eectrotherapy Operating temperatures Storage temperatures IP Grade TYPE BF between 15 C to 45 C between 5 C to 55 C, IP 54

7 6. CONTROLS AND FUNCTIONS SYSTEM SPECIFICATIONS 1 Channe-2 Output Receptace 7 Mode Seector Switch 2 3 Channe-1 Output Receptace LOW BATTERY Indicator Light Burst Norma Moduation 4 Output ON Indicator Light 8 Timer Seection Switch Channe-1 On/Off and Ampitude Contro Channe-2 On/Off and Ampitude Contro 9 10 Puse Width Contro Puse Rate Contro 11 9 Vot Adaptor Socket (*Optiona) * 7. HOW TO OPERATE Side Cover A cover conceas the contros for the Puse Rate, Puse Width, Mode and the Battery compartment. Pu down in order to open the cover. Mode This device offers three settings via the Mode switch. Be sure the ampitude contros knobs are set to off '0' before changing the mode switch position. Burst Mode (B) This mode provides a series of 9 puses. Puse rate, puse width and ampitude contros are fuy adjustabe in this mode. Norma Mode (N) This mode provides norma stimuation through the puse rate, puse width and ampitude contro seections, resuting in a continuous stimuation as per seection of puse width and puse rate. Moduated Puse width Mode (M) Puse width decreases up to 40µS from the seected vaue and then returns back to the seected vaue over a preset period.

8 Timer Switch Switch Position at 30, unit runs for 30 minutes and output intensity turns off automaticay. Switch position at C When switch is set at position is at C, the unit runs continuousy unti it is turned off manuay. Switch Position at 60 When switch is at position of 60 unit runs for 60 minutes and output intensity turn off automaticay. Ampitude Contros The ampitude contro knobs are ocated on the top of the unit. The ampitude contro knobs functions as ON/OFF contro and contros the intensity of the stimuator for Channe 1 and 2. ELECTRODES 9. CONNECTING THE DEVICE LEAD WIRE IMPORTANT Be sure both ampitude contro knobs are turned to the OFF position before connecting the device. 8. ELECTRODE CARE AND SELECTION There are many kinds of eectrodes. Be sure to use the eectrodes recommended by your physician or provided by the Manufacturer. After using any of these eectrodes, grasp the corner of the eectrode and genty remove it from your skin. Do not pu on the eectrode snap or wire connection. Reappy the reease iner to the adhesive side of the eectrode. Store the eectrode in a re-sea abe pouch or pastic bag. To proong the ife span of the eectrodes, remoisten them by appying a few drops of tap water when they show signs of drying out or osing their adhesives. Appy the water with your fingertip. After repeated usage, reusabe eectrodes begin to ose their adhesives and therefore deiver ess stimuation and shorten battery ife. Repace reusabe eectrodes when needed. Prepare the skin Thoroughy cean the area of skin where eectrode have to be pace with mid soap and water, rinse we and bot dry thoroughy. Any excess hair shoud be cipped, not shaved, to ensure good eectrode contact with the skin. You may choose to use a skin treatment or preparation that is recommended by your Physician or Physiotherapist. Appy a skin treatment o preparation, et dry and appy eectrode as directed. This wi reduce the chance of skin irritation and extend the ife of the eectrode. Connect ead wires to the eectrode Connect the ead wires to the eectrodes before appying the eectrode to the skin. Lead wires provided with the device are compiant with mandatory compiance standard set forth by internationa standards. Pacement of Eectrodes In genera, eectrodes are paced around the area of pain. In some cases, eectrodes are paced on acupuncture points. However, it is advisabe to consut your physiotherapist or physician to determine the exact area of appication for your specific condition. Remember, to sighty change the ocation of the eectrodes paced on your body, if device is used continuousy for

9 many days, to avoid skin irritation. Avoid excessive stretching of skin where appying eectrode and smoothening, pressing it in pace from center outward. Lead wire connection Insert the ead wires into the output receptace ocated on the side of the unit by hoding the insuated portion of the connector, and pushing the pug end of the wire into one of the jacks. Note Use caution when you pug and unpug the wires. Puing on the ead wire instead of its insuated connector may cause wire breakage. Puse Rate Adjustment As shown in the front view of the device on page no. 5 set the puse rate by turning knob, as recommended by your physician. Puse width Adjustment As shown in the front view of the device on page no. 5 set the puse width by turning knob, as recommended by your physician. Treatment Time Adjustment As shown in the front view of the device on page no.5 seect the time through the time switch. Ampitude Contro Turn the ampitude contro knob for Channe 1 and 2 cockwise as shown in the top view of the device on page no.5 The ON indicator wi ight up whie the unit in operation. Sowy turn the Ampitude Contro Knob in a cockwise direction, unti you reach the settings recommended by your Physician. Repeat with other channes, if both channes are to be used. Turning the unit off Turn both ampitude contro knobs to '0', and then disconnect the ead wire from the jack. If treatment is to be resumed shorty, the eectrode may be eft on the skin. On remova of the eectrode from the skin, wash the skin thoroughy with mid soap and water. If the stimuation eves are uncomfortabe or become uncomfortabe, reduce the stimuation ampitude to comfortabe eve. If probems persist, stop treatment and contact your physician. 10. BATTERY INFORMATION If battery is too weak it wi not power up or a ow battery indicator wi ight up. When the ow battery indicator is ON, the battery shoud be repaced with a fresh battery. Side the cover upward. This wi revea the battery compartment Remove the od Battery from the device. Pace a new battery in the compartment. Note the proper poarity aignment indicated on both the battery and the battery compartment. Ensure od battery is disposed off safey. 11. CLEANING THE DEVICE The device may be ceaned by wiping genty with a damp coth moistened with mid soap and water. Never immerse the device in water or other iquids. Wipe ead wires with damp coth if they become soied. To propery store the device for an extended period of time, remove the battery from the unit. Pace the unit and accessories in the pouch and store in a coo and dry pace. 12. MAINTENANCE Ceaning The soied device shoud be ceaned with a damp coth. Side cover upwards Battery Band Eectrode Cabes Do not pu out cabes. For routine ceaning of the eectrode cabes use soap and water and thoroughy dry them after ceaning. Eectrode wires shoud be kept oosey winded or breakage may occur.

10 Storage Keep the device propery covered, when not in use to keep out dust. Store the device in a proper and dry pace. Damp environment cause rust and affect the functioning of device. Skin Care Appy eectrodes on cean, dry and unbroken skin ony. Aways wash the seected treatment area with mid soap and water and dry it thoroughy before appying eectrodes and after removing them. Do not stretch the skin or eectrodes whie appying or removing the eectrodes. When removing eectrodes, aways pee back in the direction of the hair growth. If there is difficuty moisten the edges underside of the eectrode. Appying unfavored Mik of Magnesia over eectrode pacement sites after removing eectrodes heps maintain the natura ph of the skin and reduces irritation. If perspiration occurs in the area of the eectrodes causing the eectrodes to side out of position, wipe area with unscented antiperspiration pads and dry before reappying eectrodes. If skin irritation arises and persists from the use of eectrica stimuation and certain type of eectrodes, discontinue their use immediatey and consut your cinician. 13. TROUBLESHOOTING If your unit does not seem to be operating correcty, refer to the chart beow to determine what may be wrong, Shoud none of these measures correct the probem, the unit wi need servicing. Observation Possibe causes Remedy Weak stimuation or No Stimuation even at maximum ampitude setting Skin irritation at eectrode pacement site Sudden high intensity whie increasing ampitude Unit doesn't switch ON. Poor eectrode contact or Insufficient ge on the eectrode Eectrode conduction is ow/ Lead wire is worn out Improper contact/ Ge dried up Increasing ampitude too fast. Battery deepy discharged or not connected propery. Check the eectrodes for sufficient ge Change eectrodes/ Change ead wires Wet or Change the eectrode Increase ampitude sowy giving time to patient to indicate his comfort. Repace battery with a new one or connect propery.

11 14. SUGGESTED ELECTRODE PLACEMENT CHART 15. WARRANTY This product warranty extends to the origina consumer /purchaser of the product. Warranty duration This product is warranted to the origina consumer for a period of one (1) year from the origina purchase date. Warranty coverage This product is warranted against defective materias or workmanship. This warranty ceases if the product has been damaged by accident, in shipment, unreasonabe use, misuse, negect, improper service, commercia use, and repair by unauthorized personne. This warranty does not extend to any units which are used in vioation furnished by manufacturer, or to units which have been atered or modified, or to damage to products or parts there of which have the seria number removed, atered or defaced or rendered iegibe. The warranty doesn't cover norma wear & tear or repacement of eectrode cabes, eectrodes and other accessories. Warranty discaimers This warranty is in ieu of a warranties expressed or impied and no representative or person is authorized to assume for manufacturer/ any other iabe in connection with the sae of our products. There sha be no caims for defects or faiure of performance or product faiure/ any theory of tort, contract or commercia aw incuding, but not imited in negigence, gross negigence, and strict iabiity, breach of warranty and breach of contract. Some states do not aow the excusion or imitation of impied warranties or consequentia damages, so the above imitations may not appy to you. Manufacturer is not responsibe or iabe for indirect specia or consequentia damages arising out of or in connection with the use performance of the product or other damage with respect to oss of property or oss revenues or profit. 18

12 Lega remedies This warranty gives you specific ega rights, and you may aso have other rights that vary from state to state. Warranty performance During the above one-year warranty period, a product with a defect wi be repaired or repaced with a reconditioned comparabe unit at distributor's option when the product is returned to the distributor. The repaired or repacement product wi be in warranty for the baance of the one-year warranty period and an additiona one-month period. No charge wi be made for such repair or repacement. Consumer service For in warranty service for a product covered under the warranty period, no charge is made for service and return postage. Pease return the product insured, packed with sufficient protection, postage insurance, prepaid to the address. Customer's duty/brokerage fee, if any, must be paid by the consumer. JOHARI DIGITAL HEALTHCARE LTD. G , EPIP, Boranada, Jodhpur Rajasthan, India Te info@joharidigita.com Out of warranty service There wi be charges rendered for repairs made to the product after the expiration of the aforesaid one (1) year warranty period, after purchaser is advised appropriatey. The distributor cannot assume responsibiity for oss or damage during shipment. For your protection, carefuy pack the product for shipment and insure it with the carrier. Ensure that you return the unit and accessories reated to your probem and aso that you indicate fu return address. Aso send a copy of saes receipt or other proof of purchase to determine warranty status. C.O.D. shipments cannot be accepted. Carry Bag 50SFG SFG MF CFG00003 IMPORTANT The contents of this document is soey avaiabe for informationa purpose ony and are iustrative in nature and must not be interpreted to be exhaustive and fina & we reserve excusive rights to change or modify the contents at any stage without any prior intimation. Subject to excusive Jurisdiction to Courts in Jodhpur ony 19 20