Ken, It would seem to me that the relevant standard is:
"IEC 60601-2-10 (1987-12) Medical electrical equipment. Part 2: Particular requirements for the safety of nerve and muscle stimulators Specifies particular requirements for the safety of electrical stimulators of muscles and nerves in the specialized practice of physical medicine. It excludes stimulators used with implanted electrodes, brain stimulation, neurological research, cardiac pacemakers, defibrillators and other surgical procedures. " This standard should, of course, be used together with the base standard IEC 60601-1. The device described may not fall under the definition of a medical device, and so may not be subject to FDA or EU regulations for such devices. (This depends mainly on the manufacturers' claims for intended use). Nevetheless, from the purely technical point of view, the standard above would appear to be the most suitable. Regards, Jon Griver http://www.601help.com > > > > Actually, I have experienced such a unit at my former chiropractor, and it > actually felt pretty good to loosen my back before the back adjustment > session. I was really astonished to see a UL mark on this unit, > especially > on the front panel. Note that this unit was a line connected unit, rather > than a battery operated one. So if anyone frequents the > chiropractor, would > someone ask the chiropractor who makes that unit, and please relay that > information to us. I am quite interested as to what standards or > requirements would apply. > > > Thanks, > > ~Ken > > -----Original Message----- > From: Art Michael [mailto:[email protected]] > Sent: Wednesday, August 22, 2001 1:09 PM > To: [email protected] > Cc: [email protected] > Subject: RE: Electroshock exercising devices ... > > > > Hello PSTC-ers > > Further and contrary to the ideal requisites noted below by Richard Woods, > TENS and Muscle Stimulators ARE sold, via mail-order from the back of > Muscle-builder magazines (without any restrictions or need for > prescriptions). > > They can also be found in shops in most any Chinatown here in the USA. > These are sold over-the-counter, for sums in the vicinity of US$25.00 or > less, without prescriptions and without doctor's orders. You can even > find them on E-Bay once in a while. > > They are usually powered by AA batteries (or sometimes, 9V batteries); I > guess the "industry sense" is that they don't require agency approval (the > agencies we work with daily). And, I've never noted any agency markings or > notations on the ones used by professionals (physical therapists) > either. > In their case - they sometimes open the units, set the levels, seal the > units, and allow patients to take them home for self-monitored therapy > sessions. > > And, to borrow Richard's words, "Approvals? What Approvals?" > > Regards, > Art Michael, the Safety Link <www.safetylink.com> > o-o-o-o-o-o-o-o-o-o-o-o-0-o-o-o-o-o-o-o-o-o-o-o-o > > ------------------------------------------------- > > > On Wed, 22 Aug 2001 [email protected] wrote: > > > > > TENS units (Transcutaneous electronic nerve stimulation) are widely used > to > > treat pain. Muscle stimulators work on the same principle. Nerves will > > activate (e.g., muscle contraction) with an e-field of 1.2 V/m. > Here is a > > spec for a typical TENS: > > > > Pulse amplitude: 0-80 ma, adjustable > > Pulse freq.: 2-150 Hz, adjustable > > Pulse width: 50-250 usec, adjustable > > Maximum open circuit voltage: 100V > > Maximum charge: 16 mC/pulse > > > > TENS are available only with a prescription and the user manual says to > use > > the device only as directed by your doctor. The devices are battery > > operated, transformer coupled and impedance limited, so they are > considered > > to be safe even under a fault condition. One safety note - it > should not > be > > used where a current path would cross the heart since the > pulses might be > > disrupt the heart beat. > > > > My guess is that the "exercisers" operate on a lower power > level in order > to > > get under the FDA regulations - just enough power to stimulate > the nerves. > > Approvals? What approvals? > > > > > > Richard Woods > > > > ---------- > > From: Doug McKean [SMTP:[email protected]] > > Sent: Wednesday, August 22, 2001 2:00 PM > > To: EMC-PSTC Discussion Group > > Subject: Electroshock exercising devices ... > > > > > > These things have been around for a while, IIRC. > > > > Basically, you hook up a pad or pads to places on > > your body, adjust the level of muscle contraction you > > think you need, and off you go "exercising " your > > muscles while you ... walk the dog, read a book, ... > > > > I have several questions: > > > > 1. How the heck do these things get approval? > > > > 2. What standards include these devices? > > > > 3. How in the heck do you label these things > > for warnings? I.e. languages? > > > > 4. Is there any evidence continued electrocompulsive > > activation of muscle causes any sort of permanent > > nerve damage? > > > > 5. Is there some sort of history with these things > > regarding failures and injuries to the users? > > > > - Doug McKean > > > > > > > > ------------------------------------------- > > This message is from the IEEE EMC Society Product Safety > > Technical Committee emc-pstc discussion list. > > > > Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ > > > > To cancel your subscription, send mail to: > > [email protected] > > with the single line: > > unsubscribe emc-pstc > > > > For help, send mail to the list administrators: > > Michael Garretson: [email protected] > > Dave Heald [email protected] > > > > For policy questions, send mail to: > > Richard Nute: [email protected] > > Jim Bacher: [email protected] > > > > All emc-pstc postings are archived and searchable on the web at: > > No longer online until our new server is brought online and the > > old messages are imported into the new server. > > > > ------------------------------------------- > > This message is from the IEEE EMC Society Product Safety > > Technical Committee emc-pstc discussion list. > > > > Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ > > > > To cancel your subscription, send mail to: > > [email protected] > > with the single line: > > unsubscribe emc-pstc > > > > For help, send mail to the list administrators: > > Michael Garretson: [email protected] > > Dave Heald [email protected] > > > > For policy questions, send mail to: > > Richard Nute: [email protected] > > Jim Bacher: [email protected] > > > > All emc-pstc postings are archived and searchable on the web at: > > No longer online until our new server is brought online and the old > messages are imported into the new server. > > > > > ------------------------------------------- > This message is from the IEEE EMC Society Product Safety > Technical Committee emc-pstc discussion list. > > Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ > > To cancel your subscription, send mail to: > [email protected] > with the single line: > unsubscribe emc-pstc > > For help, send mail to the list administrators: > Michael Garretson: [email protected] > Dave Heald [email protected] > > For policy questions, send mail to: > Richard Nute: [email protected] > Jim Bacher: [email protected] > > All emc-pstc postings are archived and searchable on the web at: > No longer online until our new server is brought online and the old > messages are imported into the new server. > > ------------------------------------------- > This message is from the IEEE EMC Society Product Safety > Technical Committee emc-pstc discussion list. > > Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ > > To cancel your subscription, send mail to: > [email protected] > with the single line: > unsubscribe emc-pstc > > For help, send mail to the list administrators: > Michael Garretson: [email protected] > Dave Heald [email protected] > > For policy questions, send mail to: > Richard Nute: [email protected] > Jim Bacher: [email protected] > > All emc-pstc postings are archived and searchable on the web at: > No longer online until our new server is brought online and > the old messages are imported into the new server. > ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Michael Garretson: [email protected] Dave Heald [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: No longer online until our new server is brought online and the old messages are imported into the new server.
