Comment Unpopular opinion: But this is just dangerous (Score 1) 69
Full disclosure: I design Class IIb medical equipment for a living and our (really old) manuals are on the site as well.
I really love ifixit when it comes down to tear-downs of phones or game consoles, but when I noticed last month they published these service manuals I just thought: "this is insane and really dangerous". I know due to COVID-19, repairs were difficult since access to facilities were blocked and exemptions should be made, but publishing these service manuals online so that your average washing machine repair guy can "try" and repair a medical device is dangerous.
The company I work for requires a hands-on training for all repair technicians for the devices we make, and for good reason. Most modern medical devices are complex machines which require proper tools to service and re-certify. A faulty repair can at the least compromise the "essential performance" of the device and at worst kill people. Even trained technicians screw up but at least you minimized the chance of this happening due proper training.
Besides the liability point of view (burden of proof will be on the manufacturer) this can be damaging to the general patient population.
If the hospital or outpatient clinic decides to save money by going with the cheaper unlicensed (read untrained) service shop there is no guarantee that the repairs are done properly. Most manufacturer these days earn their money on initial sale and disposables, service is just the extra's but you get what you pay for.
Basic example: Cheap service shop repairs a medical device as a side gig but fails to properly reconnect all the Protective Earth parts during reassembly. Normally after repairs you would do a full EST review but they are a cheap shop, they skip on the expensive testing tools (like a Electrical Safety Tester) that can test stuff like patient leakage or Earth bonding test. Device is put back into service but accidentally zaps a operator/patient during use due unconnected PE parts. If it was Functional Earth it might not zap anyone but screw up any measurement the device needs to do (erroneous readings)
Basic example 2: John Doe (hospital tech), downloaded the service manual of a malfunctioning device. Reads the troubleshooting guide and wiggles some parts and pokes some software parameters in the service menu changing the calibration settings. YaY,
the error they were experiencing goes away, back into general use. But the calibration parameters were controlling the flow control of an IVU. Its now give double the output that the is shown on the screen. Nobody will know, since they tech does not have a flow control calibration tool.... until someone dies over overdose.
Would you want to have an untrained tech working on a commercial airplane that you fly on and your life depends on its properly operation? I guess you wouldn't, same goes for medical equipment.
Side note, which is commercially oriented.
Service manuals usually contain complete schematics and BOM of devices for repair purposes. If your device does not heavily rely on software, your competition just got free industrial espionage handed to them making it trivial to copy your device.
