Monthly Archives: August 2012

Passwords, Codes and Keys in Imaging

Trish Payne of Block Imaging has just published a free ebook.  It deals with their success in obtaining Passwords, Codes, and Keys in Imaging.  Visit this link for a copy.   Pat

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Siemens Requires DMLA Before Providing AIAT Information

I was working on a Siemens Ecam system where the gantry locked up and wouldn’t move. I manually reconfigured the gantry and then I had to enter the new “Reconfiguration Mask and Angle” into the system database to get it to recognise the correct gantry position. I could not perform this task as the level of service key I had was a level 4 and I needed a level 7 key to enter this data.

I called Siemens service and asked for a higher level service key, they told me (as did the area service manager) that I needed to fill out a DMLA (Diagnostic Maintenance Licensee Agreement) license agreement to get this key. I explained to them that the machine I was working on was “Not meeting manufacturers specifications” and all I wanted was to get the correct Assembly and Test Instructions per CFR Title 21 to allow me to get the system back into manufacturers specifications. They refused until I filled out a DMLA.

I do not ever remember reading anywhere in the CFR Title 21 regarding xray equipment that states I have to fill out a DMLA before a manufacturer will allow me access to AIT. What recourse do I have when a manufacturer refuses to comply with CFR? Is this what a FDA 3500 form is for?

Any help is appreciated.

Stephen Longchamps

ImageTalk supported by MedicalParts.com 8-30-2012

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FDA hits Hospira with warning over infusion pump quality snafus

By Mark Hollmer
FDA officials are taking Hospira ($HSP) to task over quality problems at an infusion pump manufacturing plant in Costa Rica.The Illinois maker of medical devices and injectable drugs disclosed in a recent regulatory filing that the FDA issued its Aug. 22 warning letter detailing the various violations. Regulators base their assessment based on an inspection of the company’s plant in La Aurora de Heredia, Costa Rica from April 16 through April 19, 2012.

Many of the issues involve the company’s Plum infusion pump. For example, Hospira recalled its Plum infusion pumps based on an alarm failure in February 2011, but the alarm still malfunctioned even after the company redesigned a crucial part, according to the warning letter. Subsequent parts for at least one related model caused similar issues, the FDA said. The FDA also faulted the company for setting deadlines for improving its relevant quality processes and management procedures and then for not having any proof that it completed the required actions.

A Hospira spokesperson told Reuters that the company expected to complete its switch to new alarm components for the product by 2013.

Hospira’s 2012 first-quarter net income dropped a massive 73% from nearly $150 million to $40.2 million after being hit with quality issues and generic competition. But company CEO F. Michael Ball recently said that the company had been making progress on various quality improvement initiatives. Net sales for the second quarter hit just over the $1 billion mark, a nearly 3% decline over the same period in 2011.

– read the SEC filing
– here’s Reuterstake

Related Article:
Hospira to spend $375M in manufacturing upgrades
Hospira plant remediation stings company financials
Troubled Hospira plant puts production, sales in jeopardy

Read more about: infusion pump, quality issues
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Making Equipment Hard to Service

This article refers to general technology, including computers.  But I am sure that there are a lot of additional ways that Medical Device manufacturers deliberately make it hard for others to field repair their devices.  Anybody want to comment on their observations?    Pat

Five ways manufacturers make devices hard to repair

August 16, 2012, 10:27 AM PDT

Takeaway: Bill Detwiler shows you five ways manufactures are making our gadgets harder to fix and gives you tips on working around these self-repair roadblocks.

Computers, smartphones, and tablets are smaller, thinner, and lighter than ever before. But to build today’s ultra-slim, ultra-portable devices, designers and engineers often make their creations more difficult, if not impossible, to repair.

On this special episode of Cracking Open, I show you five ways manufactures are making our gadgets harder to fix and give you a few tips on working around these self-repair roadblocks.

 

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1. Tamper-resistant screws

Tamper-resistant pentalobe screw on the MacBook AirTamper-resistant pentalobe screw on the MacBook Air

Our first self-repair roadblock, tamper-resistant screws, aren’t new or unique to computers, but manufacturers are using them on a lot of devices. Nintendo used tri-wing screws on the Wii and Gamecube. Sony used special security torx screws on the slimline PS3. And, Apple uses pentalobe screws on the iPhone, MacBook Air, and Retina MacBook Pro.

Luckily, this roadblock is also the easiest to overcome. With a little online research, you can buy a driver or bit to handle any of these screws.

2. Glued-on components

Unfortunately, some manufacturers are abandoning screws altogether–choosing to glue components in place. And, that’s our second roadblock.

Whether is the iPad’s front panel, Galaxy S III’s ribbon cables, or Retina MacBook Pro’s battery, removing glued-on components can be difficult and risky. And, it’s best not to remove a working component that’s glued in place. If you absolutely must do so, heat can sometimes help weaken the adhesive, but should be used very carefully.

3. Tiny, fragile connectors

If glued-on components weren’t enough, today’s gadgets are also filled with tiny, fragile connectors.

Whether it’s a board-to-board connector or flexible-flat-cable connector, tablets and smartphones are filled with them. The keys to working around this roadblock are a little patience, a light touch, and a few really thin tools.

4. Battery soldered to the motherboard

Up to now, I’ve been able to help you overcome the repair roadblocks on our list. But, the last two aren’t as easy to work around.

At number four is a roadblock that manufactures are using less frequently, but that still appears from time to time–batteries that are soldered to the motherboard.

Favored by some tablet and smartphone manufacturers, there’s no way to replace a battery like this without using a soldering iron or wire cutters. Replacing a soldered battery is definitely an advanced do-it-yourself fix.

5. Fused front/panel display assembly

iPhone 4 fused front panel/display assemblyiPhone 4 fused front panel/display assembly

Lastly, there’s one repair roadblock that’s almost impossible to overcome. And unlike soldered batteries, device manufacturers are actually using it more frequently. It’s a fused front panel and display assembly.

Whether it’s on the Apple iPhone or Google Nexus 7, a fused front panel and display assembly makes repairs more expensive. Because, if one component breaks, you have to replace both. And while it’s sometimes possible to separate the two components, you often risk damaging the working half in the process. It’s just not worth the risk.

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Carestream DR1 Mobile System AIAT

Does anyone have a Carestream DR1 mobile system? What should I expect to get for AIAT documentation. I am told from the dealer that sold us this system that we cannot get any type of service documentation until after someone here attends the weeklong training session which costs $5000.00. I have no problem sending someone to the training, but thought we were entitled to some type of documentation to provide us the ability to make basic adjustments if necessary to assure proper system performance. Any and all comments would be welcome.

Thanks,

John Laine

 

Answer:  [from Imagetalk 8/16/2012]

This is correct. You will have to attend their service training in Rochester, NY. You will be granted Carestream’s Secure Link access for one year, entitling you to service access. After that year, you will have to pay $2k per year to keep this access active.

You can do detector calibrations (daily dark & X-ray) without service access but the training is recommended.

Jeff Moser

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Humphrey Instruments Lens Analyzer – Zeiss won’t sell service manual or provide tech assistance

I have a Humphrey Instruments Lens Analyzer which will not capture and save. Zeiss tells me it that it’s likely that the capture switch is at fault. They will sell me the switch, but they warn me that they don’t advise doing the repair without the service manual. When I ask for a part # on service manual, they tell me they won’t sell it to me. When I ask if they would walk me through the repair over phone, you know what their answer is. I of course told the technician what I thought of their approach and policy (I was polite).

Anyway, does anyone have this manual, and could you make the pertinent section available?

Thanks.

Robert

Robert Resnicoff CBET, BA

Senior Clinical Engineering Technician

Union Memorial Hospital

Baltimore, MD 21218

[Biomedtalk 8/9/12]

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Stryker SmartPump tourniquet-Battery Replacement cannot be done in the field?

Does anyone have a solution to get around send in the Stryker SmartPump tourniquet for a simple battery replacement? Can you believe this! Stryker wants us to send all of our tourniquets in for a BATTERY REPLACEMENT….please.

Thank you in advance for your help

Roger Preciado

[from TechNation Listserv – 8/9/12]

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