This is list 6, a continuation of List 5:
 
No.
System
Model
Manufacturer
Local agent
No. in Service
Potential effect and Status
Solution and Comments
291
Fetal Heart Detector
12901
Healthdyne
 
 Not supplied by Ministry
   
292
Infant Incubator/
Transportable
IB-695
Fragal
 
 Not supplied by Ministry
   
293
Ventilator
MA-2B
Bennets
 
 Not supplied by Ministry
   
294
Ventilator
OV-127709
Penlon Limited Home Page

e-mail: export@
penlon.co.uk

 
1
 According to a fax sent by manufacturer on 13/3/1999, all products are Y2K compliant. Certificates of compliance is available.
 Contact manufacturer. An e-mail was sent on 27/2/1999. Manufacturer responded by e-mail that current production models are all compliant. Send e-mail inquiring about this specific product. The manufacturer sent a fax on 13/3/1999 certifying that all products, at this date, are Y2K compliant. 
295
Ventilator
OB-1277011
Penlon Limited Home Page

e-mail: export@
penlon.co.uk

 
1
 According to a fax sent by manufacturer on 13/3/1999, all products are Y2K compliant. Certificates of compliance is available.
 Contact manufacturer. An e-mail was sent on 27/2/1999. Manufacturer responded by e-mail that current production models are all compliant. Send e-mail inquiring about this specific product. The manufacturer sent a fax on 13/3/1999 certifying that all products, at this date, are Y2K compliant.
               
297
Echo
7000
Esaote Home Page

Contact the Company

 Al-Ri'ayah
Al-Tibiya
1
 
Web site does not include y2k information.Contact the manufacturer directly. E-mail sent on Wednesday 24/2/1999.
298
Treadmill
T144
Esaote Home Page

Contact the Company

 Al-Ri'ayah
Al-Tibiya
1
 
Web site does not include y2k information.Contact the manufacturer directly. E-mail sent on Wednesday 24/2/1999.
299
Haematology analyzer?
Micros 8
ABS
Shuqair
     
300
Treadmill
Bodyguard
Oglaend?
       
301
X-Ray Film Developer
1523
Durr
 
 3
   
302
Pulse Oximeter
70450A1
BCI International Home Page

BCI International Y2K Site

Service Master
2
 No internal clock/calendar.
Not affected by Y2K issues. Compliance certificate available on Internet Site.
 
303
Capnochek Plus
9004
BCI International Home Page

BCI International Y2K Site

Service Master
15
 Tested compliant.Compliance certificate available on Internet Site.
 
304
Endo Camera (Laban scope?)
5501001
Wolf X-Ray
Carol Price
Tel: (US) 516-485-7000
 Sukhtian
 
 The company has reported to the FDA that Y2K issues do not apply to its products.
 
305
Cell Counter,
Blood analyzer?
Cobas Micros
Roche
 
 Not supplied by Ministry
 
 
306
Microelisa Washer
MW0021P?
Den Ley?
 
 Not supplied by Ministry
 
 
307
Anaesthesia
MK4
Medishield
 
 Not supplied by Ministry
 
 
308
Cell Counter
CX310
LIC
(Sweden)
 
 2
 
 
309
Pulse Oximeter
340
Palco Labs
Michael McLay
408-476-3151
 Al-Nimr
 5
 The company has reported to the FDA that Y2K issues do not apply to its products.
 
310
Portable Incubator
RWT
Volldefcz
 
 Not supplied by Ministry
   
311
Autoclave
-?
(Ruwaishid)
Astell Hearson
 
 Not supplied by Ministry
   
312
Autoclave
1000
Matachana?
Mottachana?
 Shuqair
1
   
313
Autoclave
Series 1000
1350 LE-1
Matachana?
Mottachana?
 Shuqair
1
   
314
Autoclave
Series 1000
1980 LE-1
Matachana?
Mottachana?
 Shuqair
2
   
315
Blood Bank Refrigirator/
deep Freezer
-?
(Ruwaishid)
Kiesota
 
 Not supplied by Ministry
   
316
Anaesthesia Unit
CAV-500
MIE
 
 Not supplied by Ministry
   
317
ECG Monitor
CR55
Perhaps this is made by NEC-SAN-EI
Cardiac?
Portascope?
Is this Cardiac recorder?
Al-Smadi?
 1
   
318
Defibrillator Monitor
CL-26
Cardiac Recorder?
Is this Cardiac?
       
319
Blood Bank Refrigirator/
Deep Freezer
B.B.2?
Jewett
Refrigirator

Contact Leslie Hollingworth
Tel: 716-881-0030

 
 10
 The company has reported to the FDA that its products are not affected by Y2K issues.
 
320
Blood Bank Refrigirator/
Deep Freezer
ARR 25
Jewett Refrigirator

Contact Leslie Hollingworth
Tel: 716-881-0030

 
 2
 The company has reported to the FDA that its products are not affected by Y2K issues.
 

 
321
Blood Bank Refrigirator/
Deep Freezer
GT-1
Jewett
Refrigirator

Contact Leslie Hollingworth
Tel: 716-881-0030

 
 2
 The company has reported to the FDA that its products are not affected by Y2K issues.
 
322
Resuscitator
8200?
(Badee'a)
Wisup?
       
323
Resuscitator
3YZC
Shanghai?
       
324
Blood Bank Refrigirator/
Deep Freezer
-?
(Badee'a)
Forma
Biofreezer?
       
325
Blood Bank Refrigirator/
Deep Freezer
MDF 492 AT
Sanyo
       
326
Blood Bank Refrigirator/
Deep Freezer
-?
(Badee'a)
Baern
       
327
CodeMaster XL(+) Defibrillator/ Monitor
M1722A
M1723A
M1722B
M1723B
HP (Hewlett-Packard) Co. Medical Equipment Y2K Site

Product Y2K Status Search Facility
Medical Products Group Y2K Administrator
800-934-7372

Al-Lawazim
Al-Tibiya
 2
  Y2K compliant. Discharge test successfully carried out with date set to 01/01/00. No date related problems evident.
 Leap year calculations will not be accurate after 2100!
328
Ultrasound
M2410
HP (Hewlett-Packard) Co. Medical Equipment Y2K Site

Product Y2K Status Search Facility
Medical Products Group Y2K Administrator
800-934-7372

 Al-Lawazim
Al-Tibiya
2
   
329
Fetal Heart Detector
PD 120?
WM
 
 Not supplied by Ministry
   
330
Ventilator
(Karak)
10270?
Clacam(s)?
Glacom?
 
 Not supplied by Ministry
   
331
Incubator
(Karak)
-?
Clacam(s)?
Glacom?
Berwunder?
 
3
   
332
ECG Monitor
(Karak)
H-500
Denfam?
Berwunder?
 
 Not supplied by Ministry
   
333
Resuscitator
(Karak)
-?
Denfam?
 
 Not supplied by Ministry
   
 334
 ECG Monitor
(Al-'eeman)
Lifepack 300?
 -?
 
 Not supplied by Ministry
 
 
 335
Chemical Analyzer 
PR 16 
 SEAC
Via di Prato N. 74
I-50041 Calenzano-Firenza
Tel.: ++39 55 - 8877469
Fax: ++39 55 - 8877771
 Shuqair/
Al-Wafi
 1
 
 Contact manufacturer.
 336
 Auto Analyzer
CH 16 
 SEAC
Via di Prato N. 74
I-50041 Calenzano-Firenza
Tel.: ++39 55 - 8877469
Fax: ++39 55 - 8877771
 Shuqair/
Al-Wafi
 1
 
 Contact manufacturer.
 337
Diluter
 Hema 1
 SEAC
Via di Prato N. 74
I-50041 Calenzano-Firenza
Tel.: ++39 55 - 8877469
Fax: ++39 55 - 8877771
 Shuqair/
Al-Wafi
 1
 
 Contact manufacturer.
 338
 Blood-Cell Counter 
 Hema 10
 SEAC
Via di Prato N. 74
I-50041 Calenzano-Firenza
Tel.: ++39 55 - 8877469
Fax: ++39 55 - 8877771
 Shuqair/
Al-Wafi
 1
 
 Contact manufacturer.
 339
 Flame Photo-
meter
 EP 20
 SEAC
Via di Prato N. 74
I-50041 Calenzano-Firenza
Tel.: ++39 55 - 8877469
Fax: ++39 55 - 8877771
 Shuqair/
Al-Wafi
 1
 
 Contact manufacturer.
 340
Elisa Reader 
Hema 12
SEAC
Via di Prato N. 74
I-50041 Calenzano-Firenza
Tel.: ++39 55 - 8877469
Fax: ++39 55 - 8877771
 Shuqair/
Al-Wafi
 1
 
 Contact manufacturer.
 341
Defibrillator with Monitor
(Karak)
 TM 800s?
 Telemed Technologies International Incorporated (Cardiac Telecom Corporation)
Lee Ehrlichman
412-824-6600
 
 Not supplied by Ministry
 The company reported to the FDA that all its products are Y2K compliant.
 
 342
Ambulatory pH, Gastro-Intestinal Motility and Urodynamic Systems
NYMPH 
Albyn Medical Ltd.
Bridgend Road Industrial Estate
Dingwall
Ross-shire IVV15 9QF
Scotland
Tel.: +44 1349 862388
Fax: +44 1349 864146
e-mail: valeriel@albyn.com
 
 1
The NYMPH product range stores the date and time in its memory. The date and time can be set either from the keypad or by downloading from the host computer. When setting the date and time from the keypad, the year is displayed in two digit format only and only years from 80 to 99 are recognised; however, in our experience few users if any set the date from the keypad, most rely on the automatic download from the PC and realistically these data loggers will not present a problem. The analysis software works in the same way as the PHOENIX family and the host computer can be checked in the same way. If you find that there are problems with Year 2000 compliance with our products, contact manufacturer, who will take the matter up and discuss it with the computer manufacturers concerned. 
 
 343
Normocap
CD-200
Datex-Ohmeda

Datex-Ohmeda Y2K Site

 
 
 Y2K compliant.
 
 344
Fetal Heart Monitor
(Faisal)
ES101AS 
-? 
 
 
 
 
 345
 Spectro-
photometer
(Faisal)
6/20? 
 Labfuge?
 
 Not supplied by Ministry
 
 
 346
 Fetal Doppler
 D104R
 Oxford Instruments Medical Systems Home Page

Oxford Instruments Medical Systems Y2K Site on Fetal Monitors

 
 Not supplied by Ministry
 Y2K Compliant.
No date recognition.
 
 347
 Fetal Monitor Recorder
T20257? 
 Oxford Instruments Medical Systems Home Page

Oxford Instruments Medical Systems Y2K Site on Fetal Monitors

 
 Not supplied by Ministry
 Check the model number, then refer to manufacturer's Y2K Site.
 
 348
Anaesthesia
(Karak)
Narkomed 20B?
Is it perhaps Narkomed 2B?
 North American Drager Y2K Site

Y2K Specific Contact Information
3135 Quarry Road
Telford, PA 18969
USA
Tel: (215) 721 5400
Fax.: (215) 723 5934
e-mail: brennanj@
nad.com

 
 
 Check the model number, and then refer to manufacturere's Y2K Site.
 
 349
Multi Parameter Monitor 
Point of View 
Datascope
 Techno-
Medix
 2
 According to a fax from the manufacturer, this product is Y2K compliant.
 
 350
Central Station Monitor 
VISA 
 Datascope
 Techno-
Medix
 1
 According to the manufacturer, this product is Y2K compliant for Software version 6.01M or above.
 
351
X-Ray
MVP/SFXII FLUORO
General Electric (GE) Medical Systems Y2K Site

GEMSE
Jean-Paul Tailhardat
Fax: 33130704390

Ghazi Al-Masri
6
Affected products (pdf file)

 Non-affected Products (pdf file)

Site does not include information on this specific product.

 
352
X-Ray
ADVANTX/
RTIRAD
General Electric (GE) Medical Systems Y2K Site

GEMSE
Jean-Paul Tailhardat
Fax: 33130704390

Ghazi Al-Masri
4
Affected products (pdf file)

 Non-affected Products (pdf file)

Site does not include information on this specific product.

 
353
 Electrosurgical Unit
 ME 200
 Martin Medizin-Technik?
Barbara Von Runnen
703-406-0008
 
 Not supplied by Ministry
 If this is the right company, then it has reported to the FDA that all their products are Y2K compliant.
 
 354
 Electrosurgical Unit
 -? (Surgery)
 Alsthom T & D Systems Ltd
 
 Not supplied by Ministry
 
 
 355
Pump, Infusion, Syringe 
Graseby 3100
Manufacturer lists Pleth Oximeter 3100, and it has been tested compliant.
 BCI
International? (Perhaps Graseby)
Home Page

BCI International Y2K Site

Contact Information:
1-800-558-2345
FAX: 1-414-542-0718
E-mail: bciintl@bciintl.com

 Service Master
 There is no timing/dating functions. Hence, will not be affected by Y2K issues
 
 356
Pump, Infusion, Syringe 
MF2000 
 BCI
International?
(Perhaps Graseby)
Home Page

BCI International Y2K Site

Contact Information:
1-800-558-2345
FAX: 1-414-542-0718
E-mail: bciintl@bciintl.com

 Service Master
 There is no timing/dating functions. Hence, will not be affected by Y2K issues
 
 357
 Pump, Infusion, Syringe 
 MS2000
 BCI
International? (Perhaps Graseby)
Home Page

BCI International Y2K Site

Contact Information:
1-800-558-2345
FAX: 1-414-542-0718
E-mail: bciintl@bciintl.com

 Service Master
 2
 S/W Version 7.There is no timing/dating functions. Hence, will not be affected by Y2K issues
 
 358
 ECG
8823 
Greenmedix
 
 Not supplied by Ministry
 
 
 359
Elisa Reader 
LP 400 
Pasteur
 
 
 
 360
Elisa Reader 
 LP 300
Pasteur
 
1
 
 
 361
Steam Sterilizer 
4582/
4580
Schearer
 
 3
 
 
 362
 Steam Sterilizer
 GETTIG ECI? 
Gettig Pharmaceutical Instruments Co.?

James Benz
Phone: (814) 422-8892

 George Khouri
 If this is the right manufacturer, then Y2K issues do not apply to all products. Also, from function of equipment, there seems to be no time/date entry point. 
 
 363
Steam Sterilizer 
Pacs 2000 
British Sterilizer
 
 
 
 364
Electro-
phoresis System
 CliniScan 2

Catalogue No. 1260/
1261

Helena Laboratories Y2K Site

Rita Ellerbrook
800-231-5663

 
 1
 There are two parts to the question of Year 2000 Compliance, software and hardware. The software is written by Helena Laboratories. All software upgrades are available from us at no cost. The latest version of CliniScan 2 software is Rev. H. Older versions of the software have not been verified as being able to handle Year 2000, and an upgrade to Rev. H is recommended.

The CliniScan 2 software has been found to be compliant for the year 2000 with one exception. Stored data can not be retrieved by date in one pass across the millennium. You must retrieve data from before 01/01/2000 in one pass, and data after 12/31/1999 in a second pass. Data can be retrieved across the millennium by patient ID or other parameter, with no regard for date as always. Instructions for data retrieval by date over a range including 1/1/2000 are found at the end of this letter. A summary of the activities that this software performs correctly is listed below.

  • The instrument functions in exactly the same manner before and after 1/1/2000. 
  • It recognizes the year 2000 as a leap year. 
  • It correctly handles all 9s in the data field (9/9/1999 was evaluated). 
  • It correctly handles an 8-digit date in the year 2000 (10/10/2000 was tested). 
  • The date may roll over to a prior year and may then be reset to 2000. 
  • After the year 2000, the date rolls over correctly to the year 2001. 
  • The date format for the 21st century must contain 4 digits (i.e., 2000, 2 digits assume the 20th century). 
The second part of Year 2000 Compliance, hardware, regards the nature of the BIOS chip on the computer board. This chip will determine if the date will automatically change from 12/31/1999 to 01/01/2000 and from 02/28/2000 to 02/29/2000. You will need to check the date on January 1, 2000 and again on February 29, 2000 and, perhaps, manually reset the date. Once this is done, the software will perform as described.

NOTE: Because of the possibility of the date improperly rolling over, do not create data at the time of the date change.

Setting the Date:
1. Press F6 to enter Utilities.
2. Press 2 (Date).
3. Press 1 or 2 for date format.
4. Enter the date as 01-01-2000 and press Enter. You must enter the year as four digits for the 21st century.
5. Press F2 to return to the Test Select menu.

Retrieving Data by Date Range:
1. On the Test Select menu, press A to N for the Test List.
2. Press F5 (Files).
3. Press R, Enter.
4. At date scanned, type the date, such as 01-01-98...* to retrieve data from 1/1/98 through 12/31/99, even if there are data present at later dates. 
5. Press F5 to retrieve the data.
6. To retrieve data after 12/31/1999, enter a date range such as 01-01-00...05-01-00 to retrieve data from 1/1/2000 to 5/1/2000.
7. Press F5 and the data will be retrieved.

 
 365
Micros Analyzer?
(Al-'eeman)
Micros OT? 
-? 
 
 
 
 
 366
Audiometer 
 AC 30 
Interacoustics AS

Ole Hviid
Phone: -45-6371-3555

 
 The manufacturer has reported to the FDA that all products are Y2K compliant.
 
 367
Impedance Audiometer 
AT 22 
 Interacoustics AS

Ole Hviid
Phone: -45-6371-3555

 
 2
 The manufacturer has reported to the FDA that all products are Y2K compliant.
 
 368
Atomic Absorption
Spectro-
photometer
 Solar GF 90 plus?
 UNICAM
 
 1
 
 
 369
UPS 
D6-11? 
 Vectron
 
 1
 
 
 370
 UPS
D5-11? 
Vectron
 
 1
 
 
 371
Densitometer 
CD 60 
De Saga
 Al-Mu'assasa
Al-Tibiya Al-'ilmiya Al-Keemiya'iya
 1
 
 
 372
Ultrasound 
GDS 5000 
Perception?
Or is it
Perceptive Scientific Instruments Inc.?

Christine M. Small
Phone: 781-551-0100

 
 1
 If it is the second name, then company has reported to the FDA that all products are Y2K compliant.
 
 373
HPLC 
-? 
Knauer
 Al-Ri'aya Al-Dawa'iya
 
 
 374
Spectro-
photometer
Cary?
Please specify which series.
Varian Associates

Equipment Y2K Status

 Al-Mu'ashir
 All Cary series are Y2K compliant.
 
 375
ELC System? 
1010? 
Boehringer 
 
1
 
 
 376
 
As stand alone system
Technicon DAX

Technicon DAX (UIW)

Bayer Corporation, Business Group Diagnostics Y2K Site
Richard Kaplan
Phone: 914-631-8000
Techno-
Medix
 As stand alone system: Customer Bulletin to be made available with instructions by 4/1/1999.
S/W Version 4.03, 4.10
Date Format: mm/dd/yy

Technicon DAX (UIW): Compliant software projected to be released by 4/1/1999.
S/W Version 5.11
Date Format: mm/dd/yy

 Contact local agent or manufacturer for solution.
 377
HPLC 
-?
 Chrompack Home Page

Chrompack Y2K Site

 
1
 Check model number, then look up status on Y2K Site.
 
 378
Electro-
phoresis System 
180 
LRE Medical
 
1
 
 
 379
 Immunoassay Instrument
TDX Version 12?
If it is Version 15, then comments herein are valid.
Abbott Laboratories Y2K Site
 
 Year 2000 compliant with intervention such as software or hardware upgrade or special instructions, etc.
Software upgrade Rev. 16.0 shipping. Contact local Abbott representative.
 380
Spectro-
photometer
Tube Elisa? 
 Abbott Laboratories Y2K Site
 
2
 
 

 
381
Ultrasound
(Mafraq)
DYU?
and
UME?
Dynamic Imaging Home Page
Dynamic Imaging Y2K Product List


For further information on Year 2000 product compliance contact 

 
 
 
 
 
 
 

Andrew Johnston, Quality Systems Manager

andrew.johnston@
dynamicimaging.co.uk

Madar
one of each
 Check model number, then refer to Y2K Site.
 
382
Multidata System?
Plan(n)ing System?
Siemens' Y2K Site, Product Information
Wa'il Abdil-Hadi
1
Check name and model number.
 
383
X-Ray Unit
-?
Siemens' Y2K Site, Product Information, X-Ray Section
Wa'il Abdil-Hadi
Not supplied by Ministry
Check model number, then consult Y2K Site.
 
384
Spectro-
photometer
700?
Beckman Company Web Site

 Beckman Company Y2K Site

Al-Taqaddum
2
Not listed. Check model number, then refer to Y2K Site. 
 
385
Hemodialysis Unit
System 1000
Althin
Kurze Str. 40
D-70794 Filderstadt
Germany
Tel: ++49 711-775560
Mu'assast Duwa' Lil-Ajhiza Al-Tibiya
10
   
386
Defibrillator Monitor
430
S&W Enterprises Y2K Specific Contact Information
10044 Goodhue St NE
Blaine, MN 55449
USA
Phone: 6127862800
Fax: 6127862801
e-mail: speckter@pclink.com
Al-Derhally
1
The company has reported to the FDA that Y2K issues do not apply to its products
Manufacturing company must be contacted.  An e-mail was sent on 27/2/1999.
387
Ultrasound
Performa
Dornier 
(Acoustic Imaging)
 
8
Testing/Results

The testing methodology encompassed full system functionality testing both during and after the year 2000 transition. The testing investigated several issues; the rollover and retention of the time and date from 12/31/99 to 1/1/00, the proper identification and use of leap years subsequent to 1/1/00, i.e. 2000, 2004 etc., the real time functionality of the unit including display information and transducer operation, the data archiving functionality of the system, the two dimensional and velocity measurement functionality of the system, and the calculation package functionality of the system

Completion of the aforementioned testing has indicated that subject systems will roll over to January 1, 2000 but will not retain this information after the system is powered off. The testing did indicate however, that once the date and time had been reset to January 1, 2000 or later, then the system would perform as expected including the functionality as indicated above.
 

 

Corrective Action
Each customer must install the enclosed software upgrade version 2.18 to assure the latest and tested version of the software is installed. To install the software, please follow these instructions:
Turn the system off.

Insert the version 2.18 software diskette into the floppy disk drive on the front of the system.

Turn the system on.

The system will load the files from the floppy into the hard drive. This will take approximately 5 minutes. Once the files are loaded, the system will beep.

Remove the diskette.

Turn the system off and on again to resume normal function.

Store the version 2.18 software diskette in a safe place.

After installing the new version software, the customer must use the system settings utilities to reset the time and date of their system upon its initial use anytime AFTER 12:00A.M. January 1, 2000 to accurately transition from 1999 to the year 2000 and thereafter. The following steps from the "System Customization" portion of the operators manual explains the proper sequence for setting the time and date.
From the Top Menu of the Soft Key Panel choose the button labeled "OTHER CHOICES".

Press the Soft Key button labeled "CH TIME & DATE".

Activation of the Change Time and Date Panel will provide an on screen prompting to guide you through changing the time and date. To enter press Select Key.

Note: It is important that the customer reset the system to the current time and date upon initial use AFTER 12:00 A.M., January 1, 2000.

Conclusion

After performing the aforementioned corrective action, regardless of when any data was taken for system storage (before, during or after the year 2000), the unit will function properly in all imaging, measurement, and calculation conditions.

 388
 Gamma Counter
PC RIA MAS 
 Stratec Biomedical Systems
Gewerbestrasse 11
D-75217 Birkenfeld 2
Germany
General information:
Dorothea Gauss
Phone: ++49 7082 791 658
Fax: ++49 7082 791 690
E-mail:
STRATEC_BIOMEDICAL@
compuserve.com
 This equipment is a present from the Atomic Energy Agency. It has not been received yet (4/3/1999).
 1
No Y2K information on Site.
Contact manufacturer.
 389
 
 Plasauto 100
 Asahi Medical Co., Ltd.
9-1, Kanda Mitoshirocho, Chiyoda-Ku, Tokyo, 101-8482 Japan
Phone: +81-3-3259-5880
Fax: +81-3-3259-5899
 
 
 Y2K issues do not apply to this equipment.
A letter from the manufacturer to this effect is available.
 
 390
 
 Plasauto-iQ
 Asahi Medical Co., Ltd.
9-1, Kanda Mitoshirocho, Chiyoda-Ku, Tokyo, 101-8482 Japan
Phone: +81-3-3259-5880
Fax: +81-3-3259-5899
 
 
 Y2K issues do not apply to this equipment.
A letter from the manufacturer to this effect is available.
 

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