Endoscope

November 2001
Flexible Endoscope Reprocessors, Automatic

Purpose
Scope of this Product Comparison
Endoscope reprocessors are designed to standardize
This Product Comparison covers automated dis- and automate the preparation of a manually pre-
infecting and sterilizing units for immersible cleaned endoscope so it is safe for immediate reuse.
flexible endoscopes (e.g., gastroscopes, Because of the number of complicated steps involved
colonoscopes, bronchoscopes). Some units also in- and the need to reprocess endoscopes quickly between
clude a wash cycle, although this does not replace patient procedures, manual reprocessing is not always
the need to manually clean the scopes before performed effectively or consistently. Automatic re-
automatic reprocessing. Some of the units cov- processors can reduce the likelihood that a crucial
ered in this report can also reprocess other de- reprocessing step will be skipped, help ensure that
vices (e.g., rigid endoscopes, surgical reprocessing is performed consistently using a recom-
instruments). Devices intended to aid in manual mended protocol, and reduce personnel exposure to the
cleaning of endoscopes are excluded, as are the irritating effects of liquid disinfectants/sterilants. En-
disinfecting and sterilizing agents used in these doscopy staff exposure to 2% activated glutaraldehyde
devices. For information on other disinfecting has caused respiratory complications such as asthma
and sterilizing units, see the following Product and sinusitis, serious skin sensitivity reactions, and
Comparisons: conjunctivitis, thus precluding the use of glutaral-
Sterilizing Units, Ethylene Oxide dehyde in many hospitals.
Sterilizing Units, Plasma Medical devices can be divided into three groups
according to the risk of infection associated with their
Sterilizing Units, Steam, Bulk
use: critical, semicritical, and noncritical. Endoscopy
Sterilizing Units, Steam, Tabletop
Washers/Decontaminators
Washers/Sterilizing Units
UMDNS information
This Product Comparison covers the following
device terms and product codes as listed in
ECRIs Universal Medical Device Nomenclature
System (UMDNS):
Disinfecting Units, Liquid, Flexible Endoscope
[11-279]
Sterilizing Units, Liquid [18-006]
226193 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA

424-008 Telephone +1 (610) 825-6000 Fax +1 (610) 834-1275 E-mail hpcs@ecri.org
Healthcare Product Comparison System
is a minimally invasive diagnostic and therapeutic A basin (with a lid) in which the endoscope is reproc-
procedure that is gaining wider acceptance; the Cen- essed
ters for Disease Control and Prevention (CDC) and the
Association for Professionals in Infection Control and Channel tubing with adapters that irrigate most,
Epidemiology (APIC) consider flexible endoscopes but not necessarily all, of the endoscopes channels
semicritical devices because they come in contact with
A timing mechanism to control the time of the
mucous membranes but do not normally enter sterile
reprocessing phases
tissue. Consequently, CDC and APIC recommend that
flexible endoscopes receive at least high-level disinfec- Liquid and air pumps
tion (HLD). The U.S. Food and Drug Administration
(FDA) has required all liquid chemical germicide A reservoir for the disinfectant/sterilant
manufacturers to submit premarket 510(k) applica-
Using the connecting sections of the endoscope and
tions for their products. As a result, labeling of certain
the connectors of the endoscopic reprocessor, the op-
2% glutaraldehyde solutions now specifies exposure
erator attaches the reprocessor to the endoscopes
conditions of 45 minutes at 25C (77F) to achieve
channels, places the endoscope in the unit, and starts
HLD. However, this does not include any manual or
the reprocessing procedure. (Some units can reprocess
automatic precleaning (Walter 1996). Some hospitals
several scopes at a time.) The disinfectant/sterilant is
may prefer to sterilize their scopes.
transferred from a reservoir into the basin containing
Because endoscopes are used repeatedly during the the endoscope; one processor uses a prepackaged, sin-
course of a day, they must be reprocessed quickly gle-use sterilant container that is automatically
between procedures. Therefore, neither ethylene oxide opened, aspirated into the basin, and mixed with ster-
(EtO) sterilization, which can take up to 36 hours, nor ile, filtered water. Some models contain a heater to
glutaraldehyde cold sterilization, which can take up to raise the temperature of the disinfectant/sterilant,
10 hours and possibly damage endoscopes, is practical. allowing a wider variety of solutions to be used. How-
In addition, no current flexible endoscopes can with- ever, if the temperature of the disinfectant/sterilant
stand steam sterilization without deterioration. exceeds 25.6C, the concentration of irritating fumes
Therefore, most hospitals usually choose either HLD could increase.
or liquid sterilization (at present, there is no conclusive
Most reprocessors provide documentation of the
evidence indicating that one method is safer than the
disinfection/sterilization cycle, either in the systems
other). Most hospitals use either an activated 2% glu-
memory or as a hard-copy printout. The documenta-
taraldehyde solution for HLD or 6% hydrogen peroxide
tion should indicate either that all the necessary pa-
or peracetic acid for sterilization. For more information
rameters have been met or that the cycle has been
on endoscope manufacturers reprocessing recommen-
automatically canceled or aborted by the user and the
dations, see the following Product Comparisons:
reason why.
Bronchoscopes
Once the final rinse cycle is complete, the endoscope
Colonoscopes; Sigmoidoscopes is ready for reuse. If the endoscope is going into stor-
age, it may be necessary to purge its channels with
Duodenoscopes; Gastroscopes; Choledochoscopes forced air to ensure thorough drying, preventing the
Laparoscopes proliferation of bacteria. Sometimes an alcohol rinse is
performed to facilitate the drying process.
To reduce the possibility of contaminating an en-
Principles of operation doscope during reprocessing, the reprocessor itself
Endoscope reprocessors are designed to either dis- should be regularly disinfected or sterilized according
infect or sterilize using an automatic system to soak to the manufacturers recommendations; some units
the endoscope and purge its channels. All reprocessors have programmed cycles that perform this function.
have a disinfect/sterilize and rinse cycle; some units
The Society of Gastroenterology Nurses and Associ-
allow the cycling times to be set by the operator. Some
ates recommends wearing protective equipment
models also offer wash or predisinfection, multiple
(e.g., gloves, gown, eyewear) while operating en-
rinse (including alcohol), and air-purging cycles.
doscopic reprocessors, having leakage test equipment
An automatic reprocessor connects to the facilitys and channel cleaning adapters, and using separate
water supply and typically consists of the following rooms for endoscopic procedures and endoscopic re-
components: processing.
2 2001 ECRI. Duplication of this page by any means for any purpose is prohibited.
Reported problems The type of disinfectant/sterilant the unit can ac-

There are two major ways in which a flexible en- commodate and its cost per cycle
doscope can cause nosocomial infection: the endoscope The space required for the unit (i.e., whether it is a
can autoinoculate a patient with his or her own mi- tabletop or floor model)
crobes (i.e., endogenous infection), or a contaminated
Special temperature and pressure requirements for
endoscope can act as a carrier, transmitting a wide
the water supply
variety of microorganisms to the patient (or physician)
from either a previous patient or the environment. The processors ability to circulate liquids through
There have been reports of reprocessors becoming con- channels without producing air pockets
taminated and subsequently passing contamination to The length of the rinse and forced-air cycles
scopes that were processed in them. (See the citations
in the Bibliography for specific reports.) The microor- The processors capacity to self-disinfect
ganisms often found in tap water can proliferate to Cost containment
significant levels in endoscopes, their accessories, and
ancillary equipment during improper storage. A life-cycle cost (LCC) analysis can be used to com-
pare high-cost alternatives and/or to determine the
Glutaraldehyde residues are toxic and can have
positive or negative economic value of a single alterna-
deleterious effects on a patients mucous membranes tive. For example, hospitals can use LCC analysis
when not adequately removed from the endoscope techniques to examine the cost-effectiveness of leasing
during rinsing. Endoscopy staff must be aware of
or renting equipment versus purchasing the equip-
possible glutaraldehyde exposure, even with an auto- ment outright. Because it examines the cash-flow im-
mated system. pact of initial acquisition costs and operating costs over
a period of time, LCC analysis is most useful for
Purchase considerations comparing alternatives with different cash flows and
Before purchasing an endoscope reprocessor, hospi- for revealing the total costs of equipment ownership.
tals need to assess their current endoscope reprocess- One LCC technique present value (PV) analysis
ing protocol. Hospital staff may want to consider an is especially useful because it accounts for inflation
automatic reprocessor if they are experiencing the and for the time value of money (i.e., money received
following problems: (1) glutaraldehyde exposure com- today is worth more than money received at a later
plaints, (2) reprocessing inconsistency, and/or (3) in- date). Conducting a PV/LCC analysis often demon-
ability to handle the volume of endoscopes that need strates that the cost of ownership includes more than
reprocessing. just the initial acquisition cost and that a small in-
crease in initial acquisition cost may produce signifi-
Several issues need to be considered before purchas-
cant savings in operating costs. The PV is calculated
ing a reprocessor:
using the annual cash flow, the dollar discount factor,
Whether to choose HLD or sterilization and the lifetime of the equipment (in years) in a mathe-
The level of disinfectant/sterilant exposure reduc- matical equation.
tion and whether extra ventilation may be required The following represent sample five-year PV/LCC
by the manufacturer analyses for a disinfecting unit and a sterilizing unit.
Whether the reprocessor requires the endoscopes to
be modified by the manufacturer to fit into the unit Present Value/Life-Cycle Cost Analysis
The ability to abort/skip a cycle without warning the Assumptions
operator
Operating costs are considered for years 2 through
The number of scopes a unit can process simultane- 5
ously
Dollar discount factor is 6.25%
The time per cycle
Inflation rate is 4% for disposables
The ease and adequacy of reprocessor disinfection/
Operating and ownership costs are for 1 unit being
sterilization
used 10 times/day for 365 days/year
Reports of reprocessor contamination
Alternative 1 Disinfecting Unit
Whether the reprocessor is equipped with a water
filtration system and the life expectancy and re- Capital Costs
placement costs of its filters Disinfecting unit = $32,781
2001 ECRI. Duplication of this page by any means for any purpose is prohibited. 3
Total Capital Costs = $32,781 Stage of development

Operating Costs Automatic flexible endoscope reprocessors were in-
troduced in the 1970s. Since then, manufacturers and
Disinfectant (2% glutaraldehyde) = $6,388/year healthcare professionals have become more aware of
Service contract = $2,046/year the potential hazards associated with contaminated
endoscopes and reprocessors and are moving toward
Total Operating Costs = $8,434/year producing better systems for disinfecting/sterilizing
them.
PV = ($41,079)
One manufacturer offers a sterile disposable outer
Alternative 2 Sterilizing Unit sheath that fits over its colonoscopes and sigmoi-
Capital Costs doscopes. The sheath has air, water, and biopsy/suction
channels, eliminating the need to clean and disinfect
Sterilizing unit = $22,471 the endoscope between procedures (only removable
control knobs require cleaning and disinfection).
Total Capital Costs = $22,471
Operating Costs Future trends will most likely be toward a more
automated endoscope cleaning process to eliminate
Sterilant = $17,870 for year 1; $18,250/year for the need for manual precleaning. More units may
years 2 through 5 incorporate an alcohol rinse, along with higher air
pressures to facilitate drying. Manufacturers will also
Service contract = $1,525/year
investigate new ways of reprocessing endoscopes, in-
Total Operating Costs = $19,395 for year 1; cluding chlorine dioxide, ozone, vapor-phase hydrogen
$19,775/year for years 2 through 5 peroxide, and plasma sterilization, and disposable en-
doscopes and sheaths.
PV = ($109,238)
Other costs not included in the above analysis that Bibliography
should be considered for budgetary planning include
those associated with the following: American Society for Gastrointestinal Endoscopy. Re-
processing of flexible gastrointestinal endoscopes
Replacement filters [position statement]. Gastrointest Endosc 1996
Disinfectants other than glutaraldehyde (per cycle) May;43(5):540-6.
Contributions to overhead Babb JR, Bradley CR. Endoscope decontamination:

where do we go from here? J Hosp Infect 1995 Jun;
Installation of additional ventilation 30(Suppl):543-51.
Potential staffing changes
Bottrill PM, Axon AT. Cleaning and disinfection of
Personal protective equipment (e.g., gloves, gowns, flexible endoscopes and ancillary equipment: use of
eyewear) automatic disinfectors. J Gastroenterol Hepatol
1991 Jan-Feb;6(1):45-7.
Accessory equipment (e.g., leakage test equipment,
channel cleaning adapters) Bradley CR, Babb JR, Ayliffe GA. Evaluation of the
Use of separate rooms for endoscopic procedures Steris System 1 peracetic acid endoscope processor.
and reprocessing J Hosp Infect 1995 Feb;29(2):143-51.
As illustrated by the above sample PV/LCC analysis, Brown NM, Hellyar EA, Harvey JE, et al. Mycobacte-
the initial acquisition cost is only a fraction of the total rial contamination of fibreoptic bronchoscopes.
cost of operation over five years. Therefore, before mak- Thorax 1993 Dec;48(12):1283-5.
ing a purchase decision based solely on the acquisition
cost of an endoscope reprocessor, buyers should con- CS: know thy scopes. Hosp Purch News 1993 Jun 15;
sider operating costs over the lifetime of the equipment. 17(6):23, 25.
For further information on PV/LCC analysis, cus- Daschner F, Kralovic RC. STERIS System 1 in Ger-
tomized analyses, and purchase decision support, many [letter and reply]. Infect Control Hosp
readers should contact ECRIs SELECTGroup. Epidemiol 1994 May;15(5):294-5.
DesCteaux JG, Tye L, Poulin EC. Reuse of disposable Nosocomial outbreaks linked to endoscope cleaning.
laparoscopic instruments: cost analysis. Can J Surg Hosp Infect Control 1993 Jun;20(6):83-5.
1996 Apr;39(2):133-9.
Pineau L, Roques C, Luc J, et al. Automatic washer
DiMarino AJ, Bond WW. Flexible gastrointestinal en- disinfector for flexible endoscopes: a new evaluation
doscopic reprocessing [editorial]. Gastrointest En- process. Endoscopy 1997 Jun;29(5):372-9.
dosc 1996 May;43(5):522-4.
Reichert M. Automatic washers/disinfectors for flex-
Fraser VJ, Jones M, Murray PR, et al. Contamination ible endoscopes. Infect Control Hosp Epidemiol 1991
of flexible fiberoptic bronchoscopes with Mycobac- Aug;12(8):497-9.
terium chelonae linked to an automated broncho-
Reynolds CD, Rhinehart E, Dreyer P, et al. Variability
scope disinfection machine. Am Rev Respir Dis 1992
in reprocessing policies and procedures for flexible
Apr;145(4 Pt 1):853-5.
fiberoptic endoscopes in Massachusetts hospitals.
Fraser VJ, Zuckerman G, Clouse RE, et al. A prospec- Am J Infect Control 1992 Dec;20(6):283-90.
tive randomized trial comparing manual and auto- Rutala WA, Weber DJ. Disinfection of endoscopes:
mated endoscope disinfection methods. Infect review of new chemical sterilants used for high-level
Control Hosp Epidemiol 1993 Jul;14(7):383-9. disinfection. Infect Control Hosp Epidemiol 1999
Jan;20(1):69-76.
Glutaraldehyde: FDA holds firm on need for 45-minute
soak. OR Manager 1996 Jun;12(6):12-3. Society of Gastroenterology Nurses and Associates, Inc.
Standards for infection control and reprocessing of
Gurevich I, Qadri SM, Cunha BA. False-positive re-
flexible gastrointestinal endoscopes. Gastroenterol
sults of spore tests from improper clip use with the
Nurs 1997 Mar-Apr;20(2 Suppl):1-13.
STERIS chemical sterilant system [letter]. Am J
Infect Control 1993 Feb;21(1):42-3. Urayama S, Kozarek RA, Sumida S, et al. Mycobacte-
ria and glutaraldehyde: is high-level disinfection of
Ido K, Ishino Y, Ota Y, et al. Deficiencies of automatic endoscopes possible? Gastrointest Endosc 1996
endoscopic reprocessors: a method to achieve high- May;43(5):451-6.
grade disinfection of endoscopes. Gastrointest En-
dosc 1996 Nov;44(5):583-6. Vesley D, Norlien KG, Nelson B, et al. Significant
factors in the disinfection and sterilization of flex-
Jackson J, Leggett JE, Wilson DA, et al. Mycobac- ible endoscopes. Am J Infect Control 1992 Dec;20(6):
terium gordonae in fiberoptic bronchoscopes. Am J 291-300.
Infect Control 1996 Feb;24:19-23.
Walter V. Reprocessing of flexible gastrointestinal en-
Kaczmarek RG, Moore RM, McCrohan J, et al. Multi- doscopes an American Society for Gastrointesti-
state investigation of the actual disinfection/sterili- nal Endoscopy white paper. Gastroenterol Nurs
zation of endoscopes in health care facilities. Am J 1996 May-Jun;19(3):109-12.
Med 1992 Mar;92:257-61.
What does it cost to clean an endoscope? Mater Manag
Lynch DA, Parnell P, Porter C, et al. Patient and staff Health Care 1992 Jun;1(4):52.
exposure to glutaraldehyde from Keymed auto-dis-
infector endoscope washing machine. Endoscopy
Standards and guidelines
1994 May;26(4):359-61. Note: Although every effort is made to ensure that the
following list is comprehensive, please note that other
Lynch DA, Porter C, Murphy L, et al. Evaluation of applicable standards may exist.
four commercial automatic endoscope washing ma- American National Standards Institute/Association
chines. Endoscopy 1992 Nov;24(9):766-70. for the Advancement of Medical Instrumentation.
Safe current limits for electromedical apparatus
Martin MA, Reichelderfer M. APIC guideline for infec-
[standard]. 3rd ed. ANSI/AAMI ES1-1993. 1985 (re-
tion prevention and control in flexible endoscopy.
vised 1993).
Am J Infect Control 1994 Feb;22(1):19-38.
Safe handling and biological decontamination of
Muscarella LF. Advantages and limitations of auto- medical devices in health care facilities and in non-
matic flexible endoscope reprocessors. Am J Infect clinical settings [standard]. 2nd ed. ANSI/AAMI
Control 1996 Aug;24(4):304-9. ST35-1996. 1996.
American Public Health Association. Cleaning, sterili- Medical electrical equipment part 1: general re-
zation and disinfection of rigid and flexible en- quirements for safety. Section 2. Collateral stan-
doscopes and their accessories [position paper]. dard: electromagnetic compatibility requirements
1982. and tests. IEC 60601-1-2 (1993-04). 1993.
American Society for Gastrointestinal Endoscopy. Is- Society of Gastroenterology Nurses and Associates,
sues of flexible gastrointestinal endoscope reproc- Inc. Standards for infection control and reprocess-
essing [position statement]. Ad Hoc Committee on ing of flexible gastrointestinal endoscopes [guide-
Disinfection. Gastrointest Endosc 1996 May;43(5): line]. 1997 (revised 2000).
541-6. Standards Association of Australia. Code of practice
for cleaning, disinfecting and sterilizing reusable
Technology assessment position paper: transmis-
medical and surgical instruments and equipment,
sion of infection by gastrointestinal endoscopy.
and maintenance of associated environments in
Technology Assessment Committee. Gastrointest
health care facilities [standard]. AS 4187-1994.
Endosc 1993 Oct;39(6):885-8.
1994.
American Society for Testing and Materials. Practice
for cleaning and disinfection of flexible fiberoptic Citations from other ECRI publications
and video endoscopes used in the examination of the Health Devices
hollow viscera [standard]. ASTM Committee F04 on
Medical and Surgical Materials and Devices. F1518- Contamination of the modified Olympus EW-10 and
94. 1994. EW-20 automatic flexible endoscope reprocessors
[hazard]. 1994 Apr;23(4):143-5.
Association for Practitioners in Infection Control.
Liquid disinfecting and sterilizing reprocessors used
APIC guideline for infection prevention and control
for flexible endoscopes [evaluation]. 1994 Jun;23(6):
in flexible endoscopy. Am J Infect Control 2000 Apr;
214-53.
28(2):138-55.
Reducing endoscopic contamination levels: are liquid
APIC guideline for selection and use of disinfec- disinfecting and sterilizing reprocessors the solu-
tants. Am J Infect Control 1996 Aug;24(4):313-42. tion? 1994 Jun;23(6):212-3, 252-3.
Association for the Advancement of Medical Instru- Liquid disinfecting and sterilizing reprocessors used
mentation. Chemical sterilants and sterilization for flexible endoscopes [evaluation update]. 1994
methods: a guide to selection and use [technology Dec;23(12):477-81.
information report]. TIR7-152-EC. 1990. ECRIs recommended protocol for reprocessing immer-
Safe handling of biologically contaminated medical sible flexible endoscopes [clarification/update].
devices in nonclinical and clinical settings [stan- 1995 Dec;24(12):506-7.
dard]. TIR10-152-EL. 1994. MediVators endoscope disinfector does not alarm for
disinfection failures caused by blown fuse [hazard
Association of Operating Room Nurses. Care of instru-
report]. 1998 Apr-May;27(4-5):171-2.
ments, scopes, and powered surgical instruments
[recommended practice]. 1997. ECRI responds to Newsweek article on dirty en-
doscopes [editorial]. 1999 May-Jun;28(5-6):177-9.
Recommended practices for the use and care of
endoscopes [recommended practice]. AORN J 1998 Automated LCG reprocessors. An alternative for flex-
Jan;67(1):256-8, 261-2. ible endoscopes [guidance article]. 1999 Nov;28(11):
434.
International Electrotechnical Commission. Medical
Health Devices Alerts
electrical equipment part 1: general require-
ments for safety [standard]. IEC 60601-1 (1988-12). This Product Comparison lists Health Devices
1988. Alerts (HDA) citations published since the last update
of this report. Each HDA abstract is identified by an
Medical electrical equipment part 1: general re-
Accession Number. Recalls and hazard reports include
quirements for safety. Amendment 1 [standard].
descriptions of the problem involved; abstracts of other
IEC 60601-1-am1 (1991-11). 1991.
published articles are referenced by bibliographic in-
Medical electrical equipment part 1: general re- formation. HPCS subscribers can call the Hotline for
quirements for safety. Amendment 2 [standard]. additional information on any of these citations or to
IEC 60601-1-am2 (1995-03). 1995. request more extensive searches of the HDA database.
A3899 FDA and CDC have issued a Public Health Goods Administration. Safety alert endoscope
Advisory alerting healthcare facilities to several inci- cleaning. Aust Ther Device Bull 1999 Dec; No. 40-
dents in which patients developed serious infections 3/99:8-9.
after being examined with bronchoscopes that appar-
ently were inadequately reprocessed in an automated 35593 Tsuji S, Kawano S, Oshita M, et al. Endoscope
endoscope reprocessor (AER). CDC reported apparent disinfection using acidic electrolytic water. Endoscopy
patient-to-patient transmission of infections following 1999 Sep;31(7):528-35.
bronchoscopic procedures that used bronchoscopes Health Technology Trends
that were inadequately reprocessed by AERs. Investi-
gation of the reported incidents revealed that there Endoscope infection control needs more hospital atten-
were inconsistencies between the reprocessing in- tion. 1994 Feb;6(2):3, 5.
structions provided by the manufacturer of the bron-
choscope and the manufacturer of the AER and that
bronchoscopes were inadequately reprocessed when Supplier information
inappropriate channel connectors were used with the
AER. Additionally, some users are using AERs to ASP
reprocess endoscopes that are not suitable for AERs;
this practice may have resulted in damaged en- Advanced Sterilization Products
doscopes and also raises questions about whether such A Johnson & Johnson Co [186653]
processing results in an endoscope that is properly 33 Technology Dr
prepared for patient contact. Source: United States. Irvine CA 92618
Food and Drug Administration. Center for Devices and Phone: (949) 581-5799, (800) 595-0200
Radiological Health. Centers for Disease Control and Fax: (949) 450-6800
Prevention. National Center for Infectious Diseases. E-mail: aspcomment@aspus.jnj.com
FDA and CDC public health advisory: infections from Internet: http://www.sterrad.com
endoscopes inadequately reprocessed by an automated
Advanced Sterilization Products (Belgium)
endoscope reprocessing system. 1999 Sep 10.
c/o Johnson & Johnson Medical NV [307241]
A4376 FDA has designated Class II Recall Nos. Z- Eikelenbergstraat 20
0364/0366-1 STERIS liquid sterilizing units. Accord- B-1700 Dilbeek
ing to STERIS, the instruction booklets for the C1402, Belgium
C1403, and C1622 Quick Connect Kits may not be clear Phone: 32 (2) 4817400
to all users regarding the appropriate processing of Fax: 32 (2) 4817350
Pentax 30/40/30K Series gastroscopes with forward Internet: http://www.sterrad.com
water jets. All affected U.S. customers have received
Advanced Sterilization Products (Singapore)
the revised instruction booklets. The manufacturer
c/o Johnson & Johnson Medical Inc [306945]
initiated a recall by letter dated December 12, 2000.
3 International Rd
Verify that you have received the December 12, 2000,
Jurong
letter from STERIS. Identify and isolate any affected
Singapore 2261
product in your inventory. Source: FDA Enforcement
Republic of Singapore
Rep 2001 Mar 14; Manufacturer.
Phone: 65 2658922
D4389 The Australian Therapeutic Goods Admini- Fax: 65 2686974
stration (TGA) issued a Safety Alert informing health- Internet: http://www.sterrad.com
care facilities that there have been reports of patients
developing serious infections after being examined with
Belimed
bronchoscopes that were inadequately cleaned in an
automated endoscope cleaner (AEC). TGA states that Belimed AG [140149]
investigation of the reported incidents revealed that Dorfstrasse 4
there were inconsistencies between the cleaning in- Postfach 188
structions provided by the bronchoscope manufacturer CH-6275 Ballwil
and the AEC manufacturer; that bronchoscopes were Switzerland
inadequately cleaned because inappropriate channel Phone: 41 (41) 4497888
connectors were used; and that some users were using Fax: 41 (41) 4497889
the AEC to clean endoscopes that should not be proc- E-mail: info@belimed.com
essed in an AEC. Source: Australia. Therapeutic Internet: http://www.belimed.com
BHT Lancer UK Ltd [391354]

BHT HygieneTechnik GmbH [230341] 1 Pembroke Ave
Winterbruckenweg 30 Waterbeach
D-86316 Friedberg/Derching Cambridge, Cambridgeshire CB5 9QR
Germany England
Phone: 49 (821) 2789313 Phone: 44 (1223) 861665
Fax: 49 (821) 784099 Fax: 44 (1223) 861990
E-mail: bht.verkauf@t-online.de Internet: http://www.lancer.com
Internet: http://www.bht-hygienetechnik.de
Lancer USA Inc [107921]
Custom Ultrasonics 140 State Rd 419
Custom Ultrasonics Inc [107046] Winter Springs FL 32708
PO Box 850 Phone: (407) 327-8488, (800) 332-1855
Buckingham PA 18912 Fax: (407) 327-1229
Phone: (215) 364-1477 E-mail: sales@lancer.com
Fax: (215) 364-7674 Internet: http://www.lancer.com
E-mail: q-net@msn.com
Internet: http://www.customultrasonics.com
Krause Medlore
Krause Medizin Technik Service GmbH [279550]
Medlore [232375]
Hoher Holzweg 44
D-30966 Arnum 43 boulevard de la Barniere
Germany F-13010 Marseille
France
Phone: 49 (510) 13006
Fax: 49 (510) 15093 Phone: 33 (491) 832122
E-mail: info@kmts.de Fax: 33 (491) 832110
E-mail: medlore@aix.pacwan.net
Internet: http://www.kmts.de
Internet: http://www.medlore.com
LABcaire
LABcaire Systems Ltd [184258]
15 Hither Green Newamatic
Clevedon, Avon BS21 6XU
England
Netzsch Belimed GmbH [328040]
Phone: 44 (1275) 340033
Liebigstrasse 28
Fax: 44 (1275) 341313
Postfach 1240
D-84465 Waldkraiburg
Lancer
Germany
Lancer Holland bv [391355] Phone: 49 (8638) 946300
Postbus 33 Fax: 49 (8638) 881830
NL-6659 ZG Wamel E-mail: netzsch-belimed@iiv.de
The Netherlands Internet: http://www.belimed.de
Phone: 31 (487) 518088
Fax: 31 (487) 517978
Internet: http://www.lancer.com
Lancer Industrie Olympus
Div Getinge Industrier AB [138079]
30 boulevard de lIndustrie Olympus America Inc
Zone Industrielle de Pahin Endoscopy Group [364575]
F-31170 Tournefeuille Two Corporate Center Dr
France Melville NY 11747-3157
Phone: 33 (5) 61151111 Phone: (631) 844-5000, (800) 645-8130
Fax: 33 (5) 61151616 Fax: (631) 844-5442
Internet: http://www.getinge.com Internet: http://www.olympus.com
Pauldrach STERIS Singapore [320749]

61 Lam Leong Bldg
Pauldrach Medical GmbH [366855] #03-01 Geylang Lorong 17
Porschestrasse 22 Singapore 388574
D-30827 Garbsen Republic of Singapore
Germany Phone: 65 8417677
Phone: 49 (5131) 49650 Fax: 65 8417655
Fax: 49 (5131) 92014 Internet: http://www.steris.com
E-mail: endoman@t-online.de
Internet: http://www.pauldrach.de
About the chart specifications
The following terms are used in the chart:
Manual air capability: The ability of the user to force
air through the endoscopes channels.
Plade
Autodisinfection: A cycle that disinfects the reproces-
Plade Ltd [397119] sor. In some units, this cycle is part of the overall
Plade Works reprocessing procedure; other units have a separate
Gladstone Avenue autodisinfection cycle.
Barrhead, Glasgow G78 1QT Abbreviations:
Scotland
Phone: 44 (141) 8818241 ARO After receipt of order
Fax: 44 (141) 8818143 CE mark Conformite Europeene mark
E-mail: plade@plade.com
Internet: http://www.plade.com CSA Canadian Standards Association
DGHM Deutsche Geseuschaft Hygiene and Mik-
robiology
STERIS
ETL ETL Testing Laboratories
STERIS Corp [107114] FDA U.S. Food and Drug Administration
5960 Heisley Rd
Mentor OH 44060-1834 GERMANDE French association of gastroen-
Phone: (440) 354-2600, (800) 548-4873 terologists working on washer-disinfectors in
Fax: (440) 350-7086 Europe to establish a standard procedure to test
E-mail: john_kurowski@steris.com these devices
Internet: http://www.steris.com ISO International Organization for Stand-
ardization
STERIS Corp (Hong Kong) [227264]
Room 301-2 3/Floor Kodak House II LCD Liquid crystal display
39 Healthy St E
LED Light-emitting diode
North Point
Hong Kong SAR MDD Medical Devices Directive
Peoples Republic of China
Phone: 852 25633623 PC Personal computer
Fax: 852 25637387 TUV Technischer Ueberwachungs Verein
Internet: http://www.steris.com
UL Underwriters Laboratories
STERIS Ltd (Europe)
UV Ultraviolet
Jays Close
Viables, Basingstoke Note: The data in the charts derive from suppliers
Hampshire RG22 4AX specifications and have not been verified through inde-
England pendent testing by ECRI or any other agency. Because
Phone: 44 (1256) 840400 test methods vary, different products specifications are
Fax: 44 (1256) 866502 not always comparable. Moreover, products and speci-
E-mail: duncan_wilson@steris.com fications are subject to frequent changes. ECRI is not
Internet: http://www.steris.com responsible for the quality or validity of the information
presented or for any adverse consequences of acting on listed the conversion to U.S. dollars to facilitate com-
such information. parison among models. However, keep in mind that
exchange rates change often.
When reading the charts, keep in mind that, unless
otherwise noted, the list price does not reflect supplier
discounts. And although we try to indicate which Need to know more?
features and characteristics are standard and which
For further information about the contents of this
are not, some may be optional, at additional cost.
Product Comparison, contact the HPCS Hotline at +1
For those models whose prices were supplied to us (610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); or
in currencies other than U.S. dollars, we have also hpcs@ecri.org (e-mail).
About ECRI . . .
ECRI is a nonprofit health services research agency and a Collaborating Center of the World Health
Organization, providing information and technical assistance to the healthcare community to support
safe and cost-effective patient care for more than 25 years. The results of ECRIs research and
experience are available through its publications, information systems, databases, technical assistance
program, laboratory services, seminars, and fellowships.
Our full-time staff includes a wide range of specialists in healthcare technology, hospital admini-
stration, financial analysis, risk management, and information and computer science, as well as
hospital planners, attorneys, physicists; biomedical, electrical, electronic, chemical, mechanical, and
registered engineers; physicians; basic medical scientists; epidemiologists and biostatisticians; and
writers, editors, and communications specialists.
Underlying ECRIs knowledge base in healthcare technology are its integrity and objectivity. ECRI
accepts no financial support from medical product manufacturers, and no employee may own stock
in or consult for a medical equipment or pharmaceutical company.
The scope of ECRIs resources extends far beyond technology. ECRI keeps healthcare professionals,
manufacturers, legal professionals, information specialists, and others aware of the changing trends
in healthcare, healthcare standards and regulations, and the best ways to handle environmental and
occupational health and safety issues. ECRI also advises on management issues related to healthcare
cost containment, accreditation, risk management, human resources, quality of care, and other
complex topics.
ECRI has more than 35 publications, databases, software, and services to fulfill the growing need
for healthcare information and decision support. They focus on three primary areas: healthcare
technology, healthcare risk and quality management, and healthcare environmental management.
Product Comparison Chart

MODEL ASP BELIMED BHT BHT
Automatic Endoscope WD 420 INNOVA E 2 INNOVA E 3

Reprocessor
WHERE MARKETED Worldwide Asia, Australia, Worldwide Worldwide
Europe, Middle East
FDA CLEARANCE Yes Submitted No Submitted

CE MARK (MDD) Yes Yes Yes Yes
CONFIGURATION Floor Floor, stand-alone Freestanding under Freestanding under
counter counter
DISINFECT/STERILIZE High-level disinfect Disinfect Disinfect Disinfect
CHAMBER SIZE,
H x L x W, cm (in) 12.7 x 58.4 x 50.8 51 x 51 x 55 55 x 48 x 38 53.5 x 51 x 52
(5 x 23 x 20) (20.1 x 20.1 x 21.7) (21.7 x 18.9 x 15) (21.1 x 20.1 x 20.5)
SCOPES PER CYCLE 1 or 2 1 or 2 1 1 or 2
CYCLE TIME, min

Wash 1-166, user select See footnote * Varies Varies
Disinfect/sterilize 1-166, user select See footnote * Varies Varies
Rinse 3 fresh water See footnote * Varies Varies
Dry 5 See footnote * Varies Varies
GERMICIDAL AGENTS
Types used Orthophthaldehyde, 0.15% All All
peracetic acid, 2% glutaraldehyde,
glutaraldehyde, peracetic acid
hydrogen peroxide
Heater Yes Yes Yes Yes

Temp range, C 25-50, set at To 95 <60 <60
factory
WATER SUPPLY Tap, filtered, 1 and Tap Cold and warm mixed Cold and warm mixed
0.2 micron potable filtered potable filtered
tap water tap water
Temperature
requirements, C Not to exceed 50 55 warm water, 30 30-60
~18 cold water
DETERGENT LOADING Automatic Automatic Automatic Automatic
RESERVOIR VOLUME,
L (gal) 18.9 (5) 5 (1.3) Not specified Not specified
MANUAL AIR
CAPABILITY Yes Yes No No
DOCUMENTATION Identification Optional printer, Optional printer Printer and optional

codes, LED display, bar code bar-code reader
printer
AUTODISINFECTION Yes Yes Yes Yes
AVAILABLE CHEMICAL
PROCESS INDICATORS From chemical Metering device Digitally controlled Digitally controlled
germicide dosing pumps dosing pumps
manufacturer
Colons separate data on similar models of a device. This is the first of

* Total processing time is 20 min without dry cycle and 40 min with dry cycle. two pages covering
the above model(s).
These specifications
continue onto the
next page.

MODEL ASP BELIMED BHT BHT
Automatic Endoscope WD 420 INNOVA E 2 INNOVA E 3

Reprocessor
SCOPE COMPATIBILITY All flexible All All flexible All flexible
fiberoptic and
video
OVERALL SIZE,
H x W x D, cm (in) 99.1 x 69.2 x 76.2 90 x 90 x 70 85 x 60 x 60 90 x 80 x 70
(39 x 27.25 x 30) (35.4 x 35.4 x 27.6) (31 x 23.6 x 23.6) (35.4 x 31.5 x 27.6)
WEIGHT, kg (lb) 90.7 (200) 148 (326.3) 80 (176.4) 160 (352.8), depend-
ing on configuration
POWER REQUIREMENTS,
VAC 100, 60 Hz or 230, 208, 60 Hz, 9.5 kW 208-230, 400, 3 x 208, 60 Hz;
50 Hz (10, 20, 50 A) (10.3 kW total) 50/60 Hz 3 x 400, 50 Hz
PLANNING & PURCHASE
List price $17,900 Not specified Not specified Not specified
Warranty 1 year, parts/labor 1 year 1 year 1 year
Delivery time, ARO 2-4 weeks 3 weeks 4-6 weeks 4-6 weeks
Service contract Not specified Available Available Available
Training w/purchase On-site Full service with Included Included

installation;
included in price
Year first sold 1989 1990 1999 1997
Number installed
USA Not specified NA Not specified Not specified
Worldwide Not specified 800 Not specified Not specified
Fiscal year January to December January to December January to December January to December
OTHER SPECIFICATIONS Large basin Microprocessor Stainless steel; Stainless steel;

capacity; hydro- controlled; auto- microprocessor con- microprocessor con-
dynamic spray tower; matic, continous trolled; LCD; trolled; LCD;
thermostatic density test. Meets leakage testing; foam-control
disinfectant requirements of thermal disinfection feature; leakage
reservoir; 6 German Workshop of final rinsing; testing; thermal
separately of Endoscopy. sterile drying. disinfection of
controlled pressure Meets requirements final rinsing;
perfusion ports; of CSA, German sterile drying.
custom-fit lid; Association of Meets requirements
portable or Endoscopy, and of CSA, German
permanent installa- ISO 9001. Association of
tion; optional Endoscopy, and
water-filtration ISO 9001.
system.
Colons separate data on similar models of a device.

MODEL CUSTOM ULTRASONICS CUSTOM ULTRASONICS KRAUSE LABCAIRE
FAILED TO RESPOND *
83 Plus (Models 83+ 83 Plus DT (Models Profi 2000 Autoscope F2
2 : 83+9 : 83+10) 83+2 : 83+9 : 83+10)
WHERE MARKETED Australia, Canada, Australia, Canada, Europe, other Asia, Australasia,
Ireland, Italy, Ireland, Italy, countries on demand Europe, Middle East,
Japan, Korea ** Japan, Korea ** UK
FDA CLEARANCE Yes Yes Not specified No
CE MARK (MDD) Yes Yes Not specified Yes
CONFIGURATION Floor with mobile Floor with mobile Floor Cart
casters casters
DISINFECT/STERILIZE Wash cycle, high- Wash cycle, high- Disinfect Both
level disinfection level disinfection
CHAMBER SIZE,
H x L x W, cm (in) 41.9 (16.5) or 49 41.9 (16.5) or 49 23 x 2.5 x 2.5 Molded tray, 8
(19) diam x 19 (7.5) (19) diam x 19 (7.5) (9 x 1 x 1) (3.1) W x 65 (26) D
depth depth
SCOPES PER CYCLE 2:4:6 2:4:6 1 or 2 (18 cm in 1 or 2
length)
CYCLE TIME, min
Wash 3 3 1-60 2 washes @ 2 each
Disinfect/sterilize Chemical dependent Chemical dependent 1-60 4-599, variable
Rinse 3-4 rinses @ 1.5 ea 3-4 rinses @ 1.5 ea 1-60 2 rinses @ 2 each
Dry 40 sec 40 sec 1-60 1
GERMICIDAL AGENTS
Types used Not limited Not limited Liquids after DGHM Glutaraldehyde,
peracetic acid,
super-ionized water,
chlorine dioxide,
orthophthaldehyde
Heater Optional *** See footnote *** Yes Optional

Temp range, C Unlimited Unlimited 20-40 20-25
WATER SUPPLY Tap, filtered at 5 Tap, filtered at 5 UV-sterilized water Multistage

microns, 0.1 micron microns, 0.1 micron filtration to 0.22
for sediment and for sediment and micron
bacteria bacteria
Temperature
requirements, C 43 5 43 5 0-40 Ambient
DETERGENT LOADING Manual Automatic Automatic Semiautomatic w/full

fume containment
RESERVOIR VOLUME,
L (gal) 22.7 (6), 16.5 in; 22.7 (6), 16.5 in; 12 (3.2) 15 (4)
30 (8), 19 in 30 (8), 19 in
MANUAL AIR
CAPABILITY Also automatic Also automatic Yes Yes
DOCUMENTATION Printer; database Printer; database Possible printer Printer

available available connection
AUTODISINFECTION Yes Yes Yes Fully automatic
AVAILABLE CHEMICAL
PROCESS INDICATORS From chemical From chemical Endozyme Low-flow alarms,
germicide germicide user locked out when
manufacturer manufacturer chemical exceeds
maximum use life

* Specifications current as of February 2000. two pages covering
** Also marketed in Scotland, UAE, UK, and USA. the above model(s).
*** Thermocouple/computer controlled. These specifications
Preset based on chemical and scope compatibility. continue onto the

next page.

MODEL CUSTOM ULTRASONICS CUSTOM ULTRASONICS KRAUSE LABCAIRE
FAILED TO RESPOND *
83 Plus (Models 83+ 83 Plus DT (Models Profi 2000 Autoscope F2
2 : 83+9 : 83+10) 83+2 : 83+9 : 83+10)
SCOPE COMPATIBILITY All channels of all All channels of all All flexible fiber- All flexible
scopes scopes optic and video
OVERALL SIZE,
H x W x D, cm (in) Model dependent Model dependent 240 x 58.5 x 62 154 x 82 x 72
(94.5 x 23 x 24.4) (62.6 x 32.3 x 28.3)
WEIGHT, kg (lb) Model dependent Model dependent ~86 (189.6) 130 (286.7)
POWER REQUIREMENTS,
VAC 120, 60 Hz, 10 A 120, 60 Hz, 10 A 230, 60 Hz, 6 A 110/230, 50/60 Hz
PLANNING & PURCHASE

List price $20,000 : $38,000 : $22,000 : $40,000 : ~$43,200 for 1, 16,500
$56,000 $59,000 ~$64,800 for 2 (US$23,352)
Warranty 1 year 1 year 1 year, parts/labor 1 year
Delivery time, ARO 8-10 weeks 8-10 weeks 8 weeks 4-6 weeks
Service contract Available Available ~$2,664/year Depends upon

location
Training w/purchase 2 days on-site 2 days on-site Not specified 2 days on-site
Year first sold 1980 1980 Not specified 1999

Number installed
USA Not specified Not specified Not specified NA
Worldwide >2,000 >2,000 Not specified Not specified
Fiscal year July to June July to June Not specified July to June
OTHER SPECIFICATIONS PC controlled with PC controlled with Ring nozzle washes Automatic detergent
proprietary, patent- proprietary, patent- the tube of the loading (enzyme
ed software; hard- ed software; hard- endoscope lift up cleaner). Tested
copy documentation; copy documentation; system; magnetic and passed by
low-intensity low-intensity tapes for doors; Hospital Infection
ultrasound. Meets ultrasound. Meets 1-channel steer- Research Laboratory,
requirements of CE, requirements of CE ing; reuse of disin- Birmingham; full
CSA and ETL. CSA and ETL. fection solvent. COSHH compliance
assured (independent
test report
available).

* Specifications current as of February 2000.

MODEL LABCAIRE LABCAIRE LABCAIRE LABCAIRE
Autoscope F4 Autoscope Guardian Autoscope Guardian Autoscope RF2

G2 G4
WHERE MARKETED Asia, Australasia, Asia, Australasia, Asia, Australasia, Asia, Australasia,
Europe, Middle East, Europe, Middle East, Europe, Middle East, Europe, Middle East,
UK UK UK UK
FDA CLEARANCE No No No No
CONFIGURATION Cart Cart Cart Cart
DISINFECT/STERILIZE Both Both Both Both
CHAMBER SIZE,
H x L x W, cm (in) 2 molded trays, 7.4 Molded tray, 8 2 molded trays, 7.4 Stainless steel, 8
(2.9) W x 65 (26) D (3.1) W x 65 (26) D (2.9) W x 65 (26) D (3.1) W x 65 (26) D
SCOPES PER CYCLE 1 or 2 per tray 1 or 2 1 or 2 1 or 2 and/or selec-

tion of rigid scopes
CYCLE TIME, min
Wash 2 washes @ 2 each 2 washes @ 2 each 2 washes @ 2 each 2 washes @ 2 each
Disinfect/sterilize 4-599, variable 4-599, variable 4-599, variable 4-599, variable
Rinse 2 rinses @ 2 each 2 rinses @ 2 each 2 rinses @ 2 each 2 rinses @ 2 each
Dry 1 1 1 1
GERMICIDAL AGENTS
Types used Glutaraldehyde, Glutaraldehyde, Glutaraldehyde, Glutaraldehyde,
peracetic acid, peracetic acid, peracetic acid, peracetic acid,
super-ionized water, super-ionized water, super-ionized water, super-ionized water,
chlorine dioxide, chlorine dioxide, chlorine dioxide, chlorine dioxide,
orthophthaldehyde orthophthaldehyde orthophthaldehyde orthophthaldehyde
Heater Optional Optional Optional Optional
Temp range, C 20-25 20-25 20-25 20-25
WATER SUPPLY Multistage Multistage Multistage Multistage

filtration to 0.22 filtration to 0.22 filtration to 0.22 filtration to 0.22
micron micron micron micron
Temperature
requirements, C Ambient Ambient Ambient Ambient
DETERGENT LOADING Semiautomatic w/full Semiautomatic w/full Semiautomatic w/full Semiautomatic w/full
fume containment fume containment fume containment fume containment
RESERVOIR VOLUME,
L (gal) 15 (4) per tray 15 (4) 15 (4) per tray 15 (4)
MANUAL AIR
CAPABILITY Yes Yes Yes Yes
DOCUMENTATION Printer Printer, smart card Printer, smart card Printer

data recorder data recorder
AUTODISINFECTION Fully automatic Fully automatic Fully automatic Fully automatic
AVAILABLE CHEMICAL
PROCESS INDICATORS Low-flow alarms, All channels indi- All channels indi- Low-flow alarms,
user locked out when vidually monitored vidually monitored user locked out when
chemical exceeds for flow and connec- for flow and connec- chemical exceeds
maximum use life tion tion maximum use life

two pages covering
the above model(s).
continue onto the
next page.

MODEL LABCAIRE LABCAIRE LABCAIRE LABCAIRE
Autoscope F4 Autoscope Guardian Autoscope Guardian Autoscope RF2

G2 G4
SCOPE COMPATIBILITY All flexible All flexible All flexible All flexible and
rigid
OVERALL SIZE,
H x W x D, cm (in) 154 x 150 x 72 154 x 82 x 72 154 x 150 x 72 154 x 82 x 72
(60.6 x 59 x 28.3) (60.6 x 32.3 x 28.3) (60.6 x 59 x 28.3) (60.6 x 32.3 x 28.3)
WEIGHT, kg (lb) 200 (441) 130 (286.7) 200 (441) 130 (286.7)
POWER REQUIREMENTS,
VAC 110/230, 50/60 Hz 110/230, 50/60 Hz 110/230, 50/60 Hz 110/230, 50/60 Hz
PLANNING & PURCHASE

List price 25,000 25,000 39,000 17,000
(US$35,383) (US$35,383) (US$55,197) (US$24,062)
Warranty 1 year 1 year 1 year 1 year
Delivery time, ARO 4-6 weeks 4-6 weeks 4-6 weeks 4-6 weeks
Service contract Depends upon Depends upon Depends upon Depends upon
location location location location
Training w/purchase 2 days on-site 2 days on-site 2 days on-site 2 days on-site
Year first sold 1999 2001 2001 1999

Number installed
USA NA NA NA NA
Worldwide Not specified Not specified Not specified Not specified
Fiscal year July to June July to June July to June July to June
OTHER SPECIFICATIONS Automatic detergent All variable cycle All variable cycle Automatic detergent
loading (enzyme parameters assessed parameters assessed loading (enzyme
cleaner). Tested and reported; and reported; cleaner). Tested
and passed by automatic detergent automatic detergent and passed by
Hospital Infection loading (enzyme loading (enzyme Hospital Infection
Research Laboratory, cleaner). Designed cleaner). Designed Research Laboratory,
Birmingham; full to ensure compliance to ensure compliance Birmingham; full
COSHH compliance with HTM2030 and with HTM2030 and COSHH compliance
assured (independent prEN ISO 15883. prEN ISO 15883. assured (independent
test report Tested and passed by Tested and passed by test report
available). Hospital Infection Hospital Infection available).
Research Laboratory, Research Laboratory,
Birmingham; full Birmingham; full
COSHH compliance COSHH compliance
assured (independent assured (independent
test report test report
available). available).

MODEL LABCAIRE LANCER MEDLORE NEWAMATIC
FAILED TO RESPOND *
Autoscope RF4 Fibro-Cleaner Soluscope WD 440
WHERE MARKETED Asia, Australasia, Europe Asia, Australia, Asia, Australia,

Europe, Middle East, Europe Europe, New Zealand
UK
CONFIGURATION Cart Stand-alone Tabletop, optional Floor with casters
cart
DISINFECT/STERILIZE Both Disinfect Disinfect Disinfect
CHAMBER SIZE,
H x L x W, cm (in) 2 stainless steel 46 x 51 x 50 59 x 40 x 15 Not specified
trays, 7.4 (2.9) W x (18.1 x 20.1 x 19.7) (23.2 x 15.7 x 5.9),
65 (26) D oval
SCOPES PER CYCLE 1 or 2 and/or selec- 1 or 2 See footnote ** 1 or 2, simultaneous
tion of rigid scopes or asynchronous
CYCLE TIME, min
Wash 2 washes @ 2 each 5 3 5
Disinfect/sterilize 4-599, variable 12 5 5
Rinse 2 rinses @ 2 each 5, 6 3 1
Dry 1 3 1 5, 10, or 15
GERMICIDAL AGENTS
Types used Glutaraldehyde, Aperlan (peracetic Soluscope D Neutral agent with
peracetic acid, acid) glutaraldehyde, 6% glyoxal and 3.5%
super-ionized water, Soluscope E enzyme glutaraldehyde
chlorine dioxide, cleaner (diluted to 1%)
orthophthaldehyde
Heater Optional No Yes Yes
Temp range, C 20-25 NA 45 Up to 58
WATER SUPPLY Multistage Filtered; Prefiltered tap, Tap, sterile

filtration to 0.22 1, 0.3, 0.1 micron 0.2-micron filter filtered, 0.2 micron
micron
Temperature
requirements, C Ambient Ambient 45 Ambient
DETERGENT LOADING Semiautomatic w/full Automatic dosing Automatic Automatic

fume containment
RESERVOIR VOLUME,
L (gal) 15 (4) per tray 115 (30.4) 11 (2.9) NA
MANUAL AIR
CAPABILITY Yes Airtightness Yes Automatic after each
control wash & rinse cycle
DOCUMENTATION Printer Printer Yes Optional printer or
RS232 interface
AUTODISINFECTION Fully automatic Yes Chlorine and Yes

glutaraldehyde ***
AVAILABLE CHEMICAL
PROCESS INDICATORS Low-flow alarms, Not specified No No
user locked out when
chemical exceeds
maximum use life

* Specifications current as of February 2000. two pages covering
** Capacity includes 1 gastroscope, 2 bronchoscopes, and 1 colonoscope. the above model(s).
*** Through hydraulic circuit including filter. These specifications
continue onto the
next page.

MODEL LABCAIRE LANCER MEDLORE NEWAMATIC
FAILED TO RESPOND *
Autoscope RF4 Fibro-Cleaner Soluscope WD 440
SCOPE COMPATIBILITY All flexible and All flexible All All flexible scopes
rigid from leading
manufacturers
OVERALL SIZE,
(60.6 x 59 x 28.3) (68.5 x 35.4 x 26.7) (24.8 x 24.8 x 12.2) ** (44.1 x 56.7 x 29.5)
WEIGHT, kg (lb) 200 (441) 230 (507) 40 (88.2) 180 (397) + 80 (176)
for boiler
POWER REQUIREMENTS,
VAC 110/230, 50/60 Hz 230, 50 Hz 220-240, 50 Hz 230, 50/60 Hz + 400,
50/60 Hz (boiler)
PLANNING & PURCHASE
List price 27,000 $23,000-30,000 15,900 Not specified
(US$38,220) (US$13,843)
Warranty 1 year 1 year, parts/labor 1 year 1 year, parts/labor
Delivery time, ARO 4-6 weeks 8 weeks 4 weeks 8-12 weeks
Service contract Depends upon Not specified Not specified Not specified
location
Training w/purchase 2 days on-site Not specified Not specified Not specified
Year first sold 1999 1994 1994 1994

Number installed
USA NA NA NA Not specified
Worldwide Not specified Not specified 800 Not specified
Fiscal year July to June Not specified July to June January to December
OTHER SPECIFICATIONS Automatic detergent Independent washing 8 cycle programs; Automatic leakage
loading (enzyme and cleaning of each standard cycle of test; channel-
cleaner). Tested channel; tightness 15 min; optional separation system
and passed by control; total printer. Validated provides cleaning
Hospital Infection cycle time of in Australia by action by a separate
Research Laboratory, 29.3 min. AMAL Laboratories, pump for each
Birmingham; full in England by channel; automatic
COSHH compliance Hospital Infection obstruction test on
assured (independent Research Laboratory, each channel;
test report and in France by tightness control.
available). GERMANDE. Hygienically tested
and approved by
leading European
institutions.

* Specifications current as of February 2000.
** Overall size is measured while device is closed.

MODEL OLYMPUS OLYMPUS OLYMPUS OLYMPUS
DSD by MediVators MV-1 by MediVators MV-2 by MediVators SSD by MediVators
WHERE MARKETED Puerto Rico, USA Puerto Rico, USA Puerto Rico, USA Puerto Rico, USA
FDA CLEARANCE Yes Yes Yes Yes

CONFIGURATION Floor Tabletop, optional Tabletop, optional Floor
cart cart
DISINFECT/STERILIZE High-level High-level High-level High-level
disinfection disinfection disinfection disinfection
CHAMBER SIZE,
H x L x W, cm (in) 14 x 47 x 30.5 15.2 x 47.6 x 38.1 15.2 x 50.2 x 38.1 14 x 47 x 30.5
(5.5 x 18.5 x 12), (6 x 18.7 x 15) (6 x 19.8 x 15) (5.5 x 18.5 x 12),
oval oval
SCOPES PER CYCLE 1 or 2 1 1 or 2 1
CYCLE TIME, min

Wash 0-90, variable 3-5 3-5 0-90, variable
Disinfect/sterilize 5-90, variable 5, 12, 22, 32, 47 5, 12, 22, 32, 47 5-90, variable
Rinse 4-180, variable 2 or 3 rinses @ 3-4 2 or 3 rinses @ 3-5 4-180, variable
Dry 0-180, variable 2.5, 10 2.5, 10 0-180, variable
GERMICIDAL AGENTS
Types used 2.4-2.6% glutaralde- 2.4-2.6% glutaralde- 2.4-2.6% glutaralde- 2.4-2.6% glutaralde-
hyde, hydrogen hyde, hydrogen hyde, hydrogen hyde, hydrogen
peroxide, ortho- peroxide, ortho- peroxide, ortho- peroxide, ortho-
phthaldehyde phthaldehyde phthaldehyde phthaldehyde
Heater Yes Yes Yes Yes

Temp range, C 20-50 20-50 20-50 20-50
WATER SUPPLY 2-stage prefiltra- 3-/1-micron pre-fil- 3-/1-micron pre-fil- 2-stage prefiltra-
tion (0.45 micron)/ ter and 0.2-micron ter and 0.2-micron tion (0.45 micron)/
0.2-micron bacterial bacterial retention bacterial retention 0.2-micron bacterial
final filter final filter final filter final filter
Temperature
requirements, C Cold tap Cold tap Cold tap Cold tap
DETERGENT LOADING Automatic Manual Manual Automatic
RESERVOIR VOLUME,
L (gal) 15 (4) 18.9 (5) 18.9 (5) 15 (4)
MANUAL AIR
CAPABILITY Yes, also automatic Yes Yes Yes, also automatic
DOCUMENTATION Printer, log No No Printer, log
AUTODISINFECTION Yes Yes Yes Yes
AVAILABLE CHEMICAL
PROCESS INDICATORS NA NA NA NA

two pages covering
the above model(s).
continue onto the
next page.

MODEL OLYMPUS OLYMPUS OLYMPUS OLYMPUS
DSD by MediVators MV-1 by MediVators MV-2 by MediVators SSD by MediVators
SCOPE COMPATIBILITY All flexible All flexible All flexible All flexible
OVERALL SIZE,
H x W x D, cm (in) 116.8 x 91.4 x 53.3 43 x 61 x 46 43 x 61 x 46 122 x 56 x 53
(46 x 36 x 21) * (17 x 24 x 18) (17 x 24 x 18) (48 x 22 x 21) *
WEIGHT, kg (lb) 159 (350) 32 (70) 32 (70) 91 (200)
POWER REQUIREMENTS,
VAC 110, 60 Hz, 15 A 110, 60 Hz, 15 A 110, 60 Hz, 15 A 110, 60 Hz, 8 A
PLANNING & PURCHASE

List price $26,500 $8,750 $17,000 $17,000
Warranty 1 year, parts/labor 1 year, parts/labor 1 year, parts/labor 1 year, parts/labor
Delivery time, ARO 3 weeks 3 weeks 3 weeks 3 weeks
Service contract Available Available Available Available
Training w/purchase 1 day on-site 1 day on-site 1 day on-site 1 day on-site
Year first sold 1996 1999 1999 2001

Number installed
USA Not specified Not specified Not specified Not specified
Worldwide Not specified Not specified Not specified Not specified
Fiscal year April to March April to March April to March April to March
OTHER SPECIFICATIONS Automated alcohol Liquid chemical Liquid chemical Automated alcohol
purge; 9 program- germicide fume germicide fume purge; 9 programma-
mable cycles; control; control; ble cycles; disin-
disinfectant- semiautomated semiautomated fectant-filtration
filtration system; alcohol purge alcohol purge system; double-bar-
double-barrier dis- of endoscope of endoscope rier disinfectant
infectant vapor channels; channels; vapor containment;
containment; disinfectant reser- disinfectant reser- onboard liquid
standard 2-stage voir housed outside voir housed outside chemical germicide
water prefiltration unit; optional unit; optional transfer pump; stan-
system; full sensor mobile cart and mobile cart and dard 2-stage water
package; 4 germicide transfer germicide transfer prefiltration sys-
endoscope connector pump; optional water pump; optional water tem; full sensor
sets; optional filtration system. filtration system. package; 2 endoscope
active-charcoal Meets require- Meets require- connector sets; op-
filter vapor manage- ments of ETL and ments of ETL and tional automatic en-
ment system, TUV. TUV. doscope leakage
passive vapor tester; optional ac-
management system. tive-charcoal filter
Canadian vapor management
distribution, Cook system,
County, City of passive vapor
Los Angeles; ETL and management system.
TUV listed. Canadian distribu-
Warnock Hersey mark. tion, Cook County,
City of Los Angeles.
ETL and TUV listed. **

* Height with lid open is 162.5 cm (64 in).
** Warnock Hersey mark.

MODEL PAULDRACH PAULDRACH PAULDRACH PLADE
ECOCLEANER HANDY CLEANER UNICLEANER PLADE 2000
WHERE MARKETED Brazil, England, Brazil, England, Austria, Egypt, UK

Greece, Morocco, Greece, Morocco, France, Germany,
Poland, South Africa * Poland, South Africa * Italy, New Zealand **
CONFIGURATION Floorstanding with Floorstanding with Floorstanding with Floorstanding
casters casters casters cabinet
DISINFECT/STERILIZE Disinfect Disinfect Disinfect Disinfect
CHAMBER SIZE,
H x L x W, cm (in) 16 x 55 x 45 16 x 55 x 45 16 x 55 x 45 60 x 84 x 64
(6.3 x 21.7 x 17.7) (6.3 x 21.7 x 17.7) (6.3 x 21.7 x 17.7) (23.6 x 33.1 x 25.2)
SCOPES PER CYCLE 3 3 3 1 x 2 cycles
CYCLE TIME, min

Wash 1-99 1-99 1-99 See footnote ***
Disinfect/sterilize 1-99 1-99 1-99 See footnote ***
Rinse 1-99 1-99 1-99 See footnote ***
Dry 1-99 1-99 1-99 See footnote ***
GERMICIDAL AGENTS
Types used Minimum 3% Minimum 3% 2% glutaraldehyde 2% peracetic acid,
glutaraldehyde glutaraldehyde 2% glutaraldehyde,
5% formaldehyde

Heater No No Water temp regulator Optional
Temp range, C 15-40 15-40 15-40 Not specified
WATER SUPPLY Tap or filtered Tap or filtered Tap or filtered As delivered to ma-
chine; bacteria
filters available
Temperature
requirements, C Not specified Not specified 40 Ambient
DETERGENT LOADING Semimanual Manual Automatic Automatic
RESERVOIR VOLUME,
L (gal) 15 (4) 15 (4) NA 2, each 15 (4)
MANUAL AIR
CAPABILITY Yes Yes Yes Yes
DOCUMENTATION Yes No Optional printer Standard printer and

resident database in
PC
AUTODISINFECTION Yes Yes Yes Overnight automatic
program
AVAILABLE CHEMICAL
PROCESS INDICATORS Not specified Not specified Glutaraldehyde None (proprietary
indicators from
chemical supplier
recommended)

* Also marketed in Tunisia. two pages covering
** Also marketed in Poland and Saudi Arabia. the above model(s).
*** All times programmable using IBM or PC controller. These specifications
Cold and warm. continue onto the

next page.

MODEL PAULDRACH PAULDRACH PAULDRACH PLADE
ECOCLEANER HANDY CLEANER UNICLEANER PLADE 2000
SCOPE COMPATIBILITY Yes Yes Yes All flexible scopes
OVERALL SIZE,
(43.3 x 27.6 x 23.6) (43.3 x 27.6 x 23.6) (43.3 x 27.6 x 23.6) (92.5 x 44.1 x 38.6)
WEIGHT, kg (lb) 85 (187.4) 85 (187.4) 85 (187.4) ~200 (441) *
POWER REQUIREMENTS,
VAC 230, 60 Hz 230, 60 Hz 230, 60 Hz 220-240, 50 Hz
PLANNING & PURCHASE

List price DM12,000 DM8,000 DM18,000-24,600 ~$50,000 **
(US$5,295) (US$3,530) (US$7,943-10,856)
Warranty 1 year 1 year 1 year 1 year
Delivery time, ARO 4-5 weeks 4-5 weeks 4-5 weeks 6 weeks
Service contract Yes Yes Yes 10% of new machine

value per year
Training w/purchase 1-2 days on-site 1-2 days on-site 1-2 days on-site 2 days on-site
Year first sold 1999 1999 1995 1990

Number installed
USA NA NA NA NA
Worldwide 20 80 180 ~50
Fiscal year Not specified Not specified Not specified April to March
OTHER SPECIFICATIONS None specified. None specified. None specified. Integral fume
containment and
filtration system
for operator pro-
tection. Approved by
the Hospital
Infection Research
Laboratory.

* Weights vary depending on fitted components and the working conditions of the machine.
** Prices of the machines vary depending on the chemical used for disinfection.

MODEL PLADE PLADE STERIS
PLADE 2004R SELECTA 2000 Mobile STERIS SYSTEM 1

PROCESSOR
WHERE MARKETED UK UK Worldwide
FDA CLEARANCE No No Yes

CE MARK (MDD) Yes Yes Yes
CONFIGURATION Floorstanding Cart Tabletop
cabinet
DISINFECT/STERILIZE Disinfect Disinfect Sterilize
CHAMBER SIZE,
H x L x W, cm (in) 60 x 84 x 64 18 x 45 x 38 See footnote *
(23.6 x 33.1 x 25.2) (7.1 x 17.7 x 15)
SCOPES PER CYCLE 2 flexible x 2 2 flexible or rigid 1

independent cycles scopes/instruments
CYCLE TIME, min
Wash See footnote ** Variable NA
Disinfect/sterilize See footnote ** Variable 12, standardized
Rinse See footnote ** Variable 4 (sterile water)
Dry See footnote ** Variable 1 (sterile air
purge)
GERMICIDAL AGENTS
Types used 2% peracetic acid, 2% peracetic acid, Peracetic acid
2% glutaraldehyde, 2% glutaraldehyde, (active ingredient)
5% formaldehyde 5% formaldehyde
Heater Optional No Yes

Temp range, C Not specified NA 50-56 (standardized)
WATER SUPPLY As delivered to ma- As delivered to ma- Potable tap water,

chine; bacteria chine; bacteria filtered
filters available filters available ***
Temperature
requirements, C Ambient Ambient 43-48

DETERGENT LOADING Automatic Manual See footnote
RESERVOIR VOLUME,
L (gal) 2, each 25 (6.6) 15 (4) NA
MANUAL AIR
CAPABILITY Yes Yes No
DOCUMENTATION Standard printer and Optional printer Printer

resident database in
PC
AUTODISINFECTION Overnight automatic Self-disinfection Sterilizes all fluid
program includes trailing pathways during each
lines cycle
AVAILABLE CHEMICAL
PROCESS INDICATORS None (proprietary None (proprietary Chemical indicator
indicators from indicators from strips, biological
chemical supplier chemical supplier monitor kits
recommended) recommended)

* Flexible scope tray (usable dimensions) are 53 x 50 cm (21 x 19.7 in). two pages covering
** All times programmable using IBM or PC controller. the above model(s).
*** Use of sterile bags with program control optional. These specifications
Sterilant is housed in a prepackaged, premeasured container. continue onto the

next page.

MODEL PLADE PLADE STERIS
PLADE 2004R SELECTA 2000 Mobile STERIS SYSTEM 1

PROCESSOR
SCOPE COMPATIBILITY All flexible All flexible All leading
and rigid scopes and rigid scopes manufacturers
OVERALL SIZE,
H x W x D, cm (in) 235 x 112 x 98 105 x 96 x 54 81.3 x 96.5 x 61
(92.5 x 44.1 x 38.6) (41.3 x 37.8 x 21.3) (32 x 38 x 24)
WEIGHT, kg (lb) ~250 (551.2) * 50 (110.3) * 68 (150)
POWER REQUIREMENTS,
VAC 220-240, 50 Hz 220-240, 50 Hz 120, 20 A
PLANNING & PURCHASE

List price ~$60,000 ** $24,000 ** $16,200 ***
Warranty 1 year 1 year 1 year, parts/labor
Delivery time, ARO 6 weeks 4 weeks Immediately
Service contract 10% of new machine 10% of new machine $1,995 after
value per year value per year warranty
Training w/purchase 2 days on-site 2 days on-site 2 days at STERIS,
operator training

available on-site
Year first sold 1993 1995 1988
Number installed
USA NA NA >16,000
Worldwide ~30 ~60 >20,000
Fiscal year April to March April to March April to March
OTHER SPECIFICATIONS Integral fume Chemical transfers Meets requirements

containment and carried out under of UL.
filtration system vacuum using an
for operator pro- integral fume
tection. Approved by filtration system
the Hospital for maximum protec-
Infection Research tion of the
Laboratory. operator.

* Weights vary depending on fitted components and the working conditions of the machine.
** Prices of the machines vary depending on the chemical used for disinfection.
*** Price includes 2 cases of sterilant (20 single-use containers per case). Additional sterilant costs $99 per case.
Or Web-based training.

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November 2001

Flexible Endoscope Reprocessors, Automatic

226193 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA

Reported problems The type of disinfectant/sterilant the unit can ac-

Total Capital Costs = $32,781 Stage of development

Contributions to overhead Babb JR, Bradley CR. Endoscope decontamination:

BHT Lancer UK Ltd [391354]

Pauldrach STERIS Singapore [320749]

Product Comparison Chart

Automatic Endoscope WD 420 INNOVA E 2 INNOVA E 3

FDA CLEARANCE Yes Submitted No Submitted

SCOPES PER CYCLE 1 or 2 1 or 2 1 1 or 2

CYCLE TIME, min

Heater Yes Yes Yes Yes

DOCUMENTATION Identification Optional printer, Optional printer Printer and optional

Colons separate data on similar models of a device. This is the first of

Product Comparison Chart

Automatic Endoscope WD 420 INNOVA E 2 INNOVA E 3

Warranty 1 year, parts/labor 1 year 1 year 1 year

Service contract Not specified Available Available Available

Training w/purchase On-site Full service with Included Included

OTHER SPECIFICATIONS Large basin Microprocessor Stainless steel; Stainless steel;

Colons separate data on similar models of a device.

Product Comparison Chart

WATER SUPPLY Tap, filtered at 5 Tap, filtered at 5 UV-sterilized water Multistage

DETERGENT LOADING Manual Automatic Automatic Semiautomatic w/full

DOCUMENTATION Printer; database Printer; database Possible printer Printer

AUTODISINFECTION Yes Yes Yes Fully automatic

Colons separate data on similar models of a device. This is the first of

Preset based on chemical and scope compatibility. continue onto the

Product Comparison Chart

PLANNING & PURCHASE

Service contract Available Available ~$2,664/year Depends upon

Year first sold 1980 1980 Not specified 1999

Colons separate data on similar models of a device.

Product Comparison Chart

Autoscope F4 Autoscope Guardian Autoscope Guardian Autoscope RF2

DISINFECT/STERILIZE Both Both Both Both

SCOPES PER CYCLE 1 or 2 per tray 1 or 2 1 or 2 1 or 2 and/or selec-

WATER SUPPLY Multistage Multistage Multistage Multistage

DOCUMENTATION Printer Printer, smart card Printer, smart card Printer

AUTODISINFECTION Fully automatic Fully automatic Fully automatic Fully automatic

Colons separate data on similar models of a device. This is the first of

Product Comparison Chart

Autoscope F4 Autoscope Guardian Autoscope Guardian Autoscope RF2

PLANNING & PURCHASE

Year first sold 1999 2001 2001 1999

Colons separate data on similar models of a device.

Product Comparison Chart

WHERE MARKETED Asia, Australasia, Europe Asia, Australia, Asia, Australia,

WATER SUPPLY Multistage Filtered; Prefiltered tap, Tap, sterile

DETERGENT LOADING Semiautomatic w/full Automatic dosing Automatic Automatic

AUTODISINFECTION Fully automatic Yes Chlorine and Yes

Colons separate data on similar models of a device. This is the first of

Product Comparison Chart

Delivery time, ARO 4-6 weeks 8 weeks 4 weeks 8-12 weeks

Year first sold 1999 1994 1994 1994

Colons separate data on similar models of a device.

Product Comparison Chart

DSD by MediVators MV-1 by MediVators MV-2 by MediVators SSD by MediVators

FDA CLEARANCE Yes Yes Yes Yes

CYCLE TIME, min

Heater Yes Yes Yes Yes

DETERGENT LOADING Automatic Manual Manual Automatic