IEC 60601 Dermátomos

rIIII
·1tiIIt
CB TEST CERTIFICATE
CERTIFICAT D'ESSAI OC
Product
Produit
Name and address of the applicant

Nom et adresse du demandeur
Name and address of the manufacturer

Nom et adresse du fabricant
Name and address of the factory

Nom et adresse de I'usine
Rating and principal characteristics

Valeurs nomina/es et caraeteristiques prineipales
Trademark (if any)

Marque de fabrique (si elle existe)
Model IType Ref.

Ref. de type
Additional information (if necessary)

Information eomplementaire (si necessaire)
A sample of the product was tested and found

to be in conformity with
Un echantiflon de ee produit a ete essaye et a etB
considere conforme a /a
as shown in the Test Report Ref. No.

which forms part of this Certificate
comme indique dans Ie Rapport d'essais numero
de reference qui constitue partie de ce Certificat
This CB Test Certificate is issued by the National Certification Body

Ce Certificat d'essai OC est etabJi par I'Organisme National de Certification
Issue Date: 2005-01-10 Page 1 of 1 Report Reference # E181905-A1-CB-1
I -
COVER PAGE FOR TEST REPORT

Test Item Description: Electric Dermatome - Skin Grafting Instrument
ModellType Reference: Electric Dermatome
Rating(s): 100 - 240 V, 50/60 Hz, 150 VA
Standards: IEC 60601-1 :1988 + Ai :1991 + A2:1995
Applicant Name and ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
Address: 200 W OHIO AVE
PO BOX 569
DOVER OH 44622
Factory Location(s): ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
200WOHIOAVE
PO BOX 569
DOVER OH 44622
This Report includes the following parts, in addition to this cover page:
1. Specific Technical Criteria
2. Clause Verdicts
3. Critical Components
4. Test Results
5. Enclosures
a. National Differences
b. Collateral
c. Phbtographs
d. Diagrams
e. Manuals
f. Miscellaneous
g. Licenses
All applicable tests according to the above standard(s) have been carried out.
Test results are valid only for the tested equipment.
This Test Report can be reproduced only in whole.
Amendments and corrections can be reproduced only with the original CB Test Report.
Written permission from Underwriters Laboratories Inc. is required if the test report is ccpied in part.
Copyright © 2002 Underwriters Laboratories Inc.
Underwriters Laboratories Inc.

Issue Date: 2005-01-10 Page 1 of46 Report Reference # E181905-A1-CB-1
TEST REPORT
IEC 60601-1
Medical Electrical Equipment
Part 1: General requirements for safety
Report Reference No ......................: E181905-A1-CB-1
Compiled by (+ signature) ...............,: Alex Grob

~ -
~_.,r;:,-
Reviewed by (+ signature) ...............: Stephen T. Gardner
Date of issue ....................................: 2005-01-10
CB Testing Laboratory ..................: Underwriters Laboratories Inc.
Address ............................................: 333 Pfingsten Road, Northbrook, IL, 60062-2096, USA
Testing location/procedure ............... : CBTL [x] SMT [ ] TMP [] WMT [ ]
Address ............................................: Underwriters Laboratories Inc. 333 Pfingsten Road, Northbrook, IL,
60062-2096, USA
Applicant's name ............................ ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
200 W OHIO AVE
Address ............................................ : PO BOXS69
DOVER OH 44622
Test specification:
Standard ........................................... IEC 60601-1:1988 + A1:1991 + A2:199S
Test procedure ................................. : CBScheme
Non-standard test method ................ N/A
Test Report Form No. ....................... IEC60601 1C/97-04
-
TRF originator ..................................: Underwriters Laboratories Inc.
Master TRF ......................................: dated 97-04
Copyright © 2001 IEC System for Conformity Testing and Certification of Electrical Equipment
(IECEE), Geneva, Switzerland. All rights reserved.
This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is
acknowledged as copyright owner and source of the material. IECEE takes no responsibility for and will not
assume liability for damages resulting from the reader's interpretation of the reproduced material due to its
placement and context.
Test item description ....................... : Electric Dermatome - Skin Grafting Instrument
Trade Mark .......................................: ~
znn:UJ!.e:r
ModellType reference ......................: Electric Dermatome
Manufacturer ....................................: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
200 W OHIO AVE
PO BOXS69
TRF No.: IEC60601_1C Underwriters Laboratories Inc. TRF originator: UL

DOVER OH 44622
Rating , : 100 -240 V, 50/60 Hz, 150 VA
Marking Plate - Refer to Enclosure tilled Miscellaneous for copy.
GENERAL INFORMATION
Test item particulars (see also clause 5):
Classification of installation and use .......................... : Portable
Supply connection...................................................... : Appliance coupler
Accessories and detachable parts included in the
evaluation ...................................................................: Detachable Handpiece
Options included ........................................................ : None
Possible test case verdicts:
- test case does not apply to the test object .............. N/A
- test object does meet the requirement ................... : P(Pass)
- test object does not meet the requirement ............. : F(Fail)
Abbreviations used in the report:
- normal condition ............................................. N.C. - single fault condition ................. : S.F.C.
- operational insulation ..................................... : OP - basic insulation ......................... : BI
- basic insulation between parts of opposite BOP - supplementary insulation .......... SI
polarity:
- double insulation ....................................,.,..... : DI - reinforced insulation ................. : RI
General remarks:
This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and
appended to a CB Test Certificate issued by a NCB in accordance with IECEE 02.
The test results presented in this report relate only to the object tested.
This report shall not be reproduced, except in full, without the written approval of the Issuing testing
laboratory.
List of test equipment must be kept on file and be available for review.
"(see Enclosure #)" refers to additional information appended to the report.

"(see appended table)" refers to a table appended to the report.
Throughout this report a point is used as the decimal separator.
General Product Information:
Report Summary
All applicable tests according to the referenced standard(s) have been carried out.

Issue Date: 2005-01-10 Page 3 of 46 Report Reference # E181905-A1~CB-1
Product Description
The Electric Dermatome is an electricaJly-powered surgical skin grafting instrument. The thickness control
adjustment ranges from 0 to 0.030 in. (0.75 mm) in 0.002 in. (0.050 mm) increments.
Individual graft widths of 1 in., 1.5 in., 2 in., 3 in., and 4 in. (2.5 em, 3.8 em, 5.1 cm, 7.6 em, 10.2 cm) are
obtained with five width plates. Two stainless steel machine screws secure the plates to the underside of the
instrument.
Model Differences
N/A
Additional Information
This report does not include the investigation of the power supply. A test report for the power supply may be
required when submitting this CB Test Report to a National Certification Body (NCB) for obtaining
certification at a national level.
All markingnabeling were reviewed in English - alternate language versions may be required when submitting
this CB Report to an NCB for abtaining certification at a national level.
This product has been evaluated for use in a maximum ambient temperature of 31"C.
Technical Considerations
The product was investigated to the following IEC 60601-1, IEC 60601-1-2, EN 60601-1: 1990 +
additional standards: Ai :1993 + A2:1995 + A13:1996 , CAN/CSA C22.2
No. 601.1-M90 (R1997), CAN/CSA C22.2 No.
601.1S1-94, and CAN/CSAC22.2 No. 601.1B-98
(National Differences for Canada)
The product was not investigated to the following Clause 52.1, Programmable Electronic Systems (IEC
standards or clauses: 601-1-4), Clause 48, Biocompatibility (ISO 10993-1)
The product is Classified only to the following Casualty Fire Shock
hazards:
The degree of protection against harmful ingress of Ordinary
water is:
The following accessories were investigated for use None
with the product:
The mode of operation is: Continuous
Software is relied upon for meeting safety No
requirements related to mechanical, fire and shock:
The product is suitable for use in the presence of a No
fiammable anesthetics mixture with air or oxygen or
with nitrous oxide:


IEC 60601
Clause IRequirement + Test IResult - Remark IVerdict
3 GENERAL REQUIREMENTS Pass

3.1 Equipment when transported, stored, installed, Pass
operated in normal uSe and maintained according
to the instructions of the manufacturer, causes no
safety hazard which could reasonably be foreseen
and which is not connected with its intended
application in normal condition (N.C.) and in single
fault condition (S.F.C.)
3.4 An altemative means of construction is used to that N/A
detailed in this standard and it can be
demonstrated that an equivalent degree of safety is
obtained
5 CLASSIFICATION Pass
5.1 Type of protection against electric shock Pass
Class I equipment Pass
Class II equipment N/A
Intemally powered equipment N/A
5.2 . Degree of protection against electric shock Pass
Type B applied part N/A
Type BF applied part Pass
Type CF applied part N/A
Not classified - no applied parts N/A
5.3 Classification according to the degree of protection Ordinary Equipment N/A
against ingress of water as detailed in the current
edition of IEC 529 (see 6.1.1 )................................ :
5.4 Methods of sterilization or disinfection See Manual Attachment Pass
5.5 Equipment not suitable for use in the presence of Pass
fiammable mixtures
Category AP equipment N/A
Category APG equipment N/A
5.6 Mode of operation: Pass
-continuous operation Pass
-short-time operation, specified operation; period. :
-intermittent operation, specified operation; rest
period ....................,................................................ :

IEC 60601
-continuous operation with short-time, stated

permissible loading time :
-continuous operation with intermittent, stated
permissible loadinglrest time :
TRF No.: JEC60601_1C Underwriters Laboratories Inc. TRF originator: UL

IEC 60601
Clause IRequirement + Test I Resu It - Remark IVerdict
INSULATION DIAGRAM

Issue Date: 2005-01-10 Page 8 of 46 Report Reference # E181 905-A1-CB-1
IEC 60601
Clause IRequirement + Test IResuIt - Remark IVerdict
ITABLE: to insulation diagram I
lnsulalion twa: Referemr: Required Requffied Measured: flJ!easur€d "
Area Qpera'tional {basic e '\!oltage creepage clearance' 13reepage clearance

R€marks
1'Suppfementary I ,(\1) (mm) (mm) tmm) tmm)
dQuble {reinfQrce:d
A BOP 240 3.0 1.6 10 10
B BI 240 4.0 2.5 4.0 4.0

C 01 240 8.0 5.0 Provided by power supply
o DllBI 15/240 3.4/4.0 1.6/2.5 12.0 12.0

E OP
INSULATION DIAGRAM CONVENTIONS
Insulation diagram is a graphical representation of equipment insulation barriers, protective impedanr:e and
protective earthing. If feasible, use the following mnventions to generate the diagram:
1. All isolation barriers are identified by lelters between separate parts of diagram, for example separate
transformer windimgs, optocouplers, wire insulation, creepage and clearance distances.
2. Parts connected to earth with large dots are protectively earthed. Other connections to earth are
functional.
3. Applied parts are extended beyond the equipment enclosure and terminated with an arrow.
4. Parts accessible to the operator only are extended outside of the enclosure, but are not terminated with
an arrow.
5. Blocks mntaining the lelter "Z" indicate protective impedance.
6. Operational Insulation (OP) - indicates insulation that may be required for function of the equipment,
but is not required or relied on fQr compliance with the requirements of clauses 17, 20 and 57.
TRF No.: IEC60601 1C Underwriters Laboratories Inc. TRF originator: UL

Issue Date: 2005-01-10 Page 9 Of 46 Report Reference # E181905-A1-CB-1
IEC 60601
6 IDENTIFICATION, MARKING AND DOCUMENTS Pass

6.1 Marking on the outside of equipment or equipment parts Pass
6.1c Markings of the specific power supply affixed N/A
6.1d If marking is not practicable due to size or nature of N/A
enclosure, information is included in accompanying
documents
6.1e Name and/or trademark of the manufacturer or See Cover Page Pass
supplier .................................................................. :
6.1f Model or type reference...................................,..... : Electric Dermatome Pass
6.1g Rated supply voltages or voltage range(s) Pass
Number of phases ................................................. : Single Pass
Type of current ...................................................... : ac Pass
6.1h Rated frequency or rated frequency range(s) (Hz): 50/60 Hz Pass
6.1j Rated power input 0!A, W or A) ............................ : 150 VA Pass
6.1k Power output of auxiliary mains socket - outlets N/A
6.11 Class II symbol N/A
Symbol for degree of protection against ingress of ordinary equipment N/A
water provided ....................................................... :
Symbol for protection against electric shock ......... : Class I Pass
If equipment has more than one applied part with N/A
different degrees of protection, the relevant
symbols are clearly marked on such applied parts,
or on or near reievant outlets
Symbol for protection of defibrillation-proof applied N/A
parts
Symbol 14 from Table DI for defibrillation-proof with N/A
protection partly in patient cable
6.1m Mode of operation 0f no marking, suitable for Continuous - not marked Pass
continuous operation)
6.1n Types and rating of external accessible fuses ...... : 250 V, T 800 mA Pass
6.1p Ratings of external output: ..................................... : N/A
6.1q Symbol for physiological effect(s): Pass
- attention, consult accompanying documents Pass
- non-ionizing radiation, or symbols as adopted by N/A
ISO or IEC 417
6.1r Anaesthetic-proof symbol: AP or APG .................. : N/A

IEC 60601
Clause IRequirement + Test IResult - Remark !Verdict
6.1s Dangerous voltage symbol N/A

6.11 Special cooling requirements N/A
6.1u Limited mechanical stability N/A
6.1v Protective packing requirement(s) Pass
- Marking(s) for unpacking safety hazard(s) N/A
- Equipment or accessories supplied sterile, Cutting blades Pass
marked as sterile
6.1y Potential equalization terminal Pass
- Functional earth terminal N/A
6.1z Removable protective means N/A
Durability of marking test Pass
6.2 Marking on the inside of equipment or equipment parts Pass
6.2a Nominal voltage of permanently installed N/A
equipment
6.2b Maximum power loading for heating elements or N/A
holders for heating lamps
6.2c Dangerous voltage symbol N/A
6.2d Type of battery and mode of insertion N/A
- Marking referring to accompanying documents N/A
used for battery not intended to be changed by the
operator
6.2e Fuses accessibie with a tool identified either by Pass
type and rating or by a reference to diagram
6.2f Protective earth terminal Pass
6.2g Functional earth terminal N/A
62h Su pply neutral conductor in permanently installed N/A
equipment (N)
6.2j Markings required in 6.2 I), h), k), and I) remain Pass
visible after connection and are not affixed to parts
which have to be removed
- Markings comply with IEC 445 Pass
6.2k For permanently connected devices the supply N/A
connections are clearly marked adjacent to the
terminals (or in accompanying documents for small
equipment)

IEC 60601
6.21 Statement for suitable wiring materials at N/A

temperatures over 75°C
6.2n Capacitors and/or circuit parts marked as required N/A
In Sub-clause 15c
6.3 Marking of controls and Instruments Pass
6.3a Mains switch clearly identified Pass
- ON and OFF positions marked according to Pass
Symbols 15 and 16 of table D1 or indicated by an
adjacent indicator light
6.3b Indication of different positions of control devices Pass
and switches
6.3c Indication of the direction in which the magnitude of N/A
the function changes, or an indicating device
6.3f The functions of operator controls and indicators Pass
are identified
6.3g Numeric indications of parameters are in SI units N/A
except for units listed In Am. 2
6.4 Symbols Pass
Used symbols comply with Appendix D or IEC 417 Pass
and/or IEC 878 or ISO publications (if applicable)
6.5 Colors of the insulation of conductors Pass
6.5a Protective earth conductor has green/yellow Pass
Insulation
6.5b All insulations of intemal protective earth Pass
conductors are green/yellow at least at their
terminations
6.5c Only protective or functional earthing, or potential Pass
equalization conductors are green/yellow
6.5d Color of neutral conductor ..................................... : Blue Pass
6.5e Colors of phase conductor(s) ................................ : Brown Pass
- Compliance with IEC 227 and IEC 245 Pass
6.5f Additional protective earthing in multi-conductor, N/A
cords are marked green/yellow at the ends of the
additional conductors
6.6 Medical gas cylinders and connections N/A
6.6a In accordance with ISO ISO/R 32 N/A
6.6b Identification of connection point N/A
6.7 Indicator lights and push-buttons Pass
TRF No.: IEC60601_1 C Underwriters Laboratories Inc. TRF originator: UL

1-'
IEC 60601
Clause \Requirement + Test I Result - Remark IVerdict
6.7a Red indicator lights used exclusively to indicate a N/A

warning of danger and/or a need for urgent action
- Yeliow used to indicate caution or attention N/A
required
- Green used to indicate ready for action Pass
6.7b Color red used only for push-buttons by which a N/A
function is interrupted in case of emergency
6.8 ACCOMPANYING DOCUMENTS Pass
6.8.1 Equipment accompanied by documents containing Pass
at least instructions for use, a technical description
and an address to which the user can refer
Classifications specified in Clause 5 inciuded in Pass
both the instructions for use and the technical
description
Markings specified in Sub-ciause 6.1 included in Pass
the accompanying documents if they have not
been permanently affixed to equipment
Warning statements and the explanation of warning Pass
symbols provided in the accompanying documents
6.8.2 Instructions for use Pass
6.8.2a General information provided in instructions for use Pass
- state the function and intended application of the Pass
equipment
- include an explanation of: the function of controls, Pass
displays and signals
- the sequence of operation Pass
- the connection and disconnection of detachable Pass
parts and accessories
- the replacement of material which is consumed N/A
during operation
- information regarding potential electromagnetic or Pass
other interference and advice regarding avoidance
- include: indications of recognized accessories, Pass
detachable parts and materials, if the use of other
parts or materials can degrade minimum safety
- instructions concerning cleaning, preventive Pass
inspection and maintenance to be performed
including the frequency of such maintenance
General information provided in instructions: Pass

IEC 60601
- information for the safe performance or routine Pass

maintenance
- parts on which preventive inspectiDn and Pass
maintenance shall be performed by other persons
including the periods to be applied
- explanation of figures, symbDls, waming Pass
statements and abbreviations on the equipment
6.8.2c Signal Dutput or signal input parts intended only for N/A
connection to specified equipment described
6.8.2d Details about acceptable cleaning, disinfection or Pass
sterilization methods included
6.8.2e Warning statement for mains operated equipment N/A
with additional power source
6.8.2f A warning to remove primary batteries if equipment N/A
is not likely to be used fDr some time
6B.2g Instructions to ensure safe use and adequate N/A
maintenance of rechargeable batteries
6.8.2h Identification of specified external power supplies N/A
or battery chargers necessary to ensure
compliance with the requirements of IEC 601-1
6B.2j Identification of any risks associated with the Pass
disposal of waste products, residues, etc.
- Advice in minimizing these risks Pass
6.8.3 Technical description Pass
6.8.3a All characteristics essential for safe operatiDn Pass
prDvided
6.8.3b Required type and rating Df fuses utilized in the N/A
mains supply circuit external tD permanently
installed equipment
- InstructiDns fDr replacement Df interchangeable Pass
and/Dr detachable parts which are subject tD
deteriDratiDn during nDrmal use
6.8.3c InstructiDns Dr reference infDrmation for repair of N/A
equipment parts designated by the manufacturer
as repairable provided
6.8.3d Environmental conditions for transpDrt and stDrage Page 8 of the manual Pass
specified in accDmpanying dDcuments and marked
Dn packaging
TRF ND.: IEC60601_1C Underwriters LabDratDries Inc. TRF DriginatDr: UL

IEC 60601
7 POWER INPUT Pass

Power Input Measurements I Pass
10 ENVIRONMENTAL CONDITIONS Pass

10.1 Equipment is capable while packed for transport or Pass
storage of being exposed to the conditions stated
by the manufacturer
10.2.2a Rated voltage not exceeding 250 V for hand-held Hand piece Pass
equipment
Rated voltage not exceeding 250 V d.c. or single- Pass
phase a.c. or 500 V polyphase a.C. for equipment
up to 4kVA
Rated voltage not exceeding 500 V for all other N/A
equipment
Rated input frequency not more than 1kHz Pass
10.2.2b Internal replaceable electrical power source N/A
specified
14 REQUIREMENTS RELATED TO CLASSIFICATION Pass

14.4a Class I and Class II equipment in addition to basic Pass
insulation provided with an additional protection
14.4b Equipment supplied from external dc source of N/A
reverse polarity results in no safety hazard
14.5a Duai classification for internally powered equipment N/A
with a means of connection to supply mains
14.5b Internally powered equipment complies with N/A
requirements for Class I or Class II equipment
while connected to supply mains, and with
requirements for internally powered equipment
when not connected
14.6c Applied parts intended for direct cardiac application N/A
are of type CF
TRF No.: IEC60601 1C Underwriters Laboratories inc. TRF originator: UL

IEC 60601
15 LIMITATION OF VOLTAGE AND/OR ENERGY Pass

15b Voltage measured one sec after disconnection of Pass
the mains plug does not exceed 60V
15c For live parts accessible after equipment has been N/A
de-energized the residual voltage does not exceed
60 V nor residual energy exceed 2 mJ
Marking provided for manual discharging N/A
16 ENCLOSURES AND PROTECTIVE COVERS Pass

16a Equipment enclosed to protect against contact with Pass
live parts, and with parts which can become live
(finger, pin, hook test)
Insertion or removal of lamps - protection against N/A
contact with live parts provided
16b Opening in a top cover positioned that accessibility N/A
of live parts by a test rod is prevented
16c Conductive parts accessible after the removal of handles, knobs, levers N/A
- have a resistance of not more than 0.2 Ohm N/A
- separated from live parts by one of the means N/A
described in Sub-clause 17g
16d Parts with voltage exceeding 25V a.c. or 60V d.c. N/A
which cannot be disconnected by external mains
switch or plug protected against contact
16e Removable enclosures protecting against contact with live parts Pass
- Removal possible only with the aid of a tool Pass
- Use of automatic device making parts not live N/A
when the enciosure is opened or removed
- Exception 16e applied to the following parts ....... : N/A
16f Openings for the adjustment of controls using a N/A
tool. The tool not able to touch basic insulation or
any live parts

IEC 60601
17 SEPARATION Pass
17a Separation method of the applied part from live parts: Pass
1) basic insulation: applied part earthed N/A
2) by protectively earthed conductive part (e.g. N/A
screen)
3) by separate earthed intermediate circuit limiting N/A
leakage current to applied part in event of
insulation failure
4) by double or reinforced insulation Pass
5) by protective impedances limiting current to N/A
applied part
- Additional leakage current test in single fault N/A
conditions
17c There is no conductive connection between applied Accesible conductive parts are N/A
parts and accessible conductive parts which are double insulated from earth
not protectively earthed within the equipment
17d Supplementary insulation between hand-held N/A
flexible shafts and motor shafts (Class I)
17g Separation method of accessible parts other than applied parts from live parts: Pass
1) basic insulation: accessible part earthed Enclosure Pass
2) by protectively earthed conductive part (e.g. N/A
screen)
3) by separate earthed intermediate circuit limiting N/A
leakage current to enclosure in event of insulation
failure
4) by double or reinforced insulation N/A
5) by protective impedances limiting current to N/A
accessible part
- Additional leakage current test in single fault N/A
conditions
17h Arrangements used to isolate defibrillation-proof applied parts so designed that: N/A
- no hazardous electrical energies appear during a N/A
discharge of a cardiac defibrillator
- after exposure to the defibrillation voltage, the N/A
equipment continues to perform its intended
function
TRF No.: IEC6060t 1C Underwriters Laboratories Inc. TRF originator: UL

IEC 60601
18 PROTECTIVE EARTHING, FUNCTIONAL EARTHING AND POTENTIAL Pass

EQUALIZATION
18a Accessible parts of Class I equipment separated Pass
from live parts by basic insulation connected to the
protective earth terminal
18b Protective earth terminals suitable for connection to Pass
the protective earth conductor
18e Potential equalization conductor Pass
- Readily accessible Pass
- Accidental disconnection prevented in normal use Pass
- Conductor detachable without the use of a tool Pass
- Power supply cord does not incorporate a Pass
potential equalization conductor
- Connection means marked with Symbol 9, Pass
Table 01
18f For equipment without power supply cord, N/A
impedance between protective earth terminal and
accessible metal part <= 0.1 Ohm
- For equipment with an appliance inlet, impedance Pass
between protective earth contact and any
accessible metal part <= 0.1 Ohm
- For equipment with a non-detachable power N/A
supply cord, impedance between protective earth
pin in mains plug and accessible metal part <= 0.2
Ohm
18g If the impedance of protective earth connections N/A
other than in CI. 18 f) exceeds 0.1 Ohm, the
allowable value of the enclosure leakage current is
not exceeded in single fault condition
18k Functional earth terminal not used to provide Pass
protective earthing
181 Class II equipment with isolated internal screens N/A
- insulation of screens and all internal wiring N/A
connected to them is double insulation or
reinforced insulation
- functional earth terminal clearly marked N/A
- explanation of functional earth terminal provided N/A
in the accompanying documents

IEC 60601
19 CONTINUOUS LEAKAGE CURRENTS AND PATIENT AUXILIARY CURRENTS Pass

19.1b Leakage currents Pass
- earth leakage current Pass
- enclosure leakage current Pass
- patient leakage current Pass
- patient auxiliary current N/A
20 DIELECTRIC STRENGTH Pass

Overall compliance with Clause 20 Pass
I
21 MECHANICAL STRENGTH Pass

21a Sufficient rigidity of an enclosure tested by: Pass
force of 45 N
21b Sufficient strength of an enclosure tested by: Pass
impact hammer
21c On portable equipment carrying handles or grips Pass
withstand the requirements of the loading test
21.3 No damage to parts of patient support and/or N/A
immobilization system after the loading test
21.5 Hand held equipment or equipment parts are safe Handpiece Pass
after drop test
21.6 Portable and mobile equipment is able to withstand Pass
rough handling

IEC 60601
22 MOVING PARTS . Pass

22.2a Moving parts of a transportable equipment are N/A
provided with guards which form an integral part of
the equipment
22.2b Moving parts of a stationary equipment are N/A
provided with similar guards as above, unless it is
evident that equivalent protection is separately
provided during installation
22.3 Cords (rOpes), chains and bands are provided with N/A
guides to prevent them from running off or from
jumping out of their guiding devices
Guides or other safeguards are removable only N/A
with a tool
22.4 Dangerous movements of equipment parts, which Pass
may cause physical injury to the patient, are
possible only by the continuous activation by the
operator
22.6 Parts of equipment subject to mechanical wear are Cutting blades Pass
accessible for inspection
22.7 Means provided for emergency switching of an N/A
electrically produced mechanical movement which
could cause a safety hazard
The means for emergency switching is readily N/A
identifiable and accessible and does not introduce
a further safety hazard
Devices for emergency stopping able to break the N/A
full load current of the relevant circuit, taking into
account possible stalled motor currents
Means for stopping of movements operate as a N/A
result of one singie action
23 SURFACES, CORNERS AND EDGES Pass

Rough surfaces, sharp corners and edges which Pass
may cause injury or damage avoided or covered I

IEC 60601
24 STABILITY IN NORMAL USE (see appended table 24) Pass

24.1 Equipment does not overbalance during normal Pass
use when tilled through an angle of 10 0
24.3 Equipment overbalances when tilted through an angle of 10 0 N/A
- does not overbalance when tilted through an N/A
angle of 50 in any position excluding transport
- carry a warning notice stating that transport N/A
should only be undertaken in a certain position
- in the position specified for transport does not N/A
overbalance when tilted to an angle of 100
24.6a Equipment or its parts with a mass of more than 20 kg is provided with: N/A
- suitable handling devices (grips etc.), or N/A
- instructions for lifting and handling during N/A
assembly
24.6b On portable equipment with a mass of more than N/A
20 kg canrying handle(s) is (are) so situated that
equipment may be carried by 2 or more persons
25 EXPELLED PARTS N/A

25.1 Protective means are provided where expelled N/A
parts of the equipment could be a hazard
25.2 Display vacuum tubes with a face dimension N/A
exceeding 16 em are provided with adequate
protection against implosion

IEC 60601
28 SUSPENDED MASSES N/A

28.3 Suspension system with safety device N/A
Safety device provided where the integrity of a N/A
suspension depends on parts which may have
hidden defects, or on parts having safety factors
not complying with Sub-clause 28.4
Safety device has safety factors complying with N/A
Sub-clause 28.4.2
Clear indication to the operator that the safety N/A
device has been activated after failure of
suspension means
28.4 Suspension systems of metal without safety devices N/A
1) Total load does not exceed the safe working N/A
load
2) Safety factors not less than 4 where it is unlikely N/A
that supporting characteristics will be impaired
3) Safety factors not less than 8 where impairment N/A
is expected
4) Safety factors muitiplied by 1.5 for metal having N/A
an elongation at break of less than 5%
5) Sheaves, sprockets, band wheels and guides so N/A
constructed that the safety factors maintained till
replacement
29 X-RADIATION N/A
29.2 EQUIPMENT not intended to produce X-radiation N/A
produces an exposure <= 130 nC/kg (0.5 mR) I
36 ELECTROMAGNETIC COMPATIBILITY Pass

Equipment complies with IEC 601-1-2 ISee Enclosure Collateral Pass
37 COMMON REQUIREMENTS FOR CATEGORY AP AND CATEGORY APG N/A

EQUIPMENT
Requirements for category AP and APG equipment I N/A
(CI. 37 -41)

Issue Date: 2005-01-10 Page 22 of46 Report Reference # E181 905-A1-CB-1
IEC 60601
Clause 1Requirement + Test IResuit - Remark IVerdict
42 EXCESSIVE TEMPERATURES Pass

42.1 Equipment does not attain temperatures exceeding Pass
the values given in Tabie Xa over the range of
ambient temperatures per Ciause 10.2.1
42.2 Equipment does not attain temperatures exceeding Pass
the values given in Table Xb at 25'C ambient
42.3 Applied parts not intended to supply heat have Pass
surface temperatures not exceeding 41'C
42.5 Guards to prevent contact with hot surfaces N/A
removable only with a tool
43 FIRE PREVENTION Pass

Strength and rigidity necessary to avoid a fire Pass
hazard I
44 OVERFLOW, SPILLAGE, LEAKAGE, HUMIDITY, INGRESS OF LIQUIDS, Pass

CLEANING, STERILIZATION AND DISINFECTION
44.2 Equipment contain a liquid reservoir: N/A
- the equipment is electrically safe after 15% overfill N/A
steadily over a period of 1 min
- transportable equipment is electrically safe after N/A
additionally having been tilted through an angle of
15' in the least favorable direction(s) (if necessary
with refilling)
44.3 Electrical properties of the equipment do not N/A
change in connection of spillage test (200 ml of
water)
44.4 Liquid which might escape in a single fault N/A
condition does not wet parts which may cause a
safety hazard
44.5 Equipment sufficiently protected against the effects Pass
of humidity
44.6 Enclosures designed to give a protection against N/A
harmful ingress of water classified according to IEC
Publication 529
44.7 Equipment capable of withstanding cleaning, Pass
sterilization or disinfection without deterioration of
safety provisions

IEC 60601
45 PRESSURE VESSELS AND PARTS SUBJECT TO PRESSURE N/A

45.2 Pressure vessel with pressure volume greater than N/A
200 kPa x I and pressure greater than 50 kPa
withstand the hydraulic test pressure
45.3 Maximum pressure does not exceed the maximum N/A
permissible working pressure for individual parts
45.7 Unless excessive pressure can not occur, N/A
pressure-relief device provided
45.7a a) Pressure-relief device connected as close as N/A
possible to the pressure vessel
45.7b b) Readily accessible for inspection N/A
45.7c c) Not capable of being adjusted or rendered N/A
inoperative without a tool
45.7d d) Discharge opening located that the released N/A
material is not directed towards person
45.7e e) Discharge opening located that operation will not N/A
deposit material which may cause a safety hazard
45.7f f) Adequate discharge capacity to ensure pressure N/A
does not exceed the maximum permissible working
pressure
45.7g g) No shut-off valve between a pressure-relief N/A
device and the parts intended to be protected
45.7h h) Minimum number of cycles of operation: N/A
100.000
48 BIOCOMPATIBILITY N/A
Parts of equipment and accessories intended to Not Evaluated by UL N/A
come into contact with biological tissues, cells or
body fluids are evaluated in accordance with ISO
10993-1

IEC 60601
49 INTERRUPTION OF THE POWER SUPPLY Pass

49.1 Thermal cut-outs and over-current releases with N/A
automatic resetting not used if they may cause a
safety hazard
49.2 Interruption and restoration of power supply does Pass
not result in a safety hazard other than interruption
of intended function
49.3 Means are provided for removal of mechanical N/A
constraints on patient in case of a supply mains
failure
51 PROTECTION AGAINST HAZARDOUS OUTPUT N/A

51.4 Equipment furnishing both low-intensity and high- N/A
intensity outputs provided with means minimizing
possibility of a high intensity output being selected
accidentally

IEC 60601
52 ABNORMAL OPERATION AND FAULT CONDITIONS Pass

52.1 Equipment is so designed and manufactured that Pass
even in single fault condition no safety hazard as
described under 52.4 exists (see 3.1 and CI. 13)
The safety of equipment incorporating N/A
programmable electronic systems is checked by
applying IEC 601-1-4
52.5.2 Failure ofthermostats presents no safety hazards N/A
52.5.3 Short-circuiting of either part of double insulation N/A
presents no safety hazard
52.5.5 Impairment of cooling: No cooling provided N/A
temperatures not exceeding 1.7 times the values
of Clause 42 minus 17.5'C
52.5.6 Locking of moving parts presents no safety hazard Pass
52.5.7 Interruption and short-circuiting of motor capacitors N/A
presents no safety hazard
52.5.8 Duration of motors locked rotor test in compliance 5 sec - continuious activation Pass
with CI. 52.5.8 by the operator only
52.5.9 Failure of one component at a time presents no Pass
safety hazard
52.5.10 Overload of heating elements presents no safety N/A
hazard
52.5.1 Of Motors intended to be remotely controlled, N/A
automatically controlled, or liable to be operated
continuously provided with running overload
protection
52.5.10h Equipment with three-phase motors can safely N/A
operate with one phase disconnected

Issue Date: 2005-01-10 Page 26 of46 Report Reference # E1 S1905-A1-CB-1
IEC 60601
56 COMPONENTS AND GENERAL ASSEMBLY Pass

List of critical cemponents Pass
56.1b Ratings of cemponents not in cenflict with the Pass
cenditions of use in equipment
Ratings of mains components are identified Pass
56.1d Components, movements of which could result in a Pass
safety hazard mounted securely
56.1f Conductors and connectors secured and/or Pass
insulated to prevent accidental detachment
resulting in a safety hazard
56.3a Connectors provide separation required by Sub- N/A
clause 17g
Plugs for cennection of patient circuit leads can not N/A
be connected to other outlets on the same
equipment
Medical gas connections not interchangeable N/A
56.3b Accessible metal parts can not become live when N/A
detachable interconnection cord between different
parts of equipment is loosened or broken
56.3c Leads with cenductive connection to a patient are N/A
constructed such that no conductive connection
remote from the patient can contact earth or
hazardous voltages.
56.4 Connections of capacitors Pass
Not connected between live parts and non- Pass
protectively earthed accessible parts
If connected between mains part and protectively Certified power supply and Pass
earthed metal parts cemply with: appliance filter used
IEC Publication 384-14
Enclosure of capacitors connected to mains part N/A
and providing only basic insulation, is not secured
to non-protectively earthed metal parts
Capacitors or other spark-suppression devices are N/A
not connected between centacts of thermal cut-
outs
56.5 Protective devices which cause disconnection from Pass
the supply mains by producing a short-circuit not
provided in equipment
56.6 Temperature and overload control devices N/A
56.6a Thermal cut-outs which have to be reset by a N/A

IEC 50501
soldering not fitted in equipment

Thermal safety devices provided where necessary N/A
to prevent operating temperatures exceeding the
limits
Audible warning provided where the loss of N/A
function caused by operation of a thermal cut-out
presents a safety hazard
Self-resetting thermal cut-outs and self-resetting N/A
over-current releases operated 200 times
Non-self resetting over-current releases operated N/A
10 times
Independent non-self-resetting thermal cut-out N/A
provided where a failure of a thermostat could
constitute a safety hazard
55.5b Thermostats with varying temperature settings N/A
clearly indicated
Operating temperature of thermal cut-outs N/A
indicated
55.7 Batteries N/A
55.7a Battery compartments: N/A
- adequately ventilated N/A
- accidental short-circuiting is prevented N/A
55.7b Incorrect polarity of connection prevented N/A
55.8 Indicators - unless indication provided by other means (from the normal operation Pass
position), indicator lights are used (color see 5.7):
- to indicate that equipment is energized Mains switch clearly marked Pass
- to indicate the operation of non-luminous heaters N/A
if a safety hazard couid result
- to indicate when output exists if a safety hazard N/A
could result
- charging mode indicator provided N/A
56.10 Actuating parts of controls N/A
56.10b Actuating parts are adequately secured to prevel1t N/A
them from working loose during normal use
Controls are secured to prevent the movemel1t N/A
relative to scale marking (safety related only)
Detachable indicating devices are prevented from N/A
. incorrect connection without the use of tool

IEC 60601
56.10c Stops are provided on rotating controls: N/A

- to prevent an unexpected change from maximum N/A
to minimum or vice versa where this couid produce
a safety hazard
- to prevent damage to wiring N/A
56.11 Cord-connected hand-held and foot-operated control devices Pass
56.11a Contain voltages not exceeding 25 V a.c. or 60 V Pass
d.c. and isolated from the mains part by CI. 17g
56.11b Hand-held control devices comply with the Pass
requirement and test of Sub-clause 21.5
- Foot-operated control devices designed to N/A
support the weight of an adult human being
56.11c Devices not change their setting when N/A
inadvertently placed
56.11 d Foot-operated control devices are at least IPX 1 N/A
- For surgical use, electrical switching parts are IPX N/A
8
56.11e Adequate strain relief at the cord entry provided Pass

IEC 60601
Clause IRequirement + Test IResu It - Remark IVerdict
57 MAINS PARTS, COMPONENTS AND LAYOUT Pass

57.1 Isolation from supply mains Pass
57.1a Equipment provides means to isolate its circuits Pass
electrically from the supply mains on all poles
simultaneously
Means for isolation incorporated in equipment or, if Pass
external, specified in the accompanying documents
57.1d Switches used to comply with Sub-clause 57.1 a N/A
comply with the creepage distances and air
clearances as specified in IEC Publication 328
57.1f Mains switches not incorporated in a power supply Pass
cord
57.1h Appliance couplers and flexible cords with mains Pass
plugs provide compliance with Sub-clause 57.1 a
57.1m Fuses and semiconductor devices not used as Pass
isolating devices
57.2 Mains connectors and appliance inlets Pass
57.2e Auxiliary mains socket-outlets on non-permanently N/A
installed equipment of a type that cannot accept a
mains plug
57.2g Unless functional earth needs to be provided, N/A
Class I appliance inlet is not used in Class II
equipment
57.3 Power supply cords Pass
57.3a Not more than one connection to a particular Pass
supply mains
If alternative supply allowed, no safety hazards N/A
when more than one connection is made
simultaneously
The mains plug has only one power supply cord Pass
Non-permanently connected equipment provided Pass
with power supply cord or appliance inlet
57.3b Power supply cords sufficiently robust to comply Pass
with the requirements of IEC 227, designation 53
and IEC 245, designation 53
Polyvinyl chloride insulated power supply cords not N/A
used for equipment having external metal parts
with a temperature exceeding 75°C
57.3c Nominal cross-sectional area of conductors of Pass
power supply cords not less than in Table XV

IEC 60601
Clause IRequirement + Test I Result - Remark IVerdict
57.3d Stranded conductors not soldered if fixed by any N/A

clamping means
57.4 Connection of power supply cords Pass
57.4a Cord anchorages Pass
Equipment provided with power supply cords has Pass
cord anchorages such that the conductors are
relieved from strain, including twisting
Tying the cord into a knot or tying the ends with Pass
string not used
Cord anchorages made of insulating material or Pass
metal insulated from unearthed accessible metal
parts by supplementary insulation
Cord anchorages made of metal proVided with an Pass
insulating lining
Clamping screws do not bear directly on the cord N/A
insulation
Screws associated with cable replacement are not N/A
used to secure other components
Conductors of the power supply cord arranged that N/A
the protective earth conductor is not subject to
strain as long as the phase conductors are in
contact with their terminals
57.4b Power supply cord protected against excessive Applied part cord Pass
bending
57.4c Adequate space inside equipment to allow the N/A
supply cable conductors to be introduced and
connected
57.5 Mains terminal devices and wiring of mains part N/A
Mains connected equipment other than those with N/A
a detachable supply cord provided with mains
terminals, where connections are made with
screws, nuts or equally effective methods
If a conductor breaks away, barriers are provided N/A
such that creepage distances and air clearances
cannot be reduced
Screws and nuts which clamp external conductors N/A
not serve to fix any other component
57.5b Terminals closely grouped with any protective earth N/A
terminal
Mains terminal devices accessible only with use of N/A
a tool

IEC 60601
Clause IRequirement + Test IResult - Remark jVerdict
Mains terminal devices located or shielded that, N/A

should a wire of a stranded conductor escape
when the conductors are fitted, there is no risk of
accidental contact
57.5c Internal wiring not subjected to stress when the N/A
means for clamping the conductors are tightened
or loosened
57.5d Cord terminals not require special preparation of N/A
the conductor
57.6 Mains fuses and overcurrent releases Pass
Fuses or over-current releases provided Class I - fuses provided in line Pass
accordingly for Class I and Class II and neutral
Current rating Of mains fuses and over-current Pass
releases such that they reliably carry the normal
operating current
Protective earth conductor not fused Pass
Neutral conductor not fused for permanently N/A
installed equipment
57.8 Wiring of the mains part Pass
57.8a Individual conductor in the mains part with Pass
insulation not at least electrically equivalent to that
of the individual conductors of flexible supply cords
complying with IEC Publications 227 or 245,
treated as bare conductor
57.8b Cross-sectional area of conductors up to protective Pass
device not less than the minimum required forthe
power supply cord
Cross-sectional area of other wiring and the sizes Pass
of tracks on printed wiring circuits sufficient to
prevent any fire hazard
57.9 Mains supply transformers NlA
57.9.1 Overheating N/A
External to the transformer protective devices N/A
connected in such a way that failure Of any
component cannot render the protective devices
inoperative
57.9.1a Short-circuit of secondary windings not caused N/A
excessive temperature
57.9.1b Overload of secondary windings not caused N/A
excessive temperature

IEC 60601
57.92 The dielectric strength of the electrical insulation of N/A

a mains supply transformer such that it passes
tests
57.9.4 Construction N/A
57.9.4a Separation of primary and secondary windings N/A
- separate bobbins or formers N/A
- one bobbin with insulating partition N/A
- one bobbin with concentric windings and having N/A
copper screen with a thickness of not less than
0.13 mm
- concentrically wound on one bobbin with windings N/A
separated by double insulation
57.9.4c Means provided to prevent displacement of end N/A
turns
57.9.4d Insulated overlap of not less than 3 mm if a N/A
protective earthed screen has only one turn
57.9.4e Insulation between the primary and secondary in transformers with double N/A
insulation
- 1 insulation layer having a thickness of at least 1 N/A
mm
- at least 2 insulation layers with a total thickness of N/A
at least 0.3 mm
- three layers provided that each combination of N/A
two layers can withstand the dielectric strength test
for reinforced insulation
57.9.4g Exit of the wires of toroidal transformers provided N/A
with double sleeving complying with requirements
for double insulation and having total thickness at
least 0.3 mm extending at least 20 mm outside the
winding
57.10 Creepage distances and air clearances Pass
57.10a Values: Pass
compliance with at least the values of Table XVI
Creepage distances for slot insulation of motors at N/A
least 50% of the specified values
57.10b Minimum creepage distances and air clearances in N/A
the mains part between parts of opposite polarity
not required if short-circuiting does not produce a
safety hazard
57.10c Creepage distances or clearances of at least 4 mm N/A

Issue Date: 2005-01-10 Page 33 of 46 Report Reference # E181905-A1-CB"1
IEC 60601
are maintained between defibrillation-proof applied

parts and other parts
58 PROTECTIVE EARTHING - TERMINALS AND CONNECTIONS Pass

58.1 Clamping means of the protective earth terminal Pass
Not be able to loosen without the aid of a tool Pass
Screws for internal earth connections are covered Pass
or protected against loosening from outside
58.7 Earth pin of the appliance inlet regarded as the N/A
protective earth terminal
58.8 The protective earth terminal not used for the Pass
mechanical connection or the fixing of any
component not related to earthing
58.9 Where the protective earth connections are made N/A
via a plug or socket device the protective earth
connection is made before and interrupted after the
supply connections during connection and
interrupting

IEC 60601
59 CONSTRUCTION AND LAYOUT Pass

59.1 Internal wiring Pass
59.1a Cables and wiring protected against contact with a Pass
moving part
Wiring having basic insulation only protected by N/A
additional fixed sleeving
Components are not likely to be damaged in the N/A
normal assembly or replacement of covers
59.1b Movable leads are not bent around a radius of less N/A
than five times the outer diameter of the lead
59.1c Insulating sleeving adequately secured N/A
If the sheath of a flexible cable or cord is used as N/A
supplementary insulation it complies with
requirements of IEC 227 and IEC 245 and
dielectric test
Conductors subjected to temperatures exceeding N/A
70'C have an insulation of heat-resistant material
59.1d Aluminum wires of less than 16 mm2 cross-section N/A
not used
59.1f Connecting cords between equipment parts Pass
considered as belonging to the equipment
59.2 Insulation Pass
59.2b Mechanical strength and resistance to heat and Pass
fires retained by all types of insulation
59.2c Insulation not likely to be impaired by deposition of . Pass
dirt or by dust resulting from wear of parts
Parts of rubber resistant to ageing N/A
59.3 Excessive current and voltage protection N/A
Internal electrical power source provided with N/A
device for protection against fire hazard
Fuse elements replaceable without opening the N/A
enclosure fully enclosed in a fuseholder
Protective devices between an isolated applied part N/A
and the body of the equipment do not operate
below 500 V r.m.s.
59.4 Oil containers N/A
Oil containers adequately sealed N/A
Container allow for the expansion of the oil N/A

IEC 60601
Oil containers in mobile equipment seaied to N/A

prevent the loss of oil during transport
Partially seaied oil-filled equipment or equipment N/A
parts provided with means for checking the oil ievel

IEC 60601
6.1 ITABLE: marking durability I Pass

Markin!lil!'~tIJQ
Front Label
Rear Label
supplementary information:
7 ITABLE: power input I Pass

Ol"£lraUng~l1mliUQil Brequency Current iP~~ ~emarks
, (Vf (Hz) tA) .i~·· ".,
Motor Operating 100V 60 Hz 0.13A 7.0W
Motor Operating 120V 60 Hz 0.11 A 7.3W
Motor Operating 220 V 60 Hz O.OBA B.5W
Motor Operating 240 V 60 Hz O.OBA B.7W
Motor Operating 100V 50Hz 0.12A 6.6W
Motor Operating 120V 50Hz 0.11 A 7.0W
Motor OperaUng 220 V 50 Hz O.OBA B.3W
Motor OperaUng 240 V 50 Hz O.OBA B.5W
supplementary informaUon:
15b I TABLE: residual voltage in attachment plug Pass

Voltage measur.ed Measurements rV 1 Remarks
-between: j 23415678 9 10
Pin 1 & Pin 2 0 0 0 0 I 0 0 0 0 o 0
Pin 1 & Earth 0 0 0 0 I 0 0 0 0 o 0
Pin 2 & Earth 0 0 0 0 I 0 0 0 0 o 0
Enclosure connected to Earth

IEC 60601 .
Clause I Requirement + Test IResult - Remark IVerdict
15c TABLE: residual voltage or energy in capacitors N/A

Capacitor :and.its foeation Residual
energy
(m,J~
17h1 ITABLE: defibrillation-proof applied parts I N/A

'.' -< ltes!. Tesl Measured
.condltion; voltage·
Rg.500r51. between
Y1 :andY2
(mY) .
17h2 ITABLE: defibrillation-proof recovery time I N/A

Applietl part T'est Remarks
with test vol!f\ge
18 ITABLE: protective earthing I Pass

ITelrt,
I . t1M ,- -J
(V)"
Inlet Ground Pin to Potential Equilazation Terminal 30 1.64 0.06 2 min
Inlet Ground Pin to Enclosure Top 30 1.67 0.06 2 min.

IEC 60601
19 ITA8LE: leakage current I Pass
~~,~~ •....
:"r =~':'~" . ••
:Remarks
.vV,iVt'"
-
IV
ER, NC, 81-1, 85-1, B 264 V

ER, NC, 81-1, 85-1, A 264 V 60 Hz 86 uA
ER, NC, 81-1, 85-0, B 264 V 60 Hz 72 uA
ER, NC, 81-1, 85-0, A 264 V 60 Hz 87uA
ER, 8FC-Open Neutral, 81-0, 85-1, 8 264 V 60 Hz 139 uA
ER, 8FC-Open Neutral, 81-0, 85-1, A 264 V 60 Hz 170 uA
ER, 8FC-Open Neutral, 81-0, 85-0, B 264 V 60Hz 139 uA
ER, 8FC-Open Neutral, 81-0, 85-0, A 264V 60 Hz 170 uA
EN, NC, 81-1, 85-1, 87-1, 89-1, B 264 V 60 Hz OuA
ER, NC, 81-1, 85-1,87-1,89-1, A 264 V 60 Hz OuA
ER, NC, 81~1, 85-0, 87-1, 89-1, B 264 V 60 Hz OuA
ER, NC, 81-1, 85-0, 87-1, 89-1, A 264 V 60 Hz OuA
EN, 8FC-Open Neutral, 81-0, 85-1, 87-1, 89-1, 264 V 60 Hz OuA
812=0,8
812=0, A
812=0,B
812=0, A
EN, 8FC-Open Ground, 81-1, 85-1, 87-0, 89-1, 264 V 60 Hz 69uA
812=0, B
812=0, A
EN, 8FC=Open Ground, 81-1, 85-0,87-0,89-1, 264 V 60 Hz 72uA
812=0,8
812=0, A
P,NC,81-1,85-1,871,813-1,B 264 V 60 Hz o uA
P, NC, 81-1, 85-1, 87-1, 813-1, A 264 V 60 Hz 1 uA
P, NC, 81-1, 85-0, 87-1, 813-1, 8 264 V 60 Hz OuA
P, NC, 81-1, 85-0, 87-1,813-1, A 264 V 60 Hz 1 uA
P, 8FC-Open Neutral, 81-0, 85-1, 87-1, 813-1, B 264 V 60 Hz 1 uA
P, 8FC-Open Neutral, 81-0, 85-1, 87-1, 813-1, A 264 V 60 Hz 1.5 uA
P, 8FC-Open Neutral, 81-0, 85-0, 87-1, 813-1, B 264 V 60 Hz 1 uA
P, 8FC-Open Neutral, 81-0, 85-0, 87-1, 813-1, A 264 V 60 Hz 1.5 uA
P, 8FC-Open Ground, 81-1, 85-1, 87-0, 813-1, B 264 V 60 Hz 5uA
P, 8FC-Open Ground, 81-1,85-1,87-0,813-1, A 264 V 60 Hz 5uA

IEC 60601
P, 8FC-Open Ground, 81-1, 85-0, 87-0, 813-1, B 264V 60Hz 5uA

P, 8FC-Open Ground, 81-1, 85-0, 87-0, 813-1,A 264 V 60 Hz 5uA
P,NC,81-1,85-1,87-1,813-1,A 264 V 60 Hz 16, OuA AC, DC •
P, NC, 81-1,85-0,87-1,813-1, A 264 V 60 Hz 16, OuA AC, DC •
P, 8FC-Open Neutral, 81-0, 85-1,87-1,813-1, A 264 V 60 Hz 22, o uA AC, DC •
P, 8FC=Open Neutral, 81-0, 85-0, 87-1, 813-1, A 264 V 60 Hz 22, o uA AC, DC •
P, 8FC=ODen Ground, 81-1,85-1,87-0,813-1, A 264 V 60 Hz 16, o uA AC, DC •
P, 8FC-ODen Ground, 81-1,85-0,87-0,813-1, A 264V 60 Hz 16, OJ uA AC, DC) •
P, NC, E shorted, 81-1, 85-1, 87 1, B 264V 60 Hz 1 uA
P, NC, E shorted, S1-1, S5-1, S7-1, A 264 V 60 Hz 19.6 uA
P, NC, E shorted, S1-1, S5-0, S7-1, B 264 V 60 Hz 1 uA
P, NC, E shorted, S1-1, S5-0, S7-1, A 264 V 60 Hz 19.6 uA
P, SFC-Open Neutral, E Shorted, S1-1, S5-1, 264 V 60 Hz 1.5uA
S7=1,B
P, SFC-Open Neutral, E Shorted, S1-1, S5-1, 264 V 60 Hz 29uA
S7=1,A
P, SFC-Open Neutral, E Shorted, S1-1, S5-0, 264V 60 Hz 1.5 uA
87=1,B
P, 8FC-Open Neutral, E 8horted, S1-1, S5-1, 264V 60Hz 29uA
S7=1, A
P, SFC-Open Ground, E 8horted, S1-1, S5-1, 264 V 60 Hz 5uA
S7=0,B
P, SFC-Open Neutral, E Shorted, S1-1, 85-1, 264 V 60 Hz 63 uA
S7=1, A
P, SFC-Open Ground, E Shorted, 81-1, S5-0, 264 V 60 Hz 5uA
S7=0, 8
P, SFC-Open Ground, E Shorted, S1-1, S5-0, 264 V 60 Hz 63uA
S7=0,A
PM, SFC, E Shorted, S1-1, S5-1, S7-1, S9-1, 264 V 60 Hz 19 uA •
S13=1,A
PM, SFC, E Shorted, S1-1, S5-0, S7-1, S9-1, 264V 60 Hz 56uA •
S13=1,A
PM, SFC, E Shorted, S1-1, S5-1, 87-1, S9-0, 264 V 60 Hz 19 uA •
S13=1, A
PM, SFC, E Shorted, S1-1, S5-0, S7-1, S9-0, 264 V 60 Hz 56uA •
S13=1, A
• measured with ground wire on power supply (primary to secondary) removed. This is the indended
construction of the device.
ER - Earth leakage current A - After humidity conditioning
EN - Enclosure leakage current B - Before humidity conditioning
P - Patient leakage current 1 - Switch closed or setto normal polarity
PM - Patient leakage current with mains on the applied parts o - Switch open or set to reversed polarity
PA - Patient aUXiliary current NC - Normal condition
Fig. 15 - refers to Fig. 15 in iEC601-1 SFC - Single fauit condition
MD - Measurino device

IEC 60601
20 Pass
Insu'lation un
~ri'a from InsliJ
BI 240 1500
C RI 240 4000
D DIIBI 15/240 500/1500
supplementary infonnation:
21 ITABLE: mechanical strength I Pass

-
""""\""""y,,drBp.,farde,i""")"~
,,"
'Q"U"u~"~'"
i",,,,,-;;1'
j> >
"""
Power Supply Unit Enclosure 21a No DamaQe
Power Supply Unit Enclosure 21b No Damane
Hand Piece 21a No Damane
Hand Piece 21b No Damaoe
Handle 21c-11Ibs;4xweiahU2,5Ibs) No Damaae
Hande Piece 21.5, USD55 1.22 m Drao No Damaoe
Power Supply Unit Enclosure 21.65 cm Drop No Damaae
24 ITABLE: - stability
,
,
I Pass
,iPart i",.,,,,,, ,,,,,,, ,.'" 'FasLadndilion .> i< 'i,'
Power Suoolv Unit Enclosure 10 0 Remained Stable
TRFNo.: IEC60601_1C Underwriters Laboratories Inc. TRF originator: UL

IEC 60601
29 TABLE: X - radiation N/A
42 ITABLE: normal temperature I Pass

Supply voltage: 264 V, 60 Hz Test Condition: On, Running motor until stabilization
Ambient temperature: 24 'C
.
.1
•••
< ··kt.c:\ . •.
••••• <
T2Windings 67
T2 Core 62
Motor Case (Hand Piece) 38
01 Heatsink 38
L1 Winding 38
Inlet/Filter Body 27
SWITch Body 30
Handpiece Handle near Motor 34
COR - indicates measurements taken using change-of-resistance method
Maximum Ambientfor use 31 'C
44 TABLE: overflow, spillage, leakage, humidity, ingress of liquids, cleaning, Pass
.....
sterilization, desinfection I
.,., ... o~",· II"';;' .. ..... Remarks
Normal Humiditv (93% RH, 28 'C, 48 Hrsl Complete Unit No Effect
Normal Cleanina Complete Unit No Effect
Steam Sterilization Hand Piece See Misc Attachment

IEC 60601
45 ITABLE: hydrostatic pressure and pressure-relief device cycling test I N/A

.," ,and Part under test , . Test
52 ITABLE: abnormal operation·

.i.e,:: ,...,; I Pass
Ii .... '
VUi'P'''''' '"","'", .,','
52.5.6 - Lockina of movina parts No effect on safety of the device

IEC 60601
56.1 ITABLE: list of critical components I Pass

.
dbJe-dtllifllrt !l'I0- manuTaetLlteff lyriC >. ma;k{s1 pf ....
tra~matK ..! .! •• ••••
. OOnfOranjty~)
••
Enclosure - - Painted - -
Aluminum, 1/16
in. thick, 9.125
by 6.625 by
3.875 in.
Power Supply Various VariOus Type SJT, 18/3 UL817, UL, CSA
Cord (molded-on AWG, 125 V, 10 IEC60799
fittings) A; One end with
NEMA5-15P.
Other end with
appliance
coupler
Power entry Schurter KFC Series, Part 250Vac,6A UL498, UL, CSA
moduie (with No. 4303.2904 IEC60309-1,
integral IEC60309-2,
. appliance iniet IEC60320-1,
and filter) IEC6032Q..2-2
Fuses Various Various 250 V, 800 rnA, UL248, UL, CSA
time deiay IEC60127
Power Switch Arcolectric C1553AABG3- 2 pole, double UL1054, UL, cUL, Demko
EN602AW throw, 250 Vac, EN61058 Certificate
16A
Power Supply Condor GLM65-15 Input 100-240 V, UL 60601-1, IEC UL, CSA, TUV
1.5 A , 50/60 Hz; 60601-1
Output 16 V, 4.3
A
Wiring, Internal Various Various FEP, PTFE, UL758 UL, CSA
Secondary PVC, TFE,
neoprene,
polyirnide or
marked VW-1 ;
min 300 V
Hand piece Cooner CW3438 Cadmium, 4 - -
Cable conductor
jacketed cable
suitabie for
steam
sterilization
Hand piece Micro-Mo 3042L-012C 18V,70W - -
Motor I(Faulhaber)
Hand piece Lemo Receptacie- All plastic UL498, UL1977,
Cable PNG.MOATL.M housings with 4 IEC60950
Connectors G, Piug contacts.
PFG.MO.4GL.CC

IEC 60601
I 139Z I I I
') an asterisk indicates a mark which assures the agreed levei of surveillance

IEC 60601
Clause IRequirement + Test IResult - Remark IVerdicl
56.10 ITABLE: actuating parts and controls I N/A

Torque applied 1 Remarks
56.11 b ITABLE: foot operated control devices-loading I N/A

Parl !LUJder lest
57.4 ITABLE:.... cord anchorages I Pass

..~
o !""",
,",.. '"
". Pull Torq!J$
.!
IT .·c '"
Hand Piece Cord
.>'
1.25 Kq 30N 0.1 Nm
•
>
','
no noticable displacement
.'
57.4b ITABLE: cord bending I N/A

,
ICord l..,,~~, ',~, T-est
N"'''~'h "0
~~,
57.9.1a TABLE: transformer short circuit I N/A

;CC)
~.'~q~ Alnbi"rtt
.

IEC 60601
Clause IRequirement + Test IResu It - Remark !Verdict
57.9.1b TABLE: overload I N/A

I
Windirlg '"C} 'H~"
... I .... -J
U~. • d~
suppiementary infonnatlon:
57.9.2 ITABLE: trarlsformer dielectric strerlgth I N/A

Transformer under Rel'Jlarl$
test 110
TABLE: additional tests N/A

Clause Remarks ,an~ observed results ,

Enclosure
National Differences
(Total 10 Pages including this Cover Page)
Australia
Austria*
Belgium*
Brazil*
Canada
Czech Republic*
Finland*
France*
Germany*
Greece*
Hungary*
India*
Ireland*
Israel
Italy"
Netherlands*
Norway"
Poland*
Portugal*
Russia*
Siovakia*
Siovenia*
Sweden*
Switzerland*
Turkey"
USA
United Kingdom*
* No National Differences Declared

** Only Group Differences

IEC 60601
I
SubClause Difference + Test IResult - Remark IVerdict
Australia - Differences to lEe 60601-1 :1988 + A1:1991 + A2:1995

6.1g Insert the following between the first and second Pass
dashes:
For low voltage equipment rated at 200 V or more,
a voltage rating (which may be part of a range) of
not less than 230 V. Supply frequency ratings
which include 60 Hz must also include 50 Hz.
6.6 Replace the existing text of Item a) with the N/A
following:
a) Identification of the content of gas cylinders used
in medical practice as part of electrical
EQUIPMENT shall be in accordance with AS 1944,
(see also sub-clause 56.3a).
28.2a Ceiling-supported EQUIPMENT N/A
28.2a i. EQUIPMENT fitted with an anticrash device or N/A
have suspension cables duplicated and
independently anchored.
28.2a ii. Motorized drives designed to prevent the driven N/A
part from becoming hazardous in the event of a
power failure.
28.2a iii. Carriages, brakes, and supports designed such N/A
that any single failure will not constitute a hazard to
the PATIENT.
28.2a iv. Effective means incorporated to prevent N/A
carriages running off supporting rails.
28.2a v. Effective means incorporated to facilitate N/A
adequate inspection of cables and anchorages.
28.2a vi. Proximity or pressure switches may be used to N/A
minimize hazards.
28.2a vii. Ceiling-supported EQUIPMENT or parts N/A
thereof connected by electrical supply cables
provided with stops (e.g. for limitation of rotation or
linear movement) to restrict movement in a manner
which avoids any undue strain on the wiring
termination or damage to the wiring.
28.2b Floor and floor-to-ceiling supported (including mobile) EQUIPMENT. N/A
28.2b i. Anticrash devices fitted to cable, chains, etc. N/A
28.2b ii. Means incorporated to facilitate adequate N/A
inspection of cables and anchorages.
28.2b iii. Cross-arms or pivots fitted with adequate stops, N/A
locknuts. arub screws. or similar devices to orevent

IEC 60601
SubClause IDifference + Test IResult - Remark IVerdict
supported masses from being dislodged.

42.3 Item 2) Add the following to the first dash: Pass
For this ciause only, low voltage equipment rated at
greater than 200 V is regarded as having a
maximum rated voltage of 230 V.
52.5.8 Table XII: N/A
In second row, first dash, after "if impedance
protected", add "maximum value".
56.3a Replace the text in the third dash by the following: N/A
Medical gas connections on EQUIPMENT shall, if
operating at positive pressures greater than 50 kPa
in NORMAL USE, comply with AS 2472, AS 2473,
or AS 2896 as appropriate.
57.2a Replace "not used" with: Supply plugs - Provision N/A
for inspection
Where a supply flexible cord is fitted with a
rewirable piug of a type complying with the
requirements of AS 3112 for 3 pin plugs, the plug
clear-backed to facilitate inspection of the cord
colors and the condition of the terminations.

IEC 60601
I
Canada - Differences to IEC 60601·1:1988 + A1:1991 + A2:1995

6 Where wrltten safety wamings appear as Refer to Enclosure for letter of Pass
equipment markings, they should appear in French assurance
and English
6.61 Point of connection of gas cylinders: N/A
6.61 - is gas specific N/A
6.61 - is non-interchangeable N/A
6.61 - is identified N/A
56.3a Medical gas inlet connectors: N/A
56.3a - are gas specific N/A
56.3a - are non-interchangeable N/A
56.3a - are DISS type complying with CGA V-5 N/A
56.3a - are configured to permit the supply from N/A
assemblies complying with CAN/CSA "Z305.2
56.6a Where consequential loss of function caused by N/A
operation of a thermal cut-out presents a safety
hazard, both visible and audible warnings provided
57.2g Mains plug of non-permanent installed equipment: Pass
57.2g - if molded on type - hospital grade complying with Pass
CSA C22.2, No. 21
57.2g - hospital grade disassembly type complying with N/A
CSA C22.2, No. 42
57.2g - if Class II equipment - polarized hospital grade N/A
CSA configuration 1-15P
57.3b Detachable power supply cords: Pass
57.3b - unlikely to be detached accidentally Pass
57.3b - impedance of earth contacts presents no safety Pass
hazard
57.3b - possibility of replacement by a cord which could Pass
make equipment hazards minimized
57.3b - complies with GSA C22.2 NO. 21 Pass
57.3b - not smaller than No. 18 AWG Pass
57.3b - minimum serviceability of Type SJ for mobile Pass
equipment or Type SV for other
57.9 Switching power supplies conform to CSA Certified power supply used N/A
Electricai Bulletin 1402C

IEC 60601
58.2 Protective earth connections Comply with CSA Pass

C22.2 No. 0.4
59.1 Connecting cables comply with Canadian Electrical Pass
Code, Part I
60 Creepage distances or clearances of at least 4 mm N/A
are maintained between defibrillation-proof applied
parts and other parts.
Israel - Differences to lEe 60601-1:1988 + A1:1991 + A2:1995

4.7a Equipment that is to be connected to the mains is intended for one of the permitted Pass
voltages and frequencies:
4.7a a) Nominal frequency of 50 Hz Pass
4.7a b) Nominal voltage of 230 V, for portable and hand- Pass
held equipment
4.7a c) Nominal voltage of 230 V, for one phase N/A
equipment with input power not exceeding 4 kVA
4.7a d) Nominal voltage of 400 V, for multiphase N/A
equipment
4.7b Other equipment is allowed to be connected to the mains if it has the following N/A
ratings:
4.7b a) Single phase equipment, for the range of 220 to N/A
240 V
4.7b b) Multiphase equipment, for the range of 380 to N/A
440 V

IEC 60601
I
USA - Differences to lEe 60601-1:1988 + A1:1991 + A2:1995

3.100.1 a Printed wiring boards comply with U.S. National or Pass
internationally harmonized component standards
unless they are connected totally in a SELV circuit
limited to 15 W, or lesS, maximum availabie power
and whose faiiure will not result in a Safety Hazard.
3.100.1b Lithium batteries comply with U.S. National or NfA
3.100.1c Optical isolators comply with U.S. National or NfA
limited to 15 W, or less, maximum available power
and whose failure will not resuit in a Safety Hazard.
3.100.1d Wiring and tubing comply with U.S. National or Pass
limited to 15 W, or less, maximum available power
and whose failure will not result in a Safety Hazard.
3.100.1e CRT's> 5 inches comply with U.S. National or NfA
3.101.1 Primary circuit components up to isolation Pass
transformer meet U.S. national or international
harmonized component standards
6 a) All words in "CAUTION", WARNING", and Pass
"DANGER" markings at least 1.6 mm (1f16 inch)
high
6 b) Signal words "CAUTION", WARNING", and Pass
"DANGER" at least 2.8 mm (7f64 inch)
6 c) Letters in contrast color to the background Pass
6 Equipment capable of emitting ionizing radiation NfA
provided with warning statement
6 If equipment produced in more than one factory, NfA
factory identification marked on the equipment
6 Multiple-voltage equipment intended for permanent NfA
connection marked with voltage for which it is
connected when shipped
6.21 Statement for suitable wiring materials at NfA
temperatures over 60 'C
6.6a Identification of the content of gas cylinders in NfA
accordance with the color coding requirement of
ANSlfNFPA99.

IEC 60601
SubClause IDifference + Test IResult· Remark IVerdict
6.8 Cord-connected equipment provided with N/A

instructions to Indicate type of attachment plug for
alternate voltage
10.2.2a Rated voltage not exceeding 250 Vdc or single Pass
phase ac or 600 V polyphase ac for equipment up
t04kVA
10.2.2a Rated voltage not exceeding 600 V for all other N/A
equipment
14 Fixed equipment and permanent equipment is N/A
Class I
18m Earthing of X-ray equipment: N/A
All parts operating at over 600 Vac, 850 V dc, or
850 V peak are enclosed in protectively earthed
enclosures
18m Earthing of X-ray equipment: N/A
Connections from high-voltage equipment to other
high voltage components made with high voltage
shielded cables
18n Accessible non-current carrying conductive parts or seperated from live parts by Pass
are protectively earthed double insulation
19 Enclosure and earth leakage currents comply with Pass
U.S. limits
22 When risk of injury can occur, end stops are N/A
provided
22 End stops have mechanical strength as determined N/A
by the test
22.4 Dangerous movements of equipment parts which Pass
may cause physical injury to the patient or operator
are possible only by the continuous activation by
the operator
22.7a Emergency off switch has red actuator N/A
22.7a Emergency off switch: N/A
once actuated, maintains the equipment in "off'
condition until action, different from that used to
actuate, is performed
22.7a Emergency off switch is readily accessible to N/A
operator
22.7b Emergency off switch is marked with word "STOP" N/A
or symbol 5110 of IEC 878 in compliance with U.S.
Clause 6
22.7b Emergency off switch: separate and independent of N/A

IEC 60601
the intended movement control

28.3 No evidence of damage to a safety catch after test N/A
28.3 Safety catch marking provided N/A
28.4 No damage to structural parts as a result of loading N/A
test
42 Insulation systems with measured temperatures N/A
exceeding Class A 105°C (based on 40°C ambient)
comply with UL1446
55 Polymeric enclosures and external combustible surfaces N/A
55 Polymeric enclosures comply with: N/A
Conductive coatings applied to nonmetallic
surfaces comply with UL 746C
55 External combustible surface of more than 9.47 m2 N/A
or single dimension of 3.7 m have flame spread
rating not exceeding 75 (Steiner Tunnel Test)
55 External combustible surface of more than 4.74 m2 N/A
but not exceeding 9.47 m2 have flame spread
rating not exceeding 75 (Radiant Panel or Steiner
Tunnel Test)
55 Polymeric enclosures for transportable equipment N/A
rated 94V-2 or better
55 Polymeric enclosures for fIXed or stationary N/A
equipment rated 94V-0 or better
55 Polymeric enclosures withstand 6.78 Nm impact N/A
test
55 Polymeric enclosures: N/A
no deformation after mold stress test
55 Polymeric enclosures of hand-held equipment N/A
withstands 1.22 m drop test
56.3a Connector, pin, plug attached to patient connected Pass
lead or contact cannot engage any part on the
Elquipment, including separable cord set
56.3a Connector, pin, plug attached to patient connected Pass
lead or contact cannot make contact with live parts
of power receptacle outiet (if product can be used
without professional supervision)
57 Penmanently connected equipment provided with N/A
field wiring provision in accordance with NEC,
ANSI/NFPA 70
57.2 Power cord mains plug is "Hospital Grade" type Pass

IEC 60601
57.2 Grounding reliability marking provided Pass

57.2 Plug for radiography equipment acceptable for N/A
current not less than 50 % of maximum input
57.2 Plug acceptable for use with current not less than Pass
125 % of rated current
57.2 Plug acceptable for voltage for which the Pass
equipment is configured when shipped
57.2 Polarized plug wired such that the center contact of N/A
edison-base lampholder, single-pole switch or
single-pole overcurrent device connected in
ungrounded side
57.3b Detachable power supply cord unlikely to become Pass
detached accidentally
57.3b Flexible cord is of type acceptable for application Pass
57.3b Flexible cord not smaller than 18 AWG Pass
57.3b Flexible cord complies with serviceability Pass
requirements
57.5b If leads are provided for connection to branch N/A
circuit, the free end is in separate compartment
57.5b If leads are provided for connection to branch N/A
circuit, the free length of leads inside field-wiring
compartment is at least 152 mm long
58.2 Connections are mechanically secured in addition Pass
to soldering
59.1 Installation of connecting cords between parts of Pass
equipment in compliance with NEC
59.1 Cable type acceptable for ex1ernal interconnection Pass
400 Oxygen N/A
400.1 At least one of the following three requirements is N/A
satisfied:
400.1.1 Electrical components separated by barrier per N/A
400.2
400.1.2 Compartments with electrical components N/A
ventilated per 400.3
400.1.3 Electrical components comply with 400.4 So that N/A
cannot be a source of ignition
400.2 Barrier required by 400.1 is sealed at all joints and N/A
holes

IEC 60601
I
400.3 Ventilation required by 400.1 is such that oxygen N/A

content does not exceed 4% above ambient
400.4 Under N.C. and S.F.C. the product of the value of N/A
no load rms voltage and short circuit rms current
less than 10 VA
400.4 Surface temperature of components below N/A
300'C in N.C. and S.F.C
400.5 Extemal exhaust gas outlets located at least 20 cm N/A
from any electrical component mounted on the
outside
400.6 Hospital beds intended for use with oxygen N/A
administering equipment provided with required
markings
400.7 Pendant controls on hospital beds with oxygen N/A
administering equipment marked as required
400.8 Instructions for installation are in compliance with N/A
requirements of this clause
600.1 Separate power units packed with equipment N/A
600.1 Separate power units provided with correlation N/A
marking
6002.1 Direct plug-in unit construction and performance N/A
comply with required sections of UL1310
600.2.2 Direct plug-in unit external temperature rise during N/A
overheating test do not exceed 65'C
600.2.3 If direct plug-in unit provided with a mounting tab - N/A
unit marked as required by UL1310

Issue Date: 2005-01-10 Page 1 of 75 Report Reference # E181905-A1-GB-1
Enclosure
Collateral
Supplement Id Description
11-01 lEG 60601-1-2
11-02 lEG 60601-1-2

Collateral ID 11-01
:Jl nbr ... rl<;r,,1 ="1>1': ~,.~. ~"
D::J?~ ~gs.."'O- Ro~

No-:~tr.::cl:. "!Iino..;: ",O~S2-:2:r€
lXD: Gi:~·~':'::>(:
~ ..;. ~::'.:&1 ,; 2:~2-S~-'l
·:tr,;.';\'IV....I.t.i.c::,...'&~'c.'
ZiJl.:J!J~r (ll~JJ(:p.!l':~E~ Sll~·l4iwl t'J'ul':.ucls

AlLJ:: J\k ~l':'(.lJ H"'-":i~:')Ll
~MI IN 0[,;1.1 .'hlJ' p() BL1">: S(~l.)
:li,.1ov,;;:r ()h ·H{:I2:::
F~\fC T ,,;:;1 :Jl1d f\.1c-..::;;ur,:mcnt Rcr~tr~ ;:(.,

\:1,...,d,' /;ml'-'\"t l,kf1rj{" J}:':I'm~lr0m'·
'\'i'~ lHLye -.;["\.:..,.i~k·t.I ;.\·:~1J Lhh kL\~' yuur t..::.\K" Te~~ R:,,'p:'lr'. ~t'l' Lll;,) nu:.,,,;;: r;d~:·":H('..;:d m.;xlc:l. '.~.:')('
pr,:·d".lt:. ~'I'I:I5. Lt: ...:mti""lcd ~Ii \;C}:llf.'l;:: w:ill lh.: X(llI7:-;:n:'::~IL<'; :In-..:::l ill I.r~ rc;(lrL
\1,,'r.: <::~p·;;;~iil1:l;" your ;1l7..::r.::~~t i I~ l L. '~ Ef\.lC :':.";:,,,,.ic.:o;, flI~';:; ""11.:;)".lra,;;~ r(';11 tc C8.1t:\(:T 11~; in T.1L:
t~!11.:.re !'llwllld yCl] pecd F.~fC reS: ~;er ....:..,.C"s_ Thi;:; ..:-10':'1::': Prr~ie{J n4N~";:2(;7.W.
_-rj,t f<,·k;.Villif.lms- c?-,;t':':2 [.5 I __.;]d:)t·~iI1'::-

~·;~j"::·'::T Rn~inc·.::r :)c:c:tion M~,m.g.c:r
:llT·~:l1ati(:I~·"l Fl\·lC St:n'Jx.<;; :lltt::~Il~dr.n'll F.l\·lC S~r\,j.::-~<;;

Issue Date: 2005-01-10 Page 3 of75 Report Reference # E181g05-A1-CB-1
ColiaterallD 11-01
EMe - TEST REPORT
;j EM ISSIO:\,S
,,I IMMU,\-ITV
Iest Report Fik No. E181!J05

Projecl No. 04:\"K2673<J
Modd I Type Zimmer

Kind of}'1'Odu"l j{lectl"ic lJermalmne
Applicant I:imm;:::r Orthopa..:-dic- Surglc.al Produc:t~

Ue",,"~ Holder Zi11lm;;,- Orthopaedic. Surgic.all'mducts
Addr~gs 200 W Ohio ;\v~}>o Box 569
Dover Oh 44622
Manuiketllrer Samt "" Applicant
Test Re,ult COMPLIANT
This nvorL willl1.lut 31)peudicor2's ('onri....1s lIf .t 7 JlLlg.-L:S, i\.pprndix A C'IJiJl;liL1:i: t{'::,t J~hutJ.II~. lind
.-\.p))cmH.:.. uri;::imllle-::;t .G,lht, Thol:" datn ,;:ollt..,iRed:W lhi.. report It:ne-c.t~ unlr (h-l:"
lI-CiJl\tlllllS
it~m.s ttst~~ ill th~ ctmlita:ul'"!lli'iJil~ illld mudt:: vI -IjP"''nlli,m~ drtsc;rib~'d. All :ttlt::mpt hllS bt::otn
III ad~ tel arrullgr: till:" F.L'T, WiNl tho(' ,.'quipm~llt ]l\"tl;:icled. inm a test cftllfignration 'which
mm:jmrf.:C~ tin:. Ilh~~ncd L::ml5,~j,nt>i or 1111..' RUT wblle l':lmul:ating. :a~ dma..' <I~ pr<lcr.kal.:a
t:t'lli...:nl t'1H~·Il~l' imt:allaticln.
Crld;,:rwTjJ'c:-~ :.Hh~:nL,I·'T;r.:;:11r'(;_ m:.~.hmi/.;::s 1'(; ~·.~~m:.:: r.::l:TJ'p~r}· .J! r..:pm:lu;,;(;
7hi,:: 1'::P(:I': pJ'(l'i;j;kd it i,:: 1ocpo':)dL.'.c.:!"d in irs CI'~I·:::!tr.
lllJdoL:.fi'l.-liloL:.r~ L:IIlJlJf81olk\ lilt. .32i.3 rIinl:!;~lcn Rd, :"iod±lbnnJk,IL 601.1(ll

r),l~; (S47) 272-8SG4
~iL' :'O.!!'lICKr' 'l.. ,~I"'.1.; fl'o~.fIC!:;~~ -";<t L' , c:r ,; ;

lIl, Infel·Mrinu:<.] rMc S,en:irr.il- (HilOlIlSl: \ 1. "AJ("

Collateral ID 11-01
REPORT DIRECTORY
SECTI()~ TfTU:
GENERAL
LO (j":J:r:-r..l.l PwuuCl D~Clilfj(llL
,.1 \It!tl:l Dil!'..::r":ll-:'::':''';
:_~ ~nirtl~lrll~llt:l.; C;nLli.jlm~ 'n T..:;.:.. Lab
C~J~bn:[':'>~'J DcurJ~ . . .rE:t:1ip:w:.:nl C~t~~ fllr M~·a.-;.u.r..:m:·n·_
'-4 .-.U r {.-,cuipmcm: LJnQ.cr"1 ~Sn C.-'l1fi.ipra::ifJI'
:.:- .-.U r Orc'<:tjll~ :\1~1;t(:
:Jt...... icc ~...frld:tl~.i:n:1.<;
r,:\:lISSln'\~
'.0 . :ll1's;;;i,~n'" t';q n\'fEI:Jtir:I~~
C'll~J'lhr":-·l.:'d VoJL;;'l~>;.'
:t.a..:ialctll.:let..lrk. fiG:\" I..::mit.::;itl":'
~b:rn~lni{,; l"..l't"r.:I1~ l.::TIjs.~i;;m.~ f..m ; \'tll'..;;l.~ L"'l'Lu::1LiIJns,·: l-lil·.kt'~-
T,l~ll!:'irTY
3J) :,rrrr.lTli,y T .:.;1. R..::,;::L:l:Jliol"~
~.l '::: i'fiy 11"':1:1 r.t~ C I' iT,~,·j;;]
.·.J...'dl\~:'t<ltj::: j)i",;:oh,L;'ge-
_~.iJ<J~lt ...'d ~J.:: ..."iril:: :;i'f: d ln~I~1t'I~i'Q'
:"::ko:..:triwt l ~I~L ,"rmbi"::JL::,! BtIE:>:':;
S..lL~:;; \.'o~L~t~('
C'll<lllllcJ~"(ll)i':;J ll.-!l:l"K'("
?L!~rc:- ::-t"qL(:n.;,:...· }"·1a:.:;n..·!Lr.' FiJ.·k ImLrLlTli~""
V:":U·.~ Dip,,- sf..\lrt lr;L¢lT~Ir-L," tlJlJ "V·tlk..g~ V~lf.t'".t{llJ!:.
(~OhCLl.·S.IOX
4.0 GCI"J".'T~I 'R~mtlrk!'l
4.1 ~ur.~IlElry
.-\I'I,..-,I"(·IIo:S
/'.. ':'.':;j" !;CJ:'.l~ ::'ilOt,;:.., D:.;lgl'i'!-""l1$: ~ll'd :)I':J\;.·ing;;.)
::.\ ·.'::::iL DUht
~'il" ::.I~I~·r" "nljr..·, {i'.~-IK~.!j:~'" 'r-';::L' "f:f 1;'

[11, Inrt~;·n~fTjrm~l EMf: St~n:k('.h {:rllll0,lllSl-: \1. 1:',I\:lC

Collateral ID 11-01
IJ) (";1·-f\,YEH:,<\I. 1~lol:{)nllC"r In:~'I~II'Tlf)",
rlu' 1.111"'1'1:;:1' =-1('('f.I':<:: k'11·'~nllP ...~:S;'l ...kil1 ::.I';Tftill;3 il'.stl~lmt~r: m:3'" i~ int("l,krl m ·~I'c:\·id.~
'i~ri::.b!.t' ~JL tr,j,...·k.!J~:i.~ arow w:clU; !"'f.p~,:tdl:~_
VIIIUI!!C (V) Fj'CUUt'IH~'\" {liz)

~,(j ~.l)
1.1 11OTlF,1. J)fF~RF.NCr."
All}' (ITllel" mfl'l1ILI{~) ...epl·e......ntoed hJ.: thc- Inf.fI.eI, t,..fi.tf'.l in thi" in't'..... Ii~ti(1I11;'i"ill ht~
uilC"unli.'nted h~' LM.·lmHlIlf;a(t1.;Ye~·_
I.:! E.W Ij{U~-'lli.YrALCON1.>lTlU~S IS US,,- LAB
TCfn))('i"lltlln;:; 20-2.5 <tC

i~dalh'e Hllrnillit",: .Ml-tii'J'r.. RH
.·\lmw"illheric Pr.e~sllrE'~ MO· Ij)60 mh~u"
L'50 C\LrSK.·-\TION 01-' EQIJlJ'l\n~NT t.SElH:DK MI~:\Sl.l.r:E\lhYI'
All Lcs! ct!niruuc.nl Hud h:~t ll'i:(,c~~!Jri~~ lln~ l·.Hlibr~tcd "ll ~.I n:~ulur bu:,c". The
IIIU>:illllllll limc hc".. (~cr~ c~lillT:Hlhm", i ... mu' YCJH' (101" wt~..'ll i'li n.'Clllli IlICllth:iE h..... jJu~
1U:JllI~r~.cllln~r~ ~ltid~L""'~r i... lt~.. 'i"_
AIl1'l~1" t.'qLlipmcIll c;;JUbnttion:s }lr-l: U"ltC-~}lblll tu thll j"'-l,itilJl1}llll1stilllle (IfSlolmfm"tls

}lnd T-I:.'chnulu:!{l; l~IST}. lhtrel'oH.ltli tt:"'.ir dlit:l R ......o.rdlld il. lhis n'porl is lnce}lltlt.'
frl NU';:T.
~-[ l' :':1 :'119(1" "''';:jr.L~ fl~~.j"K"'!.:"~'" 'i',i:l':;' r,r 9

lll, Infe1·n:lTjj)n~] EMf: S.enir~~ {:':llO) lI~l': 1 1. 1:".IV1{"

CollaterallD 11-01
1.4 10:1: r(:()"'FI(~l:l~.'\TI()N{:o.)
S..:e i\pllendix A rtn- iRl'Fb,:jdual set-u.p c.Llllli,ll!;LI.f<1litmh). In liU.ditif.ln to [11.. .• EUT, tb~
fdll'\JI't>"ill;!: !lniJlbu..10'1.<\ ic... .~ ..ndl<J I" 't"M" M..... wne C'(lmH~c.1C"d cl Gj" j n:=: the
rn(!-l'biup,:;mcnt~
Mttnuf'lc.lu.re.r FCC IU
The eqniJ1'll1~nt under tf'S!: ''\"'l.\~ Ojl~ra~d dllring du" meamrelll enfi; IlI"lder tllf-
rnllll","irt~ 1l:IIIldili'JfI"':
1·:).·I~Ji~IT..:-d .~ni.;;s-krll:'::; J':::;.::'ti~i'" IC.ill m)\: Il~':-: if'lI"TIl.:- 'ltl'h~ h~dd d" ...·:('('", fer :;:: ;~·I',~,'
T:'''l- rhe "l:u'd rl.~vic...~ Wtl.. (,.,.>1:!:.i7oC>: ~C1l'tjll:Jfn..:.jr
1.6 nr.~lCr. MOTJ[F!CA Tro,~
l'"j,' ::'1f:[~'I' ;'I~~f!L~ f,~~..rl(:r.:~·:" "'>r.!:"L,':r;!" <,;

lll. Inh~l·naThm.aJI·:McSt!l"\-it"ll& w\n\'.lll.fflm,lcm-r {Nil0.lll~l·: \1. 1=,I\:lC

Issue Date: 2005-01-10 Page 7of75 Report Reference # E181905-A1-CB-1
Collateral ID 11-01
F.K h :~{j!} ·3-2:2f){}f)

LJ{ 6~OJ(k~-J: ~i))5 A1:2;)01
;;[l' :.:r:'lIQ.;"6 ;>.nJ......: fl'.~..rK"!.(,::::-:" 'r..i.:1.'';:;: ~I· .;;.
lil. Intt!l"n:ulonJal EMf: :'i.enirC'.n. W~'\i.'·_'ll.rnm!c;m~ (MOl liS): 1 1. I'.M"
UndelWriters Laboratories Inc.

Collateral 10 11-01
J'e::.l Lu,;:::JiO'..".l
:\ d.... ~IHL;:~L ;"J;.kicl R~~3~] D s>~ ~'t..:_,[:m ALJt".JyLcr S,':--" :1:t 1~te'12
Medel R."
. 55: rrc~J.::t'to· ~:"',J ~297(IC)~3
S.Ol.i\ L~ fI.~l(:-:_o:.'"l ~hO'2-~O-1 $-:"0-" s.:\. SJ(l:~~J.j No. 1·:\·1C4(~<;:

~()l ..!',L{ fI,·lc:-::;:c-l W.~(;2·:-:(;·lS-~e·' s.'.. . ~~.J~.::.:.. No. K\K.. J.O::-'1
n:.:o= ["('qL" jr~[Jl~:Jl:::' ...lJv.

,·lLr
::j l' ::.1 ~ I 9('" T.lf=~jl"!t·: (I~~JK ~.(,:~':,I 'f..i..-!"(,t:1" {,:.

ill, Inft~,·n~ulrm.:,ll EMf: ~el"~iir~il- W\'l.-W.lll.rfml.'~R1t' (~H)O) ll~l: ll. 1=",l\l("

ColiaterallD 11-01
J'e~1 LU'..::.tIO'J
.m!4/t \.I1K·I.1'(i ·GiXl
}It... \·:~t:_ Pf.l:ci..<-.n: rvlodeJ ~5MU Spl:L':".£L1r,l :\n<tJ.::-"l.o.."f

J\·1edcl g5(6'")"~\ Q:llI;<;;i~pCilk ;-\dap:.::r
~,..fiL;::':l ;\~"f·3A.J.H)O I !.().""\i }r,,;'oiJllf'= "'\n. f('/\4nn3, P\·1C4(; :6. Pt\--lC4J S;
IvluLld g36~5i', :-{F r,;,,~;;lt:r.:Jllr '\";:'. F~"'I'f{:':;'OI.'i
C:K-.SC 1.'.;'biC L:.d" WVl1U:ntJ ..'l;JL.. .'lLUI: ;Vkuc-J VUA6~'l!6A. S;':': 12..J.(.
C"-If,So,;- L:\;1C Ld,) L~~~ P..:-riLK;i-v ,!urLeluK. r\k.-:d l·.P.-\li~(IS $,:;..' 1 ~JO
r .r~.l.: {1":r..:..V lQIr;,'!:.::' .-,:" \..f-t:';',,"'Jn"::JIl;::Jt

JtIM::J.i.-; (jLl(j:\:t~h:
Tfl<: rcql:.ir~ITI~ll:-; ~lr..::

MET
~i L' ::.1::: 1';";'" ;ll~~l"!l': fl'.~..rk: ~.:l:=~'''' "'~.1:"L' -; (:1' 0:,\

LIl. InU~;·I'l:uifm.:,Jl rMc S.el"~;irf.~ W'it"w.lll.rrml!c.m-l." (HilO) IISI: 11.1·:MC

ColiaterallD 11-01
TIm rcq"i£l":.Ln~{:; ::lr~":

MET
~iL' ::.lflJ9.;"6 l>,."jr..-' !j·.~..rK"l.r.::::-:. "'~.i:,,:"; 1:1" 0;;;
[Il. Inu~..n:uil)n.i] EMf: ~eT'1,.ir~h. W,'\",\".lll.fflm:cmr- (H;)O) "'1' I 1. 1'.Me

ColiaterallD 11-01
.~l!E 4;\ 'HK-I.l'(i ·O·:)"!
I"::dfk: ·'c'.'...,," SC1":"(:\~ fvkc,"' ·~~1·1/'....1 X J -, :pC'· '}",:·1o.'16-i ~ I:' 'I,.-1C4iH9

',l,,';f'1 ,,:I'l~~ rA3:;:":; ill1p.o::d~..rH:'I:: i!li:'Jd".h:-
TIl;]. rcq[,lmmc;~Jb ~lr...·:

MET
~'iL' ~·.l:'lll?i-r' ;>f:~C!L'; fl'.~.JK:r,:~·:, 'rot" \I f;r (,:.

til, IntL'i·n:uion~I ":MC S.t~nirr~ W'1'"t\'."Lrflm!r:R1-r {S"l)0.lllSE 11. 1'·,I\:lC

Issue Date: 2005-01-10 Page 12 Of75 Report Reference # E181905-A1-CB-1
Collateral ID 11-01
_~JI 1\'1 \-ll:N'lTY TFST I-lEf';.l:I.ATIONS
EK 6: G~IG...j...2: 1'9"15 - ..\ I: 1"iI% + :i.':::1nG I nEe: !'O(}l)•.f-.})

EJ\-l) j 1}:)1~,..j.-3~2{1'!)2 n=:c J1.l{lO,.4·3)
ht-: i):(!·:!D4.4~19:t,) .-"\l:~·:!(!: I .'\":::~:2nOI {II:(. Elj-(l:U.4•.l}
hI'( Ij 11'::,)(,: 4.j: ~9:;',) (11-:(: J l)ijJ).4-5}
- ...... J :~.:j(::
E}.- ij : 1}{)IJ .4--(,: ~ 9~(1 - /1. J :2:!(~0 ( I F:(: I flflf}.4-cJ;'
L.r-.:- 6~(IJ(I--t-i:; ~~)93 .. Al;2Jrj~ cIl..£ ll)Jl)-4-S;~
l.r..' r'i'l(1;)(1~-1--1 ~ :FN£ { .~, k'"'(I[11 (T1.(: 1 ;)(1::.-4- ~ '":-
~i L' :::.1::11 g{" ;>'~~l'!": ~i'.~..rk: ~(,:;.:" r-.,~_. If, r:f ~
1I1, Infen~:nifm~l .·:Me ~e]"1,.;"'~'=:' (SllO) 1I~1': 1 1. 1;-,I\:lC

Collateral ID 11-01
rr'!-i·-" m(1:':(l" ,';"I:,"it.-}J:' 01": ll..: .lrl~f.m/II~ >I "nil c(m~~""lL' 1,., '"'I:ot:T:ll;.: .H iTII':'Ildn:.•~J,~ d'~;:.~rl"!l"l;"·."
l"r pCJ1"4n;ll..l.::.c,,:, or :~I~~ oCl':':'uJl..:dcn LS aJI:)','i'"(G kl..:t>.:\: i:'I ;;:..:.d<:'.ornl.3;l"::'::: k ,;cJ 5:;lr.:-dI1..::c ~I~ dK
1:~.wll-:n:111l·,,,,,, Wh':::l 'f!;:- :"jlj'l'lr,ll!.J" ':-'". ':..-11 11'; inl,'rdl:tl. "! flo:': p~rr,1.1,.m'., ..., :L·.·L·~; m!·~. h.' T';1~\;]';:,J:l
bj" :.l. r~'rl~\l ,,-L~:)I:: . LI~,.... 1) r,,;r ~'l~l-l.uJ~~.
M rr;ll~ ~\,ill:~:.llJll [l::,~J~'r~.IU1:l!~ I~',~' l'l" to;,,::: [=::' ni isi:-l~'
~~1i:110;"'1l:'l"C:':: ·l·I~'" :.. 11~1
"-r.::<:i"Scd hy Til..:: l"1al'll:~L"TLlre;- ~Jli;n e.il:l~ l~f:ht$.~ 7:;:1:. I)f' dC1'?'te..i Irl)~
UK j:"C(.dlIC, ~1-<:",,~.l.j!LcI":' il,ld ·:bct tl:rlli.,!lC'l: and "":~:r.: tl~e ·..ISt, Jll.f.~' rem('.il;llc;~ e::tpcct :l·~m l:)('
:J:::p:m·.~ll~ If 1I~~;j J.~ iB~~n;jct:,
P~.:,,:f"I"r.m:..n: ,:.-!.i~'I"f';"" fl; -nl~' H"l'ur:.;JI:, l-h:.l1 L'\J·llilll...~ ·"il j}r::;:l~ H < i,,1~n:~cl :\ r~l:.R or: Ir.
Tr~T. "\I.:. d...,!f,.~-.d,jl:(m or p....,.f:~l'nH·J-'c:..:' l1!'" ]1~~ <If ii.T~·~itll· i .. 1111..,-..,....'11 bd .. w J l.,..!·t~>n7.;ll:"·C 1.".,·0.:;1
"'p~l:i·-,t:{111Y Ih· "hL;:Lr;.1C:1L:L:'·...... ~~.1 Ill:: af'l'~·r;:JI~ i-; .1N:"~1 ...-; illll:'ld..xL ;.;)~ Jl~r~l;n;;"'II';:;'! k·,·:;l
D.Jy t'~·lC'.~'Lacd l'j·!'. ;)~J1(.};::;~bk ~O~~ l.):·~·'<:rk.m:;;\ll.,;:e. DL'~U~K: jJ-:LI: T.b:"~l, DI::·(£::.J~D.""llU~
0:·· l·l:::;'l..Fl)l~_\~_:\t":CE l~ HO;Y::" ':..'~R ?...:LL()\;.,:.I:.:J, .1\0 CJ·';/.,J":G~ 0:: ""~Cl J.:.~:'" O?.l:RATl:'-lG
S-:-4.Tr OR "=TORFD nAT}, I" ~J HWL·T.D. rr Ih~ \Ol;I'imllTl; pL~TI';rl'·"'~I·,,:.;'! ·r:-••'; Dr ;h!~
f>L11Ir~... ~ih~;,o r:~":'"JiJr:l,'llJ, ..""C 1::'-~':1-- ~·l'l lP~C~ II.::': 1:.' I··c Im~).lr;;l-;;I·.In.:r b;':·J i.::~lllul·;J -ll':~.... ~ lll~ '" ~1~
L:ti:l'j~':;-d 1h"J'I; ih~ ll~"('rd:-JL;1 <"k~Cj'ipJi~ll ~1'Lt 'S~·"'T ·lli::: la~r m;Tf ,,:::c:,"Dn~.bl:,
L'hC..I';j':::J:11';lT:(IO' ;)IHI
;":'<1,o;,;L (;·,:111 1:10.:: ~PP~I:'JI~N ir~I-;"'LL ~~i bt::nkd.
t"i!: i:o/ .. tT1I.-;ce~·{"i:;:-i ;:'~; C T(:Lr:.P(UJ::!' Lo~~ ~ffLlJKlk-n is J.11(!\.\....' d. 1:=[00\ [dtd ~It.,;; :;.J~O~ ~ct r1-L:.(:~;(",L:
j~ r;.',-·. ":,·:""Hhl>~ ,lr '~·i'· '~:..ICU't.. 1 h}· I~,~ ':rP"'l·~·Jinn Il: l~(' "">I·I'tI:'II~.
l'~~::::IIC': ~'le":;= r:.: l)...'1ai::-;.-

Critcrilm .:\ U~·II:ICC~"1IL~~k. :~~:'::T::lli"'lg ....... HlLl:llJ)r!<: ;~]1un:';(;:1 ;...•..:: m:;~-:n~:rl. (Ij .r~ f-:~rr
w:l]r:;uJ -C;llll...~~l":;lm~r:l;;n.J .
..:,:rlr~'oHlI..:'nl I::";llll"~;
':-~l.1ng-es
:'fl ~:'~F-iLlJil1::-_abic :.\.1rlQ~'1~~:
-:~~ct 10 f~ct()_y 'kf£....b 'illflL:J..ra~tl.!'Cf~ P!Cg('"'t.,,~;
Cb..ll,g-e ('!"i)::,el:aUJlg nH~clc.
- rr,l:(C .::L:::IITLL~;
- ":"~"S;i;:C1" 0;. inl;:rr l:,:i'll' "f n"~ inl~':;ld~·~~ '>I-..~r;i""I·, ~'. l"n : rlin.;"n~);'lll:,·d h:. ,,"I· nhl-"",~
i:lil i~ Ii;:11 ;, M;~ LJI ;lI:":"lId~d <)r.or~ Lil~l:> ::I~·~W.L~·1'<: .1:lilll::::rdtlod [l]" IJII~<r·L:tI1:~i1 Ill;:1 j,:I1_ "~<~·1 i."
N
~~;':OJ~~<lI·:t~J I::; ~l' :ll~,";·;n;

eHoJj· (1:':1 d:;:r:.. y~;j ll1h.;.,:el LC=:I! "TllL,-= ~(r:':i.ci~L:dy l::u t:;...:. 1(1 ..i"':'-<-c:' ~liil~J10sl:. (,~ l'(:a::JHF':w:~
-·'"I'",~<'·(m _'..... ~\·L~r.l'T·' j,. ·,\h;,·s-. !h.' '"l1·';,L: i~ il·,;:}:nnt'Ji~h.llhl<·. fr.,rT1 :~~':.. }i;I1I(l~!il:'iJ.Y·:FU.h,:;:d
i::l",~I~ (lr tll~ !lOt;( i.1\;,~J:';:·,cs ' -'-;Ul jJl1~! ;H<;tnticr.: of )~yskd(;..:.,;;~al~2·-:;.Jj\~..:1.. <:.::c :'+"l::ll~~
- ,v;d,;cl 1>'- di~i.~"'l~'):' iTI _';1" i;.l~l"'::" iTI ·...·hi;;!· .~... J'",:Mj.'"';1 :}; :ndi~~j'-:::;11 ;s;·;l ... I,~ r.>I:':
p~[r:-~,'llgiL'!Cl':-'-jl',~IlII';:"'LL ,,::!-,·~II~ ,:r ,11~ <li~kI1~<>ll illl;::: Ii.:r-.:.-; :...·il~ :11t.:..Tl1:...:,:.~iL)[l !)~
r~·,y~;';II(J.~·lcaHj-l\~ <~dl)C{:.Lt ":;y'·;).I~;
fnil...,_C' {'C1.'lJ'XUJ;).~A" c'kJ~l('~J~ ·)l'tL'"en!men! hOt IH'1,lU": t ::lJt<l S~. . ~ L"l:::l'dS \0 Cklp.llo:';:,,;: N Lel7,
;;\Cl~ if ;:H:~·orr:p,"1JIlI.'~i ~./ill "Jm:=.,
Cri 1"Ti~m B JIltIL'.l):'Vl.Jhl~: I'l~nJlill=- ('ClflJlll iLII1"'': 1"~"'P(ll":""::- ar;' ; ~fl'II~' 'J~ 4.
..
i.-k.. ri"" f~ I.~r..rr:..'j'l'lhll· r'f>.;·f«.I~. ;"<fi-,,: f·.,,·,~ 1\'.' 1""'"'1".< r. ..... , <"'1:1"'· ~ .\
~·i L' :-·.J~r9\;<: ;'I~~r.L·: (j'.".rK:rl:~-:" r.I~> II f:r l,1

lll, InU':l"MnrJ<n.:<] r"MC ~e]'\i,,~,;:. {~ll)O) lIsl'~ 11, 1:",I\:1C

Collateral ID 11-01
1·:I,I:.C·n~oS'rA7IC InS{~II.<\ Rf;E
JrSc11;11':;':: • ~")ct(ll' ~.~ I ~r.;('jl:d

Jrs~ll\}rg...:: ~11l2tclallC:''; :.:no (Jhm : 1)(; r:-"
K:nu ~Jr Di:;l'~~lTl=,(' . Oi[":"l-L fl~Ul~L..·)::I) ~1J:rJ lIllJitX'l-<. iajrl
Xt1~Jlb'd ;.:.['Di~.(:b:":7:!.~~ : ~OaL...IlJ It>t:m;(,;[J:;
P:,ilrrily fJlIXili .... ,~ fl'ld -.:;·~~F:~-;'
(C~l::Jl...l";_; '1 ,j i.~
i,:\i,."t '1 :1 ~
~i.' :':1:'1 J 9\","= ll,."jr,,~ W.~.J"K 1.r;:~.;" I'.,~> l~' 1:1' 0;;-
lil. Int!!l"n:nifms] EMf: Sl~l-';ic-(l.A w""',·.111. r rlnl ,1~nT-t (~<lO) list 11. 1'.1\;'"

Collateral 10 11-01
~AnI.A, Tl-:lll~I.I,:(·-'ni::I,,""'l--ll·-I.I) 11\..l '\lll,,\ITY
~h;M,)_~~~l~.~ml::l:\lJ-_:;,pJ.W_.;'I.~
R~od<,& S:.:.h.w-a-:l:L rvh)'.:e:. S.l\·l: ijJ S:'~H~ fj'l;.L,r,:;r;,\;.or Si:\ ~L:: HJ99:
:\rnpJiJk,[ R":'$.;.'an~h :VIUi.kJ ~{lf}\,l,jl:'.\(j'L\M~· RE' _\r":lPliJi~T :::'K'll'iC'
/\::il''::I'If \-hldd E1'!2~ 1.:\ ~if!.Ili'll CiL:nc:'rtr," f:\1C4143
i\mplilh.:r R~!t~~ln:h :\il,Ll.::l ,;:f)C;:- r (i.1l\·-t; 32 ;"1 mpli Ikr :=:.....·1C42(~
.~ .!.Er:.l.'JJ.a
.I ,mc('l .\ll)d~[ 314.. Ulg__' ]}:.poJ,;; ;'''.l'\~'j' ..·:\.I~fc"n-:l J_'\-1C4244
j'\JU..:'(l '-'f~r:ll Al't.::t'lr-. !I.·lc~d :;. ~ I:'>. ~n: :.l(l.~:':
FREQU,NCY RA~GE (\tll£> ~]ODlILAT10~

~fl .\.-lll.l. - 25rXi )...1:J:.: :\;'...1 - tllJ.'y ,1L ; kflL
~J.m \n,z I"'ub..:: - :,n':'f~:J1J~'Cydca;;2 H7
."'"h~I!I •.a OdcltltlJiull ~ H:'lori7.Cl m.T ami V;:I"::,::;'1] ~Itlt~rnm Ui...I.lHlCC :3 m~""::I~
rMd Slrt'n~h :<:V_:m #. -I)l Soil CoM ~hH Ii ::m~-I1
~r~p ~i'1..e- ~ [I~" 1}Vi"{LII Time
~jL' :'·.l:1:I~r:: ;'I·"j"'.1.~ !i·.~JIC:1!:'':.I 1'....:. 1"- (:1' ...

lIl. Infcl"R:uimr.9] FMC ~{~n:ir~~ (~<lO) lisE \1. I;IIX

Collateral 10 11-01
rl_r,C"fl:j: 1(".401. I·"AST TH.4'1S' .... l'ltrS : 1~1;1~S"rs
.mE 4;\ \H K-I.]'(;.C:! C
~.!!.'!]JJ.9Jj!-:r,,_r.~C}.!mJ~rid~::'~·.I.vl~r..~·,llilI!.t.:Izi.llit!:&:.l!~
h~'::-·l-tkl.::CS: :':-Ch::i"Se:.-~!:o If'!-:' ,\,iUJ :.:571).':'-111. L5t\t~\ ;Jr"J !';'·155~~ M~\ll~
(·.fJUJ1lin~ L~lt~trinR '\1Slin$

J'ul"-t'; ."'l1pl:~mk n.::' kV
1.:) kV
2,;) f..V
BIl·.....: ·.),~··illlj "l.(I(1 tll~

Btl:=>_ ::':lnt~":LJ J5m:::
Cu~lpljfl~ )"klh~)J :\C Co'-'r-li~]g: ~ct\"'-"uIk.
r~:,.: D1l1~.'1.-l1LJ pt'f )'·l-lld.;:~ 1 mir:..
~'i l' :':IRJ9.;"r': "n,jr-.L·: fl'.~. n...:"!j;:~':.1 P.,::.• I-j (:( ~
L1l. Inft~l·n:ujrmJal EMf: ~eT'\-i"C!h (H<l0.l"Sl-: \ 1. ","'''

Collateral ID 11-01
~ _IJILJ,I::s.~U.',.:~-:" ..~~9.!-m] ~:r{:!~~:';'~llllikY.nLl S~!:!"_~_':-:'il.,1-,=kl.;;,:

K~'}'Lt'k 1..:"C'\·: :':-Cbs,;. Se~-m!:o In·:' ,l<ilL :.57"1).':'11 L 15LlJ.\ jr..d L-15:=<~ tI.-k-:uk:::i
AODlialllllG .\JIl)~fe Uiffen:ntial Commun

1)5\..\/ ;)51..V
1.=,) kV :.;l'\i:V
·; .....11..:\/
..... u llbtr ,)f,.,ur.::-'t~ : ~ rc- ~lI'lgL~

P,)l-ilrjt~' : PositlYC: ;'l'1d ""\'-cga,~'\!l: t\~r <~.ll QPpJ:r:ilt~r:n.~_
Rc:pC'0tifJll Riln:- : ~ ~11~Sr: r:cr mi m::·~
ni"' ..-.!:r .·~dlr,.lc:
~ ~
: gC'. !~l)", .~:)(;,
;:Cj., ;':Ifil'};·,~ 1'('~f:L~ fl~;'..fIC!1i'::·:" 1'_';" J'; f:l" '"

Lll. Intt~l·R:~TjJ)n~ll·:MC S.t':nirr.~ ""'",,'.'ll.rnm!cm.. (~'1O) lI~I: 11. 1'.1\;]('

ColiaterallD 11-01
Cf)".II]I:cn~nl)l~Tlln.H;\ ,n",
~h;r;~l c.~1l~j,t. . ~~!![!~U11Jt.J'.ltl,,!

}[~"\,":~l:-P::l~'l<..::lrd :'<..l~Jd ~6':::;H S:~u!ll (j.... r:.,,\nu~)r
:\l1IpliJj..:l! Rc.....':!ln.~h :...-[;.....kJ It'n...\ll'I~\ PJ: A..'lJplilr~r
C~m.i_iJ.'!J/:~~_9~1!l!~-b-k!Xiiir.~
:\E. Fioi.:.:rt:r G.1S ..::'ITI t·:m:lm:.lrli":ll~i\lr~ FO>H): ·\.13~sn
'XalllC::: ll.:.'LiJl,,'::';
fr"::--l.!.u.:r:.c..;r" R~I":.gt": 1~{1 kEL. ·:::n ;\.HE:t

~1{lj!jltui(~:: ..-\..\.1- ~O% all kHt.
VrJ1Tag-e I.e;;eL :3 Vrn-:~~
Fr"::f:llc1:1,.':",t ;)''''::1' ~i7~ 17;'
nwl,.':"]: T·n.:;: 2..!'! ~.::c_
[".':ott I~ " ..I' IT~
~i L' =-'.lfll~(I~ ""~~""L': fl'.:..rk:~E:~·:" I"'.l~." ](1 r:r ...

lll. Inft~l·Rarf('jn.9J rMc ~"'l"\-i"[!~ (:r.IllO) lISl~ 1 1. I;",MC

Issue Date: 2005-01-10 Page 190f75 Report Reference # E181905-A1-CB-1
Collateral 10 11-01
~1}.1!.~llB':J!bW~.;1~"'i&...~
S';'lblf LJ ...'t-t"':"\ULt--!:: Type 7331-l Lut'f.' S¢~Js.ur L.r....IC·1GJt:
':'~W \1(j;;i;;::: i\;\M310? .·'\n~m;:tl':r
Llli.I ;:;.;":J,f.j.cr..'!'lll
I.' I .... 1'·''1..''1,;'''' n:'lr
r,~~l rl..~. ~lJ.er("~ S(lllz.:.ml 6~)t.1:

Fio..:·]J :'.:.Lr..:n;:::Lh 3 :\!m
Rcq:lir.::d rr:rt::·rmi'.Jlc,: Crit.;ria ""-·1F.T
::j., ;:.lflJ9o;",<; "r;;jnL~ fl~~..rl(:(,:~" P.I~. 1,(:1" 9

lll. Inrt~·naTjrmJaJ rMc ~cnir~~ VlilO) liS}': 1 1. I:,I\:JC

ColiaterallD 11-01
jn E4;\ .... HK- J.l'(i.8! 4
:e'~l\~ .s..:.JIIJ['l;~ __~~9..;:J_k:!-'llq

h.::iL~k l.:c:\": :'::-Cbs,;. :S~-i;,):. Ifl~l '''iHJ ~P~.2 ~.,;lu ...iLl~~ :'-Iw.1:"h-K·'ll13 ?lJe l:MC·1:; 1,-=
'S"i:\TI.J'";,'.e1 I ~l·rl)'~.f)nt 111n'.lHitm

{~~, 01' :'\Ol"nla.[ ()p.cr:dlD~ V) ,.l.ydf'f..! Titn.e in m~)
;1) 25! jtjO

40 5:: 10(1
.;;:, ~C["·'I li'l~ (:nmliJicm} )5 ;"l:}
-:: 3is:10:tQl :t:Ji.''''{.I~·JLlj,ilJrl~ iJ.5 / 1':'
-: S lcpctllb..., c-l.m..ljLi~!']1·t ~5t,,. 5{1(tO
.: ::; {~:JtJI,Lcd :~~ l"":Jdi;.it.m·~ ~:5t\,' :.{l(ltl
::1,' ;;.If1Iq;;",-,; "1~\jW' fl-.~..rl<".f..:'l:'" I""~.' I:> f:r 9

[n. Inrm·n~~Tjrmj,jl EMf: ~enir-c.;;. (MOl liSt 11. g",..

ColiaterallD 11-01
~.IHt Ntl\-c;ilht=r I.E., 2nG.:..

;;;:[ltt Nlll,.C;:Tllxr H1- 20G4
-1.1 StJ~lM:\H:Y
\1":[
;JIl(l.;n.,,'-itcrl' f,f.~~('I·<lT('Ir:L:. 111<:.

333 J"tli:l,g:';li.:fl ~mlLl
'1ar.'lhmt'k.:1. 1-,;")1"):)2 ~;~;\
.-t1;;:; f\.-lr.;WjHjmn:::l tE..\.t :;.:2l5) ':-aek ~L;;:hJ'~';:-

_~~) i..::-::t 1~ll.i:!=in~~I· ;';c-c'[ion r"'l~:.na.£.C"I·
~m"::~Il~Lticl,~'_I""'~'lC S~r\'j,x:- :llT:~I1;'l:icl'~11 ..... [;,·1C Sen,j=:,.,s
~'i~' :'·.1~19·"''::: :>'~~fu': li·."..rK~(;:~·;" r.l~." J~ r:[' v

ul, Inti.~m:uion.sl EMf: S,l.!l....i rch W""'\'1'_lll.rnm!r.m-r {~I)O) liSE 1 1. r.I\"1('

ColiaterallD 11-01
AP.PE:\UlX ,.\
~'il' :':I:'II9;i': :l'""jl'!": W;..rK~E:~·:' r,~.", . ""1 .. f .....-I

! Il, Inri!l"n:nirtn21 EMf: S,eT....i rr.h (~')0.l1"1·: 11. (;I>H"

Collateral 10 11-01
Rfldhltl.'ii gmi:;;:-:;ions
Hannoni-cs &. Flicker
;"j l' ::.1 fll g,;',,, ...

"r;!jr.~-: li'.~..rk ~.r::~' ri~'1':: :'..~"F 0-\,1
[Il. Intt~;·n~UlfJU.il;l EMf: ~l.~]"\'i,,"~~ W" ....".lll.rrml.'r.m.f' {:,;"~lO) [I~E 1 l. 1':l\:1C

Collateral ID 11-01
ElOCl•.., Sl,uk Di,.horge
Rudiall.'tllmmuu.itJ
Sllr;ge
Ell'driral.Fast Tr,nl,.Si~..nj:!!o
Dip.. & huer...pt<
~·i., ~·.l ~ I g,:"" ;'I"t'j1"JL~ f,~~..rk: ,(,;::;'" r1;:·f:; ..<,.~ <If A-I
111. Infel"MTlflonHl EMf: ~e,~;r-M t~,)O) us}·: \1. r,~lC

Collateral 10 11-01
Condu.cted Ill1luu.uity
.\]agnetiJ.~ IlllUlunit)...
::i.' =-·.I~I'K" ;'I"~,",L': W."'.rK"'.:!:~':,; P1~'P. ..\.~ .. t" ......,j

lll. InfCl"A:ulrm£] Io:"MC S.t~''''·irf!~ {~il0.lllSl·: \1. 1:",I\:lC

ColiaterallD 11-01
Al-'PL\U1Xll
TEST OAT;ll
('Il<lllll<::kd '>«(lll,JL~
·~;II:i<t"'lll:t·dJ·ic Fil:';: J·.missi11l;~
:l::r.nl;'>llk G.IIR'I1~ [.:rlif,!>i,tln.'t (J'.m: Y\ll:.:;\.,;,:l:: r:.Jl'Lu~tium.; nk.k~~-
Prf\11 :r.,r;'r:-
0
:..:]c:t"tn;~l...I-Lk Dj:,.~~ba:.~>!:..:
:t.uci'J1('u _=:l~drj.c , j~J JH.!l!.Jw:j~:·
:":b.1riol,Mll ~1.,L • ·J11L1.~t<:::Jll:: .~ Btu"S~s
S·Jr'.?~ V!i.l.i.l.~
Ctl~J1.illd~l Dj:'LL1~-'ba::JU:
.'C1'.I..... :··..;;qL~~jl~r Mtl.6l1c.ric held. fmm~mi:y
V'J:t:E~>! Djp.~, i;l'rJlt hlt-.~lr.lpt;;. :u1d V.rJlt.=.;;c Var[Ei:"'JI1~~
~il' ;'·.;!'ll'?(,'<; 1>~f!}'l'; 1-:'-:~iJ( ..:;:~t) r:.'~.f: Rt t:1 p,.".(,

lll. Infel·ft~Tin.n~l J'~Mc St~n.-iL'r~ W'l.'\'.111. rn:m !('!RU' (R,lO) liS).: 11.1'.M"

CollaterallD 11-01
I:NIJF.lIW1UTER' 1.""B()R.-\TORrF.~ PiC

( ·{JlHtll.....t~ll'.mi:;,ljm;'
~1~uufu('llli""C'r ZilllillCl" OrLlto)J:H:dic SW}!:lcuJ fWl.l L~eL.s

.I:::quiIJ'LII~I!L rniJ..,;{ '.r~L Zilllmer .Eh:cl!"jr l)'i:mJ~lOLll'i,':
RL:ttllin:ILI~lll C1SPk CI=I;!i,~ A
Ik1t~cl ihll Mildt~ (~\.IH~i"'i.l~I". (lll) \~I- P~I'" z: p'.;.) (:1" A ';~~I'i1~~' :'tl'il~)
IlmulwiEElh :::0:, I·i, r..:rm.~...... m·rIll~-Ib. {t kTlo'.I,: 1<;(1 kH.. .
9 :,a"L J~'l" m,{,,'1:;:L,;.::'ffit::1L~ ] 51J !..fh. :..., 3r.1 :'·1l·r~
: 11'J\":\C 6t\:h:
ur.. . ·--·, -: .11-1',.:'771 "Pl1::?";
IMf"•.••.•::.•••._:_..
.~
:.L::~ __. --- -- - ---- _._. ---- -- - . -_._- ·,::,.",···,··.·-·.·o·:.·,·.··,;.·F·:.···.·.·,-:-•••:,:::'.-----.-- -----1
. ~ ~ 1 ~ 1 -,; '.- <0 ~ <'"
cl,~i : : ~;-;:'"~.-; , ".~~.. I " .. ,

!
-.~'.-:- "In! ,
F~~I= . .;,-, .~,= ~
04~'-'
701
ooL.>.~!
!oj : -",:.~
.. -·--·f ·····1-·
; ~
-... ~_" .::;::rr. '= r u'=-= [: ~

52 1... .ei..:1 ..__.. .__.. ._._ L.... ~... _ .. _...• -'.. .-~~. _
~ '1': I : ; "".,~ . }r:;;, 'j
""b' 't - 4-.: ..-.-. +·_-,··+·k' ":~i
Jl.J
'L,\~1lll'tII~ ~! .....
-. "1I, . I' -,. '-.."
''''I:'''''''''\r.r...... ~ ,
. 'M M . _ - •••• • • .:~-
"
~ j.~!..;.;~.-ll:::...'·: .... ,'r~~, ....... ·
1
~.
,.\
'.1
-1
-.- 1
l ....
a'i ---. ,
'j """""---"""""~
. :_... .__ . ~. M • • • • • _M ••• M ••• _... • • • • _. _ _ •• •
··_··_··_·····:1
• :.__..:.__ . ~ . : _._L"(••. .__. .J j __._ ------L-.--=-fU---.--.------.--.---•. :L
• ~,~ .-....(" "1H..,.j
~'i 0' ~·_iRIg.;·I<; :>~f~'>l': 11/.~,fK"-:;;~" I"'':'~i': F;.~ (:1 =t'"'(,

lIl. Inrt~;·naTjr)ll.lal rMc :'-er~irc~ (HllO) IIsl-: \ 1. "Ale

Collateral 10 11-01
.t. ~~ ;.:,-; ._
.. ...
~ ~''''. .~ ... , ':.
: .~ ,,", "
,", "
-~.
" .~. ,; .. ~- .
:', '.' , ".''-
,..
.. ' .... ~ ~ .. :.
. ,. , ;.J .",'
,~ .. :'-.
".' ',,' "',
'", .
-", .~,'.~ ,; ..'
..-', ,
•.0.1:,..
...... -." 'i~' :, ~/.,,_
...,
.- -. ";"
~ ~- ~
"'.' ".~.'
,', '.~.
..,- .. ,.
,.
' "
,.!t.;. ' . . : ..
.... ~r.~ "
.;- .', ,- .:, .,

;·.1."
..
~. -"_ .. :';':.
'.:." ~.
-:..
" I,'
,il.,·
.~- ..... '.': -:,
", .'-', : ,:<:. ..~. .:."
.':.
~i., ;;.;~IlKI';; ""n.i.·~·: 1~~.~..rK-:(,:~is r.,~~~ Fl.: (;1 :;;....(,
lJl. Inrol"l"n::lTlrmJa] '·:Mc ~el"\ir~h w,n".lll.fflm!CRl.f" t~f)O.lll~l·: 11. 1=,I\-IC

ColiaterallD 11-01
,:,,~, . ~ "~ ,.. '.... . .,'

.: ,",
'0 ;....;
..... ... ;
...... - .·'".t
.." I .'_
.:' ~.
;: ,'I
. .. ;~
'-'.
. :'.- ,< .~.:'
...... ~' .. .
..
"
-_ ..... __ .• ; .1
" .
. ~.~. ". ~:.

'.
.!~ ..... "~:. -: • '. - ·.~I
". :~ " _... ' ,.-

""'~~=~-' ~- '.~ .:'.,
-,". ,... ,.",. ..,;-
~ ""',' , -
..
: :.- ' .. " ~
~ .
:"."
~'i1' ;'".' ~ Iq.;"r" 1>~fD;'1.': 1}'.'..IK".r::~" r..I~".f: R.-: (:1 R"(,

1I1. Intm·A~ujrm,l;ll EMf: ~eni.rr~ {:'o:llO) lIS1~ 11. r,l\"lC
Underwriters Laboratories Inc,

Collateral ID 11-01
I:NIlF.RWRrTF,R~ ].A !lORA T(}RrF.~ PiC

C(lm!llcled F.m~.ljdlm:-l
\"1~nut'8ctl'l'c:r l~immel' On:IH1]1ll:t::die ~ll1Wc91I'r!lrlUt.'1'l

l:"-lUilJ'm~lll L:nt.l~f "rr,;:loL ZilllLII'I.:!" .E.1l:l:h'it [)I\:nmHUmC
l~l.:tlllin:llIl:nl CISJ'!{ CI'I:i.~ A
DctCeLtOiI M4J(~c (~L,~ls.i-~~i. (WJ1,.:r p~d.. [p:;'l ¢rA.......::mgl..' :lLY("!
r~JII~JI .....iIElh -::l)~t I·~/ r'~J' m~_.. JIWlr(~~rl!--~j I..T 11'.1,; J '1:(1 kH/
.) "d·l.r i':;11-1l1t:,1~rr":II'''~JI~ L'\(J leFI:.- Of' ~(l \-11-11
),.1:ilins: 2.].-JV:\C 5,JEL
1:::
JL C....::
_.~-- ---'--r-_ .. ~.- -I'--;----
=,,=_ ,,:_=_:!"
r-'_ -.----- J 1·1-....

~~;~~:-:-~~-:.~. ·P.F:--·.~~-- ~~-;l;
2~::::4
-
. e .!4 .:;
·········"1
·'-1 I I .., ." , , I·.. ·~I. '1I1H
.:.11'.~.- 'ffil '

D4 1 I'"....J,,_' ~l''-'''~I''_;;: !
'.I' -,." "'r- .._-- -- "--, -_.. .._--_.!
c"b
; ., GO~'" 1-· ._.. _.+-.,.

., ...
..i-'-~""-+' ,
, 'Ji
,'' -
I"J '~ . . . . .:..
=; -,:.1 -'~" .:-:~~rr.. (J ..I~ ... C; ~
3 o) j: r· :----;-:-. ..------- , .L·--·--l-[l~;,--.:,~:;-·i

4'r" "i- ---LL. ;. . . ...-......-..... ··j-·-·---·'·7," 1'1' 'i '\;··-1
til
"'I' 1-.1 1: -' J~ ~--
I
I
1.,-'
. ~
• J 'J ' .
t
; --- ..__ . : • .:-• 111
~:::..':":'~ ::-".:~I.,~ ~~~,.,:,;-".':':.:.'I·'·""
"
-, :"
·t~J
. .,'flo,.,.,..
r
.•
•..: .r':I,Il:. ,
•
.....·f
t' ~
/',I ,;
..",._- ..- - -,. . - -_.. ..•- ---..-;.. ,. . ---..-"-' .. '1

-_: __ ._----~--_.- _-_. __I.__ ._---_._-._------_.;----.:............•... _.._-----_.
1L'
__ .. _-- _._----~
.;-'
.__. ._ .__. ." .__. .::~:~~:.:::~.~·..__ 21~~:_~. .__. .__. _ _
~'i~' :--.: ~ 19{," ;>~i"L-: 1~:.;..rK -'.r.:~iS r:.'~~f: R" r,1 l=l.....(,
11l, Infcl"n:uirm.ll:] .·:Mc Seni"r.~ (~,lO.lllSl: 11. 1',Me

Collateral ID 11-01
, .....,
~....
.. ::; .~-"."
i. .. ;
~: '." ,, , ,
.., ,.:;;.
;-;
, l'::' -, "
,
"".- ",
, It: , .., ;.;

" ~'.
",
.... ,
"
.... '. , .. " ~

" .:~ '
"
.. " "
. ~:'.-
. -------------------------_._-_ .._-----
">. ,., . ,~ '". -.. ' :.",
-~:. ~
, t~ ....
': ' ... ,;._" ....
-'." , '.
" t"
.,
'·'·r-
.~ ,..;
.',", .. d . '....
.; ,.,. .. '
'." .. , ., . ~ '"
:, "....:. . ~.; .. :, ~ ').' ~, ..", : -";' ''"-' ~':

~ I • ' I ,
'"",
....
. ",
.'~
l~.'"_ . i,.:. ; .•.. "
, , j l .• "
.. ,'
,
l." .'_.". : ,~:. ," -;..

.1.'
.....
.;. ~.~.,
-;. . r
"""
. ':.
~ - '; ·;=i~
•• "A
.~ ..
~'-'. "'. ....
~'j" ~·.':'II 'K,~ 1'~:¥": I~-~~n( ~.r.:~iJ r-.l..~l': Rf, r,J ~:'(,
lfl, Infel"MT1J)Il.8] EMf: ~t~n:if'C!h W'in.\'.lll.r rlnl! C!RH" {~I)O.l wiil·: 11. 1:,J\."l("

ColiaterallD 11-01
,,'
;.'~
• ~1='
.
'. ~
",'
"';
- .;. : ••
:"~' ; ~,.., ':~- ....",,'
•':'1:1. -
. ' .. ~. ", -', ~'" ' --..'.
- "''-!'
;'. .
,Co -. :'.
:~. ~;.:" .". ..
~.
~::
-. ,.", -~, .
. '" '-:".::
;~.
. ,,,,:' .. ,.:,
."
"
-~- . i~.··
... " . .~ ..
".:~ . :.,' ..'.' :. " i'
-ii' .... ,.; ..

-.:. :,: . -':'.'-' '"
;:r: ~ "" ~'R

~~~:p ',_;~ J ~:.
~'i,' :,·.:~rO;;i-t :'''='Jj",,: 1~~.;',fK~.l!:;-i1 I'.,.:'y- Fl.::' fir ~ ...(,
lIl, Infel"n:ulrm.al I·-:Me ~t~n·jr-[')l. ,,·,n".lll. f rmt!C!. m-C' {:';llO) lIsl: ll. 1:;11,:1-("

CollaterallD 11-01
I;Nm·:.Io!:"l-\'loi:lT"-){~ 1.A.I:UHlATf)flIES I,"C

~<l:~Ifu:trorll;mi.:I.•:i{)n.iI
I )::JT,' I ~st"fl: : I-I·::'-';;y.
~1ilnul:.~J.:'lnl-cr Zimmt'=r Orth'ilp~.cdic Sn.r¢cal I'md lE'l::t.~

f.qtlipm'-'r.lt l;nrh.':r T'l~t Zimmer F:1!:t:.lrk I)e:nnammt."
R{"I!nirl!'mf-ll:f Crs.Pl~ CI~ss A
Dt:-fet"thm Ml)d~ OL·~:L:-;i-.?d...: (LP)
Bllnd"-'lidth 12{>kE-1..:.
\'Te~"l'eln-ent Uiuancc In l~lcr.L~·
Antc-ll1'tll T~'pe 301}- .'Sun ""'!H7-) Himni.c:A.I
300 - 1000 )Ull, UJ~-l'c!'illdil;
12:)\1At (iOllL
~CI~ C1tc~1 I: 1I1:'ll- :>n::.
"'1"1 •••••••••••- -••--------••• - ..-.--------.---.-.-

"i-M"-
=J_,-t· i - r.•-"--'-"'''
':;.:'IJ':- ,,>1']-..-
,0 ~ .. -=1- ..... ,..- ... -~ ,- ......: J... t [-..,1
:'{') __._._--------- ..........-----.-•.--.-- ---------.,..-- ············-·-1·--

~
.c
.::l :,H .......•.•. __•• _ •••_ ••__.-- ..-.---------.-..-.-- ·:'1~t··'·_:·1:;;::.-=-~-~m·-
-"
~ 48 'I
c
'll
lFl
~i l' :.:: :'119-:'" ,;>-rJ'L" ,~~.~JK ~J';:;'iJ P.l!.f: F;$;r:J ~""(,

til. .nrt~l·"fUlrm.sl ',:!\n: St~1';"'C'~ (:'IllO) lI~l: \1. 1:',l\lC

Issue Date: 2005--01-10 Page 34 of 75 Report Reference # E181905-A1-CB-1
Collateral ID 11-01
.. _ .~ ..,. -";~"-i ",

"t2:. . L:~".;.': [.I.:']
,',•• ~"., 4;,. , ro. - ...',

~
,'. L': ~ . ,".; "";~l 1-, ..•. ~ . ,'r:
~' .. : :,.
, ;.-,.-. -~~. .. ~!. .., .-,,":-
:.'~.' -;". ~
,., j."" <

. . ;::.;: . , :,.,
,- "-"" ,
,.,:: -~
"- "-"
""':1 ••i~:':
:_~i' •. '.:_1:
~ 0;,. I <>.l. ..:~. ",
L~ '. '.:'"
,
-.
0
,. '. ,~.-I· _.. >\ ·;·~1 .:. ~'" T .1:
,- ..
,,-"
~:
.;. ," ..
, .....-''-••:...:.' t
4" • 1'" ' ••
:J -.':'
. ., ..
'.... '.rl . .'-(i" '<
. C'.- ;.,' •.,- ····r· .,...• ",.1 ~'.- I ',,,>," •> • t .

, <""".:. " .~. ..;, ';" - i~. • ''':..' ' ::1,'1 ,:;~ •.'- ,"t ~ _'
~.:... ':'.:;-,_ .. ; ~ . ,'_'1 ;_,"
: ~.~.
:'_~II.·.,~..!.: ~: .. ~ '--- -!.:; ""
",'.... • l<
~ ,. ".,' :":,:,~.
_~ I .:'
-,' ::' .: .. -:' .::
,,"'....
':'. " " .;~
A_.·~ :j."
;. ;.',! :
-~
::...
.. -;.
~- '!.
,.-r~ ,_ ~H.''''~ ..... ~.
r.·~- -, ."':.... ,.~,' . ~> "
r: -.';.<
'.:t- :., ".-' r...:~ ,.. ,.", .~..
~i l' ~:':'II9-;j'::: "'":"~,, ....: 1~.~~..rK1.:'i:~"" r,I:'.1': F;.~ r,l ~""[,
(Il, Inrt:l·n:ull')n.l3] EMc Sm';"'l!~ {MOl liSE \1. 1'1\;1;'

Collateral ID 11"01
I:Nl) ....,I~wRln-'R~ I.AtU1K.<\Tf)'<II:.S I'C.

~~l~JU~ }·-mi.Y:.imH
~1i1nlEllt-l.·lw-.c-r Zimmu OrthcJHI:..:dic :Su.I}!:iC'il rrodtret.~

F:.[luipmc-m l;mkr T ....~t Zlmrnt::r F.ll!-clrk l):iI!-:rmatilme
Rel~llir~m~IJl Crs.PR {":I:as,~ A
])!:"It.'ctilrr.l /'l..1(ld~ ()L:;i:ii~.?d...:: Up)
B::md..'ridth l2·:H.H.::.
Vlea:Jnj'eIlH.>nt UiuJlnce In mc:u...~·
Anrellmt T:'r'pe 30 - 3Hfl MHz, RieonicaJ
300 - 1000 .'llll, tu~-l·\;.!"itldic
::nVAC =,QI~L
.:i-me-
<,111 •••••• - ••• - -•••- - - - - - - - ••• ._._--._-_.•.... =1_.-+' j - r:.-... -- ........
;:.1 ~II,':- ";1-.,-
00 :;'.._=1- ..... .,........ -r ,- -"'_r= J_... + 1-,.., I
E !'In·, .....•.•.--.-----.--- - _-_•.•_ ..__ __.- _._-_._-_••_..,. - --
;~ :,].1 -- .••- . - - - - - - -.• ....----.---.-- ···:'1-:"it'·'-7-r;-;;:.-.::-,~·tl;r-····'····. . -.-.~.---
..:1.:1
~i (' ::.:!ll""i~ ....:

;>~~,}' iY.~~JC.(,:"ti,l "''''~l,I':,r:J J:l....(,
lll. Inft~l·R:ITirlolli.ll EMf: S.i~l"'·irr.~ (R'W) lI'W \ 1. ".MC

ColiaterallD 11-01
~~,. -,'-~-""'.
:""'-
,·,.i,..;·
," 1.-:.1.',[·"
'.. 1 ro.
1-.1:.11;
-,
";-r:
~',. ;,:.,.", '.01,_! ro. -, il.:: ,,_
, .. r.·.·.~. ,'." i·~l.,t! . :.,.:,
•. ~ :'". -~ - - l~. ,:
;., ~.. ' ". "

~,.i.'.;.:: .".' ,.:_.~~ ..,J-,:.;->: ~-.~' • ':. t
.." " ,,: ".' " ,- 4.
'- .. 01'-
,; r.,.·~.
'.~'..,.
j.... ,
~:._.,
,~I
I'~
. .:.,':'
-.;_.'
~ .. -. - "
"."
.. "-; '-':
':':"_I,,",.~ ~~. I,.. i· I.' •. ",~._ l-::"
".',.' :'- "... : r" ; ' . " '_. .'!
,". l,·.·.~ _:' h';~i ! :' ,',-, • :'r: '. 'to r, ::.
IS ••: lo'J;
I ......" ._ '.c··: :.:·_'{,r_~,-

1".:1_.':'__ h.:' "J. -".... k ~~.~
.->:' .~: .~ ·;"f ~, ••• , :". 4:¥.:-' t-· ....
.(",- :, ""','.', ~"""J"-~r -,.l·;~ . j", !:'

" ' ...;:•• > 1 : .. ~'I ' " .,:.~' ' ......,,, :1."1,.-:'-,':""''-''-;
: '~-., ." 1
',e;
~- ,~.~
·:'·H
.. ...• ,. . ..... ,",
.~,.
",..:
f • "~'. .,.
; .• ,ff'~ 1, .", ~ " .,. .:;
.•::; ... ~,~, .. "~ "':' ",

'.,.0:>.: ,. ,,' ;., ,!,t. .:'
·I .. ~ (',~~ ,~. j:. ,,..= :~.:::-. --,
_'~_".·~~L: ~ .I':_·'·;'~;:".'·. ~.",:, •.•,:,,::, ,- ..
~ ~:
..•.• ···"1
:I_ ....... '~.,; :!_._ .._:~,:,:-w ;"01:_
.....,' ~..). .,. .,

:.,.~.:- "' ~. ,r. ';.: . ,
~ "
._~ .
·1' . ' .:- ~:. " .,_. -~, .:' :.. ~ .' .'.,
..•. "".:'. ~. :,..::,~ .. :.: ;:.'
;:..~·t'_.:: .... : _.~.; ~()

:'_~II.·.,~_" ;.:... ~ '--- ;.;.,;, <: .~~ ':_":
..... , ....
, ,,,~
. '-.
r·-'-
1" :',
.,l- • .:.~<_ ~'.,,-.; ':.':-;'.,., ..:.
~j" ;'·.'fil~j"= :>""'~"L': 1~~.~.f1(1~:K1 ..,~~." "';1; r:1 ~"'(,
lll. Inrel"Rarlrm.aJ 1,:Mc S.t~l,·jc-L'A (:r.IllO) (I~l: \1. r.Me

Collateral ID 11-01
l:NUr.I;::'t\' RlTF'RS I.A n.. }}t..'" Tf)loi:ll:,~ I ......C.

\-l~l"m'(~ml'n[ flf 11!lrnUlollir {'m"l'ent Ell1i~inll'i;
\hlmd':dIL::lun.:r ~ Zirnmn Orrhlll131:dk ;Surglc.al PrllUUltN

F..quiJl'tn~lJt l;ncl~r T'I..'si : l.jmmec- F.k'clr;c l)~nnatHme
\tlldc- til' OpC-r.:l:1;IlIJ \'~;-r;~i:l:
I{ efcm!'ne~~ta nd ;)l"c1 1-: "H'ilHOn-.!o-2. JO l"ANm.;::'-L1~G-lUJ6
CUl'"rGm & volta~.g waveforms
0,6 L 300
-~ ~.~ -r-r-----r----.:..---r----- -------------------~. 2GO
ii'
100 ClO
~
; GO )L-!=i~==1L-=tf==1L. o ~
<:
~ :~~ .r·-····.(.·,·---f---! ,j.. -----!------.-

.100 c
~~
-Y..,. ··----·----l· -200
-06; ; ! j -300
ElJrDO@artUmits
3,5 c········,··------ r----·· -- ------0· -----··r······- 1•••• ---r--- -- -- ------,---- -- -

;.. . j; :: t : _._._~ ~
""
c. 3,0
~
(/)
::<
2.5
2,0 :~~~:- -J··.··.::j··.··.··~:~·····:f··:::.j:::~:::f:~. ,I,.::::::'::::::r::--:::::::,
IT: 1,5
"E
1,0 r .__.__ .~ .__ .~,; ..__......,:._._... +,. . ~ . ..,'
O.f> . _
~ -j,.~- ;- .._._._.._- _.
'"
<:>
_. •__ .~----
"--- ~ . :
(-------·-~-------·T······-· ·····--·-r------'--·-[
: r
OJ]
,. -;- -j-
4 8 12 16 2U 24 28 32 36 40
Harmonic #
Tnst.rC51JIt; Pas~ Worsl n.1rmQnic: w.as #17with 8.97 % Oflhc limit.
~i~' ;:.;~119,;·1~ ",.-:~,.,,: 1~'-:~.r!(~.:!:~'iJ -""1".,-'41:·(,1 ~''{,
lll. Inu~l"RaTlrm~l rMc St~l,";rc;;r. VO'\....~'.lll.rrml,'cm-C" (~')O) IIsI: I1, r,M;-

Collateral ID 11-01
Current Test Result Surli:Jnaty (RU1' time:)

EUT: EI.e.min Derm<rt:ome T estp.d by: JM
Test C3'Wgory: C];:IIs:s-A r-er A44 (E.ul"opr::;an limUsl Test Margin: 100
Test daU!o: 1113/04- Sta.rt time: 11:31:37 AM ~rJd time: 11;.34:1S hM
Teat dural:i,on (r'!1ir'l}~ 2. .5 na.:t:.I fll.1i! n.i'ltrte: H-1JoOO7iB.>;.'ta._data.
C-ommC'nt:
CUlllLo-nll/'!r. ZirlHtlQr
T~t Re~\Ilt: FEI$51 !!SCURlE ~;!;tifica-li(Jn; NQfmal

THC~Al= O.Ol'il I·THD(pk.%): ~54-.U;S POE-lqA): NIA POHC Urnlt!A.): NlA
Highest ~r:..metel'"vI.IILl~ dl1/:'i119 t§t:
V_RMS (Volts}: 22.9.98.
I]celk (Ampsl: 1],3M I_RMS lAmps): 0,0"/'"6
U~'und tAmps): Il042 Cr£-st Fattot; 04.a2t'i
Power (Wi3.tt5);
6 PQW~ r Fft-ctor: 0.478
Harm# HatrJl~(.a"''9l 1UO%Ulnit ,%(';tf limit H~rrl1::s(.rnaJl.l 151l%L'irllit ":Qof Llilla S ..... L\.I~
2 0,1]01 1,080 0.1 iLllO;Z 1.'6.20 1110: P...

3 O.It21 :2:.~OO 0.• .cl-022: .3.4liO .QJl6 ~.a'Sl>
n.4j:0: 0.3 0.001 C1.oIl4!'i- .o.2~
•"
a.M1 t'.i!l1i&
5 IJ.lJ27 1,141) 2.' 0.023 1,110 1.60 P.Lt!3S
0..001 0.300 0." (l.llOi O,45D D.:29 P.f1-,S"~
7 0.022 D,770 2.• -o.02J. 1.155 2.00 f'a'5l!;'
,.• ••• ra>.

11
g
0.001
MI23
D.DD1
0.019
O,lJO
OAQI)
D.184
-0,3::):0
..,
50.
'.9
-0.001
ofl:.iJ24
.fLDIl1
il.O:2D
0.345
O.+:HHl
C.275
0...1-95
-0,:33
3.£11
-lJ.4[J
4.03
PallS
f1il'9B
P...
12 lUI01 n.1:i:3- '.5 iUH)1 0.23-0 n.... P...
13 0.019 D.210
•••••• {I.1l19 c.JiS ;to!). :P.#J'~H;
,.,."
0.001 0,131 0.0-01 0.1 g] D.43 P.LreS
1l:Q1fii 0.150 1 OJ) i1:1J15 O.:22!'i £'.83 Pass
O.-Q01 O.11S 0.• ofl:.n-01 0.113 '1137 P:fI.SS
1.
17
19
0.014
a,QOO
D.-D10
0.132
-o,1Q2
D.115
10.3
0.'
'-7
-o.rt14
'0.001
{I.1l11
O,1S~
0.153
etHEl
-a,9?
'IUS'
.5.92
f'asii
P...
...
:Pi.l'5E-
..,
21l 0.000 D.D9:!: 0.4 ·[LDlJD 0.138 [1.33 Pags
2l 0.009 0.107 ••1 {I.0oQ9 0.1-51 5.5-2 Pass
22 D:QOn- M6. 0.000 0.12,!S. f1.31 ~
23 0.006 (Io,IiSB 6.' 0.00. 0.147 4.12 :Pass
2.
25
0.000-
C.-Q04
0,0'77
a.oel) •••
•.9
O.OD{I:
il.llfJ5
0.115
0.135
0.33
3.4n
p.azs
P.a~l1i
2. O.O~D .0,071
•••2.7 {I.OOO 0,1-06 -0.33 :Pasii
..
2.27 0.D02
0.000
o.iJm
-o.£l8J
-o.£!fiB
DJJ18
M
1."
'0.0-02
-jUOO
oll..OIl1
0.125
0:OS9
C.115
1.92
il,JIi
1.22
P...
P...
f'a'Ss
30
,.
31
;2
CI.OC'O
O.MO
a.noo-
0.001
0,0'61
o.on
.o.05S"
•••
0.6
0.6
D.OM
i:LOM
-o.aoo
0.0~1
0.09':1
O.iDS
o.nat;
0.102
0.40
0.45
{J.4S
1,16
~
?a~~
...
Pa.:;:s
P.a-ss
,.,."
' .•6i 1.'
O.~OO OJlfi4 0.6 il.Dim O.ila1 fl.4a jJ:fI.S£;
Il..TID2 D.DS4 2.. -D.01l2 a.[Jog-s 1.lH :Pil:9S.
O.OOD -o,-lj5-1 -0.000 0,-077 M. fa"3!3-
,.
37
39
0,002
IlJ]OO
0.002
-0,-061
~.04a
O,05-S
D,'
'.0
,..
0.0
ilJlln
.(I.1I110
0.0J),2
O:IlS1
0.01]13
0.0-67
2.18
,....
UO
P...
fl.i!l1i&
P.az5
.0 0.000 0.045 • .5 0.0-0-0 0.069 D.4'9 P:a55
~'i L' ='•.: ~ 1Q(r' ""f,j.'L'; 1~~.~..rK ".r,;~ "'f,~',I' (:1 :::',:'''~,
til. Infel·n:~1iOli~l EMf: S,enirr.h W""W..lIJ.rrml:CIlH· (H'lOlll.~l-: \ 1. I,MC

ColiaterallD 11-01
1.:Nnl-:,R'tVR1TF){~ I.At:r.ilH..~TOH:IF,S 1-";('.

M;:.li~llrtmH"I!T nfVolf3~e 111Iu~tll.lHim. J!lm! F1kl;:t~l'
'l.mul'aL::lllr~r Zim mH ()rr.lwllar.:die ~llrt"pjeal Prod Llt.1"-.;

f.CiuiJl'rn~r.lt l;mle-r Ted 7..immt.'r Elt:dri~ J)e.matltme
\lml~ elf Opt!-rill;lIIJ '~)~r.:::l:
J{f'fCl'oC'llCc- Stambrl1 1':~61 OOU-.~-_!o•.JO I..jANm'.:"'LP(;-H07
Test Res\llt: P!il~!j1
Pst :ltld ljmit lin!!!
1.00 _ _- _---_. __ .. - .. _---_. __ .-.- _-----_._---. ,._. __ ._----_ _ __ ._----_. __ ._--;"
0.75
F
,.
L
8! 0.50 :.:
0.25 :-
~:
0.00 -j---·+··+--i-·--~---r-·+--~----[--·1·······~,·-+--_·-+-·f--·--·-+···f··'1"·"1·---·--·j--+
-'f---J
Tlm!!l:! too short far PII plot
Vnnll: ~t t"-e E!rlcd oil~s.t IVolt): 23ttU2

Highest dt \%}; l'I,lJO Till'st Eimit {%}; 3.30 r~ss
Tjme{mS}> dt: M TiIl'st fimit {mSl: 500.0 P;;l;sa
High~~\ d-::: t%)~ 0,00 T~:.·Hfrnit{%j: 3,3Q Pi!l:~!S
Hi!;!hest cmBX I":~): tum Test l~mit{%): 4.CG P'8:5P.l
Hi!;!bes.! Ps.t (1 II min. pE!nodj: O.CiJ1 TF.!!itlimtt. 1.m'l[) Pass
HighClst Pit (2 hf, p~:r1 cd)', 0.001 Test limit: 0.650 Pass
~i., ;.:r::; 1q,;.,.;: "'''~''''L-; ,~·-.~-rK :r::~"" "':,<:-,,- ""; 1-] (:1 l'l:'(,
1I1. Int~·I'l~mon.9l r'MC ~(~l"\'k~h (Hll0.lllSl' \1. 1'."11'

Collateral ID 11"01
I:Nm·:.lol:\\'R~TFH.~ I.Atl:1lH.AT{)t~IF.!oi I,",C.

Mf'rl$llj".c-menf crflmn11lAiry Tn
Eiccu·o.s'Glli", n.i5..... h;;lr~1i!c
D.Mt~ T~!>'_~";; 11-tl+:,.\·1

\l.mul'l:IIl:lllr'L:r : Zimmer Or~.hC11111cdiC'~llrJJlc:il1 f"rmi U:l"j~
F..[lllipm1:flt l:nder T,c.s~ : limmn- F.l1:c.lr;;,: D~Tmatlime
lJiJ;:ch:ll'1:t!' 1'fdhnu Clfn(lIt"t
:'l!llmhcr ufHillJ:1:t=lri!e'i l{l ru:,;iLi... c::·l·~'N:.:,;;i:1thc
\"lf1d{!, OfUpc-l"atioOD
I{~fu!'enc~ :stan~aTd g '1~;I-iWl~-2. ~O 1-1/\ N'tJK:"'I..))(;-i!08
I ,Rh Te.mj)-er:.. h'ft' {UlU.. t b~ 'W-ls O:<C}
1.J1h I«-Irnh'~ lI11miltlt"i' (IlUl"! h ....~ll-·fI(J(Y., Rill
TI·:s-r I'Hf~"
21~V 3 k, ..JkV (, I~V 15k\-' lk, .>kV 41\.Y .ukv 15k\'
,
}-rorr ".l. .\ - X 1
" •, ,
X
ll~td.: ~ .:: !
Len "
2
.\
X ;
2 X
X
.., " 2 X ~
X
X
; .,
Ri~l
~
2 X ~ X 2 X 2 X
Top 2 X
, 2 X
;
~ X 2 X
H~il'cl !-il!. .
;
X
, 2
.,
X 2
.,
X 2
,
l
,
X
vt::' - 1':)~ll'!-Jjck;,: ~ X X
T:('" - F')l'l' Sid..::>:
"., .\
.\ •. X
., "
X
, .,
Obs:rvati.;;JR:S;
] - N(l p(:;,-.-.:... i>;..:--J di~t~1.::.r.J=;t~ LJ(,,: ...:1;1~~·\:~1 L~~T-\J~n;~·
lr(ln; ~:"IT.
"2. D-::-;;;'h;l't"'J:t: :~h!-ler.ci.. ru \lh:';~.l:rJ f1..,,::nm,;.: Inm~ :-:~rr •
... ~ N'li PcrriH;Ttl.:~l. -
~il' ;':::'II9{I": ;:i",::}',,,, IY_~.JI(~f,:''iJ ~'r:':=·41":(:J::t.... !,
[I). InU~1"n:niflU.M] EMf: S.t~n·ir-r.~ CHilO) lISI: 11. I',"'''

ColiaterallD 11-01
I:NlJI{I<:\VRlTF)L'-i 1...\tl(ltlATO~(,II:,:S I'\"C.

M<:-it~lIl-...' ment or Jmmunitl to
fJ.t.·C'lrrj).~1;1 ti...: D~ ...~h.;II.~~
D:w..:- T('~·_.t;;; ; l-V+·:"\.1
\hmul':ilIcl ura:r 7.:;immt'r OrtfHlJl3cdie Su ruk:.tl rrfln rn:t-.;
'F..(luipma:m l;mh.'T T ",-~t Zimmt.'r EI~elr;ol:: Dermatl!me
l)iJj:choJrv~ '\1"cthml Ail"
:IIllmJ~.;'r QfDi~l:hu:r~e, l{1 Pu::-:iLiw.: 1("' No..:gaLi.. . c
Vl(1d~ ~)ft)ll~l"8ti(lD ';)"r.:.(J
].(.efcrcncc- Stll A1.1 al'd 1';'0;611100-4-2, Jgl...·'N8K-I~I~(;-,108
1,I1h"r.emper.dnl'l' {Jllll'..t b" "2;(1-2.;;;; ~C}
r,slh H.....lilrh·"'(!, IlnR1i.tit~ , {lllIll"f hl'.\l)-f,(J'% Rill
'IT~"T "()INT "ll('I.illH-I'fll;,lrih: '''It· '~Ilh·~ 1"!lhu;h
21~V ..j.1~V n kV 151iV itV ~ I.. \,! 8 Ii\' IS ltV
AC :~Il,·.rl I I I X I X
E~ll'id~L X
"
hJpLIL \ I I X \
OI;":O~l S\~t[tvJl X I , x
\ I 2 ""
Tor r I(lrd~~ 1 , ~ X 1 , , x
. NrJ p~·..::ei'\.·ed di~'ll'.r~C, 111.': cb,.·~"C'd r(.':'i~I;"I.l:'iC from ==.:IT_

::' . Ir:...llm"'e:~ nh"t~r\·~(:, I:~: ~Ih... <"··.... ,,d r'~~',:(n~:l 1;'.111,' 'nT.
X - \'n' l~:rr::;I"lt;,,1.
~i,' ;':;:'II~r:: 'l1~f:}"" 1~.o:;'.[K~.(,:"'" ",,::,-",'''''01(1(;1 ~"'(,
lIl, Inrel'n:uhm~l EMf: S.t~l"t·iC'r.h w,'\...."_lI'-rnm!~m;," (H'IO) "sE 11. ("Me

CollaterallD 11-01
I;I\"OFlH,\dllTEUS 1.-\t~OR"TORW
..4; I ..... C~ 1l.~TA ~11]<1':T
lmmLmil}· llJ Rl1dillh.'f..l l::l.~.., .. tnH1H1l'11£"ric Fie-Id
Dato: T~~~~;;: ~ l-Ui j-'...-..1

\hmul'l:IIJ.:1 "n:r Zimmt.T OrtlHl[1l:11J.::dk· ;!'O:u~k:.lll Prmlllct..;
'F..(lU illm.:m I;ru.h.'T T L~t ~ Zimmer F.1~ch"ic I)c=rmatllme
Fn.'lllleIU') Sfl1l Sl/,L:' : fO:O,{,
])~e.11 Time. : 2.8 r-c<:.
Taq!;et : _~ "'"inl
[-teret'iI!'ncC" ~t!lllrim,,1 : l'~ "'l ri'lIlOU-4-J.. 30 I...·' N'HI<-I~I~(;-iUJ9
Cl:l"libntl1UII }"ilL: l"l'11l111:
J:ii"CQllCllC~ klm~i: (l'>-lU",} ; 8U MIll - 2500 mIL
\l~liEltl:II"IHt : 4.1\1 - ;.twx. ~l I 1~11 ..
l'ohll'i7.fLticlJ'l Ob'S.(l,l·l:a:tion~
r ~t'll
f:"-',:Il
V":::-Ik:~·.l
Ilmi7('1"lT:;1
'lirL'tIUer.lC'y naJ:lg~ f~·'EH~.) : 9nnMH:.t

\"V:ll!nl:)nrm : I~n]"'t· - 5n~Fjl Hmy f"'l-'d~ M tnO 111.
J'LJohuit../iltillD Ob..~"";\-llfions
F';":1o;1J. V~7"lj'~";f.l
}:;):11: Hori7,"I:lf.,.I
~i~r·. Vlj.Jj·;;~:l
"02'I'~ Hori"'-i.lt;,1
H(lri7,",:rt?.l
l.dl:
; - N~l ~~b:k",r,:..:.:..' r-,:,~,;.pUfl:S.;;' lrtJLrI l.:·L-l_

.:... - N~ll '!.1fl;JU,-t~.
;;j., ::.' fj 1'X6 l·..... lj~'L" 1~~.~.rK ~.:,:~iJ 'f''::'.,- ""i17 (:1 :::t"(.
lll. Inrt!!-R:nirmal EMf: S.t~l"i"~h (~;)O) llSl-: \1. 1:;1\:1-("

Issue Date: 2005-01-10 Page 43 of 75 Report Reference # E181905-A1"CB-1
Collateral ID 11-01
I:Nlml~\VRlTF'H.S I.AB~l~AT{)Rlr,S Pi(',

'J\":!U of Jmmunity tu
E.i.~'1,;.trk=ll .Fli~"f ·rTl1nstt.-Rt_~lBul'"'St
\l.mllfadur..:r 7.,irnm-cr [Jl:11}l;Jl~dil.: S.urgi(.·.. 1 PrCldnd~

F.qulpm~r.lt l;mh.'T T ~f. 7..irnm:r.:r Elt.'crric. nt'rm~t()mi::
Seuin (Jfl·:l.T :'o:tn:f.-!oOO Majn.~
o Ilel'~ ti Il~ (\:] (l ~ I!' NOl'm::J-~
I{,el)ftitlcm Fl'l!'quel3-c~: ,:)/: ·~::-17
B:llnt ])nraHon L5 nl:1l.::C
n:ll!~t pcriu(E 3001loU
\'lillilmlllll\~1 I)IU1:lf:ir,n
11I"1-.4. flIWJlr.JIICl! \olmfe
R.. . .rt'n!"Ilot'e- :-':hmtl'lJ"d E~61IlQIJ-4-4, JOJ41\:;.J.llK-LPG-tl1l1
.\1;1105 tlt"{,.\C j)l1.f"J"
IlUI''St PoicntiriL kY
U.:H.:.V J kV 2 k\' 4k\:' U.s 1.V IkV 2k\' ~k\'
1 X
x
Line I J.:. L:llC 1 '.\-::h I'(!:,:p..::-::: x
":(1 R(fP
x X
Line [ ..t L:llC 1'1-. with rco:.l'It,,-,,=" X X

:0R{'j-f'
Ljw=:} ii.:. L:Il": PE ..... ith T6VC(~_ X X
:,1 HJiP
Li11~ I. ;jn-..: 2 & Un::- rF ·....·irll X X
~l~L"C1 1~1 ROT'
: - Nfl ~.lb~I'~cr: !'e';.t'J.:ln:,,(: fJ'I;~m l:l '1.

'" - NOT c-.:m:tllct::!cl..
~·i L' ~-.;~l,?\i<; "'~r,}-.·: '~'-:~..rK~.r,:=~iJ -"i'::,," "'il~ r:l ='1;""(,

lll,lnrt."l'R3Tirloll).i] EMf: ~t~l"~;ir-c.~ (MOlllSl-: \ 1. 1·:1\;1<"

Issue Date; 2005-01-10 Page 44 of75 Report Reference # E181905-A1-CB-1
CollaterallD 11-01
[NBLRWJUr£l{,~ L\BUIUTOJULS JXC

T~'Sl j)f hnm1Luit.~· ttl
1::.l.N'ui,::lI J-"::.:!~t Tr.cr.llsit:nts/llunsf
'l~nufl:llr:lln'L:1" 7..i.rnm-cr Orllmpa~dic Su:rgicol' PnlC.hH~l~

l:.~lllipnu:tn I.,n~{,>r 'E"{.'$t : ZjmDler 1~le.(tr;c: llel'llliltome
SecrnlD flfl;t.")"i'>'1l·l:,I..!-l:11 : Mai1'l:.~
Uller<ldll~ 1\:1f1~l: : N011l1:lt
RC'f)f'titiml lil'equellc~: : 5J~ :~:-17
ilUllllllunllilJ'll : 15 [JL::''':-~'
Bllf~J P'i.:r-iEld : J(Jlllll.....
~liRimum Test DLI.r;nti~ll\
pc-r App(!-tu~nC'l.' )·looe- : 1mb.
R·;:fue-ncc- :"t:tIH.l,).r(] ; L\6JljOO-4--l, 30J4A~llK-LrG-UHj
.\1<1ins : 2:~tlVr\L 5f1H.t.
O,SkV I k" 2kV 4kV O.5l-V j k't 2kV -lI.V

X J \
l.ine: ) wit:' 1"('~P'[:i to .~(;p x
Lille I J.: L:I~C 1. w:th r"~r~'':;
Rnl'
-::0
~ :-:
Line r &. 1 :1''1(: PF. witTl rcspo.::r:-: X X
:0 R(W
1.im~.&.j :I'C L'[: ~',.. irh ]'i!::p":-C ~ :-:
:0 N.frl'
LiltC [.~jn'C2& r.i,J·;:['F'.;;.·irll X X
".\.'1'r.II;:.;,;t T.e He!'
; - Nn »hYCI'......::Cl':!:'.>r.. "~..:: fi'l;~m 1:1..'1.

x - .Ntl1 "'-\.JllJtKt...">ll.
=--i l' ;':::'11 Q(I'::: "~r,j"L-; 1~~.~.f1( ~.:;,:;'J "",~'::::;I"'f:I::r,""6

1Il. Intt~l·n:uinu:<:] 1·:Mc ~t~n:irr.~ (MOl "'1-: II. 1',"1("

Collateral ID 11-01
1:1\1)F'Fn\-"R1TE1~~ I ,.:\ttOnA.T~lH.l](S I'C~ n.~TA Slll"YI"

Immunif}" to Sllr~~Tnm;!iitl1l o~ en olhl:!::t~
M.u];uJar:1 UTl.:r : 7..immt:::r (h1hHpm~rl.ic !',LCrgic31IJ rHdm::l..

F.q1l1pmr;nt l:ndl..'r T l..':'lt : 7..jrnm1.:r F.JecTrk TJ...'rm:lIlclmt:
Opt:n1tilll: Mod,," Nl'rlJL~{l
SUl'~~ . t.pplicaU':m E{at~ : Ol"l~ t"o,!"" l~lin:.IT"'"
!i::""fel'"!'ncfo :sto~~.m1 ~ l-;\ (,1 fjjm--1-5 3j Il-t.'\ "'l Kh.-l.I'C-Ol1
T
'fain).; ~ 12f)V /I.e (,llr-]7.
1·(Jh.l.ntj'~ I'ha~r OI:l-:;etVarilm~
.-\nJ,ib.:
PIJ'~ili~L: :lind ::"!''i.'~~llh·i:
.4fll)Ii~'at l~rlr~nn.91 (J:!\')
Lbu:-Lint\:
!JO" 0.5 l.0
Mmk IIr 4.1'I,lic~I{Jln I~\; ~IH·~i.: ..!"pplil'},IJIEIIl
1:;(J'" 1 2 3 . 5
roll'':: ; Wit~l ~":::'Jl.::.£:t tl~ f.J1,C":2 ! ! I I I
Pn)n:rit:",: P1:talo.,=" Oh<iCl""Fati(Jn~

ATJoj:!;lr.-
('(J ... ih'Ve. .ani1 '-e;:l:siive.
Applill"~ Plltoni;lill (kV)
},im.:_E.Hl"lh
"Uti 11.5 1.11 2.11
'\hJ:1e ..f Ap])Hcatiiltl 180'" SU:i'~e Appliurlllil
Lin.: : ".. . jth :-~·::,ip:..'d it' fiE

271)<;: 1
!
2
!
:J
•I
5
I
LiT~~ 2 ,""M :".;:::ip,....>l k Pl.:" ! I I 1
Ob':>t'.r"~tiJJns
1 - .N~l .:.~bk~!";~.:.· T-:.":>pum;;: !rum l'L-l_

"\," • NOT C::OIl.;1U·.'Ti::d.
~j <' =-:'fiI9.;',':: 'r.J"i~~'L': ,~t.;.·nO::1.ri:~'-' -"~~,,,, "":;....l i f:1 ::1,....(,
lil. Intt~l·n~ujrm.aI Io:MC ~m",:irr.h W\'\'tI:'.lltf'nm!cm-r (~<lO) lIsl' \1. '.,1>1('

CollaterallD 11-01
1:l\"nnn'VR1TEUS I.AROR.lI,:rf}RW,S r\(:_~ Il.!lr.TA Slllq·:T

hn!nll ni tr to S. L1r~~!Tnmli it'lll 0, en oltl1 ~~'S
\"~muflu::j un.:r Zirnm.,;:r OnhHrrn~ii: Sou:rgicoIl PT(ldllL:t~

F.-qniptn~lJt l:nnl...'f T ,,-~t 7.,irnma Electric TJHm:llllelmi:
Opt::ril ti ny: l\] (Ide- N(lnn~tl
Sur~~ .~PJ1'Ii("atilm Rate On ~ f"....· nl11F,IT!.?
Refl."t'encf" lStaIH!al'd t;:\{,HmfJ--t-5. 3lH-lA'IKt'o.-U'C-nl1
\-fains- ~ 23flV.-o\C SIlf-l7.
1'f1IIU'ity: l'lill~t' (Jh'l-er'\'ari~'IH

A.al:!,l~
rLl'~ilil'L: . .d ::"I'i:~-H[i,"'c
Apl;lied Prlr("ntl.'ll (tV)
Liu\..... Line
=li.I0 0.5 1.0
(i,:lr.;lt~ ltf 4."I,lic::.lillrl I~O" ~uq.,.",~ .11, pplil'.H1 iml
27rJ'" I 2 :\ , 5
Lit"':: ~ '.\'lfl, ~·.=.<;p~t K Lil'C" 2. ! ! I I I
PoJ..trit~': Ph.. :;.!: Ob"trvati(JI1~

.oil;.nj:';lr.-
l·fJ ... ithl~ .'lnd '\e~th'l.":
Aplllil'd Pnt~nt;al (I.V)
].irlt.:-Eflrlh
'l:HQ 11_, 2.11
1.11
IVltlfl:e.."f Apl)Ucatitlt1 lkfJ" ~'E'~e Appli-c:ario!ll1
lin.: ~ ,,\·j{h :';:::!ip~'~'l to:.! FE

:17JjG 1
I
2
I
;
•I
S
I
Lin~ 2 ,\·jth :-"-::::ip.:..:.t it! PL I I ; ] 1
~ - N~) ~~b;l.:,'r'i":'-· r,""::>pul'3.~':: ~[lJlrl l.:L-l_

....... Nfl! condLl·,;-tL:d•
• j l' ;;c.' ~ 19\r" :>~r=j,'~" l~··.~,fl(",!.f:::;'" '!'';'l':!('.: t:1 ~""{i
lll. InU!!"n:ulrlon.ll:] EMf: s,oL':T":j('"C'$ {~')O) liS).: \1. 1:./\:],('

Collateral ID 11-01
1:I\~nrH.'\\-·RITEn~ 1.;\t~OR~T~lRIK'o;j I"\"C... n . !\.T.'\ Sln':l~T

[mmLmit:t: l(l Condll.. . . feu I::l:t.:dn)molji:l1Nir DL"iturbLJIll"t"
\1<1nufaL:,ur..:r Zimmer Ortl:lc1Inu:dicl'illt'lJie::.ll"'rCl[luct>i

F.,q"ipm~r.lt l;ndl.l-T T~t Zimmer Eh:clr;L:: nil"rmamme
I'TL'qllol!'lley !('an~1'J: ~ 15fl 1~1I7. -l'W :\111.7.
l1fu.tuI:;lHon : AM -.~fi%3r 110:117.
T.nr~~t V!llta~e : .3 \'rm~
ri·I,;!.Ju.eJ!e~ Slc[l SllC ; 1%
D~\cl1 Time 2,8tlcl.:,
RL~ft:n:m:i' };1:lIld~I!"(1 1 1~"\{61 OOH-4-6, .1-(1 ~-I.~Nnl(-1 ,Pt.-HI!
~HTION Sl1U:SSEl> OBStRVATJOSS
: ~ Nn ;;h-;..:r... .::i T~-;pllrl~:.: lhrlTl P.(:r.

\ ~ N'l! c:lln~lLl;;I.:Li
~i., ::.'::; I ~ ....;: O)"'f,.i":"L" ,~·'.~..rK ~.;i7~{j -""l::'t4':'f:1 ::l.....(,

[11. Inft~i·M1ion.al EMf: S.Cl"\'irC.':- (SolO) lISl-: \ 1. ".M"

Collateral ID 11-01
1;(\"1)nnYH.1TEU~ I ,At~OR"TiHt.lK'" .,c.. n.'!!' TA ~1.:a1l{}':T

lmmLmil:,!-" [CI PO'>"'~I- n·.. ~u~nC}· ),.l:i1J;:m.....k Fidd~
ll:l11ufa-c-tlll"Cr : J~inm"'~l' OrIllfIJl3oCl!k Slnwc91l'r~lducH

1';Qn;llnlC"llT I nrl£:r'r~"t : .IJiRlnl~l· ..... ICdl-k l)(-l'lllaf1'mH~
"'r~(ll1 ell cy i (.-1.1 50 H:;:
RdocH::UCE: ;"lllilloll~rd t'i6100U-4-S, JOI~ANIlKCLPG-UJJ
Jbill!> 12)VAC' 6aI£..::
lVl~I~.neLb: J·"ir.::M SLn:ll~lfl:

Cui! U.ril,;uL./;IHlJLI
), A,,irn ~m 17 ., Afm bfJll7 :~ll A;.im
X rl~lllt I I X
'! rhlnt.: I I X
Z ?lar;,~ I I X
Obsr:rv:lltimHi
: . NCJ :>b'.-e:I'l;t::f,.1'l::';:r(ln!'·~ th~m H:J •

.... . N'Jt c(tndu-'::T~c:L
~i l' ='.: :'Ilgrr" ;'~~'}"~ I~'-:~.n( ~,[,::;-i,l ""':'i ':l;~: {:I R."(,
1I1, Inlel"l~:uhlollM] EMc S.l~l"t·ir['.h (Hilnl liS].: 11. I'."'..

Issue Date: 2005-01-10 Page 49 of 75 Report Reference # E181905_A1-CB-1
Collateral 10 11-01
rJ'il>ERWRITER' LAllOlU WillL' ,,,c.,

lmmtlUity lCl J-\I'\."C"l- rr...<quen~· }-l,l~ndi~ Firz:W~
llATA SHEET
\:la:nnf"aI:1'IWC;r : nmnJCl;" Orr.)UIJlgedie S11lWcall'rn!lul.'1'"l

I'.QflTpnlf'IH l...mlCl"'rC'l'T. ~ I~innucr t:ledrk Dennatonw
Fn:qu.CJIC) J"icld ; 5(111.£
Rdocn::uct !'Ililloll~l'd l:'/6lUOO-4-S. JO J~ANllK-LrG-OJJ
"l~ill'" : ~1~,\''''''C' "·:)T:I
M~IJ4llClit fid(! SlrCnll,lb

C'iJil Oriclll-lltilJII
J Aim .sUllt: J l\/m 60lb J~I Aim
X Pt!ll~ , , X
..... l'l;l.Il~ I I X
7 :-'l1lI'c I I X
n hse'Y\'ilTi rm oil
! . Nf} ;)b';,,:r...~::;' !'l;:'j.pO!l!'O·': th:m 1-:\:1 .
.,. , N·nt C(ll~;tLl-~"1~cl..
:"j l' :'-.':'1 r9\;';: "~ru,"'; r~·'.~.[K ~Ji:';~ "'>;-''?l~.·~ r,] ::t....(,
til, Intm'n:nirloll),l] EMf: ~1.!l"\'k('.h (~ilO) llSl-~ ll.I:",J\;lC

Issue Date: 2005-01-10 Page 50 Of 75 Report Reference # E181905-A1-CB-1
Collateral ID 11-01
1;"lIJ(:",RW~lnq:.t." L..!l;.Hf)RATOF{Jl~·.~~ lJ\T_, HA:fA ~IHT.T

Vult.li;:{" Dips, ~IHll1IntC'lTUPlioR5.m()Volt~:I!.C' V:Uillliol15
l)~LI..(· T.;.;::.1o....u; ~ l-r)~-:"''l4

\l.mufat:lnycr Zirnm-Cf Onlmp<lt:dic ~Llrgic-.. II)mdlll.:t'i
F.[llllpm~r.It I;mh..'1' T ....'!'lr. 7.,imm-cf Elt::t:rrie. Dt'rm:;ttclm..:
Opcr.rrhJ'Il Mode N~lnn;tl
~1l!·IlHJ.1 OpC1"anll~ \....oltage- 2311 Vac
I1rc[ll1~Il("Y 50 H7.
H,L.:locn::ut:<: ~I~lm..l~rd l::."6JOUO-4-lJ, J01<"NllK-I.PC-U!4
);]~ill!lo t~tlVAC (~O!'JL
Tc~[ Lc ... e1 D.rUJIIJllllhnIl1lJoLI CummeuLli

(% ~Jf Numml OpcmliIl~ \" ) { C.y'l:ll:.S ,r'Iilll[, iu 1IIl!- )
U.:-.:" IIJ
; - Nn ...,b""'n.. ..'~ lr'!JlIL l.::L

M
T..:":;pLJJls{, [.
2" P':;'J,"~"r :lnrup Li(.",-cr-.;,'i..' ::Jur::~ . . \·i:1=.1!.J<t· \·"';l.~%= di~J . .l;1.,T f~:WljIl(;d \)"P.~*".L~O;J('".r w~tll,.;.1') l{lS:i- (11
(:In(·lt\.IE
3· H:T7Ilf"l'I.Al'.(1:4' <111("1 t]'cn bad ",1 with tlH: n}lt~t;;~ :il'':'::IT.1IJ.. Tl':::: f-J.: :l.:;tLIm~ m .1(,<:1~~l:l:
'~rcrlllj(,T' ,.:ir:~ 1:1i: li::-Ol.
... ~ W,1[ "::l,n~lu;,;ri.:~"
~i.' ::.':'lIQ.;·,<: "'''l'j"'L'': ,~·~~.rl(":(';~"" -..,,~;: :::.;....5 r,1 R....(,

[Il. InfCl"n3rlrm,:,lJ 1-:1\4:C S'!l""i.r.~ W'''"W.1ILrrlnl,'cm. (~<lO) lIsl: 11. J;j',W

Collateral 10 11-01
1:'1IJ1·-,I("\,\-'RlTI'l<S L .... I~fW:ATHRn·:.S~ lJ'!lYi:_. -HATA ~!1El:.T

Vfilt:~~-e Dip..., SIHH't IntfL1'I"l11)ri(1I!1" :~"l1 Vnltn~ ... V.ll:l"i.ar1nnl"
l)alL- T ..:~1~.J: ~ ].tl3.:;'·1

o
\t~rmf'dL::luf"l:r :7..irnm...::r ()rllmp;L1~[jjc Surgit-..I PmdlH:t~

f..Q.lllptnl!-rJf l~ml~r T ~t 7..irnm-cr Electric lh:..m4:l1Clmi.:
o pH" tj 1;11J 1\1 ml "" NllTITI:il
'{.I)l"maJ ()rel'3flll~ \"nU3gc z:mVaot
l'r{:-(lllof'IlCy 50 117.
]{~ferC'nce Stao,hn'd E:$,HJlIO.o...1-H. _~fll.J!\.NEfK-LrG-H1..J
\-biOs ! 2fJV .-'\!~ {,Of-l7.
Te!>! Lc~d Vn1pUl1L l)Llntl1U.[1

{% fJf Nl).rm~1 UlJcnlliIl~ .... ) { Cyd~s rriuli: .in m:-. )
05;" ltj 2
U.:': IU
:~
~ - Nll :,h-:<.n:c;: n':~[1uu=",~ fn.:rn 1J <'j •

1- !-\r\y:.:r h1n;p n('.~r..:';.' :.JUT"of l,.\·i;J;, LlJ-t \'U~Ll\:?t di? LLT re:nain~d ~lpcrt'".L~O:.Jt'".1 W~1.ll :riO 1~):i;;'llJ
:\In(·Li$!;
J ·1:lM[ :.L"Etd I,E1 ::mJ Lh..n ba,,;k -~';J ",-iLlJ Lh~ "o;)Ih\;::;:~ :n~~fr.lp' •. 1"h.: .liC-: XllifLl~ W:Mh:a:
llrcmtiol' ~rre- r:h.: t~r_
\ • N,)1 ":;\Indtl:.:l;':l.l
~i.' ::_'::;19\;':: ,,~~,j,-l-: 1~'.~..rK~.:i:~'" """'?l ""1'"'11 i:] R'"'(.

(n. Inft~:rmlTjfm.lal FMc ~1.!l'1iir~l> WW""'.lll.rflm,lcm.r (H')O) IISI: \ 1. r,Me

CollaterallD 11-02
:JI :I1",·~,·1t>r:11 ;-r,.,.:: ""~ ... ;;:-';

~)::,?: ~~l;..~. Ro;'l(:
:-J~-_..,b.-iJol; 1lino~ eO~I'>1-:;:C~
~:;co: O,':"')G~
:=:1) !<>(._:&1:'; ;l:~S,};.4
~1r-:;;·""""'i ....i.~T'!"'''c.:
ZiJt.!.lu;,:!" o.dJ(~P:'IC'd;l' Sll~'!:!,jwl P'nJ1,;-LI;';lS

.-\tLl:: .I'dr. Lll~..<.J]J U~;::lIJJ]
::,(,(1 I,.V nl.in ........ ~~ p() lhn; S{~I.1
:h.l\"-;:;r 0], '14i'22
S".1hj;:ct; E\fC T..."l't i"lIH~ Mcz.~lll"':fJ1cnt Rcp:-,r, fr.·j"

\·l,...,d!; !;mln\'1" J·.kl·tl'l(" Ikl'nHIT('Iln,'
'\~,~ 1m.....'" :a-..;vh.ko:J ......:•.;J LU~ kLkr :"~HIL" L:::....lC "1"("::;:. R"'IJnr:_ ;{.'l" Lll~ ult~' .... :;! r'=:]~~"<;''jL~~J JlK,~k:I. '.';J('
jm)([:It:. Wl:l~ J.:.l.:mti<'Jc~l :1; ....U:lipl;· w:l] I Ih~ 'Xqu::::n~'::"ll\; :,n·..:::l ill J1'..: rc;:l,rL
We: ~.~p'·'::l:"i;)n: ;)'Dllr ;117-.:-r.::~t ir. lL"s t-:r...JC :':.""'"ic:-.::",, tm':' ~n.:::')".lr~L'<;l,'" yCli tc CO.1'I:<:..:-r 1.1.:: il' tIL:
futLxe :o:lWllld yell I',zcd F.:-"f(: Ti;:f: !~c:r'>:l'C'~_ This -:10'.-(:'. P'rr,j.::-c, n4C....5..;75:".
_-f),? f\·k\i,.~mi;]ll1:> (:=;"I;T -=-~2J5 I .~.j,}d~ ~t:..'in~

~·;)i":::::T RIl~in-.::·.:r S.ccticm ~kll.a~C"r
l!lt·~~ ll~Lti(~I~·;:.l F.h·1C ~CLl' j,:;,,;:::: lllt·.:~ lla:iGn~ll F.·l\,lC SH\:j,:;·.:;:::

Collateral 10 11-02
EMC - TEST REPORT
,i f.MISSIO\,S
IMMU'\"ITV
Test Report File No. 1V!C2302

Proji:d No. 04CA53?55
Model iTypc Zil1l1nCr

Kind of1'reduct Electric Dermatome
Aprlic~m1 ZillllJl~r (kLhnp;;'lt:dic ~'urglt.::..,1 PToduc1.s

Licclls. Holder Z;nuner Orlbopaodic SUl'gicall'roduds
Addr~ss 200 W Ohio A,,, Po Box 569
Dover Oh 44622
\'falmfactur:.Jr Sam;.:: as; . .\pplicant
Test Rc,uU COMPLIANT

Th.i;!; l·....jHJ["l wiL.l:hlut ~I)p'i::lldic!i!:s ct'lnml.s t~f9 Plt~'tS. "\'I)p~Rdb. A ~ontl:liRS t...'1illlhotO:i? ~Ild
..\PFr:!-IHlh: B cont"..im; m'iginal r~;:;T dub. Thr clata mmahled in rhi~ I'qlOt"l t't-fleet-.. rlllll~' the
iwm.., tt.'1'I1:I..'d in rlu. ~lmliF:urujlnn!L 31ld mmk ur HPL'r-.Ijiun~ de!'lcrih~d • .-\11 ~Ut.'1TIpt h::J>i. bt.'en
m:.ulr ICl arr.:JngL:: thl:" F.l.T~ ~'llh IhcL'(lu;pmeDT prllF1ded. inN ~l te:!li clIr.lflgIIT:d:lintl )~'hkl:l
m.BY1mi7.e.~ t~-e {lh'I'"r\'l'll-emi.':.~irm.'t l.JfH1c- Fli I'whjh~ '\imn13tin~~ 3~ "'0:'1.e ~B r.n':ffn.iil. no
t:H>ical f-IU!...,llltl? iU.';;V;tJls.rinll"
l.",..krwr!r.e~; _.ilbcra;;..-.r;c-:i rl~":-• .a:l-"'::bmi7.·~!:i -:I~~ f.,"N':: r;;);ll:pill~j' -:.-, J'L:prn:fu..'~
:bis r..::pcr:prclvj;icd IT i~ r..::r·,-,dL,,-~d ill its CP7~ri:ty .
.n.~ P'iflj;::... lu Rd. -";urlhbTllllk, II. (,llflfl2

f11:'C (8-1Tf 2:72-8864
~iL' r~-11-'1::-:"" f\'·l');',~1:(.. I(""·::7-'::~ I"'.J~~ ... I ,I!"~'

lll, Infel"n:niflnHll·:Mc Sl~l"'irr.h W''\i.''_11I.rrmt!r.m-r- {':WO) Wn·: 11. r.Me

CollaterallD 11-02
REPORT DIRECTORY
SECT10"i TITLf:
GENERAL
),(l Ci..:J:('l".J.l PwuuC[ Dt',;{;.,rip"j(>lL
,.1 \{ml;:l Din"l,.':r':II·;:'::::-:
:.2 :=::r.... im:mll..:IIl.;i.: C;nLli·.irmloi 'll TC:'h T.llh
CfJ~brr.i:o~ IlCLa:J::l' ~rE:l~lip:Tlo.:rlL l"Sl':1.' f,lr :r..·1~'a;i.ur~·m;:,n~
.-.[.1 j' {.-.r.uipmc:m lJn~er "I":-:;T", C'-Jl1tl~:lra~i{"Jn
.-,lJ r Orc-.;rin~ :\.1~1;k
:")(:\0" ic ~ ~"f (Jet: ti ~l'.i:n:1.<;
1-: \"1IS~Hl"'~
,.0 - ".(11'!';,:j,:IH 'c;;'TlktGl='!tk:I~~
Ctl:JJu("·k:d VoJL:I!;;:'i.\
~~dLil¢d l;k.t.1rk· h::.:: L.:"mis;:.i(lr;:;,
r'>lMU,ITY
J.O
f'O!)i 'J ,I SolO'"

.to (li::I~~I~lJ !-(..::n1tlL',{O':
4. J SLll:~m<.lIY
AI!t'[:\LlK1ES
A ~~ ...[ :"-i:~J.JP!'. ~':'hLJk" D~~rzl"}lrJe, .11:il ')rm" ill~.... J
,) ':'{":i-LDaLtt
::OiL' Ml-11:":'1:. ['>.r';':,\1:1~~I('.';~:7'::~ r-oI~~'" ";:.,t"~

111, Intel'R:lrlrmi.ll EMf: ::;'t~n:k('..=:. {~')O) ll~a-: 11.1~j\;]("

Collateral ID 11-02
I.U {;I·-f\"1",lol:.41. PIU)UlICT IH~~·I.u .'TIO",
nl~ 1.111*·I'l::;I' >lo:'('r.h::: )(·''f('~I-'ljP\::~ <J ..:;k'11 ;:,I'Hftjn~ k~fl~m1~~I~tth"F j" inrt"'"'ld .. rl TO ·~l'(:vid.~
,;t1ri:::.bk ~ll[ 1hk·kJ.l~;i..~ anLl w:dlh. {.t'".p'lb'-~hlc:s.
J'lJ;'" U. T tl~~d L:IL,ri,J~ [:.Jj~ ~~n";:~Lh~l~1j~~;J .....(..:; n,{1d:j<tJ i.'~ r::"'"jll\J\·iJl~ Lbl" t:l~c:h. ~.. i~·(: that
CIIT'n·;::.:ls p~ .~:. thi.: !--..:..:mlt.i.;lT; (nutf.Lll siLl;.:;. (I r.','.:: "$Lo.pply (~;::c rig L i~1 ;\]':r:IJ:=n,li:-: A,I.
nli~ I1Il1djri~!llk..-J ,.....:n~m·(:-;. Lil,,; :i~i;.:s 'l;':I.~\'JTk .;,::·,n~i:'llin~ l)i'~: r":!-':;)uf RH !If'~[ '.rc
":'Lpr.ciLo~C21.l1h.I::rLPE. R;.tL'i:r.,~·~; :;:;n;j::;~ju:r.~ ~ ..i ;,,'wm.il.:l:':!:':ll "''Jaa~ '.\-cr..: l\.:Sl'::': l.U
dt.:tel'll":i1c j:·l'.~r.;m::I1;r.llC ~~"ie~ 'lcr"}{I)I'!.:: th::m Tn.:: :;'i:{x:r1CiJI'Y ;;,1.;',.c ~:ft-he: ;;'Llr~lr TI"':I ."._
Wfad ~lf!"~~t t l~' t·~~ ",::s'L:lr::; (l~ 'l\):~;l in rJH: '\..'r('lf[ m:t~d Nm'l:m,'..::r l~). 1:1.1ll-+ ril.:::
FIS] Q:!:", P'mj.::tt: M~..:2(1"J1:;O_
A:J IHl!;..,r h.'~b .....,..:1~ lA,l:J:tiJ"'I':::d :.~, !>co :'~pr<":lo<JUlcoJ b~ tOt: LI;.'::;t;lL~ ill thoe r""p~>rl JULo::d
"\rw:~mh~""l6, ?Or}",- l'-i~-e: l~l:';~L):i.:'i. }ln~i.'[:l· (~4N~26"Ti{;'.
1,0, I Eqllipme-ra Mlj)bilil~.~
'VrJITf!'''~~\') II ;"t':filH~IH;j' {liz)

:2_W :-.l)
(il)
I.J )tullEL JJLWERENCliS
Aa)' 'Itll~l" m(ld~I{!i" .r~l'.re51ent. ."'t.I b)· th\' mddl... lo: tt.~1e-d in thi!i im-e-sli~llti(l[l willlJ.e
rluclllUellt-l:'d by til.. .• manllfllctunr.
1.2 F'\"'lIW~~TF."T.-\LC()NmTl()'i~ J'i Tf:ST UB
!'C!-Inp(!-ntpf".e: 20-25 ""{:

£~clath'c HUl1lir1.ity~ J,O-lln% Ini
Atmusl,hO::J'ir: 11.r~sllrL:; SM· [060 LEI IJ;~H.-
1_1 C4I.llI.~4:rION tW I-:QIIII'MI':NT I:Srll l·-{) ..... MI':ASl:U 1':\'1 r ....,.
;\Ill,,">sr [,"f~u:illmt"1.\l llmf te-n ~u",,"e-!l-!rotks~n .c"libnllt.'d on a rt::;:u.lltr IH~si5" 'fhe-

m~n.imum tim!.' bctwE.'"e-n ('ltlihrmim],si5 one- ~. . 'm- OT ~\-'h>Jl is r-l:('ummi:'n.d~d Dj' fllt:·
m:lulUfal.'1lmH', \l'hich-e\"{:I' j::; I~::;~,
;\1]1 c:o.'t t.'(lllipmertf t".. Jihr~liCln;~ arc lr::lrc:.c-alfl~ tlI tfJ~ op,' atinfhllln!oltil uk ell' fjJ.uJdnrrlll
::uut'; -edmfllf"lo~Y t"";-1 !\,'I'), tncl't~for-e~ .1'111 tC::lT ll~t-~ l'M-r"rol"dt':;! in ttlj.. rt~1'l(n't i... tnu:~t~:lhl~~
t~J NI~T.
~iL> r~'ll-~1~; l"'r';..."'l:I~ul(.'1~::"r, rol~:'" : >lfo;.

lll, Intefn:nfflll.aJ I,:'MC S.t~n:ic-!!~ \lolll0) lISl·: l1. 1:,1\"1'("

Collateral ID 11-02
S-L'e APJl£"lldix A f·\)[- iRlfl,,"idual Se-Hl]) cuUJiXU.rilli'll1{s). In ltddition ((J Un.' EUT, th~
f.lIlh.......·in~ ]t-l:riph-rrnl d,-'~ k ........ ~nd/\Ir -l,,'~bks w~n C'omH~'l,.';h:d durjn~ the
m(!-~:sup~mcnt;
1.5 F.I:T OPF.R;\.TlX(~ ~'i()nF;i!l)
The eqllipm-cn"llIHh~'te'll ""8'\ lljleT':lrfL.f rhll'in~Tlu~ nu~:~.ml·r-m.cnr~ IJIH!.el' tl....

ffllln:wing t'lmdmlm<..:
F:J'_" nLdi~Hi.:.J t"ini::i~oOIL;:;"t, r"::1:~Li';e 1..:.:xJ w~r:; I"l:;~;; i"lr the ~lHJL(1 b;,:t(II.:IC'>~f.c. ~.~ -t";'. ~J"J;'('·T
L;''':lt~ Ill:':' :JU1;t1 u>;.'\·i;,;;,:: \~~L1 ..:":J,,:,'(;<.LLOC ~·\)"1jJt .•j(1 ...d _'·.
~iL' r...l1~~1~'" 1'.f):,·.·.1:1:~1r....,~:;.;:~ P.I~.;.. 'l"t"~

til, Inr~l·n:nifm.8l EMc:: St~nirC!h W\'''''.'llrrml!C!m.. \:r.;.l0.lll~l-: 11. 1=,1\:1·('

Collateral ID 11-02
Jbnuunie:o. 2iuLlllil.:kci: [oI,;Mill):!, ',"ll;!' i.:llll:!ii(f"'"!oL.:d i·clm:~cll.oI,;:;j b:r lIu.: JbI.J:IllUllil,;:!l ./lnd
flicl...u lC'!!olllJg ill [lie n':pU!"L tJalc(f NiJ"'cmbc.r lb. 2004 [4"ilc: EU190S. J~njjc('[:
04N'Kloi.'I).
~jl' r~·tr11;":"". !".r';';,~l:l}r(":\·,;'7"': r-,'.e.;".,t"l;.·

[fl. Inh~I'R:ujj)n~l EMf: ~,!l~i,"!'!'\ (Mil) liSt \1. 1'."1"

Collateral ID 11-02
..\d.... l:mL~!l.l M;;.,i.:lel R~~3~lD :S>~t"'~-"L:m ALJi?.Jy..::cr ':i;'\ ~172tn·12

1\·lC1dd RJ5:); I"n::.o;:;c!.:c:tr,. ~:""\I ~297l)(}2..q,
S{)l ...... l~ ~-l.)C.?J !1:60::=-::-O.1 ;)-:"0-" Sf\. I)c,:Z':fll.:i No.1;\·fC4(;6.1::

SoOJA L{ fI,·]c.{',d lo;!~C'?. ~e.o r:'i.·:'oe .... S: .... :-.:~·/it!.:.- NCl. t-<:"\K..j.O:-~
J'lJo) r<':~Jrjn.'[JL~:Jb Jr.,.

~jU
~il' Ml-~1::-; l".r~<·,~1:(;.. I("''''~;7''~ r,,::.;..(r.,t",;>

(1l.lnrt~l·n:n~on~l EMf: S.l~l"i,"c!~ (ROO) lI~W 11. ",Me

Collateral ID 11-02
1(.<\IH.-\"fEl) 1:,I.Ft'T,ll('l'-II.].n I~Mlssl~ l"'i::;
}kw:~l~.P~.';::':"~. f.l.: !'1r](ldd 1l5MU Spcc:nlr,J "\Ml~l...'r

l\·l(Jdc] ;H:)(,~I.'\ {j.1Zl:'i:j.pc;]k {\dilF.::r
~~fiL:q >\M·3;\~Of)l) r !f!.'t :7cflltl:"': Y;"- FCi\4003, P.\·1C4G :6. P.t\·K415:
l....l dd gS6:-;S,:', :U: f'-:-,.':;i;;.h:L:I.:m- ";;. F.~.-fc::.n 1.'\
C:Jf.S(' cMC L;J .• mlA.uJ~nlJ l!.'Jl~~ltJ~·. :'v!l.:iJd VB/.l6Ilj6A Sl.'" 124(.

CJ(.s..::~.\lC Ld.~ L~'_!;!, P'~ri~,dc AilklUK, r\'h:~d CPAli}OS S/::l~.1o
ff..:'".....U.:.'l':.!....... R.ali.~.:: ;"(:'\.{::'::t!:.'.Irl';~JIe-Jl

3tl .l\·-EJ..!- ~ i-ill(i)...U Jl'.
Tn;.: rcql:.ir~IYIc:"[b; ar..::

MET
~'i l' f..,1(:>1:Y'. P,r,.:..·,'.]; 1:~Jr ''\~:''~ PoIs.;."1 _,yo;,

11), InU~;·n~fTjn.n.sl EMf: ~t~l~i"'~.\ (~dO) liSE II. J;IVW

CollaterallD 11-02
].1; 1\'lVTutlnv -rrfo;T HE{~U .ATIONs
Jmmunity lestin~ 'lol.":lS nut JleTfunned oath... .· modified ~lunplt::. lmmllrlll} lestill!::!; 1HtS
consid.. .·l·-t:ri 1"('I)n~:r.:nled by lh-t: immulljt~· to\:'51ing. in tilt' n..'port thl(~d Nll.... embel· 16,
2004 ]-'jk~ USI5.l(l5...P.ru.i...'t'~ ~)4~K26739.
~i.' r,,11--"~!':~' [>'/);<",~l:,~~I( ....,·;:'7.o::~ 1',,-;:.;. ~ "r~

1Il. Int{~I·n:~nfloU.lO:l I·:MC ~l':n;r['Jl. {~I)0.l U-!'oll: l 1. 1:'I\"lC

Collateral ID 11-02
:LHrL N\i"'~Tlht=r:::2., .:!(}G.

::llti NUI.<c;:TIr...:r 24. 20G4
-1-.1 SlJ:\-1M:\R'l;'
\·1'".L
~lnd'::I",·it;:'.r~ r.1.:~tnlt(l[ji:;; Inc.

333 PII:"lg;o;t;.:n R(md
":~T.:lhrul!k.:1. i)~}fJ~2 ::s.:\
:-~lC ~'](;'Vmjmn:.: (S-L '::';2l5j ':-;:1,": 'k ~a;::h.l~:

_' ·;)iect l~l1<!,in~1' };c;;.:uCln M1.11aSi:"I'
~llh.":llatiC:ll,<'.r hfl.X: Sc:n,j::1.::5 :llt:.::~ I1~L::r(~lltlJ h!'.-lC Sr;;rv i':-25
~il' Mj-!!:":". r.rl;',~l:I""'I,":I,·;;·?;:r, r-,,~;,-:; _It·~,
lll. Inft~l·n~fTjn.nBl EMf: :'(~l"\'irr.:~ W'1.-W.. Tll.rrml!cnlf" ,HllO) liS)': \ 1. I'."'{"

Collateral ID 11-02
A.PPE~LlIX.-\
PHOTOS
~il' !,,1l-Yl.:::' r.(~,.':.'l;I:wlC.""~::"r, p:,~.p' :\! .,f :~.'

lll.lntt~l·n~njllllli:] EMf: S.t~l,·iN·.A {~llO) lI~l': 11. 1:',1\1£"

Collateral 10 11-02
COlld"elcd ,·.It.gc
Rndhlted Emiscsions.
:=i., Mj-~:i: r,~: ...." l;(...I(.""·:::"r, P"~'f:; .-\.~ uf ..\ !

lil. Inrl~;·n:uhm,gll·:MC~e"'l,.irC!h (H,)O) HSl-: \ 1. r.iI',,"
Underwriters laboratories Inc.

Collateral 10 11-02
.. _-----------------,
• . 2,sF,:';'::::,:.,
- ........•.•.............. __ ._....••.._..- -
U'i~ !)
Cin.'uU )-ludificllli'VIbi
::"iL' r.. .l1-~1:::. l"'rl;'-,'.l:'-"IC'I"'=:"" f'~:'f:; ..... ' lIT .".'

lIl, Infel·R:~Tion,g] I·:MC St~nir-('-A W''\~'_lll. ..rml!cm," {:r.;llO) lJsl·~ \1. 1::1\:1-('

Collateral ID 11-02
"IT.ST IlATA
C'I1<lI{Il-ch:d Vnl[.JL,:.'
-~:ll:i;r.\~d ':l~'dri-t: Fic'~: J·,mi~siL11'S
~iL' 1",,1t~~:":"', f>''';'''''1:(~:(".'1't:7~·: I'".'~~f: RJ (:1 ':lJ11

1I1. Intt~l·n:ufr;n~l rMc ~er~irc~ {~,)O) lISl~ \1. 1:",I\:lC

CoJlaterallD 11-02
l:Nnr.RWIUTr,R.~ 1..\BOR.\TOIUr.~ IX...

{·(Jm!l!.... tefl ..:,mj.~ion"
}1:duut~U"lurcr umLllel' OnIWIJ:loCdi'i: SU.!:gicuJ PmUUtL,s

EQWPllIi:lll r.llr.h:r'r~L ; ZilllLlln .E.lctlril' L)~.nll.tlluIll'l:
l~L:ttllir~llIml CIS-t'R C1'I:i.'l A
J)oL:h:t~ljul1 l\llidc : (~I;}lSi_p~~r\ (~ll) ,:1- P:;:::rt. (p"i) (~I- A'i~:r:l~<' ~lfV<1
H}lurh.,.iiEl h ~ Zl):l [.: / h:l' llfe::.... Jr'"r1I,'"rh. <) II f i'. Il~ J ';;(1 J" fl~
9 ~Hl.J;"'r rn"':::l~I;;-t'I1:.e::IL~ 151) bJ]:l. '.,,-, ):'1) ).·1I:J.t.
: 12LPVAC 6(': 1L
InAf~'- !:7'~"~'~~";-'~:":::_( "r--'---1 --_.__.-- __ ~~~~~.:~~~.;.~~-:'/l.~~~. ~~}_·_--~?··~:"·~:~l

, 7i .... __
!::'~.!; : r I " .- r, I',,'~'. 'II '"
'~'.:;_ -,UI..;
04,····-;-- - ..__. ~._.-<:- •.
... ··········__··t ·····1-·

~
.,. J, !
J
I
.'l";·······i
, ,
.... ·---···1 i
.. ~_ •..:__ . L__ .--.--...:•..•.•...---LT--·-·---·---------••. L----L-.--.----..:.--.-l-iU·······------·--·-,-:,!J
'. __ ._- ,----_._-- _.------_._._-------- - ~ •...., .-""

_._._----_.". '1H
__ .__ .-._
I
_ __ ._-_. __ .__ ._----- -._-_. __ ._----
~i., MI-'1:Y'. 1"'1'.:,,"'1: (.:C .\'t"7':::·' I';,~~t:: p,::, r,I"'I1 J

LIl. Inrt~l·n~njrm.al rMc S.eT1tirc:~ (~<lO) 11,1·: \ I .•'",,]('

Collateral ID 11-02
'.-.. -.~.'"
'~.",. ,,; .•..,; ...,
;',-:,,"
;' .. .:.:
'CI,"
~l ~.•;. .'~
,,- -:", ,":;
.: ~ ,,- ','
-..... ~, -" .... :
:.. t, •.••.
'".
'.
-.~ .
.~'.
-";:' ... .,
:,.~.
:'. ..';
,;.-.
.'"
-::.~. -', :.' ~:. .1. ..'
....
;
::. ,.... :.
;
~-: ... ~~
.:~ . ~ ,.'
.,,",.'~
.... :J',- ,:
• I', :.~., 0'1',
•.•...:.
.~. ' ..'

• • 11 •• "
.~.~. : . " ..
-"~;
.. '. . ". -'. -.: .. (

"'.:
-;·.1,"
. '.'~ - ,,..
-! .." -;.;.... ', ..: -~.
~ .. ~ .. . ~.
.... _ .·1 :J
..
~. " -.,', . "'.-
,.,.,'
'''.:' ;" ';,"'
. ~'l.
.j ,,'. " ,.,', _,.J :,

'1:,"<. "
,,"' ,- ': ~ .. ;: .....

.- - ':'.", ,." .:
,"
"'-',., :: .,•.•.., '.~- .'>- .,- •

.': I·· ... '
• ~'l,
-'.," '. ',. -j"

:~~~ •._ .<': J"',h
.-....
~jl' M!-~;'i'. f'.r,:,,':!;(~:(.\':;':7"·; P.J:~f: fl.'> (,I ~J I

lIl. Inft~l·n~Tjl)n.sl·rMc St~r~;i-rc~ W''t;''I''.lll.ffll'U,'cm-r (HilO,lllSl-: \ 1. 1'."'"

Collateral ID 11-02
.
"":
~~. ;
.....
" .. I~'
. . ~ .:~ .
- ',','., ~!' ' .- ," - ' .
'~L'
",',... . ,
~.
.... " '; .~,

.i ,;. .:.. '. '.~. ".:
.: .. ..... :f. .~_., ; ,:<;; - ~ >. ~,
", "" .._:..
,
~
"" -.-~. -~
.,";',
".' .. ; -~~. ,. .','
0,',
-~ ..'
,~ .;
"f.,_ ."." ;~. '
. i"""
....- .' ...• ,:::. "',
;~;. :~~' ..'.
."
~-".~
.......-.,,' c :, •
~:. ' ...,. ": . .. ~,
..... - :.'-.-.>: •.". ~;~"";'.,

"'.' ....
~.~ ..,.
.... "',"'.
. ",".
l·,
..... ~.
': ....
..~~=!
. .~_ ..: .,..,-
.:-'. .i.;;:
..',
~j ... Mt-~l:-:~. r".t>;.,\':(~:(."\"":7<;:·; r-.,,:J': R' f:1 '=il r

lIl. Inu~l·R3Tl[m.Hl FMc: ~eT'lti,,('.h W\"·W_lll_rfml.'cm~ {~llO) us}·: 11. r.l\lC

Collateral ID 11-02
l:NDF.RWIUTF,RS U l)ORATO]lIF.S IXc:.

C1Jnd:ncll'd Em.j~sinn~
~lanllfgl:ffm:::r l~im'tUt'l' Orthflpgedic t-:'H'gic::1II'rll(luci"!

b:'4W.J.I'nI~lll t:lll.loCf Tl;~l ZinunCl" .Eh:~l.riL· Llcnu./:I!Q!IIC
l~L:.t;uin:uu:l!l ClSJ'R Clll;!i.~ A
J)-clcc:tioll Mudc Q[,ush,Jt.'<l.r-... (q:J} ~L- Fwd... (p:.;,j Cr AVoJm~ ..., -::~ly~i
Bmllh'l-llElh ":!i(, I·; ~ fl:r 1lI=~::''''' JIWII\'>:"lh. ~j kTr I".ll: 1<;0 k ~l ....
,) ";J-v '-:"I-m~,!~I·H:II·"-IJ~ 1.<;(1 If~!;> "i' 1(1 \·1I-ll
: ~.::.)V_-\c 50=:-JL
:i", .
t t ..,." i , 1·....".10, ...
.~.-n'.-:- "in! •
"1" "T-----' ;------···------------i
CO! -_."~ .L. .. L .__ +. ! ..__ j

-.;-..
;"
, .~
~--.
; =; : I"': ..... .:::?~rr. 1:1·--,~=, G ~
I~ r~-
~L~'.
:\J.
-l:
'1
It<:-~ -.:---._-- :..
:
: . -------. . .. . . . J •. _. .__\••• '-.
-:Le
. ... ··---fia'~~;j
f
! 'i ,I ii. __
·~.~ :::··t·I·C"!,.,I· '-'1
Ii.' , ' : !.... ····~·:11·
~:, . ~ j' '~G3;~~~·;,-,~:::,iL:.:::',~,~;:~:-,:~.,.1~:;L:".~::,:~.·-:;":',>:<.): 11~1
I J I. I
~';~-' ...... _._.~.;. ..._.'-"-' _... ..,_ _-;-.;. . _- ,'j

...:: :-•.••-.: : : -.••( ·--·········:·················:·Hr·················-·-•.jJ
....•. _._ _.......• _._ _ __ ._ "'*.'." _.-.,.

.,II.-J _...••.••............. _ __ ._ _ .
~jL' r~·ll~~'1. P,r);.'\l:(~:C ..... :::.:"i"<::~ f'>.,.;'.r.R'if:I~11
lll. InfCl·R:lTirm~l FMC ~er~irc~ (R.)O) liSE \ 1. ",Me

Collateral ID 11-02
..... : .... '~.

'0".
~;,..
:1 ;.: .. ,. -.:" , ;.;
•• J
0:; ,, ;<:..-
"
., ;,~
:~ .
.. ':", "
. .""
..
'" -,-' to' "
" :.-:;.
.. "'.: .-:
- '. '. ,'.
..
;;.. ~
.. ~ ,: • I.:
,", .,~, .
•. . . '-, 1,r,
,:" .. , ~',
~; .~, ,--"> -.: .-'

~.;. : ..•' . ,
.,....
~ ", ... ~.:,.
": ."~ .,- '.~
., - .. :.,:; .::.' .. :
i,',; ': '
r', ,." ." .. -
,', -'. :.' ',' .~',
•..: .., _.~
,.... :..
~ ... I.
'-'.:
.~'-
... ~.>
,', .. -, .. .",','-..
~/~,-
: ~
',,],
.,. .... -r, '-.:
: .. ~'.
-:.,.
.... ..~'
-:.~
. ;. .... .. ~'. '-, '-' .

.;. '- -~' .. ,:
"'.' . ~~
-l.'
.,'
..
.~.~ .. ';" '.-."'
,il.,·
.: .,~
.-'
".. ..' ,-, ....

:"':.'
'.
~' .: ".' .~
.,
-:... "., .. -'. .,. ,: "
-. :."" '.~ -.'. ",
~iL' r.1l'1,!!,:'l. r'(';,,\l;(~:C.\"-:'7"'~ [\'.I~'.~Ri!(:1 =tIl

lIl, Inrel'MTjJ)ll~] 1·:Mr: ~t~l''\i'''C!~ (H<lO) lISI-: 11. 1,]\;1('

Collateral 10 11-02
",
,. .~,~ '., -.;. : .. ".,'
::~ ""~: -." ..
;..~ ~:;- ~
; ..•.
.: " ",1
"
.",."
. ~.'
.~" "'.' ;C
~: .~ _•• ; 7)';·; -;".' -~~ ..;
......
P .• • .....
.... ',-,
f... _ : ~~:. ."~ .:.••• 'J<.
....... ......
;~. - .....
'
..,
or,:'
..... ,,, • i ,1".,-

I', .
-;~.' ;
','.
-:,. > -:
.. ~., '.'. -. '.~' .

;~
. : ..... .\A··
..' .,
". :~', "i;, _
:.. ;::' '. .'.;. ~, ..;:

~.'V h, • - . I.. ..",
.- ."
:~.=., '.." 1 .••.•
~i l ' Mj-",,!:-:". /""0);.,':1: (~~r .'\ . . :,.;:.; r-,I.:?r:R:7(:1 qll

til. Inft~.·n:n~rm~I rMc Sen·ir~,;r. {l';llO) lISl~ 1 1. J:.l\.'lC

CollaterallD 11-02
1;N1n:.lol:"'VRl..-..-'lt~ I.An,ilfl.~Tf)~./:II·:S ....oi"('.

FGi'di.qroC!i1 nni.~i(lIU
).1 .. mda.clul-..:r Zimmer Orth'iJIJ~-=dic~u.rJ=:ical rro-d L!\':ts

f.qnipml!'IH l;mh.'rT.. .~t ZimmEr F..lc-c:.lrk I)il!"rmlltl~mil!"
R...'1~lIirt:mt:nf Cr~PRn~ss A
l)rft-CTiHIJ l\-lcldr.: Ol".a~i~~.:a:": (LP)
B'<Imhridth l2:.)k[-l.t
\-lea';:I1l:£-llwnt Hi:ilT.al'H,:c Ii) r.lcr.:-··
AntC-llnl\ T~'pc- jll_ .'§oIIO MHz, IUc:onitlJ
300 - 1000 _\-tll,t, UI1o:,-l'c"l'iu(Jil;:
12)VAC' 60~Jz
'-IH· ...•..•.•.' ••••_._-_.' .•.• ···-·-···t---------·····-········--·f !:~~~:!= :Oe-m=~<:-~

\ ;>;=.Jr~. "--l~
1 1",,:..-1 jr ~-,,,l'_1 '. '==- ·-v",- '- ";,,
7C!· ···-··--·f·-·-;----·~·- - ,------- --.. ·····--·f·---···_+· ....... __ ..._-------

,
T, =~
; :>1)· ··-··--·r··--·j----·f.-....,..-.. +-----.-
- !
!f; 4B ~ -; \~
3.
~j:
...,
.'" '/FIPJ
~il' Mj-)l:':". p-.r);.,'1:(~{":'1';7"': I'>.J~.~RlIf:1 ~II

lll. Inn~l"RaTiJ)llB] EMf: ~m",:irr.h {l1110) USE 11. 1,',IV1!"

Collateral ID 11-02
'10',. ~,.,. . ,' ,.

.:h~'_·1.·. '.~
.... , ..•. - l"'~~""'.
-." .
......
.r"""'.
' ...... ....
~",·,,1
~ /~ ... ,
(,~""'-'-':.
"
,
,'I,:"·"
',": .~ ..'C'
4··_~
I" i:.'
r~.
! : . :',:
;
,.'-. ,.
, ,
::". '", -," r··
"
"
.~.. ..-~' i'~l_t! . .~I·:-

,I
-,. .' .,
. ,
," ;.';"-.~
.<__ 1•..:..<' .'1'

~'.: ,,"
to' i·,I.':::· I:' .,.·~L·.
-;>.
':::'. -
<
: ,.:.,
" :,-.
., ,
,
.. _:
,-. ,.s
.~ ;.~~. r:~· o.:J. ..: ~ • :. ~~
:. '. . . . . _to. ' ••• ,;'~j '" ...._,., ::~ "" .V
, ,
'. , .,OJ
, '.
.:'
""-".'''' :. .' " - ,:'··II:~ .. " ~'" ~
~ _
"r
~-'I,"".:.
.~~,
:
4~,.·:
b
I'"
i,;".:':',~
-"I. ,
".'O'L·_
:... '"" . ,
,,',
!"';L'''''~
;.
;.,.",:. ,.
1
~'.'
'''.
~:~;:""
,'> .,
;( ,: ,t. _.. ! ':,. . -. . - ,
.~.'
. ,~"
,-
!:.. ~"<~ ., . .- , ,
- ", ..
.,:.:", :l-: -.<,' .' "
;.-..",.: ,. ;,' :: ,t ',:~. :..,. . .~.
,
-..}. ;'t:i?:
_.~.I •.·~!..h' ~f
:;'" ".r:
'!-:_"",L;':';_ ::~._-.
.:'~.:.. ;
>., , ~
, .- ,
~-:
.. -- ..
. ..-
_..!i:!:::
~
~;
'
::::.: £'~ ':_.•. ,'~
.. ..
~" ~." .. ~
'-
_ ..,.
.~.
!.. .., -.',~.- .

..1' v"" -I' .... < '.";
~iL' Mt'1:":"'. P'r'.;",~':(~~C.'\ ..;;"'·: P.1~'.i': Rg.f:1 "";11

lll. Inrel·n~frhm~l Io':MC ~e,~;rC'll. w~n"_lll_"f1m!r.mt' (:c.;llO) LISE 11, 1,',JV1C

Collateral 10 11-02
I:Nm;R\VRlTr~s 1.A.t\il~AT{)RII:·.S .",c.

N1Jdi'lt...-d [mbsiurI:"i
\lanu(aL::1 UTJ.::r Zimmer Ort.hrrJ1:a~diC"SIlrule:.ll I"rcltlu:C't"i

E.qtlipml'llt l;mk.T~t Zimmer f.1l'c.Jric 1)e-rm~ltnme
n,,"'1~lIin.:-ml'r.l1 Crs.Pl~ C1:as_~ .-\
II ~"t."t."thm Moth' Ot,a::;i~:?~·.tf:l\. (If')
H: :md'widrlJ 1::::'11.:L 17.
\:le<lmrelll-ent 1)i!ITal'lcc- r I) 1:11::n:'
An.tlln~ TYIJ'i: 3d -,3UO j\-llu:~ llil:onll'1:I1
3UO - tOOO )-llIl. LU\o:.-Pc!'iudi('
: n:,\,A,('(i)Ti,.
·:u.j;",L..,J _Ill ........ _I..,
: .. i-llll"
":![j ••• _.- --:------ ~---_.~. _ •••••••• - - - - - - - ········_·i =J:::"""_ .. I-: "jr~m"::("-::
!~~~~;.~. ':~~;,~1
1111.J
~i .... Mt-Y!:":". f>,r);.<~1:(~:(":1;';7"~ :>~~;!" 4!:'1 (,I ::tIl

lll. Intel·R::I.Tjml~l EMf: ~"!l"\-;"'r!.\ {f.:1lO) [I~W \1. I::IVIC

Collateral JD 11-02
~:f.
.~ .,~.
-,'.~,,, ,. ~... ·;ti'f" ....• -... -..,' . -•. /,.,., '.
_",..,.1
\. .."
L~ ...... t.,:'
[.I~l
'., ....: ' • ,-"'r;

-,
,".' ~':., 4.,. , r>. ..
,', 1,-'.1.. 1-,·j·,,1 !,
r>.
'.~-,
-~
. ,-.:
-~_ .•. ,<.'. ".< , ,'.
'.
'.
-
4! •• 4
,
~ .... )_1!. .••
t."
:",':-
---, ., ,
,- ,
=:·1. ;,l!'f ~f..: -;>;~." ~
"
"
"':.. ;~':.:
,. ,- •..-'" '-.
\., 1', r.':::'~·:' :. .,.~~
~~_~ "J.
.;.-j ~1
..;~
''-'' 'J'
.
":'.-
-"
., ,-. ,
..
; '';''
I ,.
.,
.;
,
;
~.:;. D~_ :-i.~ ....~ .,- ; >

~ .....r:-_L
"'-'. ,I",
~i
:., " r.:
,;~'" ...
" "
.:..:
-.':' ~-,!
'. .. , '.
,:_-'~.-~.,·4.· ·.... \~~I. '" .:.,~. -,
I_.I~'" '. :(.: - ':'~~~I:'-i.:< - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - . - - - - - - - - - - - -
.....' 4: .. 4 f". - 'I .... .;,.;.
,._ b·t::. -!~:. r-, i"i! : ',',', '. <.. ... :.'-: -' ..~
:1., •• -. "., .,J '" r j I ; ,"
.•~ .....u":".'
',,~,_':, I
!..,..• ,~."", ; .' -." ':v!-.

':'. :~-!<, ".-'. ,.; '1... . '·.'·1 ..'
~". "'-",; ~~.' :.,.. '.',! ,~:; ~,- .. ~'" .F'; ,.,1
E.:. '.', ~":"~., ;l:: .~ .. ",
..!.:o._l'.·~·~; • _:: .I",_·.·"l ~.;
,.. .. , . , , .'
~'. '··.w, ..•.
'.";
._. '!:' - .. , .- .... '.' ..,

"
;~ ;;: ,t .•... ::,.• ,-;.' . -Of ••
<.. ~:. '.''''
:~:' ~; ::::-:f'~ (_~.,.,. :-. :.:.:.

. ~·r~ '. ::.. , ...' .. '" '-.
1.'. ;, -.',~ •• ;
...t. -I'~_. ~ .:,., '. '.".
~i~' Mt~'!:;.. p,,);.,':t: (~:( ;1;';::7'::', ~"'::""':l;I: (:1 ~II
lIl, Inh~;·n~ull1oll:~l rMc ~enirc:~ WWW.lllrnm.lr.m-C. (~I)O) list \ 1. ".M'·

Enclosure
Photoaraohs
3-01 Unit - rear view
3-02 Unit - internal view
3-03 Unit and hand piece




Enclosure
Diaarams
4-01 Wiring Diagram
4-02 Hand Piece Cable
4-03 Hand Piece Plug

Diagrams ID 4-01
,,1--------------1,,
,,, ,,,
1,I
"
I~ i 1',I
,,I ,,I
,, ,
,, ,,I
, ,
,I ,,
1~~~, I
ql~1!
, ,
I
I
,I
,, ,I ,
,I ,,I
,, ,I,
,,
I
,, N
,I ,,
, I
~--------------~
~
,•"
.~
c
...•
<: naa ~
~
N
0" ~ :> • ~
,• •c :• •, c
~
0 ~
1 c •''""
~
~
.~~
•• ! ,
~
0
~
,
~
~
i'
0
c c
~ 0 l'0
" ,
~
~
•x ~
~
" z
,,
~ a L
0
·
~
,'"
0
g z
~ ~
~ N !
·f"" g£ ,"
l !0
J 0
~ ~
~
0
i. 5 & & "-

!
••
"
0
mi£.,~ ~
=
u

Diagrams ID 4-02
lli"~ dra-ing l=Tooob'on,. ~ Q ,~ o-n«l
rni;",
to ....
0""
"'" ;2rMMElT P""-I~ to"!'!:: llMSIO~ "" llo~""
;c ~""o"'iomoli>' f<.g"od g"'; ;£,..,~
!"6O;~;drn ;.n <tOm'i~.n....
...
In noc.;"''''~ "lI:
tI>o "",,,,orrt "ll""'8 """ .". "'~rt<lU'" « ~0P>' It
irt "nol. N .. oon.. or to lumr.n
_",jtto~thent..".tOJ'tl<lPOo-4""''''.Olll
;"_;0"
tM' .. "" Il'IC>' bo i,Jur'"IO"" <>r ~'"'l. ZlM'1!:lI
P.oTIENT CA~E llMSlON in "''''' .....,.. ,,"<l to
I'«tl.lm '" ,mmO<li_iY " ...." "~"l.
REVISIONS
AilED ANll lIL... CI< IJIPE< 2llAIo'G. tn/so S1RflND. ",\lM

UL STILE lOIS. '"51:.
tiOOV
PVC INSULATIDNfll.LtCSI1 USTE;D.
6. r£LLD'w' Arm GF!AY 'WIRE: 2llJ1IJG" STRI'<NIl, "'..... J.l
U.L STILE 1007, eoc, 3DOv HDLEJo. CDNTr>CTS 4809 CRIMP ON
PVC INSUl.iITlDWlI.L-e'SA USTED =~
SHRI~ TUIlUIG
AEMD RIT:E:PTACU;:
PNGJIO,4TL.MG I.'ITH HUTS. IJASHEI?
CRJI'If> J:lIIolTICTSf4 ~I>lllUl:TIJ".lMU )( l rnil[;~
i'm£S,
ALL :mtlENSl!lNS 1N INCl£!.

Issue Date; 2005-01-10 Page 4 of4 Report Reference # E181905-A1-CB-1
Diagrams ID 4-03
~~z~~';!!?~-n~~~E'~J ~c;::~
to lti;:~oi~ ,;;']';:""~...:~~~ ;;od=~~::'~
t.ho N'h:Jrr~l!::r;.:..~"':. "Fr.;;t~l~~
m.m I'l -10 ol"",., .". "" ....... ony "~. ~f II
~~tr'co7l ~MI~~eul~ ":;-';;':;:: ::,~
,..,rum 'Ii rnmodTcl<lry "f'C' m;""ot.
REI1510NS
~ ~ ~H'f« NllI'1C!: ~
~
,
,
,
•
A REMOVE SIUCONE JACKET
AND E!RAI:I SHIElD STRAIN REUEF: PWC:
88.9-114.3mm (3.50-4_50 1'1.) LEMO GMA..1B.O+5.SN LE",
('SANTlJPRENE, 275' F)
~
PFG.Mo."1Gl...0::.3SZ
/
-
=
b
COONER WIRE pIN: CW :>438.

[
'Cn::c I [9
I
CONDUCTORS: 4, 22 Awe FINE STFIANDED I-\Al<O TINNED
CADI'IUl.I: Wf.[ITE, BUICK, RED, GREEN•
.D07-.00a INCH FEP. INSUI..AJlON.
SfiEI.D: 8fU1DED HARD TINNED CADr.lllJM.
JACKg, IJEDK::AL CiVDE BI..M::l< SIUCONE RUSSEll..
4.57-4.B3mm o.D. (.180-.1"90 IN. O.D.l.
NOTES:
TOTAL LEI\JGTH: 3.05m±5<:m (lOFT.±2lN.)
CONNECTOR TO BE POTTED USING
G.E. Fffi'1112 all. EOUIVAL.ENT HON SCOL.£ 00 Nrn- """'~ =-=
@__ ~
CORROSIVE Fl1V. BRAID SHIEUl TO ~-r"""""l
8E TRlMMOlF'WSIl BOTH ENDS. em
llo::!l'!llaJ' ALL
""".'1:$ .ItlC~ LHI%~ r... -1.-
"""" +SENSE 10=
+OUT ___ ~
.- -- ~
~
-om ___ ___ h __ PLlI~ I-tAIHI~SS
Bl.J;CK, GREEN, SENSE ~ ""T'£'_"
ltVl:V~ "ATE:.......
"0_
.... ..- ~
-...1'.0.""""" N~'"
IDRAWING """
DllCl>-l&-lQtJlIo

Issue Date, 2005-01-10 Page 1 of 13 Report Reference # E181905-A1-CB-1
Enclosure
Manuals
6-01 User Manual

Manuals 10 6-01
Zimmer™ Electric Dermatome Instruction Manual
INDICATIONS FOR USE
The Zimmer Electric Dermatome is a skin grafting instrument that is intended to provide variable
graft thickness and width capabilities.
DESCRIPTION
The Zimmer Electric Dermatome (See Fig. 1) is an electrically-powered surgical skin grafting
instrument. The thickness control adjustment ranges from 0 to .030 in. (0.75 mm) in 0.002 in.
(0.050 mm) increments.
Individual graft widths of 1 in., 1.5 in., 2 in., 3 in. and 4 in. (2.5 cm, 3.8 em, 5.1 cm, 7.6 cm, 10.2
cm) are obtained with five width plates. Two stainless steel machine screws secure the plates to
the underside of the instrument. The plates are easily fastened and removed with the screwdriver
provided.
The dermatome is powered by an ironless rotor, low inertia motor, which provides nearly
vibration-free power.
SPECIFICATIONS
I. POWERSUPPLY
I. Physical:
Weight: 2.6 lb. (1.18 kg)
Length: 9.12 in. (23.2 cm)
Height: 5.44 in. (13.8 cm)
Width: 6.69 in. (17.0 em)
II. Electrical:
Power Requirements: 100 - 240 V- (Auto Switching)
150 VA, 50/60 Hz
Single Phase
Power Output: 14.5 V -,4.3 A Maximum
Protection Class: Class 1
Degree of Protection Against
Electrical Shock: Type BF
II. HANDPIECE
I. Physical:
Weight: 2.1 lb. (.95 kg)
Width: 8.5 in. (21.6 cm)
Length: 5.2 in. (13.2 cm)
Vibration and Shock: Standard Commercial Practice
Nominal Speed: 4500-5500 cycles/minute
II. Electrical:
Power Requirements: 14.5 V =, FUlly Regulated and Isolated, 4.3 A Maximum
III. Operational:
Nominal Speed: 4500-5500 cycles/Minute
Ul60601·1 Classification:
I,--T.c.yup",e:..;o",f-,p::.:ro",t",e",ct",io",n,-,a",g",a",in",s"-t",e",le,,,ct"-ri"'c'-'s::.:h"'o"'ck"': I--'C"'I"'a"'ss::...c.' _

Dearee of Drotection aaainst electric shock: Type BF applied part

Classification accarding to the degree af protection against IPXO
inQress of water:
Mode of operation: Continuous operation
Maximum operatina ambient: 88'F (31'C)
Emissions !Immunity:
The Electric Dermatome complies with EMC criteria set forth in IEC 601-1-2.
POWER SOURCE
The unit is shipped with a 0.25 in. (6.35 mm) x 1.25 in. (31.75 mm) fuse drawer installed. A
separate fuse drawer is supplied for 0.197 in. (5 mm) x 0.787 in. (20 mm) fuses.
To replace input fuses, disconnect the power supply from the power source. Remove the fuse
drawer by lifting up on the tab using a tool and pulling the drawer outward. (See Fig. 6.) Replace
the fuse drawer with the correct fuses installed.
FUSES
Input fuses are located in the fuse drawer in the power entry module at the rear of the power
supply.
The ratings of the input fuses are dependent on the input voltage.
230 V - 800 mA time lag/delay
WARNINGS AND PRECAUTIONS

To avoid serious injury to the patient and operating staff while the Zimmer Electric Dermatome is
in use, the user must be thoroughly familiar with its function, application, and instructions for use.
To avoid injury, use extreme caution When handling the blade or when handling the dermatome
with the blade installed.
Use caution when inserting blade to avoid nicking it, which may result in an uneven cut. To avoid
blade damage, place dermatome blade side up when not in use.
The throttle must be in the SAFE position before changing blades, when connecting power to the
instrument, or when the instrument is not is use. Accidental activation of the instrument during
these procedures may injure the patient or operating staff. To ensure that the instrument is in the
SAFE position, the safety lock on the throttle should be toward the blade end of the dermatome
and only the work SAFE should be visible.
Handle the Zimmer Electric Dennatome carefully. Should it be inadvertently dropped or damaged l
it should be returned for service. Do not use.
Use only Zimmer Derrratome Blades (REF 00-8800-000-10). The Zimmer Dermatome Blade has
been specifically designed and engineered for use with the Zimmer Electric Dermatome. Other
blades may not fit properly in the derrratome and may cause serious injury. Use of non-Zimmer
Dermatome Blades can cause the dermatome to take grafts deeper than what the user has
selected.
Never connect the Zimmer Electric Dermatome Handpiece to any source other than the Zimmer
Electric Derrratome Power Supply. It has been factory calibrated to proVide optimum cutting

performance and maximum safety. It is also designed to meet or exceed specific medical
electrical safety standards.
Ground reliability can only be achieved when the power cord is connected to a receptacle marked
"HOSPITAL GRADE". Use only the power cord marked "HOSPITAL GRADE" supplied or one
that complies with all local and electrical requirements but does not exceed 10 feet (3.05 meters).
For continued protection against fire hazard, replace only with the same type and rating of fuse.
Refer to FUSES section.
Possible explosion hazard exists if this instrument is used In the presence of flammable
anesthetics or gasses.
Never sterilize the power supply. Disconnect the dermatome handpiece from the power supply
before sterilization.
The user and operating staff must always pay close attention to the CLEANING PRECAUTIONS
and CLEANING INSTRUCTIONS. Failure to follow these instructions may damage the
dermatome.
IMPORTANCE OF THE NEED TO ADHERE TO A CARE REGIMEN

The handpiece and accessories must be Inspected prior to each use.
• Visually inspect for damage and/or wear.
• Always inspect the handpiece carefully for possible scratches, nicks, or burrs caused by
extended use or mishandling.
• Inspect the dermatome's cord for cuts or missing insulation caused by extended use or
mishandling.
• Check the action of moving parts to ensure smooth operation throughout the intended range
of motion.
• The Zimmer Electric Dermatome should be returned every 12 months for inspection and
preventive maintenance. Annual factory calibration checks are strongly recommended to
verify continued accuracy.
Note: If damage or wear is noted that may compromise the function of the instrument, do not
use. Refer to RETURN AUTHORIZATION AND REPLACEMENT INFORMATION section.
RECEIVING INSPECTION
After receiving the Zimmer Electric Dermatome, examine the unit for extemal signs of damage.
Retain all packing material until the contents have been verified and an jnitial operational check
has been periormed. If the device has been damaged, forward an immediate request to the
delivering carrier to periorm an Inspection and prepare a "Concealed Damage" report. The terms
of all Zimmer Orthopaedic Surgical Products sales agreements concerning this unit are F.O.B.,
Dover, Ohio, U.SA., and the responsibility of the Zimmer Orthopaedic Surgical Products ends
with delivery to the first carrier. Thereafter, the shipment becomes the property of the customer.
Any claims for loss, damage, or non-delivery must be made against the delivering carrier within
10 days of shipment.
Your local Zimmer sales representative may assist you in determining the cost of replacement or
repair so that a proper claim may be filed with the delivering carrier.

Note: Do not attempt to return damaged goods without first securing proper authorization from the
delivering carrier.
SETUP INSTRUCTIONS
• Observe sterile field precautions per hospital protocol.
• Connect the Zimmer Electric Dermatome to the power supply by inserting the connector plug
into the connector receptacle. (See Fig. 7.) Remove any kinks or twists from the cord. Align
the connector plug to the receptacle by rotating the plug while gently pushing inward. When
aligned, push in until the plug clicks into the receptacle.
Note: Older Zimmer Dermatomes and Power Supplies were equipped with a metal
connector plug and receptacle. The metal connectors have been upgraded to
plastic connectors for ease of use. The older metal connectors are not
compatible with the plastic connectors.
• Before connecting the power supply to a power source, be sure that the switch on the front of
the power supply is in the OFF (0) position and that the safety lock on the Zimmer Electric
Dermatome is in the SAFE position. Connect to a power source via the "IEC" connector in the
rear of the power supply.
• Turn power on by moving the rocker switch on the front of the power supply to the ON (I)
position. The rocker switch should illuminate. Activate the dermatome by completely
depressing the throttle lever with the safety lock in the ON position. Return the safety lock to
the SAFE position, when not in use.
• During set-up procedure, Visually inspect for damage and/or wear. If damage or wear is noted
that may compromise the function of the instrument, do not use.
BLADE INSTALLATION (See Fig. 5.)

• Use a new sterile blade for each procedure. Use only Zimmer Dermatome Blades (REF
00-8800-000-10).
• To install blade:
• Place the throttle in the SAFE position. To place the dermatome in the SAFE position,
slide the safety lock on the throttle toward the blade end of the instrument to the SAFE
position. Only the word SAFE should be visible.
• Using a screwdriver, loosen width plate screws approximately two tums. Do not remove
screws from handpiece.
• Place a new blade in slot on the handpiece. if replacing a blade, remove the used blade
before inserting a new one. Refer to BLADE REMOVAL section.
• Mate the drive pin with the hole in the blade. Note: "INSERT WITH THIS SIDE UP"
message.
• Lubrication of the blade is not necessary because the backing of the blade is a self-
lubricating plastic.

• Choose proper width plate to satisfy cutting requirements. Place width plate over blade
and tighten screws. Do not overtighten. Ensure the printing on the width plate is facing
out (See Fig. 5.)
CUITING THE GRAFT

• Skin should be prepared in routine manner.
• It is not necessary to lubricate the skin; however, lubricating the donOr site with sterile
mineral oil may ease travel of the Zimmer Electric Dermatome.
• Set control lever adjustment knob pointer to desired graft thickress. Factory calibrations
indicate 0.002 in. (0.050mm). Do not insert any instrument between the blade and the
control lever as this may damage or knick the blade causing a poor cut Further, it may
compromise the calibration of the instrument (See Fig. 8.)
• Hold the handpiece on the donor site at a 30" - 45" angle. (See Fig. 10, 11.)
• To activate the dermatome, place the power supply in the ON (I) position. Lift the throttle
lever and slide the safety lock back from the SAFE position toward the hose coupling.
The word ON should be visible. (See Fig. 9.) For optimum results, it is recommended that
the dermatome operate at full speed. To ensure that full speed is achieved, completely
depress the throttle control with the safety lock In the ON position.
• Depress the throttle to start the cut Guide the unit forward using a slight downward
pressure to ensure that the cutting edge remains continuously firmly in contact with the
donor site.
• Two methods of graft removal from the instrument may be used:
• Method I
Allow the cut graft to accumulate in the pocket of the handpiece. Lift the handpiece away
from the donor site to end the graft. Return the throttle to the SAFE position and carefully
remove the graft. (See Fig. 10)
• Method II
Use tissue forceps to gently lift the graft as it emerges from the pocket area. Do not
stretch or pull the graft as this causes irregular edges and nonuniform cuts. Lift the
handpiece away from the donor site to end the graft. Return the throttle to the SAFE
position. (See Fig. 11.)
• Do not run the Zimmer Electric Dermatome without cutting for an extended time. Release
the onioff lever and return the safety lock to the SAFE position between cuts to remove
the graft.
AFTER THE PROCEDURE

• Unplug from wall receptacle.
• To remove the Zimmer Electric Dermatome connector plug from the power supply, pull
outward on the outer sleeve of the plug to separate the plug from the receptacle.
• Remove the used blade and dispose of properly in designated sharps container or per
hospital protocol.

• Remove excess body fluids and tissue with a disposable, non-shedding wipe and cover with
a damp cloth. Body fluids and tissue should not be allowed to dry on instruments prior to
cleaning.
• Return and secure instrument and width plates to instrument case for transport and cleaning.
BLADE REMOVAL
• Loosen the width plate screws. Do not remove the screws.
• To remove the width plate, hold both sides and lift. Do not lift the width plate from the
front as this will cause contact with the blade and possible injury.
• Remove the blade carefully lifting from the side.
• Dispose of used blade in a sharps container or per hospital protocol.
CLEANING PRECAUTIONS
All subsequent cleaning and sterilization steps are facilitated by not allowing blood, tissue debris,
or disinfectants to dry on used instruments.
Handie the Zimmer Electric Dermatome carefully. Should it be inadvertently dropped or damaged.
it should be returned for service.
Refer to NEED TO ADHERE TO CARE REGIMEN section.
Do not lubricate the Zimmer Electric Dermatome. Lubrication may cause extensive damage to the
motor.
Never immerse the dermatome in any solution. Some solutions will corrode the metal and
delicate moving parts and also break down the internal lubricants.
Never immerse the dermatome in liquid chemical disinfectant.
Cleaning agents with chlorine or chloride as the active ingredient are corrosive to stainless steel
and must not be used. Saline solution has a corrosive effect on stainless steel and should not be
used.
Do not process the dermatome handpiece or accessories in an automatic washer/sterilizer.
Never clean in an ultrasonic cleaner. Ultrasonic cleaning will dislodge oil from the bearings and
render the instrument inoperative. Ultrasonic cleaning may affect calibration of the Zimmer
Electric Dermatome.
Never sterilize the power supply or immerse it in any solution.
Steam sterilize the Zimmer Electric Dermatome and accessories (except power supply). Follow
instructions in STERILIZATION RECOMMENDATIONS.
CLEANING INSTRUCTIONS FOR THE DERMATOME

• Ensure the Zimmer Electric Dermatome has been fully disconnected from the power
supply.

• Use caution when handling the dermatome to determine that the used blade has been
removed. If not, safely dispose of all used blades in accordance with hospital policy for
contaminated waste and sharps.
• Never let water or detergent enter the handpiece. Permanent damage may result. (See Fig.
13.)
• Remove excess body fluids and tissue with a disposable, non-shedding wipe and cover with
a damp cloth. Body fluids and tissue should not be allowed to dry on instruments prior to
cleaning.
• Universal precautions for handling contaminated/biohazardous materials should be observed.
• Instruments should be cleaned within 30 minutes of use to minimize the potential for drying
prior to cleaning.
• Prepare cleaning agents at the use-dilution and temperature recommended by the

manufacturer.
• Thoroughly scrub the instrument with a soft-bristled brush and a pH neutral detergent. If
desired, a neutral pH enzyme solution may be used prior to scrubbing with the detergent. Use
the soft-bristled brush to gently clean the instrument, paying particular attention to any
crevices and other hard-to-clean areas until all visible soil has been removed. (See Fig, 12.)
Note: the cleaning solution should be changed if it becomes grossly contaminated (bloody
and/or turbid).
• The thickness control lever should be moved during cleaning to release any debris which
may be trapped under the lever or in the notches.
• The cavity which housed the oscillating drive pin should be rinsed clean and the water
shaken out. This will prevent the accumulation of deposits in this cavity.
• Rinse all detergent from the instrument. Purified water (from one or any combination of the
following processes: ultra-filter, RO, 01 and/or distilled) is recommended. (See Fig. 13.)
• If there continues to be blood or soil in the rinse stream, repeat proceeding two steps with
freshly prepared cleaning solution.
• Dry the instrument with a clean, disposable, absorbent, non-shedding wipe. (See Fig. 14.)
• CarefUlly inspect each instrument to ensure that all visible blood and soil has been removed.
• Visually inspect for damage and/or wear.
• Check the action of moving parts to ensure smooth operation throughout the intended range
of motion.
Note: If damage or wear is noted that may compromise the function of the instrument, do not
use. Refer to RETURN AUTHORIZATION AND REPLACEMENT section.
• Steam sterilize only. Follow instructions in STERILIZATION RECOMMENDATIONS.
CLEANING INSTRUCTIONS FOR THE POWER SUPPLY

• Ensure the power supply has been fully disconnected from the power source.
• Clean the power supply with a damp, lint-free cloth using a pH neutral detergent.
• An alcohol wipe may be used to disinfect the surface of the power supply.
• Never immerse the power supply.
STERILIZATION RECOMMENDATIONS
Steam sterilization is safe and effective, and is the only recommended method for the
dermatome. There are no contraindications for sterilizing the Zimmer EiectriC Dermatome and
accessories.
Ethylene oxide sterilization is not recommended because reliable outgassing times are difficult to
determine for lubricated powered instruments.
Never sterilize the power supply. Disconnect the dermatome from the power supply before
sterilization.
Flash sterilization (10-minute exposure in a gravity displacement sterilizer in an open tray at 270"
F [132" CD is not recommended for the Zimmer Electric Dermatome as this method may not
prOVide sterility throughout the instrument.
• Place cleaned instruments in an instrument tray or fully perforated autoclave case. The
Zimmer Dermatome Autoclave Case (REF 00-8801-003-00) is recommended. (See Fig. 18.)
• Do not kink or crimp the dermatome's cord when closing the case lid.
• If the Zimmer Dermatome Autoclave Case is used, the instruments are to be wrapped, two
double thicknesses of #140 thread count wrappers, or equivalent. If sterilization wraps are
used, they must be free of detergent residues. Foam sheets should not be reused. They may
have trapped impurities from the steam supply, and subsequently may form deposits on the
instruments. Textiles that have been scorched by overheating also may form deposits on
instruments. Exposure times are the same for wrapped or unwrapped instruments.
• Follow the instructions for prevacuum steam sterilization or gravity air displacement steam
sterilization listed below.
• Do not immerse in liquid to cool. Cool by exposure to room temperature or cover with a cold,
sterile towel.
Prevacuum Steam Sterilization

If your prevacuum steam sterilizer has prefixed cycles, use the "Hard Goods" cycle. If it does not
have a prefixed cycle:
• Set temperature at 270 - 272" F (132 - 133" C).
• Set exposure time for 4 minutes.
• Set drying time for 8 minutes minimum.
Gravity Air Displacement Steam Sterilization

• Set the temperature and corresponding exposure time as follows:
270 - 272" F (132 - 133"C) 35 minutes
250 - 254" F (121 - 123" C) 60 minutes
• Set the drying time for 8 minutes minimum.

Note: Where there is a concern about TSEIvCJD contamination, autoclavin9 at a minimum of

273° F (134° C) for at least 18 minutes is recommended by the World Health Organization.
(WHO/CDS/APH/2000.3, "WHO Infection Control Guidelines for TSE," March 1999).
TRANSPORT/STORAGE CONDITIONS
Temperature: -40 to +85°C.
Humidity: 10 - 100 %RH
Pressure: 500 - 1060 hPa
ACCESSORIES (See Fig. 15 - 22.)

Description: Blades (10 per box)
REF: 00-8800-000-10
Description: Zimmer Electric Dermatome Complete (includes: 00-8821-001-00, 00-8801-003-

00, 00-8821-006-00)
REF: 00-8821-000-00
Description: ZimmerEledric Dermatome Handpiece (includes: 00-8802-001-00, 00-8802-

002-00, 00-8802-003-00, 00-8802-004-00, 00-8803-000-00)
REF: 00-8821-001-00
Description: Power Supply (includes: Fuse drawer, 5 mm x 20 mm; Fuses, 1.25 A (QTY 2)
Fuses, 800 mA (QTY 2); Power Cord)
REF: 00-8821-006-00
Description: Autoclave Case

REF: 00-8801-003-00
Description: 1 in. (2.5 em) Width Plate

REF: 00-8802-001-00
Description: 1.5 in. (3.8cm) Width Plate

REF: 00-8802-015-00

REF: 00-8802-002-00

REF: 00-8802-003-00

REF: 00-8802-004-00
Description: Screwdriver
REF: 00-8803-000-00
Description: Width Plate Screws (10 per pack)

REF: 00-8803-001-10
TROUBLESHOOTING GUIDE
ACTION
Check input fuses. Check ower cord

off. connections. Return for service.

Dermatome not operating. Power light Check blade fit. Check handpiece
on. connection to power supply. Return for
service.
Dermatome operating too slowly. Check dermatome for damage. Check
blade for darnaae. Return for service.
Erratic speed changes. Check handpiece connection to power
supply. Return for service.
SYMBOL DEFINITIONS
It I Type of Equipment
Direct Current
xxxx~ Year of Manufacture
o OFF (Power: Disconnection from the Mains)
I ON (Power: Connection to the Mains)
Alternating Current
Protective Earth (Ground)
V Potential equalizing conductor (Ground)
Dllliiii
l
- Zimmer Dermatome Handpiece
Ai Attention, Consult Accompanying Documents
~} Conformity Marking of the Council of the European Community (TOV Product Service,
Munich, Germany)
*" Declaration that a product meets the EMC regulations per marking requirements
~~
W4l¥~.t¢e,J1Gl$¢~
Conformity Marking for Underwriters Laboratories, Inc. UL 60601-1
ff&i;1iW~~
DNl.y'~'lp1N
U.%l\lH,~Q;;!t?l%>OO1,I.;IOO) Standard
!U::_~

Issue Date: 2005-01-10 Page110f13 Report Reference # E181905-A1-CB-1
SERVICE INFORMATION
Caution: Risk of electric shock. Do not remove cover.
Return to an authorized Zimmer Orthopaedic Surgical Products service center for servicing. Do
not attempt to disassemble the handpiece. It is a factory sealed unit with no user serviceable
parts inside.
Do not attempt to adjust the power supply. It has been factory calibrated to provide optimum
cutting performance and maximum safety. It has been designed to meet or exceed specific
medical electrical safety standards.
The Zimmer E[ectric Dermatome should be returned every 12 months for inspection and
preventive maintenance. Annual factory calibration checks are strongly recommended to verify
continued accuracy_
RETURN AUTHORIZATION AND REPLACEMENT INFORMATION

When it is necessary to return the instrument for inspection and preventive maintenance or repair;
within the U.S.A. call 1-800-830-0970 to receive a Return Goods Authorization (RGA) number.
Outside the U.S.A., please contact your [ocal Zimmer representative.
The instrument must be properly packaged when sent in for repair. If the original packaging is no
longer available, proper packaging can be requested when the Return Goods Authorization
(RGA) number is received.
A purchase order must accompany all equipment for repair. The customer will be responsible for
all shipping charges.
WARRANTY (U.S.A.)
Zimmer Orthopaedic Surgical Products warrants that the Zimmer Electric Dermatome, along with
all parts and accessories, have been tested and inspected, and have left the factory in proper
working condition, free from visible defects.
Zimmer Orthopaedic Surgical Products warrants to the first consumer purchaser of new Zimmer
Electric Dermatome, Width Plates, Screwdriver, and Power Supply that these products and
accessories will, under normal and reasonable use, be free from defects in material and
workmanship for one (1) year after the date of shipment from the factory. Zimmer Dermatome
Blades are warranted to be free from defects in material and workmanship upon delivery. During
the warranty period, Zimmer Orthopaedic Surgical Products shall repair (or at its sole option
replace) the defective product or part without cost to the purchaser. Defective parts replaced
under this warranty shall become the property of Zimmer Orthopaedic Surgical Products. This
warranty does not cover damage caused by misuse, abuse, accident, neglect, or any use not
prescribed in this manual. If the unit becomes defective because of misuse or abnormal
conditions of operation, repairs will be billed at our current rate.
ALL OTHER WARRANTIES, EXPRESS, IMPLIED, OR STATUTORY, INCLUDING, BUT NOT

LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FORA
PARTICULAR PURPOSE, ARE LIMITED IN TIME TO THE PERIOD OF THE WARRANTY
GRANTED HEREBY. SOME STATES DO NOT ALLOW LIMITATIONS ON THE DURATION OF
AN IMPLIED WARRANTY, SO THE ABOVE LIMITATIONS MAY NOT APPLY TO YOU.

Issue Date: 2005-01-1 O' Page 12 of 13 Report Reference # E181905-A1-CB-1
Neither Zimmer Orthopaedic Surgical Products nor the Zimmer distributor who sells the Zimmer
Electric Dermatome is responsible for indirect, incidental, or consequential damages. Some
states do not allow the exclusion of incidental or consequential damages, so the above limitations
or exclusions may not apply to you.
Zimmer Electric Dermatomes requiring service or repair may be returned to:
Zimmer Orthopaedic Surgical Products

200 West Ohio Avenue
Dover, Ohio 44622 U.S.A.
For further information concerning warranties and repairs, contact your Zimmer sales
representative Dr the Zimmer Customer Service Department at 800-348-2759 (inside the U.S.A.).
WARRANTY (Outside U.S.A.)

Please contact your local Zimmer representative for warranty information.

~
zimmer
Revised: 11-04 Zimmer Orthopaedic
Surgical Products
© 1992,1996,1997,1999,2000,2001,2003,2004
Printed in U.S.A
CE
0123
200 West Ohio Avenue
P.O. Box 10
18-10579 Dover, Ohio U.SA.
44622
Printed on Recycled PaperO

Enclosure
Miscellaneous
7-01 Product label - front
7-02 Product label - rear
7-03 Sterilization Report

Issue Date: 2005-01-10 Page 2 ofS Report Reference # E18190S-A1-CB-1
Misc 10 7-01
B
ZIMMER
ELECTRIC DERMATOME POWER D B
D
A A
---
- -
2

Misc 10 7-02
4
I 3 2 I
o
1- • -
c c
I""
B B
o o
1- -
4 I 3 11 2

Misc ID 7-03
zrMl~mR OlUIIOP.'l.EDlC SLl{GlCAL l'1{OI},iCT$

DOVI:K, OHIO
)'RODUcr U1':YELOP:>1 OFl'ICES ",,1.'
-· . .
1<" X NUMBER, 330-364-9488
PIIO)/C NV.IIII<:R, 330-343-11SIH
THLS.FACSHnLE ME."SAGE IS l:UNI'IIll',NTlAI. AN I) ."r... Y CON' lAIN
P
A"'TORNEYPRJYII.I'·G~;])INlfOW\IAfION I'ITENDED ONLY .FUR THE
. USE OF THE ]]\;.I)IV]])1;AI, 01{ Cf[\fl'ANY K-UIED:
Tfthe u"l.lLr i!-' rwl .lil.:: illl.::rlded reci;>iel:-r,. (IX the ;.:mploye:; .)r a~e:~t tespClns.ible.l ['I
, delhcr it to f.:.:l": i mended To:.:ipien:, y.:m are he[{~b:y )1(llj ric~L Ih,J! till)' ..r s...cmimi"j():l,
w:-l.tnl-;:'...LL i~}l., 01' CC[JYing (If Lil i ~ (;;OTnIl1U1lir.;~ltiull i:-> ::;:I.rh:1.1Y J tr i"1 r I"J )~t::d. It' you ha YC: J"ccci ~"W
this c.rJnlllltmil..:.tJlicI1 in fitror.. pleF_~{: ;mmeditlU:-l~ fluLil}' u:) by t~lepbo.)e. sv tl:atl.ve m!t~·
8..{'I".a:lge fbr the r~~Ul'1"L ,oft}),: oneil,~~l rJl!.':R~~ee:o n;;:. T'hA.llk yo::....
PLEASE DJ<LlVER THE FOLLOWING FAX Ml<:b'SM~K
I' "x NTiMBFiR:

-- - ., '-
FROM~ . ~'.":~;: "~.".,"'.. :-;',.., '-
~~~"------
TOTAt· N t""'lBl:":,R OF PAGES I'RANS.'1]TT"~I),];"CLU»lNG 1'1:11:':i- YAG.t;.: .:!..

IF l'R.."L"\I~)'lliSSJ.O~J~RKOf{. CALL~
ADDITIONAL [Nl'·OID.HnON,
, ..

Misc ID 7-03
12-15-99
Tissue Bank Derma-rome
PO Projo.t QV66
Autoclave- testing
A pluLclype D~frm::ll(]ff1e Ill, (7isl::ue Br.mk Oarrr~ttlme) un't ~Jith ~ Mi~roMo
3557L012CR - (Ni{."k:~l piatecl} motor anl.1 PTfE FlexisEl'l;;i1 stlii;1r'. ~!l::!al ::;IrllJnd tho;;;:
moter shaft was assaombled and jelveted to Union hlospital for 50 Auto-;:lflvc
L)'oI;le~.
P:"iorto del:v&ry, the RPM or:.he mowr W!!II!!!! c-le~kE:d -::::: b& 5~50 R?f\ll usir.g thA
calibrated strobe' scope. (CalJbration #193) This was checked ;aUt'e mmiage :-JrlCi
no blade installed_
Th.A =f:P,",'s will {)eo ohecked aft~r the t~utaD[a'le oyo!e~. Tt-e r'1otor ~nd !lenl will
81fsQ be inspe;:;:Led. Pig ~k:n wi I be cut r.o ma~.e sure cut qLla itt Es r1ail1ta[nec.

Enclosure
Licenses
8-01 Power Supply License
8-02 Power Cord Letter of Assurance
8-03 Power Entry Module
8-04 Power Switch

License ID 8-01
lilllli! 1.\W;m1l
~-----------_._
ml
llSl1599AIUl
..._-~-
CB TEST CERTIFICATE
CERTfFICAT D'ESSAf OC
. !';'!;~~i1.1'.::l 1.rJ-;;';m:; ~~ IT,,, .':V?~;';;'~

~>bi" "I ",.1!~-", ,;<.... ';fm;U11rIu.~·
!-'<1'F"= ~~:; ""&;t~'; "': \::';;:~~Ji8.'.h.'l'\~.

..ir.'it!'J,'
l-.j.;:-;;,;;f~~(;!;t,,~,r.
1':<:.":* ~n~ ~;:.;;,~ e>1 ll~ ~;U"r

;;,,".;~l ..r#fi,~·;}r!*!'.:;;;';"'i'.
~1.;;~';;:,;: ~,d ~~:H<.~ d"""-Sw;-e'!i:;ic~

~''';'~'''-''O; ';,;;;r;,-~;,',~,<,! -t..-1 ,~m<iC~-&?.4'~a; ; ....".....;;'H;,;;;.
Tr~"""""[' iii ",-~;;

.l.t.;'-:a<* Sf<; !~.,.,.,..,'1$ iii< .;.1$ ;:>.e;~i.'.'
!~':''''"'i.: 1"'1p;;; Ra:.

r!i?t.';':J~~";:
M,·W!.~~~l i?,;....,'1"-l"-,: IJ. i;iii-.::.1~;;';';yi

i<?'<.'<":::'~~_'r; ;:;;:'"p;';Jj.!";:"~I:'<'i" f<!i _*,,1(:;?"~-';-;:.i;:i:J
,~ :';;'if"?)ie ,~ ':1« ~"'-'C<:~~c, Wf'..:! t::i5--::t.-:;: ~";':;l ~;;",;':;1

\'-: t'<, !(_ ,,;,.,,-·~~.,-;"1:"Y"""·r,
(.O;,~-u:",,~<;,uJ di! "'.... j;ii)ih,}" i:!.~''''.;:.~-,q~', ~ E "I;~
!Y_';'L",";:;j,-r: ,:"!:..,~"-)$':~ "' i2
llil d',om; 'll tl:-s- '\\'lR !~t'f.;('fl ;;;,t~. i\~~..
:;;~;~'1~;;~1=~~~ ~;;d:;~.;.1k rE.;m~r;;

;;~ O1·i!;j,rm.c~ ~,.;i ,':;:;;7m~ ,,:.tnr>il;;;.!' -;iJ C~Yil.."·,;,!
ThS 'CB1"i<:s:f r.:el1iffCilt~ ll; mJ)f)(I tJ~ tIm !'$,1J;iOIlf.li CeI'tHfC:.a1:i(m 8",\,((1
(;eG.ff1ffit;~ n~Tj DC e.,-.t 61JI1Jri p~' 1't'}rr;r~rtit;:m!J- !if<;tiom;r! iJff (',.(...rtifff;.lJfftm

License 10 8-01
CERTIFICATE
No.8 04 08 14549 040
Holder of Certificate: Condor DC Power Supplies~ Inc.
2311 statham Parkway

Oxnal'l1, CA 930JJ
USA
Certification Mark:
Product: Switching power supply unit
Power SUpply
The prod1Jt'.twas- testel:l 00 a W1lunlary bEl_ and complie& with the esserrtial requiremel"rls.
The OEr1ifil:::ation rmlrkshown aJXJv.e can be affIxed {In ItIe produtl See al= l10tes o... erteaf.
Ted,-;epart no.: $13041(17-103
Page 1 ol'4
ruv AMERICA INC. ~ !i Cnerry Hill Drive .. Oan"ersMA Ot923 USA

TO~ Suddeufsr;h hmd Grl1up

License ID 8-01
CERTIFICATE
No. B 04 0814549 040
MOdel(s): GLM65-X Series. G2M65-X ~rles &

MSP1788
Parameters: Rated Input Vollllll€-: 1OD-240VAC

R~ FreQuency: 5D.'60 Hz
Ratad 1r1~ eur.rent: 1.sA
Riilted Output. VoI~9e: See 2t:la;;l1me-nt
Rated OutpUl CUrrent See ;lltlacl".rn&rrt:
Prntedioo C!:il9:
ProClli!;lc:ion Glass: ,
I
This oorlilh:al:e and ~dlments i5=:>ucd under

project Iltlmller SI3041B7-i03
(reference project number SMlPOOO4O..05/
51301087-102)
Tested EN 606Oi-11A13:19S6
according to:
Production
Facility(ies):
Page2of4
TOY AMERICA INC. ·5 Cherry HU! Drjvs • Danvers MA {J1923 USA

TUV Siid'lleutsJl.hland Group

License ID 8-01
Attachment to Condor, Inc. DC Power Supplies

Certificate B 04 08 14549 040
GLM65-X Series* & G2M65-X Series**
Mod~1 Nunlbers: <X' is rmy number from 5 through 43 which repL;:;srent the output
voltage rating. (rcle-r to Installation Itlstfil.etions for addithmal infoTIIlation).
:j; Protecti<J1l against electrical shod:: -Class I

>loll< Protection against elec-trlcal shock~Class II
Ratings:
Output: 5.1 V de minimum, 48 V dc maxirnmn

11 A UlaXlmuril, 1.35 Anrinimum
65 Wmaxhnnm
NOles:
1, ~aximum ambient tcmpcralure for rated output current is 50"e

2. Max.bnuin Operating Rela:iive Humidity 96%. no cOIu:lcnsation.
3. Degree ofl'rotection against electric shock = Signal output or imcnnediate.
4. Mode ofoperation: C{lntintJous
5. StOl'<Lge: -40"C to +S5"e. I)nin: should be allowed to Vt.'am'~ur under non-conden.<iing
cooililioos befort:. appticalicm -0 f power.
6. Protection against hm-mful ingress ofwaIeJ=Qrdinary(no prmcction).
7. Have not been evaluated for use iu the presence offlammable <ma~sincli.c mixture with
air. oxygen, or n.i:(rous oxide. This evaluation is to be made on the-end equipment by
IheOEM.
8. Suffix·-e designation f01' Clptional chassi:;/cover available for the GLM.65 Series only.
9. Model GL\165-5 maximLMl Qlltpui CUrTf:nl "viLh 50 LFM cxtenial airflow: 11 A - 9 A
with con1Tcction cooling.
P.ge3Qf4

License ID 8-01
Attachment to Condor, Inc. DC Power Supplies

Certificate B 040814549040
MSP1788
Model Rated Output Voltage Rated Output Current Rated Tctnperatllre
MSP 1788 15.9 V 4.0A 500C ambient
Ratmgs:
1. Maximt.lm Operating Relative fillmidity96%. no condensation.

2. Storage: -40"C to +85"C. Units should be allowed io wmm-up under notl-eondens.ing
c:o.nditians before application ofpower.
3. Maximum ambient temperature for rated oufpu1 cu:r:rent is 500C.
Cla.s8ification:
4. Protection against electric shock-"- Class: 1

5. Dezrec ofprotec.1ion against electric shock = Signal output Of intermediate
6, Protection against harmful ingress ofwatcr--ordinary(oo protection)
1. Have not Deen evaluated for use in the presence of a flatnillBb1c anaesthetic mixture
mlh airl O};ygeD.. or- nitr¢us oxide. TItis ¢\'aI'uation is to be :made on the end equipment
hy1h<OEM.
8. Mode of operation= ContinlIOL.ES
Certificate and Attachments i!i.5ued as rcpla¢cmentto certificate #B 03 1014549015 under

pr~j,'ct 51400305-125 (reference project SMIF00640-05)
Depm;n<Dt: ELSUSSDiHP
Page4of4

License 10 8-02
@ OIthl7lPaOOl./:: Surgle;D Prnduetl

2OO'Na!!iTOnlo ,:"..:ar:l.ill;;
pi 0, 13-0:0: ie·
OClli3r. .QH 4«i:22·.c':H::t
P:'ICl-.c: 3~-501.3- aoo:
zimmer i-at.=. ~tJo
wm,;.:i:imme-~
34g.{1fKl!!
Kove:mber 16,2004
T.nis cl.01iJ:ms I1ml Zirr:z:c.m OrtroptL;;lUr: Sur~-.& PrbdLEC[S W~!S l;i\.l\'J::ICcl lim. lru.: fu:llu\i,-mg iLt~'l'.mI
~ to be pro\'ided 1.0 the Rt(;O~NCB along \"\'211 r~ CB rest report".
PO'''R SUPPLY CORDS AND PLUGS. - .-\11 pOVP....r iillpply ctxtd;;; .tmt pl':..1g as::ltmbuof.<; wil..t be
~ettiiied and. roi!abk fur lli;¢ in the pmi~ -=:O""J1l!.I'ies '1i'r'ill::n prc:vidcd ~\"I-ith tile product. T~
ltec~d ~CB DIDy requi!.;l certi..fi.cation.
\·'lARK"'TN"C1'S ANn SAFETYTN":'.1'"RUCT1(lNS -Sf.ie!.}' 11'1oS1tlJct'ivtl~ fJruJ. frlllrk"ing:';.lJ'1' the

larl~uag-e 3\Iiu-hle f..) { w"J,.mr~.s }:i6\.td ir:L !hot:: oI'1".l;l:~'~ 1~ ....i Ii be pI"o...·it1ed aL ~ time 'frLe CS
R~ort i~ J'l'".Jhmit:t"£d '!."'l the "Re........:-f::'t"Ved NCn f'O; ~f'lr.a-:ri(J(},
B.4:C TEST I{EPQRT - Wb.;;:re specified b the SatirJnal n1ff~~C"es, an UMC rest RelXtrt or
De';:[aJ'~OD ofCcof'Ormity w[ll ~cO!'l1Panyt~ prodUCt when ~ent 1h:' the ReOOg:llzed. ~C:.B ~ho
ro<:q'".l~s EMC testing.

License ID 8-03
POWER ENTRY MOQULES KFC
"~~ .... :..

:~
~~fri~;~;:;i&~~~J~~f~\:::;~it
1'::01 ..<1 ;:;urr~nl'" 1_"1'-' I-<. «6l"...4U"<:;
L~k:l;J~",u''''~L ';:i",nd::"d "" o~~ "Ii'. ?!l'J ",",1'.0 l-l!:)
1"-",1;""'1 ~ B).t.A t:I~O WOO H~)
1., J<\!'CCb"I~';I;,~L-I~
2.71WOC I>~two;",n LiN·PE
".Ilo"~~""I:''''=bF..nI''ir
I.. ~r.::>I""""-r.. 25"'C1,'~'"<;
Clirrclr..;;.;IliQOr-" ~:>'u:e~?1 "'::C..!::' lB::_:ENil~a.·1
l);gl'v.'·"fl""'I<'<:fi."...... ijlOnl...,.id~ 11'4".:1«", r.:, lEe if.&:9
P''''I.,;;t~'n"b=. ::"il.:i:'~ r..''''l"ipfl"J"nl ;k,lhl,,,I.<::L I.
::ICe. I::> IEC,rli4i:i
OUlct<·=nro::,~4a ~(j.cemm
t>":In~llh;,:kn",,~ ...
1,j::II~Ibt:.: Iiou=.in'l
'"=-'''''''''
TIl ..." ,1Y".T"·_I~I""I<. ULW 'f·u
::IX, I,·
IEC.'EI~;;SOX<20-.·L"C·I4.
p",I""Ti:·n-::l:.= ~
,i~·I,,", ~r.:llU'" ro"C t-",l:l_"",":li[;(l~)
1· 0' :;:.poJ~. :J.. dt~~~~;;:.;l"'.>;l"'ry1'(;:::::
=. '" 1EX:.'ENM"I27_ti.
"',' [u:le-llril<::: 5 .. Z"""i)S ~3;! ffiffi
1:'::'I;o:II:..:nMr:'~C\lp ..moe;"'t :; :L 2!):.2.3 Vi (l'po!!'>)':: W?·r....' ...)I' ... p,,01~
",,,t.f~rN .:Ii, ...: :
l<Imp.,..~tl B.ll or. ~ !l.15'i1 (l-p.. I;,)·':f~ W "!-I,.. I~)
~r "",I~
"'.<Irr~:.:;ibl<'r.........<E":;I:'.C"·"f,J~.." "",",,"""lir.;I"(Ir~ "1\<'Il-,I~"rlh~
'O~"~"",,,"~T~"~ -+,'"O'O~,,=g"~b,",~"";j;,:,,,:i;I,.-,-r,",'"' _
·;"II;r;I~""lict .., ..plb .... -.r.
~ =ilch.!I cr.,);"...,,,
;>",",1" IECiYM(l. EN1S.~ZOO.
~~;;~:J~;~~~;E.;'i!-rof,

License ID 8-03
POWERENTFN MODULES KFC
-~
~lY.lan.!~~l');bn
wjlll·,.I;lIt;lg&~IOCIor
-,.....:..:..,.:..:.•..;.
M;(Ii:alwt~n
",~h V(:iD~;;'~I~C:lOr I
P~-.dClll~1lI I=ill.. r-'~'...e- IlIdLICI.!l~
,,
L1;1..2 mHl
,;;':<10
2:<4-
,• St300.:ll-.:J ZX 15
.2)( 0,8
"Z, 2)(0,3
.2 X lCl
2X4-
•, h!=;:dk:.cl
"
.,
2;<;0.8
" 2XO,3
l"u~.5x20mm FU~5,3l(32mm
l-PO~ Z-fhlil' l·rhl:;> Z-f..o~
t=fhl;;>j !l".. ror.'~)
E&~{] ![~~~t~~
:.-::~~\~ j
;:L~=;~~~~
4 .... ,. ': 0:: a, ..,. ,.. '" .,..

License ID 8-03
POWER ENTRY MODULES KFC
At~m..'$)·l1lMi9
St.1Ildt<pj T~i:;n
dfrRlt>nlio:ll m!XI~ __
common 1l10d;1- __
'A 'A
10A
;:::':"m:"~::i '"~;<;"·;T(: ," ~:'::~< ':;T(:"!?r",n :.~
lJ"m1~lt ~l\m~i~l~l
T~ ·JKl~n(j . I~-:::tllr.>nl r-11I.. r-T~
w~llmOK3 ".
KFe 4303.5011 'A
43D3.501.2 "A
43C3.5013 4A ST.andalil j.pol2'
4303.5014- OA
OA
I "
303.500
43[}3.5032
-tJD3.5033
430::3.503<!-
4303.5D35
2.A
4A
fiA
OA
OA
4A
OA
OA
StllnreRl
Sklll'.lzll'l
303.502
4303.5022 ZA
4303.5Il~
43OO.50:!4-
4303.5025
4A
OA
OA
"".,."
303.!iZ!.
4303.5223 OA
4303.5225 4A M~ilr:..11
4303.5227 OA
'1303.5228 OA
At>~~17jj
Underwriters Laboratorjes Inc.

Issue Date: 2005-01-10 Page 11 of15 Report Reference # E181 905-A1-CB-1
License ID 8-04
C-t:n:ific:tte N° 1;l:?~06-04
ENEC CERTIFICATE
Switches for appliances (EN 61058-1)
..!:;W"ll<:h I'lf "ppHnll'::c.s
A:rc:alf<,:trk Swil.£1Jr;:, pk, 61 Cl:"ilt~l AV¢IJIl.c.
W.W Mabey, S~rc'l' };'"T8~~f' 1.rn~.~~4 King4~I.!~.
l'>Z<:II,k.""io-n site ·See th~ 3ppendix
G:o:nJ.£j(;31:~ holdl:r.
.5ltm.-:.:l;I; M"IUJ~,rlm:r
C~i.fi.d1J.t' n:'ill-=;;t ll'i .:S<ln~C"i1S Mmtllii~(UICl'"
Tl'ad=:1rk: ·,<1Rt:oLEC7RlC
ModellTW'= .1"'1:'1:: 1400 and '.5l.1ij S...r..cs (See"~~Pr~ldix)
!b\nd o;l.l..... lUl~ w: puw.;n 16(4' A
R:l.~cd~tl~: :25aVAC
P;Ute1"n m~rnh(,I~
",1 . "2, .Ii, ':i12, 6 or ~~~n
fl.;ttcJ whi~t t=r.u.peno.Lun:: n.QD~r.TJ.25
SW;J.~.h C:lE~~:ry::
.D
Pr.:lllf ~kiflf; ill.d~ ( ?n ):. '.150 V
w~ll-lAlicJl <.1~., .F:Qr Cb~~ 11 appiia'l~~~
Dcgrtc: of prOor-e.:ritlI:I: II' ';0
AMjti:O-lIal iuf",rml!-twll: RWllgJ; arlo:! J'::::li:.lipti(}IU pfI40f}! ISVU S~Iit$. .s.~.A.tU:Q./&g:l: 31n r=
rCI"0r;:: M. ,.;l-tl12'il. .
V:l1 ci:J nn> covered by this Certific.ue: are sp~.:ci1!;d ill. the a:t~i'J.Ched appendlx.
De....ulcu '''j~l.:iii':::Irion ofrhe c.ecdEr:d pIoducJ:.\slls Hs~cd in me ;Jpptndi::<.
.It snmpk: of th~ product hots Dt'CU tC!H:d and mUIld.in ~1).tPr.m.ity with EN 61.o"5g··1:1~92-t. A]:! ~~?,
.:;t,~ 3hown in me Test Re:port"....iiliref. N rJ. 9~-ll41.43, .
}'roJ~,:, i;,d"J"f i.. di> C=.~r;r"'-'r;m.~.lfm~dr" (l(.'!7l'in;J:l,hENOC l~, fJ'! :;u~ o..,.,.,b-AI.S" - fIl'J.!J.lml;~ ~1Wf;r j.
"no.. C""if..=i':"i~ M.]~!Io.1!rlfe: ~cf" W.11ltil ~,~ji!r!'IIil:.:J. !rl*=JJ~i'i..Ii.""""~~ .,wi ="~f<j(in,.dp.:~~h.J."~ mt~t<iJi>.""·""'w1u"""~~<ilt(,).
lJ1.flFO'r.J..':INII1D~_fIS.v.... ~~, ir-j"m,;,>h~ ,c"'.ri"l!Z"~e.,,,·~:I...'lJ:"1J; j" ~Ml'..il""......-;.~Jl".: ~l'L.ln.r~'Jr.1.,"=JtJriJ!bA'f~~.'~~ 'r.'f"'!-'~-!
C."Ji~(,nJ!·~~ i[~.I~ ...~c"""",,..£J=h.1r31..:-m Th', ~"I"'?'~r.>?".J.~:'(c;.· ".
..-: :.:; : :-.~

t?'~-~ -="""-----
riml Chr.h't:i111$-et)
C~. r.r,,,,,;j~;. MIIll1llU
Ullnlernaliona' Demko AlS

-'- ~~?-2-<:~::'~' ~(,:,~
_ _ _ _ _ _ _ _ _ _ _ . lib ) Uoderwrilers
~tiIlAffiJf.lto.lif
_I

License ID 8-04
APPENDIX TO
ENEC CERTIFICATE N°123~Ol,J~04
Ro"k..:r .~wjtch for use in diny poJJurion siruations; fuJI or mi-ero disc'-'JHu;.;;;\i!J.Il"
lEA; screw. t!ioJdr:-..f PCB or rab i:~LT.(l_I.,.,:~!s.~~ ~ g.ft.lJUl1..Q.r 4.. t:. ~ 0.8- mm
L.Arcol=r~ic Sw.i[~hr:.:; pic,
61 Centf31 Avenue, \v'C'~~t' _MoleBey, Sm,ey. KTs: 2.RF Un~~~ 19..l)$dOJI\

1, An::olec::rrk Switt:hesMfl; Plant.
HWl Mci Rd, HengGanR.Town, HLl:mgGeKeng,
Lo-ng Gar.t; DiSificl. Sht'n:!~cD. GuangJuug. P..R.. China
3..-\rcnlC':cnic TUnisie,
25 Rue: 8601 Cha:gtI1n 1, Carthage, PO Box BP752, lO.SO Tunis.. 'l\m.isia
4. _';'rcoJearic T ul1i~i,~!
. -2?JtU:t q.J2?! ?CJ-Ll~ r.~'j.l:lJl,rkH~ lbn K.h.a)~?}lJ4 C~l:::~rir, 2M2 J'llllh
I,
Hcdcv, 2003-02-18
UL Intel11ational Demko AlS ..<:""'\. :lin II.ffilblhl m

l.sk~~ JJ.. P.~. Bc:l5JL
0_°- IIJl } UndefWl'ilBI'S

License ID 8."-0,,,4,-_
APPENDIX TO
ENEC CERTIFICATE N° 123306,.,04
i.i-OOI15!J.Q.St.-rl.::S Type k.cy
I I l~._oody ReferenCt!
1 . A - SP U.2 x 27.2n1.lll
Ij '1 A-OJ.l223 x 27.2
! B - SP 1).0 x 30.0 PJar::ge 33.4 lOllg
"· ..n - DP 22.1 x 30.0 Fl:u\t~ 33.4 long
I I
1
J
D ~ OP 22.0 x 29_1 P1aJl.f,'"~;; 2.0 lo.ng
E- Dr 21-0 x 29A. FI~J'b'l:"30.2 long
J - Imc;r1ockinghody IdL h;!..'l.c!.SP
.j
I I K -lnrerloc.king bmly right -ullnd SP

.I
I L ·DP 22.0 x 30,0 Fiun~ 32.0 Jon~
1\'1- sr 11.0 x 30.0 FbP.'.§J 32.0 Ion!',
I I
1
1
.Q - SP 115): 23.2 r-l:nl~c.: :30.21cng.
Q OJ) 22.3 x18.2 Flange 3.0..21ons
ft
R - SP 14.0 x 28.5
S - DP 2 holes:.;lt 42.0 ~tn~s
. fI ,! T ~ SP 11.5 X 2tL21 11ange :")rl_2!ong
T - PI) 22.3 :<28.2 P1all~3C,~.l.o~
. i
iI 1_ _~_A-c!J.1:.11o(~r.
.
Rcfe.reI1ce
. A - Curved
I ". H ~ ClllYc:d
.E -large C!.ln'~::d
:I I
l' -l'J.,
G -Sm:illp:d.cl.Jle
.··H - Fbr with 5]('l.~
"J-PaddL:
I k· Cl.n.w ie-fer
I1
.1
~
!
"L - Narrow paddle
P - Round. window b
1\ ~ Round
:V ·-Cu..--ved
·W· - Curved
X - .)oftlill~ t:::t.J-1mueO. insert.
[ :Z.~ Narrow wch:-r
Ullntemational Demko AfS ~ .hJl,ffiI.lllteof

~"::!:;:~;~D.&.!:~~14 ________" I U. I Und~:rwriters:

License 10 8-04
APPENDIX TO
ENEC CERTIFICATE N° 12.3306-04
C - G3.mm. rab
, H - 4.em m I;lb tet£l:UI.il1
Ie -Akt::.rIJ:llf\.'t.'- ~clckI Ulgterminal
:S-·Sq.;:w la=iu;J,!:s
T ~501dcrmgt.. . rmimk
Po.rmed T te.tn'l.lnal
:1.} -
X PTiIl~dci.:euit bcm-d pin.
M
Y - FOlDRd C U!rninal
Z - Fnrm~:d H te.rm4i1ll
11ill C:cniikan: n:pl.:wes the- CenificatJ: wirh Nn_ 99-04243, d.a~ed 1999-12-20.
ULr IlII.:rmltif,II;,(l,1 Demko AlS has 1:iS"ued.~ m:~\, ENEc;.: Ce.!:tific~~~ iI.r, .~ ..l1.t\w 'p~Hq'.Q-.Q. she.• ¥I:
ad-J.eq .r? ~~ f"'?tJpC!. ":cr~ !fi~~t f.rpd4ct, .
Her.le¥,,1Q03-D2·-2.8
UL 1n1lll'llatlonal Damkn AlS ~ An "UlUlate of

~~~:~:D.B::-5j4 ....... r U. 1 IInderwritllrs
UndelWriters Laboratories Inc.

Issue Date: 2005-01-10 Page 150f15 Report Reference # E181905-A1-CB-1
License 10 8-04
Annex 1 to Certificate, licence No.

~~ _ _~~OIS123306·04
Annex o~ the form of t~" .Mark.
15* •
. _~ ...
$ite of the lVfurk:
..TJw l:i1:!G or lhe ID<lI'k may be reduced on the conditio.-n tboai it

:remains k\gihlv andthaHJ~ ratiQ .i?-~~ n:: .1 ~1_i~.kepL· .
Ul. InrematiolIlll Demko AlS ~ Ji.rlAmllat-llM

L;sk.;er s. P.O. ~~ ;-,4 r 11, i IInd.Mr)'.",

IEC 60601 Dermátomos

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

IEC 60601 Dermátomos

Uploaded by

Copyright:

Available Formats

rIIII

Name and address of the applicant

Name and address of the manufacturer

Name and address of the factory

Rating and principal characteristics

Trademark (if any)

Model IType Ref.

Additional information (if necessary)

A sample of the product was tested and found

as shown in the Test Report Ref. No.

This CB Test Certificate is issued by the National Certification Body

COVER PAGE FOR TEST REPORT

Copyright © 2002 Underwriters Laboratories Inc.

Underwriters Laboratories Inc.

Compiled by (+ signature) ...............,: Alex Grob

TRF No.: IEC60601_1C Underwriters Laboratories Inc. TRF originator: UL

Marking Plate - Refer to Enclosure tilled Miscellaneous for copy.

"(see Enclosure #)" refers to additional information appended to the report.

General Product Information:

TRF No.: IEC60601_1C Underwriters Laboratories Inc. TRF originator: UL

TRF No.: IEC60601_1C Underwriters Laboratories Inc. TRF originator: UL

TRF No.: IEC60601_1C Underwriters Laboratories Inc. TRF originator: UL

3 GENERAL REQUIREMENTS Pass

TRF No.: IEC60601_1C Underwriters Laboratories Inc. TRF originator: UL

-continuous operation with short-time, stated

TRF No.: JEC60601_1C Underwriters Laboratories Inc. TRF originator: UL

TRF No.: IEC60601_1C Underwriters Laboratories Inc. TRF originator: UL

ITABLE: to insulation diagram I

lnsulalion twa: Referemr: Required Requffied Measured: flJ!easur€d "

Area Qpera'tional {basic e '\!oltage creepage clearance' 13reepage clearance

B BI 240 4.0 2.5 4.0 4.0

o DllBI 15/240 3.4/4.0 1.6/2.5 12.0 12.0

INSULATION DIAGRAM CONVENTIONS

5. Blocks mntaining the lelter "Z" indicate protective impedance.

TRF No.: IEC60601 1C Underwriters Laboratories Inc. TRF originator: UL

6 IDENTIFICATION, MARKING AND DOCUMENTS Pass

TRF No.: IEC60601 1C Underwriters Laboratories Inc. TRF originator: UL

6.1s Dangerous voltage symbol N/A

TRF No.: IEC60601_1C Underwriters Laboratories Inc. TRF originator: UL

6.21 Statement for suitable wiring materials at N/A

TRF No.: IEC60601_1 C Underwriters Laboratories Inc. TRF originator: UL

6.7a Red indicator lights used exclusively to indicate a N/A

TRF No.: IEC60601_1C Underwriters Laboratories Inc. TRF originator: UL

- information for the safe performance or routine Pass

TRF ND.: IEC60601_1C Underwriters LabDratDries Inc. TRF DriginatDr: UL

7 POWER INPUT Pass

10 ENVIRONMENTAL CONDITIONS Pass

14 REQUIREMENTS RELATED TO CLASSIFICATION Pass

TRF No.: IEC60601 1C Underwriters Laboratories inc. TRF originator: UL

15 LIMITATION OF VOLTAGE AND/OR ENERGY Pass

16 ENCLOSURES AND PROTECTIVE COVERS Pass

TRF No.: IEC60601 1C Underwriters Laboratories Inc. TRF originator: UL

TRF No.: IEC6060t 1C Underwriters Laboratories Inc. TRF originator: UL

18 PROTECTIVE EARTHING, FUNCTIONAL EARTHING AND POTENTIAL Pass

TRF No.: IEC60601_1 C Underwriters Laboratories Inc. TRF originator: UL

19 CONTINUOUS LEAKAGE CURRENTS AND PATIENT AUXILIARY CURRENTS Pass

20 DIELECTRIC STRENGTH Pass

21 MECHANICAL STRENGTH Pass

TRF No.: IEC60601_1C Underwriters Laboratories Inc. TRF originator: UL

22 MOVING PARTS . Pass

23 SURFACES, CORNERS AND EDGES Pass

TRF No.: IEC60601 1C Underwriters Laboratories Inc. TRF originator: UL

24 STABILITY IN NORMAL USE (see appended table 24) Pass