Model 1100, 1101, 1102 and 1104 Wireless Probes Operation Manual Rev June 2014

“neoprobe®”, “neo2000®”, and “Devicor®” word marks and “neoprobe®” logo are registered trademarks of Devicor® Medical Products, Inc. "Bluetooth®" word mark and logos are owned by Bluetooth SIG, Inc. and any use by Devicor or its representatives is under license. Contains BLUETOOTH Module WML-C40AH (Mitsumi Electric Co., Ltd.) Contains: FCC: POOWML-C40 / IC: 4250A-WMLC40 Class: Part 15 Spread Spectrum Transmitter Bluetooth Module Rule: Parts 15 C

Devicor® Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 USA Tel: 1-877-926-2666 Fax: 1-888-260-6362 e-mail: customerservice@mammotome.com URL: www.mammotome.com

Devicor Medical Germany GmbH Südportal 5 22848 Norderstedt, Germany

Made in U.S.A. This document is sole property of Devicor® Medical Products, Inc. Any duplication, reproduction, or transmission of document or any of its content to unauthorized parties without prior written permission of Devicor Medical Products, Inc. is prohibited.

© 2014 DEVICOR® MEDICAL PRODUCTS, INC. ALL RIGHTS RESERVED.

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Table of Contents 1. ... INTRODUCTION ... 4 2. ... EQUIPMENT ASSEMBLY ... 4 3. ... SYSTEM OPERATION ... 6 4. ... CONFIGURING DYNAMIC OR BINARY PITCH MODE: ... 7 5. ... TERMINOLOGY AND SYMBOLS ... 11 6. ... CLEANING, DISINFECTION AND STERILIZATION... 12 7. ... MAINTENANCE ... 13 8. ... PROBE SPECIFICATIONS ... 14 9. ... WARNINGS, CAUTIONS AND NOTES ... 16

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1. Introduction Intended use Indications

Electronic device for detecting and quantifying gamma radiation Used intraoperatively to detect and quantify radioactive emissions from body tissues or organs where radiopharmaceuticals are administered

This manual: Purpose

Users Scope

Probe Revision

Operating the following devices: neoprobeTM Gamma Detection System (GDS) Model 1100, 1101, 1102 and 1104 Wireless Gamma Detection Probes Model 1131 Serial Port Adapter (adapter) Note: Not required with Model 2300 Console Physicians and operating room staff Supplementary information for users of wireless probes This manual does not provide: System repair and technical documentation Procedures for performing surgery Procedures related to nuclear medicine This manual describes the function of the Bluetooth wireless probes. The probes can be identified by the marking on the side of the battery compartment. See these markings in this document to identify the features available for each probe. “ ” or “ ” The wireless probes can be used with any model of console (Model 2200 requires the addition of an external Bluetooth module). The software version 6.01 or later is only available with the model 2200 and 2300 console.

2. Equipment Assembly Console: neo2000 Console

Bluetooth Probe

1

Bluetooth Serial Port Adapter

3

2

Medical Grade Power Supply

3

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1. Connect Model 1131 serial port adapter to data port on rear of console. Secure with thumbscrews. 2. Connect medical-grade power supply (NeoprobeTM PN 00-1221/Ault Model No. MW117) to receptacle on serial port adapter. 3. Connect 2 medical-grade power cords (Model 2009) to power connectors: one on the console and one on the serial port adapter power supply. Probes: Battery Installation: 1. Remove Battery Cap

2. Install Battery

3. Install Battery Cap

1. Hold probe firm; turn battery cap counterclockwise until stop; pull battery cap from probe. 2. Install 3V CR 123 lithium battery; either polarity. 3. Hold probe firm near button area; push battery cap into probe and turn clockwise until stop.

Disposable Duracell Ultra 123

Brand Ø16.5 mm

Hours of continuous operation

: >25 : 10

32.5 mm

Capacity

1550 mAh

Rechargeable UltraLast 123 (North American Battery Company) : >10 :5 750 mAh

Before installing battery cap, check that o-ring is in place. Ensure o-ring is not missing, cut or damaged (Replacements available: NeoprobeTM part number P-391).

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Sterile Sheaths, Sterilization: 1102: The Model 1102 Gamma Detection Probe is compatible with 11mm or 12mm trocars. Consult instructions for trocar selected. The Model 1102 Gamma Detection Probe with CIVCO Laparoscopic Transducer Cover should be used with 12mm sized trocars. Using sterile sheaths: For intraoperative use, install the probe in a commercially available sterile sheath, such as: Catalog number 610-658

Size 15.2 x 244cm

Description Sterile Laparoscopic Transducer Cover

1100, 1101, 1104: For intraoperative use, install the probe in a commercially available sterile sheath, such as: Catalog number 610-006 610-844 610-843

Size 4.6 x 61 cm 4 x 30 cm 2.6 x 30 cm

Description CIV-Flex Polyisoprene NeoGuard® Polyisoprene NeoGuard®

Note: CIVCO Medical Instruments may change part numbers without notice. For latest information on these sheaths, contact CIVCO Medical Instruments:1 800-445-6741 (U.S.A.) or +1 319-6564447 international. If needed, install the Model 1013 External Collimator on the probe before placing in sterile sheath (Model 1100/101 probes only). Using aseptic technique, install probe in a sterile sheath. Fold and secure sterile sheath around the probe to create a complete sterile barrier. Follow established hospital procedures to maintain a sterile environment. Alternatively, probes may be sterilized by EO, or STERRAD® SYSTEM. Sterile probes do not require a sterile sheath. Refer to individual Cleaning and Sterilization Instruction for Use Documents on Manual CD for detailed instructions. See list of documents below: Title Cleaning and Disinfection of Probes, Cables and Collimators to EN ISO 17664 STERRAD Reprocessing of Probes, Cables and Collimators to EN ISO 17664 EO Reprocessing of Probes, Cables and Collimators to EN ISO 17664 Autoclave Reprocessing of Collimators to EN ISO 17664

3. System Operation Establishing communication: AW-000893

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Before using the wireless probe, follow the next section to establish a BLUETOOTH communication link between the probe and the serial port adapter (indicated by the blue LEDs on the serial port adapter or rear of model 2300 console and the probe). Note: Link any Model 1131 adapter or Model 2300 console with any Model 1100, 1101, 1102 or 1104 wireless probe.

1.

2.

1. Adapter or 2300 LED On

Description

2. Probe LED

Description

Linked

Off

Not linked

On Blinking Off

Searching for the link Linked Not powered

4. Configuring dynamic or binary pitch mode: For more information, see the Console Operation Manual. 

Power on console.

The console indicates there is no link, as shown.

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Press the probe control button to power on the probe. 

The probe LED illuminates (searching for the BLUETOOTH link).



If the probe is already linked to the console, the console powers on normally, as shown.



The probe LED blinks and the adapter LED is on.

If the console indicates there is no link, press and hold the Target Count Button to initiate search. 

The console searches for the BLUETOOTH link, as shown.

Note: This is only required if you are using a different wireless probe than was previously attached to the console. 

When the link is established, the system is ready for use.

If the probe detects an input count under 5 counts/second for a 5-minute period, it powers down to conserve power. 

The console indicates there is no link, as shown.



Probe and adapter LEDs are off.

To continue using the probe, press and release the probe’s control button. 

The probe powers on.



The link is established and the probe is ready within 5 seconds.

Monitoring the battery: If low battery voltage occurs: 

Lo bAtt is displayed periodically and an alarm sounds to indicate low battery as shown.



Replace the battery as soon as possible.

If the battery voltage falls below a critical level, the probe shuts down and remains off.

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Probe operation: The probe operates like all NeoprobeTM probes when used intraoperatively to detect and quantify radioactive emissions. The probe’s control button lets you initiate operations without a second person operating the console outside the sterile field. 1102:

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Dynamic pitch operation: Operation

Probe

Console

Target Count

●



10-Sec Count





Activation / Comment Press and release the probe’s control button. Press and hold the probe’s control button (>1 sec).

  

Background Count Count Range Select Auto Range

: 4 radionuclides available: 125I, 99mTc, 111In, 131I

Radionuclide Selection



Volume Adjustment Mute Button Diagnostics

  

(if probe is used with a Model 2200 or 2300 console with v6.01 Software or later): 6 radionuclides available: 125I, 57Co, 99mTc, 111In, 131I, 18F

Binary pitch operation: Function

Probe

Console

Target Check (2 sec)





Target Count (6 sec)





Activation / Comment Press and release the probe’s control button. Press and hold the probe’s control button (>1 sec).



Background Count

: 4 radionuclides available: 125I, 99mTc, 111In, 131I

Radionuclide Selection



Volume Adjustment Mute Button Diagnostics

  

(if probe is used with a Model 2200 or 2300 console with v6.01 Software or later): 6 radionuclides available: 125I, 57Co, 99mTc, 111In, 131I, 18F

Powering down the system: 

Press and release the console’s Power button.



Unplug the console’s power cord from the wall receptacle.

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

Unplug the adapter’s power cord from the wall receptacle (if applicable).



Clean the console, adapter, and both power cords.



Using aseptic technique, remove the probe from the sterile sheath. Follow established hospital procedures to discard the sheath.



Separate and clean the external collimator and probe as described in this manual.

5. Terminology and Symbols Terms, symbols and graphics used in this manual. ITEM

DESCRIPTION

Count Rate

A continuous rate of gamma radiation measured in counts per second and updated every one-half second. Count Rate is displayed on same line of LED screen as Target Count data and Target Check data when these functions are not active.

Background Count

In Dynamic Pitch Mode: a baseline value in counts per second stored in console and used as threshold to activate sound In Binary Pitch Mode: baseline value in counts per second stored in console for comparison to Target Count determines if difference in radioactivity between Background Tissue and Target Tissue is statistically significant.

Dynamic Pitch

Default mode of operation: baseline value measured in counts per second that is stored in console, and used as threshold at which sound is activated.

Binary Pitch

Optional mode of operation: baseline value measured in counts per second that is stored in console for comparison to Target Count determines if difference in radioactivity between Background Tissue and Target Tissue is statistically significant. Binary Pitch Mode Only: quick check of level of radioactivity measured in counts per second detected by a probe held stationary for 2 seconds over target tissue; more accurate than Count Rate. Target Check function does not display a calculated Ratio Readout.

Target Check

Target Count

Number indicating level of radioactivity detected by probe when held stationary for 6 seconds over Target Tissue; more accurate than Target Check. Target Count activates and displays a calculated Ratio Readout; 6 seconds in Binary Pitch mode; 1 to 6 seconds in Dynamic Pitch mode.

Caution: see accompanying documents ISO Symbol: indicates product is nonsterile until properly cleaned, disinfected and sterilized. +60°C -20°C

Temperature limits Relative humidity Atmospheric pressure Caution: Federal Law restricts this device to sale by or on the order of a physician.

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ITEM

DESCRIPTION Warning: Follow instructions for use

Devicor uses recyclable materials wherever possible. There are materials in our product that do contain risk associated with Disposal. If the need arises that components, parts, accessories or devices at end of life need to be disposed of, we recommend that you comply with local, state and/or international laws and regulations for your country or area.

Inmetro certified

Anatel certified

6. Cleaning, Disinfection and Sterilization Reprocessing: 

If you detect a high count in the absence of a radioactive source, clean the probe with a radioactive decontamination solution. Follow your institution’s biohazard and radioactive decontamination and waste procedures.



Refer to individual Cleaning and Sterilization Instruction for Use Documents on Manual CD for detailed instructions

After cleaning and before using: 

Before installing the battery cap, check that the o-ring is in place. Ensure that it is not missing, cut or damaged.



Ensure the battery and probe housing are completely dry.



Check entire probe, including around silicone button area, for damage.

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7. Maintenance User maintenance is restricted to battery, battery cap and O-Ring replacement. There are no user serviceable components or items on the Model 1100, 1101, 1102 or 1104 wireless probes. Do not attempt to repair damaged battery contacts, or any other damage to the probe. WARRANTY New equipment manufactured by Company is warranted against defects in workmanship and materials for a period of one year from the date of shipment by Company to buyer, subject to the limitations hereinafter set forth. Should any defects be found and reported during that period, company, at its option, will repair or replace such defective equipment provided that Buyer ship the product containing the defect to the Company, transportation charges prepaid, with notice of the defect and representation that the equipment will be shipped C.I.P. from the Company’s plant. The terms of this product warranty do not extend to any product or part thereof, which, under normal usage, has an expected useful life of less than one year. This warranty shall not apply to any equipment where the installation, calibration or servicing of such equipment is improper, or where equipment is operated above rated load capability, or subjected to accident, tampering, alteration, or abuse. THE COMPANY’S LIABILITY UNDER THIS WARRANTY OR ANY OTHER WARRANTY WHETHER EXPRESS OR IMPLIED IN LAW OR FACT SHALL BE LIMITED TO THE REPAIR OR REPLACEMENT OF DEFECTIVE MATERIAL AND WORKMANSHIP, AND IN NO EVENT SHALL THE COMPANY BE LIABLE FOR CONSEQUENTIAL OR INDIRECT DAMAGES. THIS WARRANTY CONTAINS THE ENTIRE OBLIGATION OF DEVICOR MEDICAL PRODUCTS, INC. AND NO OTHER WARRANTIES INCLUDING, WITHOUT LIMITATION, WARRANTIES EXPRESSED, IMPLIED, OR STATUTORY ARE GIVEN. THIS WARRANTY CONTAINS THE ENTIRE OBLIGATION OF DEVICOR AND NO OTHER WARRANTIES INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR OTHER WARRANTIES EXPRESSED, IMPLIED, OR STATUTORY ARE GIVEN.

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8. Probe Specifications Parameter Crystal Energy Range Detector Efficiency

Specifications Cadmium Zinc Telluride, CdZnTe 27-364 keV >90% 125I >76% 99m Tc >60% 111In >25% 131I 140 grams 175 grams 112 grams >99.99% 125I >99.5% 99m Tc >90% 111In

Weight (Model 1100, 1101) Weight (Model 1102) Weight (Model 1104) Side/Rear Shielding (Model 1100,1101, 1102)

Side/Rear Shielding (Model 1104)

>99.99% 125I >96% 99m Tc >86% 111In

Operating Temperature Range Storage/Transit temperature Storage/Transit humidity Storage/Transit atmospheric pressure Frequency Band/Range Harmonized standard(s)

15° to 40° C (59° to 104° F) -20° to 60° C (-4° to 140° F) 10 to 95% 500 hPa to 1060 hPa (7.3 psia to 15.4 psia) 2402.0 – 2408.0 MHz ETSI EN 300 328 v1.6.1:2004 ETSI EN 301 489-17:2002 FHSS (GFSK) 79 channels 0.01382 Watts Variable (hops = 1600/sec) Chip Full duplex

Modulation Channel Spacing Max Transmit Power Limit Duty cycle Type of antenna Duplex direction Equipment Classification:

For more information, see the neo2000 Operation Manual. Type of protection against electrical shock: Console Class 1 Degree of protection against electrical shock: Applied Part: (wireless probe) Type CF [EN 60601-1] Protection against the harmful ingress of liquids: Probe IPX8 Radio Transmitter: Europe 99/5/EC R&TTE Directive Class I US & Canada (FCC Parts 15) Part 15 Spread Spectrum Transmitter Module (Bluetooth) AW-000893

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Use only detachable power cords that comply with one or more agency approvals: 100VAC/50-60Hz Dentori 125VAC/60Hz CSA, UL 250VAC/50Hz ASTA, CEBEC, CCEE, DEMKO, FIMKO, IMQ, KEMA, LCIE, NEMKO, OVE, SECV, SEMKO, SEV, VDE. This device complies with Part 15 of the FCC Rules. Operation is subject to: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation. Declaration of Conformance: Hereby, Devicor Medical Products, Inc. declares that this “Wireless Probe” is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. Česky [Czech]

Devicor Medical Products, Inc. tímto prohlašuje, že tento “Wireless Probe” je ve shodě se základními požadavky a dalšími příslušnými ustanoveními směrnice 1999/5/ES.

Dansk [Danish]

Undertegnede Devicor Medical Products, Inc. erklærer herved, at følgende udstyr “Wireless Probe” overholder de væsentlige krav og øvrige relevante krav i direktiv 1999/5/EF.

Deutsch [German]

Hiermit erklärt Devicor Medical Products, Inc., dass sich das Gerät “Wireless Probe” in Übereinstimmung mit den grundlegenden Anforderungen und den übrigen einschlägigen Bestimmungen der Richtlinie 1999/5/EG befindet.

Eesti [Estonian]

Käesolevaga kinnitab Devicor Medical Products, Inc. seadme “Wireless Probe” vastavust direktiivi 1999/5/EÜ põhinõuetele ja nimetatud direktiivist tulenevatele teistele asjakohastele sätetele.

Español [Spanish]

Por medio de la presente Devicor Medical Products, Inc. declara que el “Wireless Probe” cumple con los requisitos esenciales y cualesquiera otras disposiciones aplicables o exigibles de la Directiva 1999/5/CE.

Ελληνική [Greek]

ΜΕ ΤΗΝ ΠΑΡΟΥΣΑ Devicor Medical Products, Inc. ΔΗΛΩΝΕΙ ΟΤΙ “Wireless Probe” ΣΥΜΜΟΡΦΩΝΕΤΑΙ ΠΡΟΣ ΤΙΣ ΟΥΣΙΩΔΕΙΣ ΑΠΑΙΤΗΣΕΙΣ ΚΑΙ ΤΙΣ ΛΟΙΠΕΣ ΣΧΕΤΙΚΕΣ ΔΙΑΤΑΞΕΙΣ ΤΗΣ ΟΔΗΓΙΑΣ 1999/5/ΕΚ.

Français [French]

Par la présente Devicor Medical Products, Inc. déclare que l'appareil “Wireless Probe” est conforme aux exigences essentielles et aux autres dispositions pertinentes de la directive 1999/5/CE.

Italiano [Italian]

Con la presente Devicor Medical Products, Inc. dichiara che questo “Wireless Probe” è conforme ai requisiti essenziali ed alle altre disposizioni pertinenti stabilite dalla direttiva 1999/5/CE.

Latviski [Latvian]

Ar šo Devicor Medical Products, Inc. deklarē, ka “Wireless Probe” atbilst Direktīvas 1999/5/EK būtiskajām prasībām un citiem ar to saistītajiem noteikumiem.

Lietuvių [Lithuanian]

Šiuo Devicor Medical Products, Inc. deklaruoja, kad šis “Wireless Probe” atitinka esminius reikalavimus ir kitas 1999/5/EB Direktyvos nuostatas.

Nederlands [Dutch]

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Hierbij verklaart Devicor Medical Products, Inc. dat het toestel “Wireless Probe” in overeenstemming is met de essentiële eisen en de andere relevante bepalingen van richtlijn 1999/5/EG.

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Malti [Maltese]

Hawnhekk, Devicor Medical Products, Inc., jiddikjara li dan “Wireless Probe” jikkonforma mal-ħtiġijiet essenzjali u ma provvedimenti oħrajn relevanti li hemm fid-Dirrettiva 1999/5/EC.

Magyar [Hungarian]

Alulírott, Devicor Medical Products, Inc. nyilatkozom, hogy a “Wireless Probe” megfelel a vonatkozó alapvetõ követelményeknek és az 1999/5/EC irányelv egyéb elõírásainak.

Polski [Polish]

Niniejszym Devicor Medical Products, Inc. oświadcza, że “Wireless Probe” jest zgodny z zasadniczymi wymogami oraz pozostałymi stosownymi postanowieniami Dyrektywy 1999/5/EC.

Português [Portuguese]

Slovensko [Slovenian]

Slovensky [Slovak]

Devicor Medical Products, Inc. declara que este “Wireless Probe” está conforme com os requisitos essenciais e outras disposições da Directiva 1999/5/CE. Devicor Medical Products, Inc. izjavlja, da je ta “Wireless Probe” v skladu z bistvenimi zahtevami in ostalimi relevantnimi določili direktive 1999/5/ES. Devicor Medical Products, Inc. týmto vyhlasuje, že “Wireless Probe” spĺňa základné požiadavky a všetky príslušné ustanovenia Smernice 1999/5/ES.

Suomi [Finnish]

Devicor Medical Products, Inc. vakuuttaa täten että “Wireless Probe” tyyppinen laite on direktiivin 1999/5/EY oleellisten vaatimusten ja sitä koskevien direktiivin muiden ehtojen mukainen.

Svenska [Swedish]

Härmed intygar Devicor Medical Products, Inc. att denna “Wireless Probe” står I överensstämmelse med de väsentliga egenskapskrav och övriga relevanta bestämmelser som framgår av direktiv 1999/5/EG.

Íslenska [Icelandic]

Hér með lýsir Devicor Medical Products, Inc. yfir því að “Wireless Probe” er í samræmi við grunnkröfur og aðrar kröfur, sem gerðar eru í tilskipun 1999/5/EC.

Norsk [Norwegian]

Devicor Medical Products, Inc. erklærer herved at utstyret “Wireless Probe” er i samsvar med de grunnleggende krav og øvrige relevante krav i direktiv 1999/5/EF.

9. Warnings, Cautions and Notes This information supplements the Console Operation Manual. Warning: 

Only properly trained and qualified personnel should use the system.



Execute universal precautions when handling components that are exposed to blood or blood components. Before using or storing, clean all components used during intraoperative applications.



Always remove battery from wireless probe before cleaning and disinfecting



To avoid permanent damage, do not immerse the probe with the battery cap loose or removed. Clean the probe’s surface with a soft cloth.



Before cleaning, inspect the probe to ensure the battery is not exposed.



To ensure compliance with EN 60601-1, use only the battery type or power components listed in this document. Using other items may compromise the device’s safety or operation.



Use the probe only where the target tissue can be adequately viewed and accessed.

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

Use only the Serial Port Adapter (Model 1131 adapter) provided by Devicor Medical Products, Inc. Do not co-locate or operate the transmitter with any other antenna or transmitter.



Do not use an electrocautery or other electrosurgical devices in the patient when the probe is in the patient. Doing so may increase the risk of patient injury if the electrosurgical devices contact the probe.



Do not sterilize the probe by e-beam or gamma sterilization. Use only recommended cleaning and sterilization methods.

Caution 

The probe is a delicate surgical instrument. To avoid permanent damage, do not drop it.



Completely dry the probe’s battery and housing before use. Wet contacts may short the battery.



Modifications not expressly approved by Devicor Medical Products, Inc. will void your authority to operate the equipment.



Using this device near X-ray-producing devices may cause false counts.



Using this device near persons undergoing radiation therapy may cause false counts.

Notes 

If the device is not used for an extended time, remove the battery.

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NPB14S, NPB14A, NPB09S, NPBAK, NPB11L

Devicor Medical Germany GmbH Südportal 5 22848 Norderstedt Germany

DEVICOR® MEDICAL PRODUCTS, INC. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 USA

AW000893 | REV 06-14

TITLE

Wireless Probes Operation Manual, Model 1102 Probe Manual (Combined) IFU (English) ARTWORK NUMBER AW-000893

SCALE

REVISION

1 :1

A

PRODUCT CODE

NPB14S, NPB14A, NPB09S, NPBAK, NPB11L

ECN NUMBER ECN-000680

DATE 06.16.14

DRAWN BY

E. Tanghal

PROPRIETARY AND CONFIDENTIAL THE INFORMATION CONTAINED IN THIS DRAWING IS THE SOLE PROPERTY OF DEVICOR® MEDICAL PRODUCTS ANY REPRODUCTION IN PART OR AS A WHOLE WITHOUT THE WRITTEN PERMISSION OF DEVICOR® MEDICAL PRODUCTS, INC. IS PROHIBITED.

Notes: 1. Translations: English, French, German, Italian, Spanish, Portuguese, Polish, Netherlands, Czechoslovakian, Slovakian, Danish, Swedish, Norwegian, Finnish, Japanese, Chinese. 2. All translations part of this IFU is generated as its own file. 3. RR-001371 Artwork Requirement Document