CU User Manual Command Unit
(CU) For AutoLap User Manual 1023 Device name CU User Manual - DRAFT Command Unit Clip EU Part Number: ASS02001 Command Unit Clip US Part Number: ASS03001 Command Unit Ring EU Part Number: ASS04001 Command Unit Ring US Part Number: ASS05001 Manufactured by:
MST Medical Surgery Technologies Kochav Yokneam Building, Floor 5, P.O.B 685 Industrial Center, Yokneam Illit 20692 Israel
: +972(0)73-7965570
: +972(0)73-7965571
: info@mst-sys.com European Representative:
Donawa Lifescience Consulting Srl Piazza Albania, 10 00153 Rome, Italy EC REP Copyright 2012 by MST Medical Surgery Technologies All rights reserved. You are not permitted to reproduce or transmit this document (or part of this document) in any format or by any means, without written approval of the MST Company. MODIFICATIONS The information presented in this document may be modified without warning. Maximum effort has been made to guarantee the accuracy of the information provided in this document. LICENSE CONTRACT AutoLap CU design is the exclusive property of the MST Company. Any copying either in part or in whole is strictly prohibited. CU-90-089 ver 03, 24-Dec-2012 P a g e 2 CU User Manual - DRAFT Table of Contents CHAPTER 1. General ................................................................................................ 4 1.1 Introduction ...................................................................................................... 4 1.2 Scope of This Manual ...................................................................................... 4 1.3 Conventions Used in this Manual .................................................................... 4 CHAPTER 2. About the CU ....................................................................................... 6 2.1 Intended Use ................................................................................................... 6 2.2 The CU Modes of operation ............................................................................ 6 2.3 The CU Configurations .................................................................................... 6 CHAPTER 3. Contents of the Sterile Package .......................................................... 8 CHAPTER 4. Handling ............................................................................................ 10 4.1 On Receipt of Package ................................................................................. 10 4.2 Storage .......................................................................................................... 10 4.3 Summary of Warnings and Precautions ........................................................ 10 CHAPTER 5. Technical Characteristics .................................................................. 11 CHAPTER 6. CU Operation ..................................................................................... 11 6.1 Attaching the CU to finger or tool .................................................................. 11 CU-90-089 ver 03, 24-Dec-2012 P a g e 3 CHAPTER 1. General 1.1 Introduction CU User Manual - DRAFT This manual is an accompanying document to the Command Unit (CU) control components of the AutoLap system. The AutoLap system is designed to hold and control the movement of the laparoscope during laparoscopic surgeries. It describes the Command Unit, as well as its functioning as part of the AutoLap system. 1.2 Scope of This Manual The scope of this user manual is to provide the safety information of the product, and to explain the basic operating instructions that are performed by the systems user. 1.3 Conventions Used in this Manual The following symbols and conventions are used in this manual:
Note Notes provide plain good advice and/or additional information of which the user should be aware. A note is located next to the relevant text and should not be used for direct action. Caution Warning Alerts the user to a possible problem with the device concerning its use or misuse. Such problems include device malfunction, device failure, damage to the device or damage to other property. The caution statement includes the precaution that should be taken to avoid the hazard. Alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the device. CU-90-089 ver 03, 24-Dec-2012 P a g e 4 CU User Manual - DRAFT Explanation of Shortcuts in this manual user:
CU Command Unit DOF Degree Of Freedom OR Operating Room EMC Electromagnetic Compatibility IEC International Electrotechnical Committee CU-90-089 ver 03, 24-Dec-2012 P a g e 5 CU User Manual - DRAFT CHAPTER 2. About the CU 2.1 Intended Use The Command Unit (CU) is a sterile disposable unit that is designed to transmit low power RF signals. The main functions of the RF signals are to enable the movement of the laparoscope to the surgeon's desired location. 2.2 The CU Modes of operation The CU is designed to control the movement of the laparoscope at the discretion of the surgeon. Pressing the button of the CU will start the movement of the laparoscope. When the surgeon stops pressing the button, the movement is stopped. The CU contains a Five-Way Button. Pressing the button in its different modes enables the AutoLap to move the laparoscope up or down as presented on the surgeon's screen, move the laparoscope to the right or to the left of the screen, advance the laparoscope into the patient's abdomen (zoom in) or extract it from the patient's abdomen (zoom out). 2.3 The CU Configurations The CU is designed in two configurations:
1. Ring, which is worn by the surgeon on one of his fingers (like a normal ring), over the glove. The Ring Unit is activated with the surgeon's thumb. See Figure 1. Figure 1: CU Ring configuration CU-90-089 ver 03, 24-Dec-2012 P a g e 6 CU User Manual - DRAFT 2. Clip, which is connected to the surgical tool. The Clip Unit is activated with the surgeon's index finger. See Figure 2. Figure 2: Clip- configuration of the CU Both configurations contain the same inner components, and the user may select which configuration to work with. The Command Unit is packed in a sterile blister and is a single use device. 2.4 Protection against radio frequency interference For US only: The CU has been tested and found to comply with the limits according to the following:
CU Ring FCC ID:OSEALRU CU Clip FCC ID:OSEALCU Manufacturer: MST Ltd. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference
(2) This device must accept any interference received, including interference that may cause undesired operation. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.-Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help CU-90-089 ver 03, 24-Dec-2012 P a g e 7 CU User Manual - DRAFT Warning Changes or modifications to this equipment not expressly approved by the party responsible for compliance [Medical Surgery Technologies Ltd. (MST)] could void the users authority to operate the equipment. CHAPTER 3. Contents of the Sterile Package The CU sterile packaging consists of a blister which is closed by TYVEK. This package is called the unit package. Six (6) unit packages are packed in a cardboard box, called the storage package. Six (6) storage boxes are packed in a bigger cardboard box, which is the transportation package. During storage either transportation package or storage package can be used. The CU is sterilized using EtO. The labels affixed on the unit blister packages are depicted below. CU-90-089 ver 03, 24-Dec-2012 P a g e 8 CU User Manual - DRAFT Figure 3: CU Package labels CU-90-089 ver 03, 24-Dec-2012 P a g e 9 CU User Manual - DRAFT CHAPTER 4. Handling 4.1 On Receipt of Package The unit package should be inspected on arrival. If any damage is observed in the unit package, the package must not be opened. Warning Do not use the CU if the package is damaged or open. Check that the documentation and label description agrees with the order acknowledgment. If there are differences do not open the package, place in a secure area and notify MST. 4.2 Storage Store the CU packages in a dry location at normal room temperature away from direct heat sources. During transit, the CU may be exposed to temperatures in the range of -25C to +75 C. CU will retain its sterile status as long as the sterile package is undamaged and up to 6 months from the manufacturing date indicated on the CU's label. 4.3 Summary of Warnings and Precautions The order in which the following warning statements are presented is not a reflection of their relative importance. Some of the warnings are specified in this chapter while others - more specific -are specified in the chapter in which their related functionality is explained. 4.3.1 Sterilization Related Warnings Warning The CU is provided STERILE and is intended for use during a SINGLE procedure only. DISCARD AFTER USE. DO NOT RE-STERILIZE. If the package is found open or damaged, it must be discarded. Do not use the CU if the expiration date has passed. Warning 4.3.2 Routine Operation and Maintenance Related Cautions and Warnings CU-90-089 ver 03, 24-Dec-2012 P a g e 10 CU User Manual - DRAFT Caution The CU is to be used by licensed medical personnel. This device should only be used by a practitioner fully trained in the conventional operative Laparoscopic technique. Caution Dispose of used CU according to the common procedures for disposing batteries of the hospital. CHAPTER 5. Technical Characteristics Command Unit (CU) Ring Dimensions 49mm (H) * 16mm (W) *
24mm (D) Weight 9 g Command Unit (CU) Clip Dimensions Weight CHAPTER 6. CU Operation 6.1 Attaching the CU to finger or tool
1 Open the CU Ring or Clip blister Action according to the chosen configuration 34mm (H) * 17.4mm (W) *
27mm (D) 10 g Demonstration CU-90-089 ver 03, 24-Dec-2012 Pull P a g e 11 2 3 If the CU Ring is used, wear it on the appropriate finger at a convenient location and pull its strip to tighten it. Tighten the strip such that the device will not move when its button is pushed sideways. If the CU Clip is used, attach it to the appropriate tool by pressing the Clip against the edge of the tool. The width of the Clip can be adjusted to fit different sizes of tools. This can be accomplished by pressing the clip ears towards each other, until the clip is attached tightly to the tool. The clip can be released by pulling its ears apart. CU User Manual - DRAFT Clip ears Pull CU-90-089 ver 03, 24-Dec-2012 P a g e 12