Navigator GPS System Addendum Wireless Upgrade Rev 3 March 2016

Addendum - GPS User Manual

Important Note This document, and the information contained therein, is proprietary information of Dilon Technologies and may not be reproduced, copied in whole or in part, adapted, modified, disclosed to others, or disseminated without prior written consent of the Dilon Technologies. This document is intended to be used by customers as part of their Dilon Technologies equipment purchase. Dilon Technologies provides this document without warranty of any kind, implied or expressed, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. Dilon Technologies has taken care to ensure the accuracy of this document. However, Dilon Technologies assumes no liability for errors or omissions, and reserves the right to make changes without further notice to any products herein, to improve reliability, function, or design. Dilon Technologies may make improvements or changes in the products or programs described in this document at any time. Navigator GPS is a trademark of Dilon Technologies. Other trademarks and trade names are those of their respective owners.

Copyright Notice Copyright 2016 Dilon Technologies, Newport News, VA 23606 United States of America.

Trademarks Dilon Technologies™ is a registered trademark of Dilon Technologies. All other company and product names are trademarks or registered trademarks of their respective owners.

Part Number WP-5220-00-001 Rev 3 / March, 2016

WP-5220-00-001 Rev 3

2

Revised 3/4/2016

Addendum - GPS User Manual

User Manual 1. Introduction... 4 Description ... 4 Intended Use ... 4 Indications for Use ... 4 Manufacture and Distribution ... 4 Trademarks ... 4 Regulatory and Safety Requirements ... 5 2. Product Overview and Components ... 7 3. Precautions ... 8 3A. General ... 8 3B. Wireless Pilot Probe, Wireless Receiver and Navigator GPS Control Unit ... 8 4. Wireless Receiver ... 9 4A. Isotope Control ... 9 5. Probe Connectivity and Use ... 11 Navigator GPS System with Wireless Upgrade ... 11 6. Troubleshooting ... 16 7. Specifications ... 17 8. Support Items ... 18 8A. Product Part Numbers ... 18 8B. Sterile Drape ... 18 9. Maintenance... 19 9A. Component Check ... 19 10. Repair ... 20 11. Limited Warranty ... 21

WP-5220-00-001 Rev 3

3

Revised 3/4/2016

Addendum - GPS User Manual

USER MANUAL

1. Introduction Description This addendum to the Navigator GPS™ System User/Service Manual (PN GP-9200-96EN) details how to use the Wireless Upgrade option for existing Navigator Gamma Positioning Systems. This optional feature adds wireless gamma probe capability to Navigator GPS Control Units (PN-GP 2800-00). Use this addendum as a supplement to the Navigator GPS™ System User/Service Manual. If this manual is not readily available, download the electronic version from www.Dilon.com. The wireless receiver, when paired with the control unit, can only be used with the Wireless Pilot Probe™. The system is supplied non-sterile. This addendum includes guidelines for the use of the Wireless Pilot Probe and accessories within the sterile field.

Intended Use For the detection and quantification of gamma radiation from gamma-emitting isotopes in the body or tissues. Use for non-imaging procedures to measure the amount of radionuclide absorbed by a particular organ or body region.

Indications for Use For the detection and quantification of gamma radiation from gamma-emitting isotopes in the body or tissues. Use for non-imaging procedures to measure the amount of radionuclide absorbed by a particular organ or body region in open-surgical procedures.

Manufacture and Distribution The system is manufactured and distributed by Dilon Technologies of Newport News, VA. Please direct all inquiries to Dilon Technologies.

Trademarks The following are trademarks of Dilon Technologies: Navigator 2.0™, Wireless Pilot Probe™, Dilon Navigator GPS™, Dilon Navigator™, Dilon Technologies Navigator GPS™, Dilon Technologies Navigator™, Dilon Technologies Navigator 2.0™, Daniel Lung Probe™, and Navigator™ when used in context with the above. Navigator GPS® is a registered trademark of Dilon Technologies.

WP-5220-00-001 Rev 3

4

Revised 3/4/2016

Addendum - GPS User Manual

Regulatory and Safety Requirements The Dilon Navigator GPS™ System including Probes and accessories complies with the following standards: EC Directives EMC Directive 89/336/EEC Group l, Class B EN 55011 EMC Directive 89/336/EEC IEC 60601-1-2: 3rd Edition Reciprocal Interference The Wireless Upgrade components were designed, manufactured, and tested in accordance to the following standards recognized for Medical Devices under Directive 93/42/EEC: 1993. This product has been certified and tested by 3rd party testing facilities. • Medical Electrical Equipment - Part 1: General requirements For Safety 1: Collateral Standard: Safety Requirements For Medical Electrical Systems – IEC 60601-1-1: 3rd Ed. •

Medical Electrical Equipment - Part 1: General Requirements For Safety Collateral Standard: Electromagnetic Compatibility - Requirements and Tests – IEC 60601-1-2: 3rd Ed.

•

Medical Electrical Equipment - Part 1: General requirements For Safety 1: Collateral Standard: Safety Requirements For Medical Electrical Systems – IEC 60601-1: 2nd & 3rd Ed.

•

Medical Electrical Equipment - Part 1: General Requirements For Safety Collateral Standard: Electromagnetic Compatibility - Requirements and Tests – IEC 60601-1-2: 3rd Ed.

•

Medical Electrical Equipment - Part 1-6: General Requirements For Safety Collateral Standard: Usability - IEC 60601-1-6: 3rd Ed.

•

Information supplied by the manufacturer of medical devices- EN 1041:2008

•

Symbols for use in the labeling of medical devices - EN 980 :2008

•

CAN/CSA C22.2 No. 60601-1, "Medical Electrical Equipment, Part 1: General Requirements for Safety & Essential Performance; issued 2008-02-01 Ed. 2

•

AS/NZS 3200-1-0, Deviations to IEC 601-1 for Application in Australia and New Zealand CAUTION: Federal (USA) law restricts this device to sale and use by, or on the order of, a physician.

WP-5220-00-001 Rev 3

5

Revised 3/4/2016

Addendum - GPS User Manual

Table 1. Explanation of Symbols Attention, consult accompanying documents RX only Caution: Federal (USA) law restricts this device to sale and use by, or on the order of, a physician.

Probe

Isotope Control

Acceptable shipping/storage conditions: -15° C to 40° C

Serial number

Lot #, or batch code

FCC statements: “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 and (2) this device must accept any interference received, including interference that may cause undesired operation.” IC statements: “This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) This device may not cause interference and (2) this device must accept any interference, including interference that may cause undesired operation of the device.” Cet appareil est conforme avec Industrie Canada RSS exemptes de licence standard (s). Son fonctionnement est soumis aux deux conditions suivantes: (1) Ce dispositif ne doit pas causer d’interférences, et (2) cet appareil doit accepter toute interférence, y compris les interferences qui peuvent causer un mauvais fonctionnement de l’appareil.

WP-5220-00-001 Rev 3

6

Revised 3/4/2016

Addendum - GPS User Manual

2. Product Overview and Components

Table 2A-1. Probe Dimensions Probe

Tip Diameter

Tip Angle

Length

Wireless Pilot Probe

14mm

35°

260mm

Weight 255g

Table 2A-2. Receiver Dimensions Receiver

Height

Depth

Weight

Wireless Pilot Probe Receiver

25mm

68 mm

15g

WP-5220-00-001 Rev 3

7

Revised 3/4/2016

Addendum - GPS User Manual

3. Precautions 3A. General The output of this system is not to be considered a diagnostic measure of the extent of disease in the patient, nor the recommended source of therapy. •

Failure to thoroughly review and adhere to the information contained in this addendum and the Navigator GPS System User/Service Manual may pose a potential hazard to the patient and/or user and may void the warranty.

3B. Wireless Pilot Probe, Wireless Receiver and Navigator GPS Control Unit • • • • • • •

• •

Replace the wireless probe battery with a new battery on EACH day of use, before the first surgical procedure. This system is not designed for use in an explosive atmosphere. Keep the control unit off while connecting the wireless receiver. The probes, probe batteries, receiver and control unit are sold non-sterile. No components should be sterilized. DO NOT put any probe in an autoclave. With the exception of the Wireless Pilot Probe’s battery bay, DO NOT attempt to open probes. o All probes are tested and sealed at the factory. Attempting to open the probe may cause damage and will void the warranty. DO NOT drop the probe. DO NOT strike the probe tip against a hard surface; the detector element may become damaged and no longer be able to measure radiation. o This will also void the warranty.

WP-5220-00-001 Rev 3

8

Revised 3/4/2016

Addendum - GPS User Manual

4. Wireless Receiver 4A. Isotope Control

The wireless receiver allows the user to adjust the system’s isotope setting, specific to the isotope in use. When the wireless receiver is connected to the control unit, and the control unit is turned on, the isotope control will automatically default to the Tc99 setting. CAUTION: It is important that the isotope control is set to the isotope to be used in the procedure. Setting the isotope control incorrectly will result in incorrect detection.

WP-5220-00-001 Rev 3

9

Revised 3/4/2016

Addendum - GPS User Manual

Table 4A-1. Isotopes Switch set on: I125

Switch set on: 511keV Switch set on: In111

Switch set on: Tc99

Iodine-125

18

Technetium-99m

F-FDG (and I131)

Indium111

The Wireless Receiver and Navigator GPS Control Unit must both be set to the same isotope setting. For Navigator GPS units built after 2006, the isotope control setting on the back of the device will illuminate the corresponding light on the control unit’s isotope indicator.

For earlier Navigator GPS systems that lack the isotope indicator (built between 1999 and 2006), check the back of the control unit to ensure that the isotope setting switch matches the isotope specified on the receiver. Table 4A-2. Controls and Displays on the Front of the Wireless Receiver Control Display

Description Power LED: Indicates that the signal between receiver and Pilot Probe is connected. It will flash during receiving transmission from the probe

Isotope Indicators: Select the isotope to be detected by the control unit. Be sure to select the same isotope on the back of the Control Unit as well. See “Isotope Control” section of Navigator GPS System User/ Service Manual for more information.

WP-5220-00-001 Rev 3

10

Revised 3/4/2016

Addendum - GPS User Manual

5. Probe Connectivity and Use Navigator GPS System with Wireless Upgrade

The Navigator GPS is compatible with the wireless Pilot Probe. A typical sequence of setting up the Wireless Pilot Probe for a procedure with Technetium-99m isotope (such that would be used in a lymphatic mapping procedure for a sentinel node biopsy) is as follows:

WP-5220-00-001 Rev 3

11

Revised 3/4/2016

Addendum - GPS User Manual

5-1. Before Surgery • •

• •

• • •

Insert a fully charged PowerPak (battery) into the Navigator GPS control unit (see Navigator GPS System User/Service Manual for insertion instructions). Attach the wireless receiver to the cable port on the front of the control unit. Note that the isotope indicator will default to Tc 99 when turned on. An LED will illuminate on the receiver once the control unit is on.

Upon initial insertion of new Wireless Pilot Probe battery, probe may need to be lightly shaken to activate LED in probe base. A flashing LED on the Pilot Probe indicates that it is linked with control unit and ready for use. When placed in a resting position, the LED turns off within seconds, to save energy. When the Pilot Probe is moved, it instantly powers up for immediate use. For intraoperative use, insert the Wireless Pilot Probe into a sterile drape. Insert a probe battery into the Pilot Probe as follows. 1. Hold probe firm; turn battery cap counterclockwise and remove from probe. Inspect O-ring integrity. If O-ring is missing or damaged, use new battery cap. Contact Dilon Technologies or your distributor for battery cap reorder information.

•

WP-5220-00-001 Rev 3

12

Revised 3/4/2016

Addendum - GPS User Manual

2. Install one 3V CR 2 lithium battery in Pilot Probe battery holder with positive (+) end facing toward the base of the probe and negative (-) end toward the middle of the probe. Incorrect placement of battery into battery holder for extended periods of time will cause battery to drain quickly.

. 1. Insert battery holder into probe negative (-) end in. Lightly turn until holder lowers into place.

2. Hold probe firm; push battery cap into probe and turn clockwise until O-ring is no longer visible. • Upon initial insertion of new Wireless Pilot Probe battery, probe may need to be lightly shaken to activate LED in probe base. • LED on the Pilot Probe indicates that it is linked with control unit and ready for use. When placed in a resting position, the LED turns off within seconds, to save energy. When the Pilot Probe is moved, it instantly powers up for immediate use. • For intraoperative use, insert the Pilot Probe into a sterile drape.

WP-5220-00-001 Rev 3

13

Revised 3/4/2016

Addendum - GPS User Manual

Table 5-1. Wireless Receiver - LED Power Indicator Indication

Status

On/Flashing

Wireless receiver and Wireless Pilot Probe are linked and ready for use. The GPS system is off, or there may be a connection error between the receiver and the control unit.

Off

Table 5-2. Wireless Pilot Probe LED Indicator Indication Status On/Flashing

Probe is linked and ready for use Probe is in a resting position to conserve power; to reactivate LED indicator, simply pick up probe, or if needed, lightly shake probe.

Off

If no power upon ready to use, the battery needs to be installed or replaced. If battery has been replaced and LED light is still off, contact your distributor or Dilon Technologies directly.

5-2. During Surgery •

NOTE: For Technetium-99m (Tc 99), the control unit settings are given in the following table.

• Table 5-3. Navigator GPS with Wireless Pilot Probe - Settings and Indicators w/ Tc 99 Example Control/Indicator

Setting Controls (back of Control Unit)

SCAN/Calibrate

SCAN

Isotope

Tc 99 Indicators (front of the Control Unit)

Range

1x

Threshold

Illuminated; this control is for CABLED PROBES only. The Wireless Pilot Probe features integrated threshold, which controls the count range of photon energy detected by the probe.

Display

0

Isotope

Tc 99 Probe LED Indicator (bottom of the Pilot Probe handle)

Probe LED

Illuminated/Flashing Wireless Receiver

Receiver LED

Illuminated/Flashing

Isotope

Tc 99

5-3. After Surgery WP-5220-00-001 Rev 3

14

Revised 3/4/2016

Addendum - GPS User Manual

•

See: ‘Cleaning, Disinfection, and Sterile Use of Probe’ (Dilon doc. # 141-00005).

WP-5220-00-001 Rev 3

15

Revised 3/4/2016

Addendum - GPS User Manual

SERVICE MANUAL

6. Troubleshooting With the exception of the Wireless Pilot Probe’s battery holder, there are no serviceable components within the Wireless Pilot Probe body, or wireless receiver. Contact your representative or Dilon Technologies for additional assistance if more detail is required. Table 6-1. Navigator GPS Control Unit with WIRELESS PILOT PROBE- Settings and Indicators Problem

Possible Causes

Remedies

1. Zero in display. No signal under presence of a radioactive source.

No connection between probe, receiver and control unit.

Check that the connection between the receiver and control unit is secure.

No connection between probe, receiver and control unit.

Replace the probe battery

Isotope control indicates incorrect isotope.

Change isotope control (on front of wireless receiver) to desired isotope.

Circuit inside the control unit has been damaged.

Try a different control unit. Contact Dilon Technologies for assistance.

Probe is damaged.

Try a different probe, or contact Dilon Technologies for assistance.

Wireless receiver is damaged.

Try a different receiver, or contact Dilon Technologies for assistance.

No connection between wireless receiver and control unit.

Check that the wireless receiver is securely connected to the control unit.

LED on wireless receiver is damaged.

Contact Dilon Technologies for assistance.

No connection between wireless receiver and control unit.

Check that the connection between the wireless receiver and control unit is secure.

LED on wireless receiver is damaged.

Contact Dilon Technologies for assistance.

LED on probe is damaged.

Contact Dilon Technologies for assistance.

Probe LED is illuminated but not transmitting signal to unit (LED flashes when transmitting)

Gently shake probe to activate connectivity.

Probe battery is dead.

Replace with new battery.

Battery was not installed.

Install new battery.

2. LED on wireless receiver does not illuminate when power is on.

3. Isotope control on wireless receiver does not illuminate when power is on.

4. LED on Pilot Probe does not light as indicated

WP-5220-00-001 Rev 3

16

Revised 3/4/2016

Addendum - GPS User Manual

7. Specifications The Wireless Upgrade consists of the wireless receiver, Wireless Pilot Probe, and probe batteries. Table 7A-1. Wireless Upgrade Specifications Item Description Wireless Pilot Probe Power Source

Replaceable, Internal battery

Battery

Single use CR2; 3 V Lithium; capacity 1550 mAh

Wireless Distance

Pilot

Industry Standard Frequency

Probe

Transmission Up to 9 meters

Wireless

Operating 2.4 GHz

Visual Indicators

Wireless Receiver: • •

Power On – LED Isotope – LED (four)

Wireless Pilot Probe: • • Storage Conditions

Probe Connection – LED Isotope – LED (four)

Operating Temperature Range: 15°C to 40°C (5°F to 104°F) Humidity: 0%-80% relative humidity Atmospheric Pressure: 50 kPa to 106 kPa

WP-5220-00-001 Rev 3

17

Revised 3/4/2016

Addendum - GPS User Manual

8. Support Items The Wireless Upgrade is typically supplied as a complete system (Part # WP-9220-00). Support items may be purchased from the local Dilon Technologies Navigator representative. At time of publication of this addendum, the primary support items have the following part numbers. Feel free to contact your local representative for additional information.

8A. Product Part Numbers Table 8A-1. Product Part Numbers Item

Dilon Part Number

Wireless Receiver for Navigator GPS

N2-8000-01

Wireless Pilot Probe

WP-9000-14

Wireless Pilot Probe Batteries (Pack of 10)

WP-8500-01

Wireless Pilot Probe Battery End Cap

WP-2000-10

Wireless Pilot Probe Battery Holder

WP-9050-00

Optional Top Gun Collimator

SP-1800-00

8B. Sterile Drape A sterile drape is an accessory that is not sold or supported by Dilon Technologies. Typical characteristics of a suitable intra-operative probe drape are as follows: • • • • •

Universal Gamma Probe Cover 5 x 24 Sized with tapered tip to fit both straight and flexible probes Low density, soft polyethylene Telescopically folded w/rubber bands and medical grade tape strips Drape features: o All components, including rubber bands, guaranteed 100% Latex-free o All available EtO Sterile o Strong and durable Anti-Static material

WP-5220-00-001 Rev 3

18

Revised 3/4/2016

Addendum - GPS User Manual

9. Maintenance 9A. Component Check While Wireless Upgrade is virtually maintenance-free, a check of each system component for any visible signs of abuse, neglect, or wear, should be conducted before each use and storage. This includes checking the following: Table 9A-1. Component Check Component

Feature

Wireless Pilot Probe

Overall check - Also probe bay, battery cap and O-ring

Wireless Receiver

Overall check - Housing, integrity of its electrical connector and the connector pins

Do not use a damaged probe, wireless receiver, or probe batteries. Should abnormalities be discovered, contact Dilon Technologies directly.

WP-5220-00-001 Rev 3

19

Revised 3/4/2016

Addendum - GPS User Manual

10. Repair The Wireless Pilot Probe is sealed at the factory. No user serviceable parts are inside the probes. Damage to a probe may result if a probe is opened by the user and will void any remaining warranty, if attempted. Please contact Dilon Technologies for additional service. An RMA number is required upon return for service. •

12050 Jefferson Avenue Suite 340 Newport News, VA 23606 USA Phone: +1-844-DILONNAV www.Dilon.com CAUTION: Before using loose packing materials, such as foam pellets, shredded paper, or excelsior, be sure to wrap the component(s) separately in plastic bags or film or other protective wrapping.. • CAUTION: If a system, or system components are to be shipped from your institution for repair, then please clean and disinfect the components as described in this manual before packing for shipment. Dilon Technologies requires that a Navigator Service Sheet be attached to the outside of the shipping box, certifying that the items have been cleaned and disinfected to manufacturer’s specifications. This form can be found on the Dilon Technologies website (www.Dilon.com) or by contacting your distributor or Dilon Technologies directly.

WP-5220-00-001 Rev 3

20

Revised 3/4/2016