Itamar Medical WatchPAT 200 Unified Скачать руководство пользователя страница 11 | Manualshive

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WatchPAT™200 System

3

Operation Manual

1.6 Quality Assurance System: ISO 9001 & ISO 13485

The Itamar Medical WatchPAT™200 device is compliant to the following standards.

STANDARD

#

1.

Medical electrical equipment – Part 1: General requirements
for basic safety and essential performance

IEC

60601-1

2.

Medical  electrical  equipment  –  Part  1-2:  General
requirements  for  basic  safety  and  essential  performance  -
Collateral  standard:  Electromagnetic  compatibility  -
Requirements and tests

IEC

60601-1-2

3.

Medical Device Software – Software Life Cycle Processes

IEC

62304

4.

Medical electrical equipment - Part 1-4: General
requirements

for

safety

–

Collateral

Standard:

Programmable electrical medical systems

IEC 60601-1-4

5.

Medical  electrical  equipment  --  Part  1-11:  General
requirements  for  basic  safety  and  essential  performance  --
Collateral  standard:  Requirements  for  medical  electrical
equipment and medical electrical systems used in the home
healthcare environment

IEC 60601-1-11

6.

Degrees of protection provided by enclosures (IP Code) –
IP22

IEC 60529

7.

Quality management systems - requirements

ISO 9001:2008

8.

Medical

devices.

Quality

management

systems.

Requirements for regulatory purposes

EN ISO 13485:2012

9.

Medical devices - Quality management systems -
Requirements for regulatory purposes (Health Canada)

CAN/CSA-ISO 13485
:2003

10.

Medical devices. Application of risk management to
medical devices

ISO 14971

11.

Medical devices. Symbols to be used with medical device
labels, labelling and information to be supplied. General
requirements

ISO 15223-1

12.

Symbols for use in the labelling of medical devices

EN 980

13.

Graphical symbols for electrical equipment in medical
practice

IEC TR 60878

14.

Graphical symbols - Safety colours and safety signs --
Registered safety signs; refer to instruction manual/ booklet

ISO 7010-M002

15.

Information supplied by the manufacture with medical
devices

EN 1041

16.

Biological evaluation of medical devices - Part 1:
Evaluation and testing

ISO 10993-1

17.

Medical devices - Application of usability engineering to
medical devices

BS EN 62366

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Содержание WatchPAT 200 Unified

Страница 1: ...amar Medical REF OM2196330 Caution Federal U S law restricts this device to sale by or on the order of a physician Not for pediatric use Copyright 2002 2016 By Itamar Medical Ltd WatchPAT and PAT are...

Страница 2: ...res strictly to the instructions and safety precautions contained herein and in all supplements hereto and according to the terms of the warranty provided in the License Agreement in Appendix C Itamar...

Страница 3: ...ls specifications 1 5 1 7 1 11 1 12 10 2 4 7 8 48 Orit Kelner 8 May 2013 Updated for Itamar SBP sensor Updating standards 1 1 1 2 1 4 2 1 2 2 3 5 4 1 7 1 App A 1 6 1 2 9 11 13 24 26 37 50 54 3 Bonita...

Страница 4: ...Module specifications Adding spare parts list All 1 9 1 11 2 1 App F App G App I All 5 7 10 67 70 71 74 Orit Kelner 15 July 2015 Add FDA K to section 1 14 1 14 8 Efrat Litman 16 Jan 2016 Updating comp...

Страница 5: ...10 2 2 User Interaction with the WatchPAT Device Keys 11 2 3 WatchPAT Device Function 13 2 4 Built In Self Diagnostic Procedures 14 3 PREPARATION FOR SLEEP STUDY 19 3 1 Charging the Battery 19 3 2 Pre...

Страница 6: ...ttaching the PAT Probe 40 7 5 Switching On the WatchPAT Device 42 7 6 When You Wake Up 42 7 7 Important Notes 42 8 PATIENT TRAINING GUIDELINES 44 8 1 Walk Through the Process of Using the WatchPAT Dev...

Страница 7: ...AT 200 System vi Operation Manual APPENDIX F MANUFACTURING DECLARATION ACCORDING TO IEC 60601 1 2 67 APPENDIX G SPO2 ACCURACY IN THE WP200 71 APPENDIX H TRAINING RESOURCES 73 APPENDIX I SPARE PARTS LI...

Страница 8: ...ce with Bracelet 28 Figure 18 Bracelet and WatchPAT Device on a Patient s Hand 28 Figure 19 Cut the Bracelet at the Specified Location 29 Figure 20 Case for a 3 Night Multi Night Study 29 Figure 21 Re...

Страница 9: ...uld be used only in accordance with physician s instructions For exclusion criteria see Section 1 3 2 Only qualified medical personnel may authorize the use of the WP200 3 Qualified medical personnel...

Страница 10: ...VVI without sinus rhythm 3 Sustained non sinus cardiac arrhythmias In cases of patient having accumulative time of regular R R intervals of less than 1 5 hours the WP200 will not have sufficient valid...

Страница 11: ...ealthcare environment IEC 60601 1 11 6 Degrees of protection provided by enclosures IP Code IP22 IEC 60529 7 Quality management systems requirements ISO 9001 2008 8 Medical devices Quality management...

Страница 12: ...e are used to refer to the WatchPAT 200 device Warnings are used to identify conditions or actions which if the instructions are ignored may violate patient safety or cause damage malfunction to the s...

Страница 13: ...uses BF patient applied parts The WatchPAT 200 device uses UL listed power supply USA Canada only The power supply is used in a non patient environment only The WatchPAT 200 device should only be tra...

Страница 14: ...o a PC The Adult Flex Pulse Oximetry Sensor may cause skin sensitivity to the patient Discontinue use of the NONIN double backed adhesive tape strips if the patient exhibits allergic reactions to the...

Страница 15: ...e Product Labels Follow instructions for use Type BF applied part The product is certified by CSA The product complies with the CE mark according to MDD Medical Device Directive and related standards...

Страница 16: ...ousehold waste Please dispose this product and all of its parts in a responsible and environmentally friendly way 1 13 WatchPAT 200 Device Labels Located on WatchPAT 200 device Located on WatchPAT 200...

Страница 17: ...measurement of the pulsatile volume changes in the fingertip arteries which reflects the relative state of the arterial vasomotor activity and thus indirectly the level of sympathetic activation Peri...

Страница 18: ...card o Embedded micro SD card drive o Rechargeable Lithium Ion Battery o LCD display PAT probe PAT probe connection cable Pulse oximeter sensor with single use adhesive pads Wrist Strap Snore and Body...

Страница 19: ...mation refer to the zzzPAT Operation Manual 2 2 User Interaction with the WatchPAT Device Keys The WatchPAT device has the following keys see Figure 3 Central On Enter key to power on the WatchPAT dev...

Страница 20: ...nding on operational mode Status last line Message indicating device status depending on operational mode Service Ports and Peripherals The WatchPAT device has 4 ports that are used either for sensor...

Страница 21: ...ice records the following channels PAT Signal Oxygen saturation Actigraphy movement Acoustic decibel detector for Snoring evaluation optional Body Position optional Oximetry Module connector Oximetry...

Страница 22: ...ss an optional multi night option is selected which enables an up to 3 nights study with the same device see Multi night study section 2 4 Built In Self Diagnostic Procedures 2 4 1 Operator Tests The...

Страница 23: ...n for end testing turn device off If no test is selected within 3 minutes the WatchPAT device will automatically shut down The Up Down keys navigate between the lines An asterisk will indicate current...

Страница 24: ...code contact customer support SBP Snore and Body Position sensor warning sensor missing does not affect PASSED status RTC Real Time Clock warning faulty indicates problem with internal clock but does...

Страница 25: ...updated therefore wait approximately for one minute for the saturation to stabilize when testing Back will move to the previous screen if the Left button is pressed 2 4 4 Patient Test When the patien...

Страница 26: ...per proof bracelet and the wrong bracelet is connected the wrong bracelet error message appears If this is study with the tamper proof bracelet and the bracelet is not connected the connect bracelet e...

Страница 27: ...lide the WatchPAT device out of the wrist strap until a click is heard and the USB port is exposed Be careful not to damage the oximetry module connector and cable 3 Connect the USB port of the WatchP...

Страница 28: ...nd the following screen will be displayed CHARGER 22 51 Bat 4 2 V Charging complete 6 Disconnect the AC adapter or communication cable The WatchPAT device will switch off in 30 seconds 7 Reseat the Wa...

Страница 29: ...ol IPA 2 Place the new Flexi wrap pad with the printed side facing down on a flat surface 3 Partially peel off the paper covering of the pad to expose the adhesive area around the two cut out sections...

Страница 30: ...Body Positioning Sensor Operating 3 4 Preparing the Wrist Strap The wrist strap requires no special preparation other than ensuring its cleanliness You may clean it if needed Take care not to allow th...

Страница 31: ...10 and then holding the gray slider gently slide it away from the probe do not pull the slider off by pulling the cord as it may damage the wiring Properly dispose of used probes Figure 10 Disconnecti...

Страница 32: ...zzzPAT Software Manual for preparation of the WatchPAT device for a new study 3 8 Testing the WatchPAT Device Run the built in self diagnostic facility as described in Section 2 4 above 3 9 WP200 Devi...

Страница 33: ...ed in the Wrist strap with the PAT probe and oximetry sensor attached Step by Step Reference Guide to the WatchPAT device Body Position and Snore sensor optional Cable for bracelet optional for patien...

Страница 34: ...voltage that provides a clear reliable indication of the presence of these sounds The body position sensor uses a 3 axis accelerometer that provides a signal directly proportional to the patient s sle...

Страница 35: ...vice for a sleep study the technician pairs the Tamper Proof Bracelet and the device and registers the bracelet s unique ID in the WatchPAT device see Appendix B Tamper proof testing with the WP200 de...

Страница 36: ...evice on a Patient s Hand During the recording the device will periodically check the Bracelet connectivity The recording will be stopped if the connection to the Bracelet will be lost for the time ex...

Страница 37: ...eplace the PAT probe and charge the device between nights Two extra PAT probes and a WatchPAT device AC adapter must be added to the WatchPAT device case If a 2 night multi night option is selected th...

Страница 38: ...downloading and analysis by the zzzPAT software To download and analyze the study data 1 Connect the USB port of the WatchPAT device to the computer see Figure 4 The WatchPAT device will switch off an...

Страница 39: ...nance recommendations 6 1 Cleaning The various components of the WatchPAT system have different cleaning requirements The WatchPAT device The wrist strap The oximetry sensor The Snore Body Position se...

Страница 40: ...ng 70 ethyl alcohol thoroughly clean both sensor and cable 6 7 Handling Handle with care Use only the designated case for transportation Store at room temperature and avoid direct sun light Do not exp...

Страница 41: ...site for preventive maintenance recommendations 6 9 Replacing the PAT Probe Cable To replace the PAT probe cable 1 Carefully disconnect the PAT probe cable from the WatchPAT device Make sure you remov...

Страница 42: ...ical web site for preventive maintenance recommendations 6 10 Replacing the Battery In the event of a battery error message during the self diagnostic tests or after charging it may be necessary to re...

Страница 43: ...e the battery connector closed with a small piece of transparent tape 6 Close the battery compartment cover and secure back the screw Figure 24 Replacing the Battery Note Please refer to the Service M...

Страница 44: ...d be stored in its carrying case at room temperature and low humidity In order to preserve battery performance when the WatchPAT device is not in use store with the battery fully discharged Before sto...

Страница 45: ...ls of fingers that will be monitored are well trimmed less than 1mm from nail bed with no jagged edges Clip and file nails if necessary Remove artificial fingernails or dark nail polish from the monit...

Страница 46: ...sition You will hear a click when the WatchPAT device is properly seated in the strap 3 Place the wrist strap with the WatchPAT device on the non dominant arm and close it snugly but not tightly Ensur...

Страница 47: ...ttom short flaps around your finger see Figure 29 4 Fold top flap over the finger and fold the short flap around your finger see Figure 30 5 Complete this procedure by wrapping the long flap around th...

Страница 48: ...and gradually remove the tab marked TOP slowly and firmly while pressing the tip of probe against a hard surface WatchPAT case table etc until the tab is completely removed from the probe Figure 34 4...

Страница 49: ...ure 36 Wearing the WP200 Ready for Sleep Note DO NOT remove the PAT probe before the night study is terminated Once the probe is removed it cannot be re attached Note If the Snore Body position sensor...

Страница 50: ...all parts in the carrying case 7 7 Important Notes Wearing the WatchPAT device should not cause any discomfort or pain If you experience wrist or arm discomfort loosen up the wrist strap If the disco...

Страница 51: ...e or computer If any part appears disconnected or does not resemble the illustrations call the service number for assistance Do not under any circumstances attempt to fix the problem yourself If you h...

Страница 52: ...Kit Demonstrate how to apply the WatchPAT device on your wrist while following the step by step guidelines and referring to the relevant figures Demonstrate the following 1 Hand Preparation Remove rin...

Страница 53: ...f the Flexi wrap pad to secure sensor properly Make sure it is not too tight 6 Attaching the PAT Probe Insert finger all of the way into the probe Press tip of probe against a hard surface WatchPAT de...

Страница 54: ...demonstration have the patient attach the demo device by himself Verify that the attachment is properly done Especially monitor carefully attachment of the oximetry sensor 8 7 Review Safety General an...

Страница 55: ...probe Bad Probe is defective Replace probe Oximetry sensor error No sensor Sensor absent Replace sensor Disconnected Sensor disconnected Connect sensor cable to port No communication Module not conne...

Страница 56: ...nto the WatchPAT device Faulty oximetry sensor Check the oximetry sensor probe for damage and replace if necessary Oximetry sensor disconnected Sensor not properly connected or faulty Check connection...

Страница 57: ...l Bandwidth 0 1 10 Hz Data Storage Media Micro SD card Capacity 64 MB minimum Format type Formatted to FAT 32 Power Supply Battery Proprietary rechargeable Lithium Ion Battery Capacity 500 700 mAh Cel...

Страница 58: ...decibel detector It uses a very sensitive microphone that responds to snoring and other sounds in the audio range and converts them to a small analog voltage that provides a clear reliable indication...

Страница 59: ...g up after peeling off the round adhesive sticker and pressing against the skin Make sure the sensor is tight against the skin Secure the sensor in place with medical tape Cleaning the sensor Using 70...

Страница 60: ...e study included 26 patients and the analysis was done in 30sec epochs The correlation coefficient was calculated using Pearson method assuming a linear relation between the results of the two devices...

Страница 61: ...5 66 11 39 40 63 50 49 07 50 28 52 335 50 00 5 58 11 17 40 64 51 49 39 50 59 53 311 51 18 5 56 10 86 40 63 51 50 56 51 79 54 253 51 71 5 78 11 19 40 66 52 51 00 52 42 55 209 51 85 5 49 10 59 40 66 52...

Страница 62: ...WatchPAT 200 System 54 Operation Manual Summary statistics mean SD of WatchPAT 200 device by dB meter levels...

Страница 63: ...version is 2 2176 or higher Make sure you enabled the Tamper Proof Testing option from the zzzPAT Setup menu General Settings Study Preparation 1 Preparing a New Study on zzzPAT While preparing the n...

Страница 64: ...gular site diagnostic test device test oxi test as described in the user manual Make sure the bracelet is connected before starting the test After tests passed successfully disconnect the bracelet fro...

Страница 65: ...o the two separated holes flat side facing up Wrap the bracelet around the wrist of the non dominant arm tested arm of the subject Insert the white plastic parts into the holes Make sure it is snug bu...

Страница 66: ...WatchPAT device only after it is connected to the bracelet THE BRACELET IS NOT TO BE REMOVED UNTIL THE NIGHT STUDY IS COMPLETED Removing the bracelet before or during the night will cause the device t...

Страница 67: ...reement with respect to the Licensed Software and Licensed Products If you do not agree to the terms of this License Agreement including without limitation the Restrictions on Use as provided in Secti...

Страница 68: ...single hard disk provided you keep the original solely for backup or archival purposes However you may not cause any Licensed Software which is not designed for use on a server to execute or be loaded...

Страница 69: ...from defects in materials and workmanship and will perform substantially as it is intended to perform If during such ninety 90 day period the Licensed Software has a defect in materials or workmanshi...

Страница 70: ...ABILITY A TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW EXCEPT FOR DAMAGES ARISING UNDER SECTION 4 A ABOVE IN NO EVENT SHALL ITAMAR BE LIABLE TO YOU FOR DAMAGES IN EXCESS OF THE PURCHASE PRICE YOU...

Страница 71: ...Party Product 7 TRANSFERABILITY You may only transfer or assign the rights and obligations hereunder together with the Licensed Software and or the Licensed Product or Third Party Product as a whole w...

Страница 72: ...license by Itamar to you of Licensed Software and Licensed Products and supersedes all prior agreements and representations between the parties with respect to the subject matter hereof unless specif...

Страница 73: ...ration Manual APPENDIX D REGULATORY REPRESENTATIVE Itamar Medical s authorized regulatory representative is MEDES Ltd 5 Beaumont Gate Shenley Hill Radlett Hertfordshire WD7 7AR England Tel 44 208123 8...

Страница 74: ...tip of the finger This design prevents venous blood pooling engorgement and stasis which inhibits retrograde venous shock wave propagation and allows partial unloading of arterial wall tension that si...

Страница 75: ...lectromagnetic Emissions WP200 is intended for use in the electromagnetic environment specified in the following tables 1 2 4 and 6 below The user and or installer of the unit must ensure that it is u...

Страница 76: ...tage power supply network that supplies buildings used for domestic purposes commercial or hospital clinic environment Voltage dips short interruptions and voltage variations on power supply input lin...

Страница 77: ...n meters m Field strengths from fixed R F transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range d Interference may occur in th...

Страница 78: ...m output power of transmitter Watts W Separation distance according to frequency of transmitter in meters Meters m 150kHz to 80MHz d 1 17 P 80MHz to 800MHz d 1 17 P 800MHz to 2 5GHz d 2 3 P 0 01 0 12...

Страница 79: ...acy of these measurements according to module manufacturer information 1 Overall the ARMS is estimated to be 1 85 across the range of 70 to 100 percent saturation and with 95 confidence ranges from 1...

Страница 80: ...n Non Motion Conditions Version B Date 2010 01 27 Report ID QATR5334 Abbreviated Clinical Investigator s Hypoxia Research Laboratory Department of Anesthesiology M1427 UCSF San Francisco CA 94143 0542...

Страница 81: ...al com training These files can also be viewed through any smartphone running QR code reader or optical scanner application by scanning the code next to each resource The following resources can be fo...

Страница 82: ...ion cable Wrist Strap Snore and Body Position sensor Adhesive set for Snore and Body Position sensor Pulse oximeter sensor Adhesive set for Pulse oximeter sensor Cable for Tamper Proof Bracelet Tamper...

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