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SEER Light Recorder - Tiger Medical, Inc

1. 9 N wy NN SS G We 046A A EM Channel Lead Location Color Color A Red Yellow CH1 mV5 Fifth intercostal space at the left axillary line White Red CH1 mV5 Right clavicle just lateral to the sternum C Brown Green CH2 mV1 Fourth intercostal space at the right sternal edge D Black White CH2 mV1 Left clavicle just lateral to the sternum Orange Orange CH3 mV3 Equidistant between the normal locations for precordial leads V2 and V4 2040604 012D SEER Light 3 3 Preparing the Patient Modified aVF Leads ABA Ev Channel Lead Location Color Color Blue Blue CH 3 mV3 Mid sternum at the level of the clavicles Green Black Ground Lower right chest wall A modified aVF lead may be helpful in identifying ST segment changes in ischemic episodes associated with the right coronary or circumflex arteries The following are the recommended electrode locations to record the modified V5 mV5 on channel 1 the modified V1 mV1 on channel 2 and the modified aVF maVF on channel 3 B C G 047A ANA P Channel Lead Location Color Color A Red Yellow CH1 mV5 Fifth intercostal space at the left axillary line B White Red CH 1 mV5 Right clavicle just lateral to the sternum C Brown Green CH2 mV1 Fourth intercostal spa
2. De deca d RR ia 1 9 Responsibility of the Manufacturer kk kk kk kk kk kk kK kk kk kk kk ka 1 10 G n ral ies p ve eR ek oe kc Oe e RC UR E RO bet ew wie COR 1 10 Classification s as si aka Saka ala tar k ba mmm 1 11 Underwriters Laboratories INC kk kk IIR 1 12 Information Technology Equipment kk kk kk kk kk kk kk kk kk ka 1 12 Equipment Symbols Mu kk kk kk kk kk kk kk kk kk kk aka ka nnn 1 12 Service Information uk kk kk kk kk kk kK kk kk kk kak ka ka kk ka kk kak ka 1 14 Requirements ose roter Pee k ne A Wana Ser w id 4 a a ah n c 1 14 Serial Number iro vaca da acre Wee Dry A 1 14 Equipment Overview General Information kk kk kk kk kk kk kK ka ka kk kk ka kk kk ak aka kala 2 2 SEER Light Device Compatibility kk kk kk kk kk kk kk 2 3 SEER Light SEER Light Extend Compact Digital Holter Recorder 2 3 SEER Light i SEER Light Connect eb chee ee ae nay d wae eee ERE eae 2 7 Installing SEER Light Hookup 1 cece cee kk kk kk kk kk kk kk kk 2 9 Po ch cu u k n sek pe some wu oie atin sa uie ae R V aw d 2 11 Operating Modes SEER Light Controller sss 2 11 SEER mode a t eet ree ee bob b Hb bete bebes 2 11 cay TT 2 12 Set up Condition din s k aA E 2 12
3. Shorter Test Do NOT tamper with the recorder electrodes or lead wires Do NOT take the recorder from the case and do not touch the cable or switch unnecessarily during Holter ECG checking Do NOT drop or hit the recorder as the Holter recorder is precision equipment Do NOT use other low frequency medical equipment at the same time Do NOT push the Stop button Do NOT take a shower or bath or get the electrodes or recorder wet Do NOT submerge the recorder in water or other liquids otherwise you may damage the recorder When wearing the recorder at night do NOT use an electric blanket It may interfere with the recording Record all diary entries with the date and time Record any physical signs and symptoms When a symptom is felt press the AZ Start Event button describe it in the diary and correlate it with the patient s activity and position Press the 4 Start Event button for about one second to mark the beginning of an event For prolonged events you can also press the button to signal the end of an event Record activities throughout the test period Make notations about physical activities rest periods meals strong emotional conditions and sleep If you perform a test shorter than 24 hours or 48 hours with SEER Light Extend recorder instruct the patient to disconnect the recorder when the test is complete Make sure the patient understands at what time the recording 1s complete Inst
4. Transferring Data for more information Clean and store the SEER Light devices Refer to Care and Cleaning on page 2 16 and Storage and Operating Conditions on page 2 16 for more information 5 2 SEER Light 2040604 012D Recording Data Connecting the Patient Cable marks indicate placement Connect the patient cable to the connector of the recorder with the a mark facing up Make sure it is connected properly Checking the Leads After the patient is hooked up to the recorder check the quality of the connections using the controller or the connect Check Leads Using the SEER Light Extend Controller 1 Turn the controller s power on Confirm the date and time adjust if necessary Refer to Set up Condition Mode on page 2 12 for more information 2 Align the infrared terminals on the controller and the recorder Press the F1 button Waveforms or lead quality information is displayed here 43A 9 Press the F1 button on the controller 2040604 012D SEER Light 5 3 Recording Data The Preview screen is displayed on the controller showing the following elements The patient s heart rate is displayed in the upper right corner Two or three channels of waveform data are displayed Adjust patient hookup if waveform height quality are not satisfactory or if messages are displayed instead of waveforms CAUTION WAVEFORM DIAGNOSTIC QUALITY The ECG waveform
5. Equipment Overview 2 18 SEER Light 2040604 012D 3 Preparing the Patient 2040604 012D SEER Light Preparing the Patient Placing Electrodes Two Channel Five Electrode In the two channel five electrode configuration two channels of ECG data are bipolar Red positive is referenced to white negative and brown positive is referenced to black negative 045A AHA IEC Color Color Channel Lead Location A Red Yellow CH 1 ll Fifth intercostal space anterior axillary line B White Red CH 1 Il Below the right clavicle just lateral to the midclavicular line C Brown Green CH2 mV1 Fourth intercostal space right sternal edge D Black White CH 2 mV1 Below the left clavicle just lateral to the midclavicular line E Green Black Ground On the lower right chest wall on a rib 3 2 SEER Light 2040604 012D Preparing the Patient Three Channel Seven Electrode There are three possible electrode configurations for three channel seven electrode recording Modified V3 Leads A modified V3 lead may be helpful in identifying ST segment changes in ischemic episodes associated with the left anterior descending coronary artery The following are the recommended electrode locations to record the modified V5 mV5 on channel 1 the modified V1 mV1 on channel 2 and the modified V3 mV3 on channel 3
6. Refer to Confirming Flash Card Contents on page 6 5 if this occurs m The flash card contains any data that has not been analyzed by the Holter analysis system m The recording is stopped by pressing the button on the recorder with a ball point pen or removing the recorders batteries before recording 24 hours 48 hours if using the SEER Light Extend recorder NOTE An error message will appear on the screen if a flash card is not inserted into the controller Make sure the card is inserted before attempting to transfer 7 Data transfer is completed when the transfer progress bar on the controller reaches 100 Confirm the time displayed on the screen 8 Remove the flash card by pressing the EJECT button 6 4 SEER Light 2040604 012D Transferring Data 35A 9 Disconnect the data transfer cable from the recorder Switch off the power supply by pressing the controllers POWER button Confirming Flash Card Contents You can confirm that the data transferred to the flash card through the controller This data includes m Patient information ID age gender and name m ECG waveform close to the event point close to the starting point close to the ending point specific times copied into the card By confirming the contents of the flash card the patient information can be edited Confirming Patient Information 1 Insert the flash card into the controller NOTE If the flash card is not inserte
7. Selecting a Language cee Inn 2 12 Parameter Descriptions and Configuration c cece eee 2 13 Battery OPPIDA 2 14 Battery Disposal i xak eee eee eens 2 16 Care and Cleaning si a aa Ae kk kwa nnn 2 16 Storage and Operating Conditions kk kk 2 16 Preparing the Patient Placing Electrodes sss 3 2 Two Channel Five Electrode 0 0 ccc ccc 3 2 Three Channel Seven Electrode 0 cece teens 3 3 Preparing the Skin s ua lah ee tenia esse dyke salk Rp ER ER NER ERR 3 6 Hooking Up the Patient ss kk akla aka kk ku kaka la kk kk aa kk a aka 3 7 POUCH dec dr EN K D ent aru 3 9 Holter ECG Patient Diary cosacos si su sa ak yk ka ada k k n 3 9 Setting Up the Patient Diary s Sal aka hak eee 3 9 Instructing the Patient LL kk kk kk kk kk kk kk kk kk kk kk kk kk kk kak kaka 3 9 Aude AANS ci o po al w k ya an wa QO AA 40 n wa al W ay ots 3 9 Activity RestriCtions iie sor H y k 04042404004504 Aaa perpe qu 3 10 Kuca EMITE 3 10 wra cd qe 3 10 Entering Patient Data Entering Patient Data 4 2 Using the SEER Light Extend Controller y u eee eee 4 2 Using the SEER Light
8. Blue CH 3 Z Mid sternum at the level of the fourth intercostal space G Green Black Ground Lower right chest wall Preparing the Skin Determine electrode placement according to one of the configurations shown in this chapter Use this procedure to insure good quality ECG data CAUTION ELECTRODES Make sure that the electrodes conducting elements do not make contact with each other or other metal parts Make sure that the device is not subject to disturbances from the electric mains Use only the specified electrodes for safety Any other electrode may not give proper recording and may cause problems with the patient 1 To minimize electrode problems be sure to use the proper type of electrode Check the expiration date on any pregelled electrode before using it Also check for dry gel pads on any pregelled electrodes that have been left out of their foil package 2 Shave hair from each electrode site This improves conductivity helps hold the electrode to the skin and makes the removal of the electrode easier 3 Rub each electrode site thoroughly with alcohol This removes oil from the skin 3 6 SEER Light 2040604 012D Preparing the Patient 4 Mark each electrode site with a felt tip pen This provides an easy way to determine when the epidermis has been sufficiently abraded 5 Use an abrasive pad to remove the epidermal skin layer at each electrode site The
9. of potential injury to a person DANGER indicates an imminent hazard which if not avoided will result 1n death or serious injury WARNING indicates a potential hazard or unsafe practice which if not avoided could result in death or serious injury 1 4 SEER Light 2040604 012D Manual Information Messages Warnings CAUTION indicates a potential hazard or unsafe practice which if not avoided could result in minor personal injury or product property damage NOTE provides application tips or other useful information to assure that you get the most from your equipment Additional safety messages may be found throughout this manual that provide appropriate safe operation information WARNING ACCIDENTAL SPILLS To avoid electric shock or device malfunction liquids must not be allowed to enter the device If liquids have entered a device take it out of service and have it checked by a technician before it is used again 2040604 012D SEER Light 1 5 Manual Information WARNING CARDIAC APPLICATION This device cannot be used for direct cardiac application WARNING LEAKAGE CURRENT Electrical shock to patient could result from component failure and lack of power isolation In the event this system is used in the patient vicinity environment it must be configured in such a way that it and all of its electrically connected peripheral devices are isolated f
10. the batteries must be removed to deactivate the Power Save mode To reset the recorder leave the recorder without the batteries for 30 seconds Make sure the batteries are set in the correct directions Then begin the recording process again Begin Recording with SEER Light Extend Controller 1 Press the F6 button on the controller to start recording Refer to Entering Patient Data on page 4 1 NOTE Recording can be started without entering patient information NOTE If data remains on the recorder that has not been transmitted to the controller the message Recorder still contains untransmitted data Press F6 to start a new recording will be displayed and a beep will sound from the recorder Press the F6 button to delete the data and start recording If the data is needed transfer the remaining data to the controller Refer to Chapter 6 Transferring Data 2 Confirm that the beep sounds for one minute and that the LED flashes twice per second for three minutes The recording date and time will be displayed on the LCD of the controller 2040604 012D SEER Light 5 13 Recording Data 3 Put the recorder in the carrying pouch with the A button facing up Begin Recording with SEER Light Connect SEER Light Hookup 1 Select the SEER Light Hookup icon located on your desktop The GE SEER Light Hookup window appears NOTE If data remains on the recorder that has not been transmitted to the
11. Accessories The following are accessories that may be included with the system Information is subject to change without notice CAUTION Use only the specified accessories Use of any other accessories may cause problems Description GE Part Number Electrodes ECG SilverTRACE MULTI P20MO Ad Foam Oval 2014768 001 Tab 300 bx Electrodes ECG SilverTRACE FIRST P28MO Ad Foam Rect 2014775 001 300 bx Electrodes ECG SilverTRACE FIRST P28MO Ad Foam Rect 2014776 001 300 bx Electrodes ECG SilverTRACE SOFT STRESS PS50MO Ad 2014780 001 Foam Rnd 300 cs Electrodes ECG SilverTRACE SOFT STRESS PS50MO Ad 2014781 001 Foam Rnd 600 cs Electrodes ECG SilverTRACE WINDOW P50TR Vinyl Tape 2014783 001 Rnd 30 pch 300 cs Electrodes ECG SilverTRACE WINDOW P50TR Vinyl Tape 2014784 001 Rnd 5 strip 300 cs Electrodes ECG SilverTRACE WINDOW P50TR Vinyl Tape 2014785 001 Rnd 7 pch 350 cs Electrodes ECG SilverTRACE Disposable Foam Oval 5 strip 900703 205 600 cs Electrodes ECG SilverTRACE Disposable Foam Oval 30 pch 900703 230 300 cs Electrodes ECG SilverTRACE Disposable Ad Clear Vinyl 9653 305 Tape 5 strip 300 cs B 2 SEER Light 2040604 012D Accessories Description GE Part Number Electrodes ECG SilverTRACE Disposable Ad Clear Vinyl 9653 507 Tape 7 pch 350 cs SEER Light Cable lead wires 2 Channel AHA 2008594 001 SEER Light Cable lead wires 3 Channel AHA 2008594 002 SEER Light Cable lead w
12. Connect s lt saya xu cece eee eee eee na na 4 4 SEER Light 2040604 012D Recording Data Operating eiie exe tees owner be a Dea ee in an Rx ne 5 2 Before Recording xelkan kulak kak kaba hl a kilk kai kalak d kd a 5 2 Alter Recordilig sain deeper e ol u kaml n pa w din ella n l ark 5 2 Connecting the Patient Cable 0 cece cece kk kk kk n 5 3 Checking the Leads s ck ak kk kk a kala ene ka a lal kalak alla 5 3 Confirming ECG Recording 5 7 Starting the SEER Light Recorder L Ls kk kk kk kk kk kk kk kk kk ka 5 11 Inserting Batteries in the SEER Light Recorder 5 12 Begin Recording with SEER Light Extend Controller 5 13 Begin Recording with SEER Light Connect cece kk kk kk eee eee 5 14 Begin Recording with SEER Light Recorder Button 5 14 Disconnecting the SEER Light Recorder cceece kk kk kk kk kk kk ka 5 15 Transferring Data Transferring Data to the Holter Analysis System k k z 6 2 Transferring to the Flash Card using the SEER Light Extend Controller 6 2 Confirming Flash Card Contents KK KK eee eee eee 6 5 Confirming Patient Information uu kk kk eee 6 5 Displaying the ECG Waveform 0 6 cece nee 6 6 Transferring Data to the Holter Analysis System via Flash Card 6 6 Transferring Data t
13. ER PATIENTS Take precautions to avoid risks of hazard due to the operation of a cardiac pacemaker or other electrical stimulators WARNING RF INTERFERENCE Known RF sources such as cell phones radio or TV stations and two way radios may cause unexpected or adverse operation of this device Consult qualified personnel regarding system configuration WARNING CABLES Cables present a possible strangulation hazard To avoid possible strangulation route all cables away from patient s throat Use short version of cables for pediatric patients WARNING CONDUCTIVITY Electric shock or device malfunction may occur if electrodes contact conductive materials Keep the conductive parts of lead electrodes and associated parts away from other conductive parts including earth 2040604 012D SEER Light 1 7 Manual Information WARNING DEFIBRILLATION Do NOT contact unit or patient during defibrillation Serious injury or death could result Patient signal inputs labeled with the CF and BF symbols with paddles are protected against damage resulting from defibrillation voltages To ensure proper defibrillator protection use only the recommended cables and leadwires Proper placement of defibrillator paddles in relation to the electrodes is required to ensure successful defibrillation WARNING ELECTROSURGERY Take precautions to reduce risks of burns a
14. GE Healthcare SEER Light Ambulatory Recorder Controller Operator s Manual 2040604 012 Revision D The information in this manual only applies to SEER Light devices Due to continuing product innovation specifications in this manual are subject to change without notice Marquette MARS MUSE and SEER are trademarks owned by GE Medical Systems Information Technologies a General Electric Company going to market as GE Healthcare All other marks are owned by their respective owners 2008 2009 General Electric Company All rights reserved T 2 SEER Light 2040604 012D 14 April 2009 CE Marking Information CE Marking Information C Compliance NOTE This CE mark information is part of the operator manual and is applicable for all products marketed and distributed by GE Medical Systems Information Technologies in the European community These SEER Light devices bear the CE mark 0459 notified body GMED indicating its conformity with the provisions of the Council Directive 93 42 EEC concerning medical device and fulfills the essential requirements of Annex I of this directive The product is in radio interference protection class A in accordance with EN 55011 The country of manufacture can be found on the equipment labeling The product complies with the requirements of standard EN 60601 1 2 Electromagnetic Compatibility Medical Electrical Equipment NOTE Refer to the SEER Light service manu
15. Transfer data noce 5 2 from recorder to controller 6 2 Transfer mode 2 e tede teen Eden 2 12 MCI Ec NENNT 3 8 Ww Warning definition esse 1 4 Wet gel electrodes eeeeeseeeeeeees 3 7 Index 2 SEER Light 2040604 012D ed Lec vn Suzuken Company Limited ANTISEL A Selidis bros S A 8 Higashikataha machi Higashi ku 6 I P Karatasiou Street Nagoya Aichi Ken Japan 54250 Harilaou Thessaloniki Greece DISTRIBUTOR DISTRIBUTOR DISTRIBUTOR GE Medical Systems GE Medical Systems GE Medical Systems Information Technologies Inc Information Technologies GmbH Information Technologies Asia GE China Co Ltd 8200 West Tower Avenue Munzinger StraBe 5 11th Floor Shanghai MAXDO Center Milwaukee WI 53223 USA D 79111 Freiburg 8 Xing Yi Road Hong Qiao Development Zone Tel 1414 355 5000 Germany Shanghai 200336 People s Republic of China 1 800 558 7044 US Only Tel 49 76145 43 0 Tel 86 215257 4650 Fax 1414 355 3790 Fax 4 49 761 45 43 233 Fax 4 86 21 5208 2008 www gehealthcare com
16. Trouble Cause Recommendation The SEER Light Hookup window displays a dialog box stating Recorder contains untransmitted data Press the Record button to start a new recording when the Record button is selected Recorder and connect The recorder contains untransmitted data Select the OK button to close the dialog box If the data is not needed select the Record button again If the data is needed transfer the data before beginning a new recording The recorder starts using the controller command through infrared However the controller displays Communication Error Recorder and controller The controller does not receive a response back to start recording from the recorder Align the infrared terminals then repeat the process If the Communication Error condition persists check with service or open a service call Patient data is not transferring between the recorder and the controller Recorder and controller An Extend device is used with a non Extend device Always transfer data from the SEER Light Extend recorder to a SEER Light Extend controller Beep sound is heard However LED does not blink Recorder The recorder is malfunctioning internally Check with service or open a service call LED blinking stops before 24 or 48 hour period Recorder May be using rechargeable or manganese type batteries Use new alkaline batteries The batteries were rem
17. al for additional compliance and exception information The safety and effectiveness of this device has been verified against previously distributed devices Although all standards applicable to presently marketed devices may not be appropriate for prior devices i e electromagnetic compatibility standards this device will not impair the safe and effective use of those previously distributed devices Any other directive s and all the standards the product complies to are listed in the general information of the operator manual for the product following this page 2040604 012D SEER Light CE 1 CE Marking Information CE 2 SEER Light 2040604 012D 2040604 012D Contents Manual Information Hmmm 1 2 Revision FISIO TY x Js 1 2 Manual Purpose ss ss xi aaay Ea Eya nes ak ka n eec a nk NE bay ricak yy di 1 2 Intended Use i g a a sed ore en ei wad bala ra kar a q ck en i a n ka 1 3 Intended Audience kk kk kk kk kk kk kk a kk ka kk ka kk aa kk kk kk kk kk aka 1 3 Product References ccc kak kk kk kk kk a kk ka kk ka kk a a kk kk kk ak kk kk kk 1 3 CONVENTIONS ii isssivernresirck eek a ERROR keene eee ee OR RR e 1 3 Safety Information i kl kla kk ka ku kala kk nnn 1 4 DC TIMMONS N vr lc 1 4 MESSAGES Tm 1 5 Warnings gt 4 i T xw a aa a a eee lal awk a a alek n be RR ER Wl 1 5 CONS ks oet dtu dp
18. ce at the right sternal edge D Black White CH 2 mV1 Left clavicle just lateral to the sternum 3 4 SEER Light 2040604 012D Preparing the Patient Modified Z Leads ABA Ew Channel Lead Location Color Color E Orange Orange CH3 maVF Sixth rib at the left mid clavicular line F Blue Blue CH 3 maVF Left clavicle at the mid clavicular line G Green Black Ground Lower right chest wall A modified Z lead mZ may be helpful in identifying ST segment changes in ischemic episodes with an anteroposterior axis The following are the recommended electrode locations to record the modified V5 mV5 leads on channel 1 modified V1 mV1 leads on channel 2 and Z leads on channel 3 048A amp 049A APA EG Channel Lead Location Color Color A Red Yellow CH 1 mV5 Fifth intercostal space at the left axillary line B White Red CH 1 mV5 Right clavicle just lateral to the sternum C Brown Green CH 2 mV1 Fourth intercostal space at the right sternal edge 2040604 012D SEER Light 3 5 Preparing the Patient ABA Pe Channel Lead Location Color Color D Black White CH 2 mV1 Left clavicle just lateral to the sternum E Orange Orange CH 3 Z Posterior just right of the spine at the same level as the anterior lead F Blue
19. connect the message Recorder contains untransmitted data Press the Record button to start a new recording is displayed If the data is needed transfer the remaining data to the connect Refer to Chapter 6 Transferring Data 2 Point the infrared terminal of the recorder to the connect 3 At the GE SEER Light Hookup window select Record A message appears stating the Holter recording started successfully Select OK NOTE If the infrared sensors are not aligned properly or if the cables are not connected a message will appear stating Error occurred while starting the recorder Check the connections and infrared sensor alignment 4 Confirm that the beep sounds for one minute and that the LED flashes twice per second for three minutes NOTE If you press the Record button after the recording has already started a message appears stating Holter recording has already started 5 Put the recorder in the carrying pouch with the E button facing up Begin Recording with SEER Light Recorder Button 1 Insert the batteries Refer to Inserting Batteries in the SEER Light Recorder on page 5 12 for more information 5 14 SEER Light 2040604 012D Recording Data 2 Connect the patient cable to the connector of the recorder with the a mark facing up 3 Press and hold the button on the recorder Confirm beep sounds for one minute and that the LED flashes twice per second for three minutes 4 P
20. controller CARD ERROR Press F6 to format the card is displayed on the controller screen Controller The flash card has not been initialized Follow the initialization instructions provided by the flash card manufacturer CARD ERROR Press F6 to format the card is displayed on the controller screen when the data transfer starts Controller A different type of card other than the flash card is inserted Insert the correct flash card Card contains unanalyzed data Pressing F6 will overwrite this data is displayed on the controller screen when the data transfer to the flash card does not start Controller The data is not transferred to the Holter analysis system and remains on the flash card If necessary transfer the data to the Holter analysis system Otherwise press the F6 button to overwrite the old data with the new recording 2040604 012D SEER Light A 5 Troubleshooting Trouble Cause Recommendation Data Error No data in the recorder is displayed on the controller screen when the data transfer starts Recorder The recorder is shut down within three minutes of when recording was started No data in the recorder Record the data again Controller connect transfers the data from the recorder up to 100 progress bar scans through twice and completes the transfer Recorder The batteries are removed before the 24 or 48 hour recordi
21. ct rectangular USB connection to the computer s USB port When the LED turns amber the USB cable is properly Connect square USB connection here 086A 3 Align the infrared terminals on the connect and the recorder 4 Atthe GE SEER Light Hookup window select the Start Preview button m Up to three channels of waveform data are displayed m Adjust patient hookup if waveform height quality are not satisfactory or if messages are displayed instead of waveforms CAUTION WAVEFORM DIAGNOSTIC QUALITY The ECG waveforms shown on the preview screen are used for assessing the quality of the connections only Do not use these preview waveforms for diagnostic purposes 5 Select the Stop Preview button to stop the lead preview 5 6 SEER Light 2040604 012D Recording Data Confirming ECG Recording The quality of a Holter ECG recording is very important To record ECG without artifact confirm the recording conditions before starting the recording To improve the ECG quality adjust the electrode attachments Wireless Data Transfer The controller and the connect use infrared wireless data transfer to confirm the ECG waveform recorded by the recorder In preview mode the controller displays two channels of real time ECG waveforms at a time and the connect displays up to three channels of real time ECG waveforms Considerations Using the SEER Light Extend Controller m Insert the bat
22. cting any devices to this equipment that are not recommended in this manual Parts and accessories used must meet the requirements of the applicable EN IEC UL 60601 or EN IEC UL 60950 series safety standards and the SEER Light 2040604 012D Manual Information system configuration must meet the requirements of the EN IEC 60601 1 1 medical electrical systems standard The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system Consideration relating to the choice shall include m use of the accessory in the PATIENT VICINITY ENVIRONMENT and m evidence that the safety certification of the ACCESSORY has been performed in accordance with the appropriate EN TEC UL 60601 1 medical or EN TEC UL 60950 information technology and EN IEC 60601 1 1 safety standard s Classification The SEER Light Connect is classified according to EN TEC 60950 The SEER Light recorders and controllers are classified according to EN IEC UL 60601 1 as Type of protection against electrical shock Internally Powered Equipment Degree of protection against electrical Type B Equipment shock Degree of protection against harmful Ordinary Equipment enclosed equipment without protection against ingress of water ingress of water Degree of safety of application in the Equipment not suitable for use in the presence of a flammabl
23. d into the controller before starting the operation error messages will appear on the screen 2 Pressthe F3 button to open Review mode where you can confirm the flash card contents 3 Select Patient Information Press ENT 4 The patient information to be transferred from the recorder will be displayed on the screen of the controller m Patient information can be edited Refer to Entering Patient Data on page 4 1 m By pressing the F4 button after editing the data a message appears prompting you whether or not to save the edited data 2040604 012D SEER Light 6 5 Transferring Data 5 Press the ENT button to save the data and return to the screen in Step 3 Press the F4 button to return to SEER mode Displaying the ECG Waveform 1 Insert the flash card into the controller NOTE If the flash card is not inserted into the controller before starting the operation error messages will appear on the screen Press the F3 button under SEER mode It will proceed to the confirmation of flash card contents Select ECG Display Press ENT Select the ECG waveform that you want to display by using the a and w buttons Choices are Event Start End and Time Press the ENT button m Ifyou select Time the starting time of the recording will be displayed first By entering the time you want to review in this screen and pressing the ENT button the ECG waveform corresponding to that specified time will be dis
24. e anesthetic mixture with presence of a flammable anesthetic air or with oxygen or nitrous oxide mixture with air or with oxygen or nitrous oxide Method s of sterilization or disinfection Not applicable recommended by the manufacturer Mode of operation Continuous operation 2040604 012D SEER Light 1 11 Manual Information Underwriters Laboratories Inc lic Classified by Underwriters Laboratories Inc with respect to electric shock fire mechanical and other specified C hazards only in accordance with UL 60601 1 CAN CSA C22 2 No 601 1 EN TEC 60601 1 and IEC 60601 2 47 Information Technology Equipment The hardware components supplied by GE for the MARS Holter analysis workstation on which the SEER Light Connect application runs are considered to be Information Technology Equipment ITE These individual components have been found to comply with the standard for Safety of Information Technology Equipment including Electrical Business Equipment EN IEC UL 60950 The software used in the MARS Holter analysis workstation is considered as medical software The software has been designed and manufactured to the appropriate medical regulations and controls In order for the MARS Holter analysis workstation to comply with medical equipment leakage current requirements a medical grade uninterruptible power supply UPS must be used EN IEC UL 60601 1 to power all non medical equipment In addi
25. e language 2 12 SEER Light 2040604 012D Equipment Overview Parameter Descriptions and Configuration The following operating parameters can be configured for the recorder and the controller Parameter Description Heart rate synchronizing sound controller Heart rate synchronizing shown as HR sound can be set ON or OFF during the preview of ECG waveforms OFF is the initial setting Press the buttons to turn the selection ON or OFF Heart rate detection channel controller Used to select a recording channel to detect heart rate to calculate the heart rate and the heart rate synchronizing sound during the preview of ECG waveform Selections are CH1 CH2 or CH3 CHT is the initial setting Press the 4 buttons to select CH1 CH2 or CH3 Auto start recorder If auto start is set to on the controller will program the SEER Light recorder so it automatically starts 30 minutes after batteries are installed Once the recorder is setup this way it will always automatically start in this manner unless is it reprogrammed If auto start is set to off it will program the SEER Light recorder so it does not automatically start 30 minutes after the batteries are installed Press the buttons to turn the selection ON or OFF NOTE The recorder will not Auto start if there is untransferred data in the recorder 2040604 012D SEER Light 2 13 Equipment Overview Parameter Descripti
26. e relevant to that equipment i e EN IEC 60950 UL 60950 The overall system device and all of its connected peripheral devices must comply with EN IEC 60601 1 Use of SEER Light Connect device in the patient vicinity requires that these measures are observed Patient vicinity environment defined as m Any volume in which intentional or unintentional contact can occur between patient and parts of the system or between patient and other persons touching parts of the system IEC 60601 1 1 m A space volume within a location intended for the examination and treatment of patients extending 6 ft 1 83 m beyond the normal location of the bed chair table treadmill or other device that supports the patient during examination and treatment and extending vertically to 8 ft 2 4 1n 2 5 m above the floor m Areas where healthcare staff members monitor patients remotely and perform charting and administrative tasks are not considered to be Patient Vicinity environment areas al SEER Light 1 Select the SEER Light Hookup icon on your desktop EIE The GE SEER Light Hookup window appears 2040604 012D SEER Light 4 5 Entering Patient Data 2 Enter the patient s information The Last Name and First Name fields are limited to a maximum of 14 characters The JD field is limited to a maximum of 10 numeric characters f1 GE SEER Light Hookup Enter Patient EE_E n E Information Here 080A 3 Refe
27. epidermal skin layer has been removed when the mark left from the felt tip pen has been erased WARNING ELECTRODE CONDUCTIVITY Keep the conductive parts of lead electrodes and associated parts away from other conductive parts including earth 6 Place an electrode on each prepared site Hooking Up the Patient Complete patient hookup and prepare the patient for ECG data recording NOTE Use only the 5 or 7 electrode patient cable designed for use with the recorder 1 Connect each cable lead wire to the correct patient electrode per the electrode placement tables 2 Use stress loops to reduce the movement of the electrodes caused by tension from the lead wires Form a stress loop in each lead wire using an electrode clip as shown below This prevents a lead wire from pulling directly on the electrode contact points Each loop should be about 1 or 2 inches in diameter about 2 inches from the electrode Electrode Clip 3 Secure the electrodes with tape to prevent movement and maintain electrical contact If you are using wet gel electrodes apply the tape loosely enough so that no gel squeezes onto the adhesive surfaces of the electrodes 2040604 012D SEER Light 3 7 Preparing the Patient NOTE Special T shirts PN 9812 011 012 013 are available from GE Medical Systems Information Technologies that minimize movement and increase comfort during the data recording period 4 Connect the pa
28. ess the F6 button to delete any old data remaining on the recorder and to begin entering patient data for this test Entering Patient Information The controller displays the patient information screen when you press the POWER button Use this screen to enter the followingpatient information ID number up to 10 digits Age Gender Last Name Displayed as NAME L First Name Displayed as NAME F Items can be selected by pressing the buttons 4 2 SEER Light 2040604 012D Entering Patient Data Alphanumeric Entry Choosing a Letter to Enter Press CLR to correct error input Each patient information field accepts alphabetic or numeric data ID and Age are numeric only fields The bottom of the display panel shows 1 Name L and Name F which are alphabetic fields by default and the bottom of the display planel shows A Press F5 before entering numbers in these fields Press F5 again to return to entering letters The 8 and 9 buttons are used in the Gender field Each numbered button represents specific letters listed above the button Each time you press the button the letter displayed will change in the order they appear first in UPPERCASE then in lowercase For example ABC if the 2 button is pressed three times in the alphabet entry mode the ABC capital letter C will display If the 2 button is pressed four times in the alphabet entry mode the lowercase letter a will be displa
29. etween the recorder and the Holter analysis system This device is also referred to as the connect in this document 2040604 012D SEER Light 2 7 Equipment Overview WARNING LEAKAGE CURRENT Electrical shock to patient could result from component failure and lack of power isolation In the event this system is used in the patient vicinity environment it must be configured in such a way that it and all of its electrically connected peripheral devices are isolated from mains power to prevent excessive leakage current to the patient Use of isolated mains power or a medical grade isolation transformer in compliance with UL 60601 CAN CSA C22 2 No 601 1 EN IEC 60601 1 with this system will support compliance with EN IEC 60601 1 1 All nonmedical peripheral devices shall comply with applicable EN IEC ISO and UL safety standards that are relevant to that equipment i e EN IEC 60950 UL 60950 The overall system device and all of its connected peripheral devices must comply with EN IEC 60601 1 Use of SEER Light Connect device in the patient vicinity requires that these measures are observed Patient vicinity environment defined as m Any volume in which intentional or unintentional contact can occur between patient and parts of the system or between patient and other persons touching parts of the system IEC 60601 1 1 m A space volume within a location intended for the examination and treatment of pat
30. ext to be entered or hardware items such as buttons or switches on the equipment Italicized text Indicates software terms that identify menu items buttons or options in various windows 2040604 012D SEER Light 1 3 Manual Information Styles Style Definition Ctri Esc Indicates a keyboard operation A sign between the names of two keys indicates you press and hold the first key while pressing the second key once For example Press Ctrl Esc means to press and hold down the Ctrl key while pressing the Esc key lt Space gt Indicates that you must press the spacebar When instructions are given for typing a precise text string with one or more spaces the point where the spacebar must be pressed is indicated as lt Space gt The purpose of the lt gt brackets is to ensure you press the spacebar when required Enter Indicates that you must press the Enter or Return key on the keyboard Do not type enter Illustrations All illustrations in the manual are provided as examples only All patient names and data are fictitious and any similarity to actual persons is coincidental Safety Information Definitions The terms danger warning and caution are used throughout this manual to point out hazards and to designate a degree or level of seriousness Familiarize yourself with their definitions and significance Hazard is defined as a source
31. ients extending 6 ft 1 83 m beyond the normal location of the bed chair table treadmill or other device that supports the patient during examination and treatment and extending vertically to 8 ft 2 4 in 2 5 m above the floor m Areas where healthcare staff members monitor patients remotely and perform charting and administrative tasks are not considered to be Patient Vicinity environment areas 2 8 SEER Light 2040604 012D Equipment Overview A B 084A Name Function A Data transfer cable Used to transfer data from the SEER Light recorder to the SEER Light Connect B Infrared terminal Used to communicate with the SEER Light IR Window recorder m Receives ECG waveform data from a SEER Light recorder to preview m Transfers patient demographics to the SEER Light recorder m Starts the SEER Light recorder C USB Connection Uses a USB patch cord to transfer data from the SEER Light Connect to the Holter analysis system D LED indicator m Flashes when data is transferring m Lights without flashing when a proper connection exists Installing SEER Light Hookup This software is used in conjunction with the SEER Light Connect device If you do not have a SEER Light Connect device you may skip this section 2040604 012D SEER Light 2 9 Equipment Overview Before you connect the SEER Light Connect device to your Holter analysis workstation follow these steps to instal
32. ires 2 Channel IEC 2008594 003 SEER Light Cable lead wires 3 Channel IEC 2008594 004 SEER Light Patient Cable lead wires 2ch AHA Short 2008594 005 SEER Light Patient Cable lead wires 3ch AHA Short 2008594 006 SEER Light Patient Cable lead wires 2ch IEC Short 2008594 007 SEER Light Patient Cable lead wires 3ch IEC Short 2008594 008 Holter Kit 5 Lead 24 kits case 400068 026 Holter Kit 7 Lead 24 kits case 400068 027 Prep Razors Disposable 3704 901 Pre Cut Tape Strips for Stress Loops 100 pack 4829 002 SEER Light Carrying Case Belt and Strap 2008596 001 Holter Patient Diary 90026 902 Holter Exercise Stress Vests Medium 9812 011 Holter Exercise Stress Vests Large 9812 012 Holter Exercise Stress Vests Extra Large 9812 013 SEER Light 64MB Memory Card 2008750 003 SEER Light Memory Card Adapter 2008751 001 Alcohol Pumice Prep Pads 4828 004 Sandpaper Prep Strips 4828 005 Dry Skin Prep Pads 9386 001 2040604 012D SEER Light B 3 Accessories B 4 SEER Light 2040604 012D Index A Entering patient information 4 2 Access LED eite hte a ERRR nnn da n al 2 5 Event nana d nek 1 13 ACCOSSOR OS 1 10 B 2 E ACCIDENTAL SPILLS u ez 1 5 nm Flash N inanin 6 3 ACQUISITION 6 6 adapter 6 6 Adapter flash Card 6 6 eee ere aaa AHA H American Heart Association 3 2 Heart
33. ks with the 24 hour SEER Light controller for setup but not for transferring data The 24 hour SEER Light controller is no longer available Always use the SEER Light Extend recorder with the SEER Light Extend controller when transferring data NOTE The 24 hour SEER Light recorder can be used with the SEER Light Extend controller SEER Light SEER Light Extend Compact Digital Holter Recorder The SEER Light SEER Light Extend Compact Digital Holter Recorder is shown and described below This device is also referred to as the recorder in this document 2040604 012D SEER Light 2 3 Equipment Overview NOTE There are two recorders available The SEER Light recorder that records up to 24 hours of ECG data and the SEER Light Extend recorder that records up to 48 hours of ECG data The stenciled label on each device identifies the recorder name Name Function A Battery box cover Slide the cover to open and set the batteries in the battery box NOTE Do not open in patient vicinity B Battery box C REC LED Holds the batteries To display operation conditions m After pressing the Start Event button the LED will flash twice per second for three minutes During this time data is not recorded m During recording the LED will flash every second Start event button Use to start recording Use mark events during recording E Patient cable connec
34. l the SEER Light Hookup software NOTE You must have administrator privileges to install the SEER Light Hookup software 1 Insert the SEER Light Hookup software CD in the CD drive of your workstation NOTE The computer you install the SEER Light Hookup software must be running Windows 2000 2000 server XP or 2003 server The software cannot be installed on Windows NT 98 or ME 2 The SEER Light Hookup InstallShield Wizard appears Choose the appropriate language and select Next 3 The SEER Light Hookup Setup welcome window appears Select Next 4 The license agreement window appears Review the license agreement and select Yes 5 The Destination Disk window appears Highlight the disk in which the SEER Light Hookup application will be installed Select Next 6 The software is now being installed When finished a message appears asking if you would like to view the installation report Select Yes to view the report or No to continue If you select Yes the Installation Report appears m To print the report select the Print button m To view previous installation reports select the View History button This button will be grayed out if no prior installations were done on your computer 7 Select Next when finished 8 Atthe InstallShield Wizard Complete window select Yes I want to restart my computer now 9 Select Finish Your computer will restart 10 Log back in as Administrator 11 Plug the Univer
35. ll shift the electrodes to find a suitable location for electrode attachment Confirming Pacemaker Pulses When viewing the ECGs of pacemaker patients it can be difficult to see the pacemaker pulses on the ECG waveform If the pacemaker pulse of CH1 is small it may not be detected Verify accurate pace detection before starting to record To verify accurate pace detection using the controller 1 While in SEER mode point the controller to the infrared terminal of the recorder and press the F1 button The Preview screen will display 2 A down pointing arrow mark is displayed above the pacemaker pulse detected by the recorder If the down pointing arrow mark is not shown on the pacemaker waveform change CH1 to another lead that produces big pacemaker pulses 3 By pressing the F4 button after checking the ECG waveform it will return to SEER mode 2040604 012D SEER Light 5 9 Recording Data CAUTION PACEMAKER PATIENTS Pacemaker pulses are only detected on CH1 Before attaching the recorder check the patient s ECG to predict which lead will produce a big pacemaker pulse That is the lead that should be assigned to CH1 refer to table below If the pacemaker pulse of CH1 is small there is a possibility that the pacemaker pulse may not be detected Change the lead of CH1 to another lead that has a bigger pacemaker pulse The down pointing arrow mark of the pacemaker pulse location for the pre
36. nd injury to the patient If an electrosurgery device is used it is necessary to disconnect the patient cable from the SEER Light recorder WARNING OXYGEN RICH ENVIRONMENT An oxygen rich environment may be flammable Do not use device in an oxygen rich environment or around other flammable or explosive gases WARNING SUPERVISED USE This device is intended for use under the direct supervision of a licensed health care practitioner 1 8 SEER Light 2040604 012D Manual Information Cautions CAUTION BEFORE OPERATION Check that the instrument operates properly See Chapter 5 of the SEER Light Ambulatory Recorder Controller Service Manual for proper maintenance practices When using with other instruments request the assistance of a specialist CAUTION DISPOSAL At the end of its service life the product described in this manual as well as its accessories must be disposed of in compliance with the guidelines regulating the disposal of such products If you have questions concerning the disposal of this product contact GE or its representatives Dispose of the packaging material observing the applicable waste regulations Keep the packaging material out of children s reach CAUTION EQUIPMENT CONFIGURATION The equipment or system should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessa
37. nformation Technologies 6 2 SEER Light 2040604 012D Transferring Data SEER Light Recorder Controller Compatibility SEER Light Controller 24 SEER Light Extend Hour Controller 48 Hour SEER Light Recorder 24 YES YES Hour SEER Light Extend NO YES Recorder 48 Hour NOTE The SEER Light Controller 24 hour is no longer available The SEER Light Extend Controller is compatible with both SEER Light 24 hour and SEER Light Extend 48 hour recorders NOTE The SEER Light Extend Recorder 48 hours is compatible with MARS v7 x and higher only It is not compatible with MARS v4 v5 or v6 Remove the data transfer cable from the back side of the controller Switch on the controller s power supply by pressing the POWER button as in the following graphic 32A Confirm the date and time Change the date and time if it is not correct Refer to Set up Condition Mode on page 2 12 Insert flash card with the a mark facing up into the controller Pivot the EJECT button to prevent inadvertent ejection of the flash card 33Z SEER Light 6 3 Transferring Data Jer 4 Connect the cable to the data output connector of the recorder gt r 5 Press the F2 button to enter the data transfer mode Press the F6 button The data will be transferred to the flash card 6 You will be asked to confirm transfers under the following conditions
38. ng Data Transferring Data to the Holter Analysis System The procedure for transferring data from the recorder to the Holter analysis system depends on which device is used to transfer the data the controller or the connect m If using the controller the transfer must undergo a two step process 1 Data is transferred from the recorder to a compact flash card via the controller See Transferring to the Flash Card using the SEER Light Extend Controller on page 6 2 2 Data is transferred from the compact flash card to the Holter analysis system See Transferring Data to the Holter Analysis System via Flash Card on page 6 6 m fusing the connect the data is acquired directly into the Holter analysis system See Transferring Data to the Holter Analysis System via Connect on page 6 7 Transferring to the Flash Card using the SEER Light Extend Controller Follow these steps to transfer data from the recorder to a compact flash card via the controller See the matrix below for SEER Light recorder and controller compatibility CAUTION EQUIPMENT DAMAGE To avoid equipment damage follow the considerations below when using a flash card Do not place the patient label over another label Do not touch the connector with your hand or scratch it with a hard object Do not get the card wet Do not subject the card to any external force or shock Use only the flash card specified by GE Medical Systems I
39. ng is completed The data recorded before the batteries were removed remains If the data is needed proceed with the transfer DATA ERROR Recorder contains data error s is displayed on the controller screen SEER Light Hookup window after the data is transferred from the recorder Files are damaged and cannot be transferred from the recorder Check with service or open a service call transferred through connect Connect Recorder Data LED does not blink while the data is LED may be broken Check with service or open a service call transferred from the recorder Recorder Data LED does not blink while the data is LED may be broken Check with service or open a service call Wrong date and time on the report Controller Date and time settings are wrong on the controller Reset date and time on the controller The backup battery for the clock in the controller is worn out Check with service or open a service call Wrong date and time on the report Date and time setting are wrong on the SEER Light Hookup dialog box when Have the IT department or biomed reset date and time on the MARS PC or Connect starting a recording stating Holter network recording started successfully Hook up date and time are dd mm yyyy hh mm ss AM PM A 6 SEER Light 2040604 012D B Accessories 2040604 012D SEER Light Accessories
40. not in use store the cable in the guide on the backside panel Used to enter controller modes Press F1 to enter Preview mode to confirm the quality of ECG recording Press F2 to enter Data Transfer mode to transmit data to SEER card Press F3 to enter Review mode to confirm SEER card contents Press F4 to return to SEER mode 2 Battery box cover 3 Data transfer cable 4 Function buttons 5 F6 button Used to start recording of the SEER Light recorder and to start transferring data to a SEER card 6 Select ENT button Used to select items and navigate around the display panel Enter the patient s alphanumeric information 7 Patient information entry keypad 8 F5 button Used to enter Set up condition mode to change certain settings on the controller and recorder 2 6 SEER Light 2040604 012D Equipment Overview Name Function 9 LCD liquid crystal Displays operating conditions display 10 D Used to turn the power on and off Power button 11 Infrared terminal IR Used to communicate with the SEER Light Window recorder m Transfer the instructions to a SEER Light recorder before recording m Receive ECG waveform recording data from a SEER Light recorder to preview 12 SEER card slot Used to insert a SEER card 13 Eject button Used to eject a SEER card SEER Light Connect The SEER Light Connect is used as a direct interface connection b
41. ny unauthorized attempt to repair equipment under warranty voids that warranty Itis the user s responsibility to report the need for service to GE Medical Systems Information Technologies or to one of their authorized agents The serial number is a unique number used for identification The serial number appears on the device label located on the back of the device similar to the following q3 9 oQ ce wo ce co w t 089A SEER Light 2040604 012D Manual Information 2040604 012D SEER Light 1 15 Manual Information 1 16 SEER Light 2040604 012D 2 Equipment Overview 2040604 012D SEER Light Equipment Overview General Information For safe and effective operation read this manual thoroughly prior to use NOTE It is unsafe to start using the device before reading this entire manual 1A SEER Light Extend Controller with Compact Flash Card 2 2 SEER Light 2040604 012D Equipment Overview 084A SEER Light Connect SEER Light Device Compatibility There are two types of recorders and controllers with different capabilities SEER Light and SEER Light Extend m The SEER Light recorder acquires stores and transfers up to 24 hours of ECG data m The SEER Light Extend recorder and SEER Light Extend controller acquires stores and transfers up to 48 hours of ECG data CAUTION DATA TRANSFER The SEER Light Extend recorder wor
42. o the Holter Analysis System via Connect 6 7 Analyzing Waveforms and Patient Treatment 0 cece eee eee 6 8 Troubleshooting Troubleshooting Chart A 2 Accessories Dc D Mm B 2 SEER Light ii SEER Light 2040604 012D 1 Manual Information 2040604 012D SEER Light Manual Information Manual Information Revision History Manual Purpose This manual includes operator s instructions for m SEER Light SEER Light Extend Compact Digital Holter Recorder m SEER Light Extend Controller m SEER Light Connect Each page of the document has the document part number followed by a revision letter at the bottom of the page The revision letter identifies the document s update level Revision History PN 2040604 012 Revision Date Comment A 30 April 2008 Initial release of this document B 11 August 2008 Revised to include the word Greece to Greek address on backcover C 19 September 2008 Revised manual to reflect Suzuken responsibility and new controller configuration D 14 April 2009 Revised to change CF Card part number This manual contains the instructions necessary to operate the equipment safely in accordance with its function and intended use These instructions include but are not limited to an explanation of the function of controls and indicators the sequence of operation connection and disconnection of detachable parts and accesso
43. on Date and Time controller Used to set the date and time of the controller The start time of the recorder is calculated based on the date and time of the controller The recorder does not have a time clock m The recorder receives the date and time information from the controller when the recorder is started by the controller m Or in instances when recording is initiated from the recorder the recording start time will be calculated from the time clock of the controller when the ECG data is transferred to a SEER card from the recorder using the controller Setting the Date 1 Press the alphanumeric buttons to enter DD MON the 3 letter code for the month and YYYY in order The Hungarian language version displays the date using the yyyy MON dd format 2 Press w toconfirm the new date Setting the Time 1 Press the alphanumeric buttons to enter HH and MM in order 2 Press w to confirm the new time Accelerometer Check Not used Battery Power The controller and the recorder use AAA alkaline batteries Always remove the batteries when storing either device SEER Light Controller According to the battery power level the battery icon will change The following table describes the battery power level icon s 2 14 SEER Light 2040604 012D Equipment Overview Battery Symbol Mark Battery Power Level Sufficient power for normal operation Battery power sufficient for 6 normal reco
44. oved while recording Do not touch or remove the batteries while recording Damage to unit caused by physical shock Check with service or open a service call When the F1 button on the controller is pressed for preview through infrared transfer error occurs Recorder and controller Infrared transfer does not work due to the distance or an obstruction between the recorder and controller Set both devices within 1 meter and adjust the direction so that the terminal of infrared between the recorder and controller are directly facing each other Press the F1 button again The F1 button was pressed 1 hour after the batteries are inserted Reset the batteries 30 seconds after the batteries are removed Press the F1 button within 1 hour The recorder beeps the first minute after the recording has started For the remaining 2 minutes of calibration the recorder s LED flashes twice per second After the beeping sound the controller cannot preview using infrared Otherwise the recorder and controller must be connected by the cable A 4 SEER Light 2040604 012D Troubleshooting Trouble Cause Recommendation The batteries are not inserted in the recorder Insert the batteries and press the F1 button The batteries in the recorder do not have enough power Replace the batteries and press F1 button The SEER Light Hookup Lead Preview window display
45. patient cable NOTE Do not clean and reuse electrodes Use new electrodes for each use The devices cannot be sterilized Do not immerse the device in any liquid or allow liquids to enter through connections ports or buttons Do not use xylene or petroleum based solvents for cleaning the device In case of a malfunction call a service technician and precisely describe the problem Check the patient cable and connectors every month by connecting to an ECG simulator Storage and Operating Conditions Follow these guidelines when storing and operating the SEER Light devices 2 16 SEER Light 2040604 012D Equipment Overview Storage and Operation Environmental Conditions Storage Conditions Remove batteries from the recorder and controller Temperature SEER Light Recorder and SEER Light Connect 4 F to 149 F 20 C to 65 C Temperature SEER Light Controller 4 F to 140 F 20 C to 60 C Relative Humidity SEER Light Recorder 5 90 RH non condensing Relative Humidity SEER Light Controller 30 90 RH non condensing Operating Conditions for SEER Light Controller and SEER Light Connect Operating Conditions for SEER Light Recorder and SEER Light Extend Recorder Temperature 50 F to 95 F 10 C to 35 C Relative Humidity 30 80 RH non condensing Temperature 32 F to 113 F 0 C to 45 C Relative Humidity 10 95 RH non condensing 2040604 012D SEER Light
46. played on the Screen m Scroll forward through the ECG waveform by pressing the or F1 button You cannot scroll backward through the waveform Press the a or F4 button until you are returned to the screen in Step 4 Press the a or F4 button again to return to SEER mode Transferring Data to the Holter Analysis System via Flash Card Follow these steps to transfer data from the flash card to the Holter analysis system 1 Insert the flash card into the flash card adapter NOTE ECG data recorded by the recorder can only be analyzed by the Holter analysis system 2 Insert the flash card adapter into the acquisition unit Proceed with data transfer as outlined in the operator s manual for the Holter analysis system 6 6 SEER Light 2040604 012D Transferring Data Transferring Data to the Holter Analysis System via Connect Follow these steps to transfer data from the recorder through the connect 088A 1 Connect the cable on the connect to the USB port of your MARS workstation The USB port may be located on the front or the back of the PC 2 Remove the lead wires 3 Connect the recorder to the connect device 4 Refer to the Holter analysis system Operator Manual for instructions on acquiring the data 2040604 012D SEER Light 6 7 Transferring Data Analyzing Waveforms and Patient Treatment Refer to the Holter analysis system Operator Manual for instructions on viewing and analyzing wavefo
47. pment i e EN IEC 60950 UL 60950 The overall system device and all of its connected peripheral devices must comply with EN IEC 60601 1 Use of SEER Light Connect device in the patient vicinity requires that these measures are observed Patient vicinity environment defined m Any volume in which intentional or unintentional contact can occur between patient and parts of the system or between patient and other persons touching parts of the system IEC 60601 1 1 m A space volume within a location intended for the examination and treatment of patients extending 6 ft 1 83 m beyond the normal location of the bed chair table treadmill or other device that supports the patient during examination and treatment and extending vertically to 8 ft 2 4 in 2 5 m above the floor m Areas where healthcare staff members monitor patients remotely and perform charting and administrative tasks are not considered to be Patient Vicinity environment areas 2040604 012D SEER Light 5 5 Recording Data 1 Select the SEER Light Hookup icon on your desktop SEER Light Hookup window appears The GE 2 Connect the USB cable to the connect and the Holter analysis PC When properly connected the LED on the connect turns amber NOTE The following picture shows a USB port on the front of the PC Some PCs have the USB port s located on the back The connect can be connected to either a front or back USB port Conne
48. power loss This function makes the F6 button not work The recorder is already in the recording process Press the F6 button again 30 seconds after batteries are replaced Select OK The dialog box closes and the recording continues The SEER Light Hookup window displays a dialog box stating Error occurred while starting the recorder Check the connections and the infrared sensor alignment when the Record button is selected Recorder and connect Infrared transfer does not work due to the distance or an obstruction between the recorder and connect Select the OK button to close the dialog box Set both devices within 1 meter and adjust the direction so that the terminal of infrared between the recorder and connect are aligned Select the Record button again Patient data not available because cables are not properly connected Select the OK button to close the dialog box Connect the cables Select the Record button again The recorder does not start up when the controller sends a start up command through infrared and Recorder still contains untransmitted data Press the F6 button to start a new recording is displayed Recorder and controller Data remains in the recorder and was not transferred to the controller If the data is not needed press the F6 button Otherwise transfer the old data to the controller 2040604 012D SEER Light A 3 Troubleshooting
49. r to Begin Recording with SEER Light Connect on page 5 14 4 6 SEER Light 2040604 012D o Recording Data 2040604 012D SEER Light Recording Data Operating Before Recording Follow these steps before recording For information on each operation see the page s indicated 1 After Recording Prepare the patient by performing skin preparation and attaching the electrodes Refer to Placing Electrodes on page 3 2 and Preparing the Skin on page 3 6 for more information Prepare the controller by checking the battery status If necessary replace the controller s batteries Install new batteries in the recorder Refer to Battery Power on page 2 14 Connect the electrode lead wires Refer to Hooking Up the Patient on page 3 7 for more information Do a lead check Refer to Checking the Leads on page 5 3 for more information Enter patient information Refer to Chapter 4 Entering Patient Data on page 4 1 for more information Start the recorder Refer to Starting the SEER Light Recorder on page 5 11 for more information Follow these steps after recording For information on each operation see the page indicated 1 Disconnect the patient from the recorder Refer to Disconnecting the SEER Light Recorder on page 5 15 for more information Transfer the patient s Holter data from the recorder controller connect to the MARS system for analysis Refer to Chapter 6
50. rate Alphanumeric detection channel controller 2 13 entry cse a KRN Ye E DN 4 3 synchronizing SOU lt E i 4yk nknkdlkaya 2 13 KEY PAG Li s 2 6 Holter analysis system sseeeee 6 6 B Holter card slot irte tens 2 7 Battery box l COMMONS doter 2 6 je 1 11 COVEN e ai 2 6 International Electrotechnical Commission 3 2 MR 2 4 Infrared terminal EUE 2 5 2 7 COVEN anan 2 4 Input COnnector one n davies cc kak ne nek n dan 1 13 Battery status checking llu EE 5 2 Instructions for use caution sssss 1 10 C L Cardiac application warning 1 6 Language Caution definition i xi il4yy lk ky kad ak 1 5 SCISCUING t ei aes 2 12 CH Ba 2 7 channel ee 3 2 Lead CHECK e 5 2 Cleaning M TS AIG WED Modifications caution eee 1 10 cleaning the recorder ssssssssss 5 2 Conductivity warning ee 1 7 N D Note definition j k i 2 aa anan lk aei 1 5 Danger definition seeeneee 1 4 O DATAJEED ecce eere e eO eee EDO ee r 2 5 Output connector sesssssseenene 1 14 2 5 Data transfer P data transfer cable 2 6 erie Parameter descriptions ssssssssss 2 13 Defibrilla
51. rding operations including preview of the ECG waveform for 5 minutes start recorder and data transfer It is recommended to replace the batteries Battery power sufficient for 3 normal recording operations including preview of the ECG waveform for 5 minutes start recorder and data transfer Replace with new batteries l No power for operation Replace the batteries 12 11 11 00 Battery Replace the battery NOTE The Auto Power OFT function will be activated to save the battery power if no button is pressed for 15 minutes The Auto Power OFF function will not be activated if any error message is displayed SEER Light Recorder Always remove the batteries when not in use and replace with new AAA alkaline batteries when ready for use See Inserting Batteries in the SEER Light Recorder on page 5 12 for details 2040604 012D SEER Light 2 15 Equipment Overview Battery Disposal Care and Cleaning Do not burn the batteries or dispose of batteries with other medical wastes Contact your local recycling center for information on proper disposal of used batteries Follow these cleaning instructions for the recorder controller and the connect device Keep the device clean between each use to prevent infection Remove the batteries and disconnect any power and USB cords before cleaning the device Use a piece of cloth dampened with alcohol to clean the device and the
52. rding occurs from within SEER mode Refer to Entering Patient Data on page 4 1 and Recording Data on page 5 1 for more information 2040604 012D SEER Light 2 41 Equipment Overview The controller starts up in SEER mode automatically Transfer mode Recorded data is transferred from the recorder to the controller from within Transfer mode Refer to Transferring Data on page 6 1 for more information Press F2 to enter Transfer mode Set up Condition Mode Use the Set up Condition mode to configure operating parameters for the recorder and controller Once configured the settings will be saved if the power is turned off 1 Press the Power button and the F5 button simultaneously Continue to hold the F5 button while releasing the Power button The Set up condition display mode opens 2 Press the v buttons to select a parameter 3 Press the lt buttons to set the parameter s conditions 4 Press the F1 button to exit the Set up Condition mode Selecting a Language Follow these steps to change the language that the SEER Light controller displays 1 Press the Power button and the F5 button simultaneously Continue to hold the F5 button while releasing the Power button The Set up condition display mode opens 2 Press the 0 button to open the Language Selection display 3 Use the Patient Information Entry keypad or the buttons to select the desired language 4 Press ENT to select th
53. ries instructions for operator cleaning preventive inspection and maintenance Where necessary the manual identifies additional sources of relevant information and or technical assistance SEER Light 2040604 012D Manual Information Intended Use The SEER Light recorder SEER Light Extend recorders are designed to acquire 2 or 3 channels of ECG signal from the chest surface of pediatric or adult patients The devices store data along with patient demographic information to on board flash memory they do not perform any analysis on the ECG data These devices are intended to be used under the direct supervision of a licensed healthcare practitioner by trained operators in a hospital or medical professional facility This device is not intended for use on patients weighing less than 10 kg 22 lbs Intended Audience This manual is intended for an operator of the SEER Light devices The SEER Light operator requires some training to become familiar with the capabilities and operations of the devices Product References Conventions Regardless of the Holter analysis system MARS PC workstation or MARS Unity workstation used the product will be referred to as SEER Light throughout this document Instances where functionality differs due to Holter analysis system will be called out specifically These are the conventions used in this manual Styles Style Definition Bold text Indicates keys on the keyboard t
54. rm data CAUTION PATIENT TREATMENT Various clinical persons may view analyze and make recommendations based on patient waveforms but a plan of treatment requires confirmation from a qualified physician or cardiologist A qualified physician or cardiologist MUST confirm all information pertaining to treatment of a patient 6 8 SEER Light 2040604 012D A Troubleshooting 2040604 012D SEER Light A 1 Troubleshooting Troubleshooting Chart Use the chart below to troubleshoot problems Trouble Cause Recommendation Alarm sound continues when batteries are inserted Recorder Battery power is low Wrong type of batteries or batteries other than alkaline are inserted Replace with new alkaline batteries No beeping sound when batteries are inserted Recorder Battery power is low Replace with new alkaline batteries Batteries are reinserted quickly right after completing the data transfer This may occur because the condenser in the recorder has power reserve function Reposition batteries 30 seconds after replacement and resume the function The damage may be caused by physical shock Check with service or open a service call No beep sound for start up when dee is pressed Recorder The recorder does not start up when the controller sends a start up command through infrared and The recording has already started is displa
55. rom mains power to prevent excessive leakage current to the patient Use of isolated mains power or a medical grade isolation transformer in compliance with UL 60601 CAN CSA C22 2 No 601 1 EN IEC 60601 1 with this system will support compliance with EN IEC 60601 1 1 All nonmedical peripheral devices shall comply with applicable EN TEC ISO and UL safety standards that are relevant to that equipment i e EN IEC 60950 UL 60950 The overall system device and all of its connected peripheral devices must comply with EN IEC 60601 1 Use of SEER Light Connect device in the patient vicinity requires that these measures are observed Patient vicinity environment defined as m Any volume in which intentional or unintentional contact can occur between patient and parts of the system or between patient and other persons touching parts of the system IEC 60601 1 1 m A space volume within a location intended for the examination and treatment of patients extending 6 ft 1 83 m beyond the normal location of the bed chair table treadmill or other device that supports the patient during examination and treatment and extending vertically to 8 ft 2 4 in 2 5 m above the floor m Areas where healthcare staff members monitor patients remotely and perform charting and administrative tasks are not considered to be Patient Vicinity environment areas SEER Light 2040604 012D Manual Information WARNING PACEMAK
56. ruct the patient how to remove the lead wires from the electrodes and how to remove the electrodes SEER Light 2040604 012D Preparing the Patient NOTE The recorder continues to record even if you remove the cable or electrodes Reconnect the patient to continue testing Noise recorded during disconnection can be handled by the Holter analysis system To stop recording before 24 hours have elapsed or 48 hours with SEER Light Extend recorder press the Stop button with a ball point pen 2040604 012D SEER Light 3 11 Preparing the Patient 3 12 SEER Light 2040604 012D 4 Entering Patient Data 2040604 012D SEER Light Entering Patient Data Entering Patient Data Patient data can be entered via the controller or the connect device WARNING MIXING PATIENT DATA Accidental mixing of patient data can result in misdiagnosis and incorrect treatment Always transfer or delete old data before beginning a new recording session and promptly enter patient demographics Using the SEER Light Extend Controller Deleting Old Data Be sure that all information from previous patient recordings has been transmitted to the controller If data remains on the recorder that has not been transmitted to the controller the controller will display the message Recorder still contains untransmitted data Press F6 to start a new recording A beep will sound from the recorder Pr
57. ry test the equipment or system to verify normal operation CAUTION INTERFERENCE Electrical emissions from an electric blanket may degrade signal quality Do not use in conjunction with an electric blanket 2040604 012D SEER Light 1 9 Manual Information CAUTION INSTRUCTIONS FOR USE For continued safe use of this equipment it is necessary that the listed instructions are followed However instructions listed in this manual IN NO WAY supersede established medical practices concerning patient care CAUTION MODIFICATIONS Do not make any modifications to the device You will void the device s warranty See Responsibility of the Manufacturer on page 1 10 CAUTION RESTRICTED SALE U S Federal law restricts this device to sale by or on the order of a physician Responsibility of the Manufacturer General Suzuken Company Ltd is responsible for the effects of safety reliability and performance only if Assembly operations extensions readjustments modifications or repairs are carried out by persons authorized by Suzuken Company Ltd The equipment is used in accordance with the instructions for use To ensure patient safety use only parts and accessories manufactured or recommended by GE Medical Systems Information Technologies and Suzuken Company Ltd Contact GE Medical Systems Information Technologies for information before conne
58. s no waveforms when the Start Preview button is selected Recorder and connect Infrared transfer does not work due to the distance or an obstruction between the recorder and connect Set both devices within 1 meter and adjust the direction so that the terminal of infrared between the recorder and connect are aligned Select the Start Preview button again Patient data not available because cables are not properly connected Connect the cables properly Select the Start Preview button again The notched waveform is displayed while using infrared preview Recorder and controller connect Infrared transfer does not work due to the distance or an obstruction between the recorder and controller connect Set both devices within 1 meter and adjust the direction so that the terminal of infrared between the devices are aligned When the flash card is set in the slot of the controller CARD ERROR Insert the SEER card properly displays Controller The flash card is inserted upside down Place the flash card with mark facing up on the card into the controller Press the power switch to on The flash card is not completely inserted into the slot of the controller Place the flash card all the way into the slot of the controller Press the power switch to on If the flash card is correctly positioned it should not protrude from the side of the controller When flash card is set in the slot of the
59. s operation before starting the recorder selecting the Record button and during the first three minutes of the recording phase after pressing the Record button The recorder will beep for the first minute of the recording phase m The recorder will enter Power Save mode after setting the batteries Confirming ECG Recording Using the SEER Light Connect 1 Atthe GE SEER Light Hookup window select the Start Preview button NOTE Selecting the Start Preview button will cause the button text to change to Stop Preview 2 Atthe Lead Preview screen review the displayed channels for ECG waveform confirmation NOTE You may continue to enter patient demographics while the waveform is scrolling 3 Select the Stop Preview button after checking the ECG waveforms Interruption of Infrared Communication Distance direction objects and so on between the recorder and controller or connect can interrupt the infrared communication causing the ECG waveform to become a bold line on the LCD display 5 8 SEER Light 2040604 012D Recording Data CAUTION SIGNAL QUALITY If there is a severe muscle interference or artifact on the ECG when you tap the top of the electrodes lightly or when the patient moves it is possible that the electrodes are not attached properly To increase the accuracy of analysis make sure that the channel has a high amplitude of QRS complex greater than 10 mV If the amplitude of QRS is sma
60. s shown on the preview screen are used for assessing the quality of the connections only Do not use these preview waveforms for diagnostic purposes CAUTION WAVEFORM DISPLAY Fluorescent lights in the room may interfere with infrared communication between the recorder and controller In this case normal ECG waveform will not be displayed on the LCD Keep the device away from fluorescent lights Turn off fluorescent lights when device is used Cover the infrared window with a hand to shield the display from the fluorescent lights 4 Select the F4 button to exit the Preview screen and return to the SEER screen 5 4 SEER Light 2040604 012D Recording Data Checking Leads Using the SEER Light Connect WARNING LEAKAGE CURRENT Electrical shock to patient could result from component failure and lack of power isolation In the event this system is used in the patient vicinity environment it must be configured in such a way that it and all of its electrically connected peripheral devices are isolated from mains power to prevent excessive leakage current to the patient Use of isolated mains power or a medical grade isolation transformer in compliance with UL 60601 CAN CSA C22 2 No 601 1 EN IEC 60601 1 with this system will support compliance with EN IEC 60601 1 1 All nonmedical peripheral devices shall comply with applicable EN IEC ISO and UL safety standards that are relevant to that equi
61. sal Serial Bus USB cable into the USB port of your computer to load the USB drivers Connect the USB cable to the SEER Light Connect device 2 10 SEER Light 2040604 012D Equipment Overview Pouch Operating Modes SEER mode The Found New Hardware window appears 12 If you are on a Windows 2000 operating system the Insert Disk window will appear Select OK Two additional files need to be loaded the WinRTUSB dll and the WinRTUSB sys The Files Needed window appears In the dropdown box type in D drivers or the letter assigned to the CD drive if it is not D Select OK The Files Needed window appears again In the dropdown box type in D drivers or the letter assigned to the CD drive if it is not D Select OK 13 If you are on a Windows XP system the Found New Hardware Wizard window appears Select the button next to Install the software automatically Select Next The Found New Hardware Wizard window appears again Select Finish The SEER Light Hookup installation is now complete It is recommended that the recorder be used in combination with the SEER Light pouch PN 2008596 001 for the entire duration of the recording The pouch protects the connection between the patient cable and the recorder SEER Light Controller There are three operating modes for the controller m SEER mode m Transfer mode m Set up Condition mode This is the main user mode of operation patient information and reco
62. teries from the recorder Otherwise the recording date and time information will be erased from the recorder memory Begin Recording with SEER Light Recorder Button on page 5 14 Inserting Batteries in the SEER Light Recorder If you are recording up to 24 hours of ECG data use the SEER Light recorder If you are recording up to 48 hours of ECG data use the SEER Light Extend recorder Slide the battery box cover to open NOTE Install new batteries for each use to prevent loss of power and data Insert two new AAA type alkaline batteries Confirm the audible beep sounds for approximately 2 seconds In case of insufficient battery level an audible alarm will continuously sound This indicates that new batteries are required Hold the battery string and slide the battery box cover to close 5 12 SEER Light 2040604 012D Recording Data CAUTION BATTERIES Do not use any battery other than new alkaline batteries Use of other types of batteries including manganese rechargeable or used alkaline batteries will not ensure ECG recording for the life of the recorder 24 hours for the SEER Light recorder 48 hours with the SEER Light Extend recorder Do not leave the batteries in the recorder for a long time This may cause leakage of battery liquid If the recorder with batteries inserted is not started for over one hour when the power is ON the battery Power Save mode will be activated In this case
63. teries in the recorder before entering the preview mode The ECG waveform cannot be checked without inserting the batteries m By entering the preview mode infrared data transfer will be checked automatically Point the controller to the infrared terminal of the recorder and press the F1 button m As the preview mode of the controller consumes battery power return to the SEER mode after checking the ECG waveform m Preview mode by remote wireless operation can only be done before starting the recorder pressing the F6 button and during the first three minutes of the recording phase after pressing the F6 button The recorder will beep for the first minute of the recording phase m The recorder will enter Power Save mode after setting the batteries Confirming ECG Recording Using the SEER Light Extend Controller 1 From the SEER screen point the controller to the infrared terminal of the recorder and press the F1 button The Preview screen will display 2 By pressing the or F4 button after checking the ECG waveform it will return to the SEER screen 2040604 012D SEER Light 5 7 Recording Data Considerations Using the SEER Light Connect m Insert the batteries in the recorder before entering the preview mode The ECG waveform cannot be checked without inserting the batteries m By entering the preview mode infrared data transfer will be checked automatically m You can only enter preview mode by remote wireles
64. tient cable to the connector on the recorder 21A 51A 3 8 SEER Light 2040604 012D Preparing the Patient Pouch It is recommended that the recorder be used in combination with the SEER Light pouch PN 2008596 001 for the entire duration of the recording The pouch protects the connection between the patient cable and the recorder Holter ECG Patient Diary Setting Up the Patient Diary Enter the following items in the patient s diary Patient name Patient identification number Data card number Recorder type and number and Hook up date and time Instructing the Patient Audible Alarms Inform the patient of the recorder s audible alarms to prevent patient anxiety when alarms sound The recorder does NOT interfere with the patient s normal routine but there are a few restrictions while wearing it Describe the diary to the patient and emphasize the importance of keeping track of activities and symptoms The patient must understand that the recorder beeps under normal operation and is NOT an indication of cardiac problems for the patient Describe these instances of audible alarms to prevent patient anxiety m Incase of insufficient battery level an audible alarm will continuously sound This indicates that new batteries are required m A beep sounds for one minute when beginning a recording 2040604 012D SEER Light 3 9 Preparing the Patient Activity Restrictions Keeping Track
65. tion non medical electrical equipment must comply with EN IEC UL safety standards that are relevant to that equipment i e IEC 60950 Safety of Information Technology Equipment Equipment Symbols The following symbols may appear on the equipment 4 Attention Consult accompanying documents pe Manufacturer name and address 1 12 SEER Light 2040604 012D Manual Information European authorized representative Serial Number RX Only USA only For use by or on the order of a physician or person licensed by state law Type B applied Part Event This symbol indicates the polarity orientation that each battery should have when you insert it into the unit This unit requires you to insert the batteries so that the polarities are oriented in alternating directions D Power Stop 6 Input connector 2040604 012D SEER Light 1 13 Manual Information e Output connector This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment Service Information Requirements Serial Number Refer equipment servicing to GE Medical Systems Information Technologies authorized service personnel only A
66. tion warning een 1 8 Patient Delete old data ke 4 2 HOOKUP RT Rm 3 7 Disconnect the patient eesesssessssssss 5 2 Patient cable Disconnecting the recorder ssssssss 5 15 pred 5 2 Disposal caution 1 9 senis N Kar M 2 4 cce nu x Ca Ur Polarity of batteries E EUj j jU jjjjjj zw 1 13 E mop ER 1 13 Eject DUtton iet A s r pua eR ERR d 2 7 button on controller 2 7 Electrode R eva M M ZEE VD 2 4 modified AVF lead M x eo ies modified V3 lead EE EEEEEEEEUE UUEUU eg U modified Z lead EEEE E 3 5 S eua ne be REA n kn dd 3 6 SEER card slot ed dee t Reed 2 7 Electrosurgery warning cccceeeesseeeeeeeesteeteeeeenaes 1 8 SEER Light controller diagram 2 5 2040604 012D SEER Light Index 1 Index SEER Light recorder diagram 2 3 Set up RR nS a eA canad nn 2 6 Skin preparation ssssssesseee 5 2 ST segment changes ssssss 3 3 3 4 3 5 Start ize e 5 11 start event button kk 2 4 Sj 1 13 eum P 2 5 recordiiig E 3 11 Stress e e or N DD EST 3 7 Supervised use warning eeee 1 8 T
67. tor Used to connect patient cable 2 4 SEER Light 2040604 012D Equipment Overview Name Function DATA LED The LED lights while transferring data to the SEER Light controller or SEER Light connect gt A data output connector For transfer of data to the SEER Light controller or SEER Light connect e B output connector Not used NOTE Do not connect to any unauthorized device Access LED Will flash during communication with the SEER Light controller Infrared terminal IR Window m Usedtoreceive the signal from the SEER Light controller to begin ECG recording m Usedtoreceive patient information and ECG recording starting time m Usedto confirm the ECG waveform recorded by the recorder ECG preview e Stop button Push this button with a ball point pen to stop the recording before 24 hours have elapsed or 48 hours with the SEER Light Extend recorder SEER Light Extend Controller The SEER Light Extend Controller is shown and described below This device is also referred to as the controller in this document 2040604 012D SEER Light 2 5 Equipment Overview Name Function 1 Battery box Holds the batteries In direction indicated lift the cover open and place four new alkaline AAA type batteries in the battery box Used to transfer data from the SEER Light recorder When
68. ut the recorder in the carry case with the E button facing up Attach the case to the patient belt Disconnecting the SEER Light Recorder NOTE ECG recording will stop after 24 hours 48 hours if using the SEER Light Extend recorder and the LED will stop flashing To stop recording before 24 48 hours press the Stop button with a ball point pen and disconnect the patient cable If the batteries are removed from the recorder before recording of 24 48 hours or before the Stop button is pressed the recorder may not transmit data correctly 1 Disconnect the patient cable from the recorder 2 Remove the electrodes 3 Clean the skin with alcohol Adhesive material remaining on the skin may cause itchiness 4 After transferring data from the recorder with controller or connect and Holter analysis system remove the batteries from the recorder NOTE Do not remove the batteries from the recorder before transferring the data from the recorder or before analyzing the data with the Holter analysis system as the time will be erased when the battery is removed from the recorder The recorder retains the data for about one week after recording Transfer the data to the Holter analysis system or copy it to a flash card within one week to prevent loss of data 2040604 012D SEER Light 5 15 Recording Data 5 16 SEER Light 2040604 012D 6 Transferring Data 2040604 012D SEER Light Transferri
69. view mode is only displayed when using the remote method Holter ECG Leads Similar 12 Leads CMs CCs Vs CM Il IIl aV4 NASA V4 To verify accurate pace detection using the connect At the Lead Preview window the position of the pacemaker spikes are displayed with vertical bars Refer to the following illustration 5 10 SEER Light 2040604 012D Recording Data Bars indicate dual pacemaker spikes 081A Starting the SEER Light Recorder There are three ways to start the recorder Startup with the controller The recorder can be started remotely by the controller The controller starts the recorder and at the same time the patient information ID number age gender and name and the recording date and time are transmitted to the recorder memory The recording date and time information remains in the recorder if the batteries are removed before transferring the data See Begin Recording with SEER Light Extend Controller on page 5 13 Startup with the connect In the SEER Light Hookup application you will enter the patient information ID number age gender and name and then select the Record button to start the recorder See Begin Recording with SEER Light Connect on page 5 14 Startup with the recorder button 2040604 012D SEER Light 5 11 Recording Data The recorder can also be started by pressing the record button In this case do not remove the bat
70. yed Recorder and controller The aa button was pressed too rapidly Press a gently and slowly The recorder is already in the recording process are inserted The recorder automatically cancels start ready mode in order to reduce battery power loss This function makes the Ae button inactive The recorder is already in the recording process It has been more than 1 hour after batteries Press aa again 30 seconds after batteries are reset Press F6 again 30 seconds after batteries are replaced A 2 SEER Light 2040604 012D Troubleshooting Trouble Cause Recommendation The recorder does not start up when the controller sends a start up command through infrared and Communication Error is displayed Recorder and controller The SEER Light Hookup window displays a dialog box stating Holter recording has already started when the Record button is selected Recorder and connect Infrared transfer does not work due to the distance or an obstruction between the recorder and controller Adjust the position of the infrared terminal part of the recorder Set both devices within 1 meter and adjust the direction so that the terminal of infrared between the recorder and controller are aligned Press F6 button again It has been more than 1 hour after batteries are inserted The recorder automatically cancels start ready mode in order to reduce battery
71. yed Pressing F4 while in an information field will display a hyphen NOTE Press the button to advance the cursor to enter the next letter in the name Button Alphabet Number 1 ABC abc 2 e DEF def 3 e GHI ghi 4 D 2040604 012D SEER Light 4 3 Entering Patient Data Button Alphabet Number JKL jkl 5 MNO mno 6 PQRS pars 7 TUV tuv 8 This button is also used to enter gender for male patients WXYZ wxyz 9 This button is used to enter gender for female patients Using the SEER Light Connect To enter patient data using the SEER Light Connect device 290609090 Space 4 4 SEER Light 2040604 012D Entering Patient Data WARNING LEAKAGE CURRENT Electrical shock to patient could result from component failure and lack of power isolation In the event this system is used in the patient vicinity environment it must be configured in such a way that it and all of its electrically connected peripheral devices are isolated from mains power to prevent excessive leakage current to the patient Use of isolated mains power or a medical grade isolation transformer in compliance with UL 60601 CAN CSA C22 2 No 601 1 EN IEC 60601 1 with this system will support compliance with EN IEC 60601 1 1 All nonmedical peripheral devices shall comply with applicable EN IEC ISO and UL safety standards that ar

SEER Light Recorder - Tiger Medical, Inc

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