Nihon Kohden ZS-910PA WMTS Transmitter User Manual
Nihon Kohden Corporation WMTS Transmitter
User Manual
OPERATOR’S MANUAL TRANSMITTER ZS-910PA First Edition: Printed: 0614-008543 TRANSMITTER ZS-910PA 0614-008543 Model: ZS-910PA Manual code no.: 0614-008543 Reader Comment Card We welcome your comments about this manual. Your comments and suggestions help us improve our manuals. Please circle the number for each of the following statements corresponding to your evaluation and add comments in the space provided. Fax or send your completed comment card to: Fax: +81 (3) 5996-8100 International Div., Sales Promotion Section, Nihon Kohden Corp., 1-31-4, Nishiochiai Shinjuku-ku, Tokyo 161-8560, Japan cutting line Strongly Agree 1 Agree Nuetral Disagree Strongly Disagree 5 This manual is organized. I can find the information I want. The information is accurate. I can understand the instructions. The illustrations are appropriate and helpful. The manual length is appropriate. Comments: Thank you for your cooperation. We appreciate it very much. Name: Occupation/Position: Hospital/Company: Address: Phone: Contents GENERAL HANDLING PRECAUTIONS ......................................... i WARRANTY POLICY .................................................................... iii EMC RELATED CAUTION ............................................................. v Conventions Used in this Manual and Instrument ....................... vii Warnings, Cautions and Notes ............................................... vii Explanations of the Symbols in this Manual and Instrument viii Introduction ......................................................................................... 1 Panel Description ................................................................................ 2 Top Panel ....................................................................................... 2 Front Panel .................................................................................... 3 Rear Panel .................................................................................... 4 Important Safety Information .............................................................. 5 General .......................................................................................... 5 Battery ........................................................................................... 6 For Patients Using Implantable Pacemaker .................................. 7 Output Signal ................................................................................ 7 Electrodes and Electrode Leads ................................................... 8 Maintenance .................................................................................. 8 Preparation ......................................................................................... 9 Installing (Replacing) a Battery ..................................................... 9 Procedure .............................................................................. 10 Situations Requiring Battery Replacement ................................. 10 WARNING and CAUTION for Battery Handling .......................... 11 Attaching a Strap to the Transmitter ............................................ 12 Turning On/Off the Transmitter .................................................... 13 Turning on the power ............................................................. 13 Turning off the power ............................................................. 13 Operator's Manual ZS-910PA Check Items Before Use ............................................................. 14 Appearance ........................................................................... 14 Battery ................................................................................... 14 Channel Setting ..................................................................... 14 Check Items After the Power On ................................................. 14 Power on ................................................................................ 14 Basic Operation ..................................................................... 14 Monitoring ......................................................................................... 15 ECG Monitoring ....................................................................... 16 Measurement Procedure ............................................................... 17 Selecting Electrode Lead and Disposable Electrode ...................... 17 Standard Accessory ................................................................ 17 Option ..................................................................................... 17 Connecting the Electrode Lead to the Transmitter .......................... 18 Selecting the Electrode Position .................................................... 19 Three Electrodes ..................................................................... 19 Two electrodes ........................................................................ 21 Electrode Position for Respiration Monitoring ................................. 22 Electrode Position Examples ................................................... 22 Connecting the Electrode Lead and Disposable Electrodes .......... 24 Prepare the patient skin ........................................................... 24 Attaching Electrodes to the Patient ................................................ 24 Using Electrode Lead Tube ...................................................... 25 Detection and Display of Measurement Condition ......................... 26 Checking Electrodes ............................................................... 26 Condition List by Sound ...................................................................... 27 Troubleshooting ................................................................................... 28 Check After Use ................................................................................. 30 Storage .................................................................................... 30 Lifetime and Disposal .......................................................................... 31 Disposing of Used Batteries .......................................................... 31 Replacement ........................................................................... 31 Disposal .................................................................................. 31 Disposing of Disposable Electrodes .............................................. 31 ii Operator's Manual ZS-910PA Lifetime .................................................................................... 31 Disposal .................................................................................. 31 Cleaning, Disinfection and Sterilization ................................................ 32 Transmitter and Electrode Lead ..................................................... 32 Cleaning .................................................................................. 32 Disinfection .............................................................................. 32 Specifications ..................................................................................... 34 ECG measurement .................................................................. 34 Transmitter .............................................................................. 34 Safety standards ..................................................................... 34 Water resistance ..................................................................... 35 Power requirements ................................................................. 35 Environment ............................................................................ 36 Dimension and Weight ............................................................. 36 Standard Accessories ........................................................................ 37 Options ............................................................................................... 38 Operator's Manual ZS-910PA iii GENERAL HANDLING PRECAUTIONS This device is intended for use only by qualified medical personnel. Use only Nihon Kohden approved products with this device. Use of non-approved products or in a non-approved manner may affect the performance specifications of the device. This includes, but is not limited to, batteries, recording paper, pens, extension cables, electrode leads, input boxes and AC power. Please read these precautions thoroughly before attempting to operate the instrument. 1. To safely and effectively use the instrument, its operation must be fully understood. 2. When installing or storing the instrument, take the following precautions: (1) Avoid moisture or contact with water, extreme atmospheric pressure, excessive humidity and temperatures, poorly ventilated areas, and dust, saline or sulphuric air. (2) Place the instrument on an even, level floor. Avoid vibration and mechanical shock, even during transport. (3) Avoid placing in an area where chemicals are stored or where there is danger of gas leakage. (4) The power line source to be applied to the instrument must correspond in frequency and voltage to product specifications, and have sufficient current capacity. (5) Choose a room where a proper grounding facility is available. 3. Before Operation (1) Check that the instrument is in perfect operating order. (2) Check that the instrument is grounded properly. (3) Check that all cords are connected properly. (4) Pay extra attention when the instrument is in combination with other instruments to avoid misdiagnosis or other problems. Operator's Manual ZS-910PA (5) All circuitry used for direct patient connection must be doubly checked. (6) Check that battery level is acceptable and battery condition is good when using battery-operated models. 4. During Operation (1) Both the instrument and the patient must receive continual, careful attention. (2) Turn power off or remove electrodes and/or transducers when necessary to assure the patient’s safety. (3) Avoid direct contact between the instrument housing and the patient. 5. To Shutdown After Use (1) Turn power off with all controls returned to their original positions. (2) Remove the cords gently; do not use force to remove them. (3) Clean the instrument together with all accessories for their next use. 6. The instrument must receive expert, professional attention for maintenance and repairs. When the instrument is not functioning properly, it should be clearly marked to avoid operation while it is out of order. 7. The instrument must not be altered or modified in any way. 8. Maintenance and Inspection: (1) The instrument and parts must undergo regular maintenance inspection at least every 6 months. (2) If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect operating condition. (3) Technical information such as parts list, descriptions, calibration instructions or other information is available for qualified user technical personnel upon request from your Nihon Kohden distributor. ii Operator's Manual ZS-910PA 9. When the instrument is used with an electrosurgical instrument, pay careful attention to the application and/or location of electrodes and/or transducers to avoid possible burn to the patient. 10. When the instrument is used with a defibrillator, make sure that the instrument is protected against defibrillator discharge. If not, remove patient cables and/or transducers from the instrument to avoid possible damage. WARRANTY POLICY Nihon Kohden Corporation (NKC) shall warrant its products against all defects in materials and workmanship for one year from the date of delivery. However, consumable materials such as recording paper, ink, stylus and battery are excluded from the warranty. NKC or its authorized agents will repair or replace any products which prove to be defective during the warranty period, provided these products are used as prescribed by the operating instructions given in the operator’s and service manuals. No other party is authorized to make any warranty or assume liability for NKC’s products. NKC will not recognize any other warranty, either implied or in writing. In addition, service, technical modification or any other product change performed by someone other than NKC or its authorized agents without prior consent of NKC may be cause for voiding this warranty. Defective products or parts must be returned to NKC or its authorized agents, along with an explanation of the failure. Shipping costs must be prepaid. This warranty does not apply to products that have been modified, disassembled, reinstalled or repaired without Nihon Kohden approval or which have been subjected to neglect or accident, damage due to accident, Operator's Manual ZS-910PA iii fire, lightning, vandalism, water or other casualty, improper installation or application, or on which the original identification marks have been removed. In the USA and Canada other warranty policies may apply. CAUTION United States law restricts this device to sale by or on the order of a physician. Equipment Authorization Requirement Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. iv Operator's Manual ZS-910PA EMC RELATED CAUTION This equipment and/or system complies with the International Standard IEC60601-1-2 for electromagnetic compatibility for medical electrical equipment and/or system. However, an electromagnetic environment that exceeds the limits or levels stipulated in the IEC60601-1-2, can cause harmful interference to the equipment and/or system or cause the equipment and/or system to fail to perform its intended function or degrade its intended performance. Therefore, during the operation of the equipment and/or system, if there is any undesired deviation from its intended operational performance, you must avoid, identify and resolve the adverse electromagnetic effect before continuing to use the equipment and/or system. The following describes some common interference sources and remedial actions: 1. Strong electromagnetic interference from a nearby emitter source such as an authorized radio station or cellular phone: Install the equipment and/or system at another location if it is interfered with by an emitter source such as an authorized radio station. Keep the emitter source such as cellular phone away from the equipment and/or system. 2.Effect of direct or indirect electrostatic discharge: Make sure all users and patients in contact with the equipment and/or system are free from direct or indirect electrostatic energy before using it. A humid room can help lessen this problem. 3.Electromagnetic interference with any radio wave receiver such as radio or television: If the equipment and/or system interferes with any radio wave receiver, locate the equipment and/or system as far as possible from the radio wave receiver. Operator's Manual ZS-910PA If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden Corporation subsidiary or distributor for additional suggestions. Conventions Used in this Manual and Instrument Warnings, Cautions and Notes Warnings, cautions and notes are used in this manual to alert or signal the reader to specific information. WARNING A warning alerts the user to possible injury or death associated with the use or misuse of the instrument. CAUTION A caution alerts the user to possible injury or problems with the instrument associated with its use or misuse such as instrument malfunction, instrument failure, damage to the instrument, or damage to other property. NOTE A note provides specific information, in the form of recommendations, prerequirements, alternative methods or supplemental information. vi Operator's Manual ZS-910PA Explanations of the Symbols in this Manual and Instrument The following symbols found in this manual/instrument bear the respective descriptions as given. On Main Unit Symbol Description Power ON Power Off Defibrillation proof type CF applied part DC Attention, consult operator’s manual Nurse call Operator's Manual ZS-910PA vii Introduction The ZS-910PA transmits ECG from a patient to a Nihon Kohden monitor. The transmitter can change channels when connected to the QI-901PK channel writer. Read the operator’s manual for the monitor together with this manual before operation. CAUTION • Do not use the same channel for different patients. Otherwise, two patients’ data will be lost due to mutual modulation interference, or another patient’s data may appear on the receiving monitor screen. • Do not use transmitters of adjacent channels in a hospital. Otherwise, radio waves from one transmitter affects the receiver of the adjacent channel’s transmitter and there may be interference. NOTE • To prevent interference between channels, assign a channel administrator in the hospital and only he or she should manage channel assignment. • Use Nihon Kohden parts and accessories to assure maximum performance from your instrument. • It is recommended to use a diversity antenna system on the receiving monitor for stable signal reception. Otherwise, spike noise from transient fading of electric field strength (for example, people moving) may interfere with the transmitter signal and may be mistaken as an arrhythmia on the receiving monitor. Operator's Manual ZS-910PA Panel Description Top Panel Attach a strap Refer to the WARNING below. Defibrillation proof type CF applied part Input socket Connects the electrode lead. WARNING • Before performing defibrillation, check that the electrode leads attached to the patient are properly connected to the transmitter. Touching the metal parts of disconnected leads and probes causes serious electrical shock or injury by discharged energy. • When performing defibrillation, all persons must keep clear of the bed and must not touch the patient, any equipment connected to the patient or the metal parts of leads connected to the patient. Failure to follow this warning may result in serious electrical burn, shock or other injury. Operator's Manual ZS-910PA Front Panel Battery case CALL key: When this key is pressed, a “peep” sounds at the transmitter, and a “CALL” message appears on the monitor. Depending on the settings on the monitor, an ECG waveform is recorded when this key is pressed. Channel number label: Indicates the channel number of the transmitter. Attach the accessory channel number label to the panel of the monitor. CAUTION Only use your finger to press the CALL key. Do not press the key with a sharp object. Otherwise the key may be broken. Operator's Manual ZS-910PA Rear PanelRefer to the CAUTION below. Battery case/Power switch Contains a battery. Opening/closing the battery case cover turns the instrument power off/on. The cover opens out in two steps. Open to one step ( position): Turns the power off. The battery cannot come out. Open to two steps: The battery can be replaced. Cover closed ( position): Turns on the power Tab for opening and closing the battery case cover CAUTION Battery replacement must be performed by medical staff. When replacing the battery of the transmitter currently used for a patient, disconnect electrode leads from the transmitter before replacing the battery or do not touch the patient during replacement. Operator's Manual ZS-910PA Important Safety Information General WARNING • Never use this instrument in the presence of any flammable anesthetic gas or high concentration oxygen atmosphere. Failure to follow this warning may cause explosion or fire. • Never use this instrument in a high-pressure oxygen medical care tank. Failure to follow this warning may cause explosion or fire. • Do not take this transmitter into the MRI test room. This transmitter is not designed to be used during MRI tests. • Before performing defibrillation, check that the electrode leads attached to the patient are properly connected to the transmitter. Touching the metal parts of disconnected leads causes serious electrical shock or injury by discharged energy. • When performing defibrillation, all persons must keep clear of the bed and must not touch the patient, any equipment connected to the patient or the metal parts of leads connected to the patient. Failure to follow this warning may result in serious electrical burn, shock or other injury. • Before performing defibrillation, remove all electrodes and gel from the chest of the patient. If the defibrillator touches electrodes or gel, the discharged energy may burn the patient’s skin. • When using this instrument with an ESU, refer to the instruction manual for the ESU. Before measurement, check that the return plate is correctly attached to the patient and check that the instrument operates correctly when using with the ESU. If the return plate is not attached correctly, it may burn the patient’s skin where the electrodes are attached. Operator's Manual ZS-910PA CAUTION • Attach a strap to the transmitter to prevent it from falling. • Turn off the power of cellular telephones, small wireless devices and other devices which produce strong electromagnetic interference around a patient (except for PHS telephones allowed by the hospital administrator). Otherwise, radio waves from devices such as cellular telephones or small wireless devices may be mistaken as respiration waves and the displayed data may be incorrect. • Do not use the same channel for different patients. Otherwise, two patients’ data will be lost due to mutual modulation interference, or another patient’s data may appear on the receiving monitor screen. • Do not use transmitters of adjacent channels in a hospital. Otherwise, radio waves from one transmitter affect the receiver of the adjacent channel’s transmitter and there may be interference. Battery WARNING • Do not dispose of the battery in fire, or it may explode. • Do not disassemble the battery. The contents of the battery are harmful and the battery may catch fire. • Never short-circuit the + and − terminals. The battery may overheat and catch fire. • Take care that the patient does not swallow batteries. Operator's Manual ZS-910PA CAUTION Battery replacement must be performed by medical staff. When replacing the battery of the transmitter currently used for a patient, disconnect electrode leads from the transmitter before replacing the battery or do not touch the patient during replacement. For Patients With an Implantable Pacemaker WARNING Interaction Between Minute Ventilation Rate-Adaptive Pacemakers and Cardiac monitoring and Diagnostic Equipment The bioelectric impedance measurement sensor of a minute ventilation rate-adaptive implantable pacemaker may be affected by the transmitter which is connected to the same patient. If this occurs, the pacemaker may pace at its maximum rate and the transmitter may give incorrect data to the monitor. If this occurs, disconnect the electrode leads from the patient or change the setting on the pacemaker by referring to the pacemaker’s manual. For more details, contact your pacemaker distributor or Nihon Kohden distributor. Output Signal CAUTION Do not use the output signal from the receiving monitor as the synchronization signal for other equipment such as IABP, MRI, echocardiography or defibrillation because there may be time delay between the monitor and the other equipment caused by waveform transmission delay and spike noise may interfere on the output signal and be mistaken as a trigger. Operator's Manual ZS-910PA Electrodes and Electrode Leads CAUTION • Use Nihon Kohden specified electrodes and electrode leads. With electrodes and electrode leads other than specified ones, the message indicating checking electrodes appears and monitoring may stop. • Do not reuse disposable products. • Do not shake or swing the transmitter holding the leads/cables connected to the transmitter. The transmitter may come off and injure a person or damage surrounding instruments. • When the message indicating checking electrodes is displayed on the receiving monitor, check electrodes and electrode leads and remove the cause. While the message is displayed, there is no ECG monitoring and no alarms. Maintenance WARNING If detergents or dirty liquid get on the transmitter, clean it and dry it completely before use. If a wet transmitter is used, the patient or anyone in contact with the transmitter may receive an electric shock. CAUTION Do not disassemble the transmitter when performing maintenance and inspection. Do not repair the transmitter. When there is any problem with the transmitter after maintenance and inspection, contact your Nihon Kohden distributor. Operator's Manual ZS-910PA Preparation Installing (Replacing) a Battery Use one AA type alkaline dry cell battery. Manganese dry cell battery, NiCd rechargeable battery or NiMH battery can also be used. With a new alkaline battery, the ZS-910PA transmitter can continuously measure ECG for approximately 5 days. CAUTION Battery replacement must be performed by medical staff. When replacing the battery of the transmitter currently used for a patient, disconnect electrode leads from the transmitter before replacing the battery or do not touch the patient during replacement. NOTE • Tell the patient not to open or close the battery case cover. • Insert the battery with the correct polarity (+ and −). If electrode leads are attached to the patient and a person replacing the battery touches the patient during battery replacement, patient leakage current over the amount allowed for the defibrillation proof type CF applied part may flow. Operator's Manual ZS-910PA Procedure 1. Open the battery case cover by pulling the tab until it clicks twice and until the cover stops. The cover opens two steps. When replacing the battery, take out the old battery. 2. Insert one alkaline dry cell battery (LR6) into the battery case observing the correct polarity. NOTE Do not use the transmitter if the battery case cover is lost. 3. Close the cover. Confirm that there is a “peep” sound for about one second. Situations Requiring Battery Replacement Replace the batteries when any of the following occurs: • With the power ON, the transmitter generates a constant alarm (continuous high-pitched sound). • The receiving monitor displays the battery replacement message on the screen. • The transmitter does not generate a “peep” sound when the power is turned on (when the battery case cover is closed). 10 Operator's Manual ZS-910PA WARNING and CAUTION for Battery Handling WARNING • Do not dispose of the battery in fire, or it may explode. • Do not disassemble the battery. The contents of the battery are harmful and the battery may catch fire. • Never short-circuit the + and − terminals. The battery may overheat and catch fire. • Take care that the patient does not swallow batteries. CAUTION When the transmitter is not in use, remove the battery or turn the power OFF. With the power ON, battery power is consumed even if measurement is not performed. Especially, when NiCd or NiMH batteries remain in the transmitter when the transmitter is not in use, the battery may become unusable from overdischarge and leak liquid which will damage the transmitter. NOTE • Remove the battery before disposing of the transmitter. • The capacity of manganese, NiCd and NiMH batteries is less than that of alkaline batteries and the battery lifetime is shorter. Type Manganese NiCd NiMH Lifetime About 1/2 of alkaline batteries About 1/3 of alkaline batteries (when fully charged) About 1/2 of alkaline batteries (when fully charged) • When using rechargeable NiCd batteries or NiMH batteries, shallow charging/discharging shortens battery capacity. For details, refer to the battery operator’s manual. Operator's Manual ZS-910PA 11 Attaching a Strap to the Transmitter CAUTION Attach a strap to the transmitter to prevent the transmitter from falling. NOTE Do not attach the clip to hard objects such as thick cloth or a zipper. It will break the clip. Attach a strap to the transmitter and fasten the clip to the patient clothes’s or bed sheets. NOTE • If the transmitter falls off, it may become damaged. • If the transmitter falls on the patient foot, it will injure the patient. • When the transmitter falls into water or a toilet, clean and disinfect the transmitter. To open the clip, firmly pull out the tab in the direction of the arrow. 12 Operator's Manual ZS-910PA Turning the Transmitter On/Off The transmitter power is turned on or off by closing or opening the battery case cover. Turning on the power To turn on the power, close the battery case cover. After about a one second “peep” sound, the power is turned on and transmission starts. Turning off the power There are two ways of turning off the power. Normal power off 1. Open the battery case cover until it clicks twice and until the cover stops. 2. Take out the battery and close the cover. When not using the transmitter, remove the battery and store the transmitter. Temporary power off Open the battery case cover until it clicks once. At this position, the battery does not fall out if the transmitter is upside down. Operator's Manual ZS-910PA 13 Check Items Before Use Before turning on the transmitter power switch, check the following to confirm that the transmitter can be used in normal and safe condition. Appearance • There are no damaged or dirty points on the outside of the transmitter and the CALL key. • The battery case cover is not lost. • The transmitter is completely dry. • The electrode lead is not broken. • There are no damaged or dirty points on the disposable electrodes. Battery • The battery polarity is correct. • The battery case spring is firmly fixed and the battery is not loose. Channel Setting • The transmitter channel corresponds to that of the receiving monitor. • No other transmitter in the surrounding area has the same channel. Check Items After the Power On After turning on the power, check the following. Power on • There are no broken points on the battery case cover. • The transmitter generates about a one second “peep” sound. • The transmitter does not generate a continuous high-pitched sound. • The transmitter does not produce excessive heat. • The transmitter does not interfere with the operation of medical instruments used near it. Basic Operation • The “signal loss” message is not displayed on the monitor when the transmitter is inside the receiving range of the monitor. • A “peep” sounds at the transmitter and a “CALL” message appears at the receiving monitor when the CALL key is pressed and the transmitter is inside the receiving range of the monitor. • The battery replacement message is not displayed on the monitor. 14 Operator's Manual ZS-910PA Monitoring WARNING • Interaction Between Minute Ventilation Rate-Adaptive Pacemakers and Cardiac monitoring and Diagnostic Equipment The bioelectric impedance measurement sensor of a minute ventilation rate-adaptive implantable pacemaker may be affected by the transmitter which is connected to the same patient. If this occurs, the pacemaker may pace at its maximum rate and the transmitter may give incorrect data to the monitor. If this occurs, disconnect the electrode leads from the patient or change the setting on the pacemaker by referring to the pacemaker’s manual. For more details, contact your pacemaker distributor or Nihon Kohden distributor. • When using this instrument with an ESU, refer to the instruction manual for the ESU. Before measurement, check that the return plate is correctly attached to the patient and check that the instrument operates correctly when using with the ESU. If the return plate is not attached correctly, it may burn the patient’s skin where the electrodes are attached. CAUTION Turn off the power of cellular telephones, small wireless devices and other devices which produce strong electromagnetic interference around a patient (except for PHS telephones allowed by the hospital administrator). Otherwise, radio waves from devices such as cellular telephones or small wireless devices may be mistaken as respiration waves and the displayed data may be incorrect. Operator's Manual ZS-910PA 15 NOTE • Noise overlaps when the transmitter is used with the ESU, but it does not cause instrument trouble. • If an electric blanket is used and incorrect heart rate is displayed on the receiving monitor, turn off the pacing pulse detection on the monitor. ECG Monitoring This transmitter sends the ECG waveform detected between the R/RA electrode and F/LL electrode to the monitor. The monitor displays the ECG waveform and measures heart rate, etc. Refer to the operator’s manual of the monitor for details. 16 Operator's Manual ZS-910PA Measurement Procedure 1. 2. 3. Select the type of electrode lead and disposable electrode according to the purpose. Connect the electrode lead to the transmitter. Connect disposable electrodes to the electrode lead and attach electrodes to the patient. After steps 1 to 3 are finished, monitoring automatically starts. Selecting Electrode Lead and Disposable Electrode CAUTION Use Nihon Kohden specified electrodes and electrode leads. With electrodes and electrode leads other than specified ones, the message indicating checking electrodes appears and monitoring may stop. Option Disposable electrode Vitrode Electrode lead BR-913PA BR-903PA BR-902PA BR-912PA 3 electrodes snap type 3 electrodes, clip type 2 electodes, clip type 2 electrodes, snap type Operator's Manual ZS-910PA 17 Connecting the Electrode Lead to the Transmitter Connect the electrode lead to the input socket on the transmitter. CAUTION • Do not shake or swing the transmitter holding the leads/cables connected to the transmitter. The transmitter may come off and injure a person or damage surrounding instruments. • Hold the connector of the electrode lead when connecting/ disconnecting the electrode lead. If you disconnect the electrode lead holding the lead, it damages the electrode lead. 18 Operator's Manual ZS-910PA Selecting the Electrode Position Follow the physician’s instructions for electrode placement when available. For ECG monitoring, electrodes are attached only on the chest to allow patient movement and obtain continuous stable ECG. Following leads are examples. When also monitoring respiration, refer to “Electrode Position for Respiration Monitoring”. NOTE The optimum electrode positions for ECG measurement of a patient are not always optimum for respiration measurement of the patient. Select positions suitable for both ECG and respiration measurements, or positions which have priority for one measurement. Three Electrodes • Lead MII, which is similar to standard lead II, used when ECG measurement has priority Electrode Position Left infraclavicular fossa Right infraclavicular fossa Below lowest rib on the left anterior axillary line Operator's Manual ZS-910PA Symbol AHA IEC LA RA LL Lead Color AHA IEC Black Yellow White Red Red Green 19 • Lead MI, which is similar to standard lead I Change F/LL and L/LA of the lead MII. • Lead MIII, which is similar to standard lead III. Change R/RA and L/LA of the lead MII. If the electrode position shown above is not available due to chest surgery, attach the electrodes to the root of the limbs or below the clavicles for stable ECG monitoring. 20 Operator's Manual ZS-910PA Two electrodes With the optional BR-912P and BR-902P electrode leads, measurement with two electrodes is available. The L/LA electrode is not used. This is effective for a neonate or a patient whose body area is small and difficult to attach three electrodes. (ex.) Lead MII, which is similar to standard lead II Electrode Position Right infraclavicular fossa Below lowest rib on the left anterior axillary line Symbol AHA IEC RA LL Lead Color AHA IEC White Red Red Green Difference between measurement with two electrodes and three electrodes Measurement with two electrodes is less stable than measurement with three electrodes because of hum overlapping and body movement. Pay sufficient attention to this point. If ECG of necessary quality cannot be obtained, measure with three electrodes. Operator's Manual ZS-910PA 21 Connecting the Electrode Lead and Disposable Electrodes Prepare the patient skin Shave off excessive body hair. To reduce skin impedance, clean the electrode site with cream or with a gauze moistened with alcohol. Thoroughly dry the skin with a clean cotton pad. NOTE • For a patient with frequent body movement, rub the sites with Skinpure skin preparation gel. However, do not use Skinpure skin preparation gel for sensitive skin. • Do not place electrodes on a wound or on an inflamed, wrinkled or uneven skin surface. Attaching Electrodes to the Patient CAUTION Do not reuse disposable products. NOTE • To maintain good contact between the electrode and skin, check that the paste of the disposable electrode is not dry. • When contact between the disposable electrode and skin becomes poor, replace electrodes with new ones immediately. Otherwise, contact impedance between the skin and the electrode increases and the correct ECG cannot be obtained. Refer to the electrode operator’s manual for details. 22 Operator's Manual ZS-910PA (ex. Attaching Vitrode C disposable electrode) 1. Connect the electrode lead to the electrode. 2. Carefully remove the backing paper from the electrode. Avoid touching the adhesive surface. 3. Place the electrode on the previously cleaned skin. Pay attention to the electrode lead color and symbol. 4. Fasten the electrode lead wire with surgical tape with an extra length of wire between the tape and the electrode. This lessens the movement of electrode leads by body movement and helps stable monitoring. Using Electrode Lead Tube (Option) The electrode lead tube can prevent the electrode leads from getting tangled during monitoring. During monitoring, slide the tube toward the transmitter. When not using the transmitter, slide the tube toward the lead clips or snaps. electrode lead tube If the tube comes off the electrode leads easily, bind the tube with tape to firmly attach it to the electrode leads. Operator's Manual ZS-910PA 23 Set one electrode lead into one opening of the tube. Detection and Display of Measurement Condition Checking Electrodes The message indicating checking electrodes is displayed on the screen of the monitor when: • An electrode is detached from skin. • An electrode lead is disconnected. • Polarization voltage between an electrode and skin is excessively high. In these cases, check the cause and if necessary, replace electrodes with new ones. CAUTION When the message indicating checking electrodes is displayed on the receiving monitor, check electrodes and electrode leads and remove the cause. While the message is being displayed, there is no ECG monitoring and no alarms. NOTE When the L/LA electrode is detached from the skin or L/LA electrode lead is disconnected, the message indicating checking electrodes does not appear on the receiving monitor. If hum overlaps or waveform is unstable for body movement, check the L/LA electrode and electrode lead condition. 24 Operator's Manual ZS-910PA Condition List by Sound Sound Single “peep” sound Continuous “peep” sound One second “peep” sound Cause The CALL key is pressed. The sound lasts while the key is pressed. Battery is completely discharged. The power is turned on. Countermeasure --Replace the battery with a new one. To stop the sound, turn off the power. --- Changing the Transmitter Channel The transmitter channel can be changed when the transmitter is connected to the QI-901PK channel writer. Refer to the operator’s manual of the QI-901PK channel writer for details. WARNING The following action must be taken to properly receive the transmitter signal of the correct patient on the receiving monitor. Otherwise, there may be signal loss or signals may mix. This causes a serious accident, such as monitoring a different patient. • Assign a channel administrator in the hospital and only he or she should manage channel assignment on his or her responsibility. • The channel administrator must manage the channels in the facility so that there is no signal interference. • When the transmitter channel is changed, the channel administrator must check that the channel on the receiving monitor is also changed and that the signal is properly received. • The channel administrator must replace the channel number label on the transmitter with the new one after changing the channel. Operator's Manual ZS-910PA 25 Troubleshooting If the problem still remains after checking the following, contact your Nihon Kohden distributor. Problem The power cannot be turned on. Nothing is displayed on the monitor after turning the transmitter power on. Signal receiving condition is poor. Cause Batteries are not installed correctly. The battery polarity is wrong. Batteries are completely discharged. The channel of the transmitter and monitor does not match. Countermeasure Install the batteries correctly. Electrode lead is not connected to the transmitter. Another transmitter of the same channel is used nearby. Connect the electrode lead to the transmitter. Signals are mixing. Transmitter radio wave is temporarily cut by people and objects moving. The transmitter is broken. 26 Replace the batteries with new ones. Set the correct channel on the monitor. Turn the transmitter power off. If the monitor still receives a signal, there is a high probability that another transmitter of the same channel is used nearby. Follow the instruction of your channel administrator and use another transmitter of a different channel. Follow the instruction of your channel administrator and use another transmitter of a different channel. It is recommended to use a diversity antenna system. Contact your Nihon Kohden distributor. Operator's Manual ZS-910PA Problem ECG baseline is thick. (Hum is overlapping) The heart rate of a patient using an electric blanket is incorrect on the receiving monitor. The transmitter is dropped in water or a toilet Cause The gel on the electrode is dried out. The gel on the electrode is coming off. Electric blanket is used. Hum filter is set to OFF on the monitor The pacing pulse detection is ON on the monitor. Operator's Manual ZS-910PA --- Countermeasure Replace the electrode with a new one. Cover the blanket with a shield cover. Set the filter to ON. Turn off the pacing pulse detection Clean and disinfect the transmitter. Refer to “Cleaning and Disinfection” in this manual. Use the strap to prevent falling. 27 Check After Use To use the instrument in safe and optimum condition, perform inspection after use. CAUTION Do not disassemble the transmitter when performing maintenance and inspection. Do not repair the transmitter. When there is any problem with the transmitter after maintenance and inspection, contact your Nihon Kohden distributor. Storage • ECG electrode leads are cleaned and disinfected. • When the transmitter gets wet, liquid is wiped off and the transmitter is thoroughly dried. • There are enough consumables, such as disposable electrodes. • The power is turned off. • The batteries are removed from the transmitter when it will not be used for a long time. • Dead batteries are disposed of properly. 28 Operator's Manual ZS-910PA Lifetime and Disposal Disposing of Used Batteries Replacement When the battery replacement message is displayed on the receiving monitor, the battery are running out. Replace the battery with a new one. When using a rechargeable battery, recharge it. Disposal NOTE Remove the battery before disposing of the transmitter. Before disposing of batteries, check with your local solid waste officials for details in your area for proper disposal. It may be illegal to dispose of these batteries in the municipal waste stream. Disposing of Disposable Electrodes Lifetime Replace the disposable electrodes with new ones 48 hours after the start of usage. Otherwise, the gel on the electrode gets dry and adhesive property decreases. This increases skin electrode contact impedance and causes incorrect measurement. Replace the electrodes with new ones even before 48 hours if the contact between skin and electrode becomes poor. Disposal Follow your local laws for disposing of medical waste. Operator's Manual ZS-910PA 29 Cleaning, Disinfection and Sterilization Transmitter and Electrode Lead WARNING If detergents or dirty liquid get on the transmitter, clean it and dry it completely before use. If a wet transmitter is used, the patient or anyone in contact with the transmitter may receive an electric shock. CAUTION • Before cleaning or disinfecting the transmitter, remove the battery. • The transmitter cannot be sterilized. Cleaning Wipe the transmitter and electrode leads with a soft cloth moistened with disinfecting alcohol or neutral detergent diluted with water. If the surface is very dirty, wash with running water. After cleaning, dry them completely. Disinfection CAUTION • Do not immerse the electrode lead connector in liquid. • Do not disinfect with hypochlorous acid. • Use the recommended concentration. Wipe the outside surface of the transmitter and electrode lead with a nonabrasive cloth moistened with any of the disinfectants listed on the next page. Use the recommended concentration. 30 Operator's Manual ZS-910PA Disinfectant Glutaraldehyde solution Hydrochloric alkyl diaminoethylglycine Benzalkonium chloride Benzethonium chloride solution Chlorohexidine gluconate solution Operator's Manual ZS-910PA Concentration (%) 2.0 0.5 0.2 0.2 0.5 31 Specifications ECG measurement Channels: Input range: DC offset: Input impedance: Pacing pulse detection: Transmitter FCC regulation: Field strength limits: Undesired emission: Antenna: Transmission channel: Transmission frequency range: Channel spacing: Type of emission: Occupied bandwidth: Effective radiated power: Safety standards Safety standard: 32 ±5mV or more ±500mV or more 5 MΩ or more (5Hz) ANSI/AAMI EC13 Based upon pacemaker pulse rejection capability FCC part 95 Subpart-H Wireless Medical Telemetry Service (WMTS) <200 mV/m(at 3 m) below 960 MHz: 200µV/m (at 3 m) above 960 MHz: 500µV/m (at 3 m) ECG electrode lead indicated on the transmitter 608.0125 to 613.9875 MHz 25kHz (12.5 kHz when interleave) F1D <8.5 kHz 1.0 mW (conducted) CSA C22.2 No.601-1 M90 (1994) IEC 60601-1 (1988) IEC 60601-1 Amendment1 (1991) IEC 60601-1 Amendment2 (1995) IEC 60601-1-2 (1993) IEC 60601-2-27 (1994) Operator's Manual ZS-910PA According to the type of protection against electrical shock: INTERNALLY POWERED EQUIPMENT According to the degree of protection against electrical shock: DEFIBRILLATION-PROOF TYPE CF APPLIED PART According to the degree of protection against harmful ingress of water: Ordinary equipment According to the degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR, OR WITH OXYGEN OR NITROUS OXIDE: Equipment not suitable for use in the presence of FLAMMABLE ANAESTHETIC MIXTURE WITH AIR, OR WITH OXYGEN OR NITROUS OXIDE According to the mode of operation: CONTINUOUS OPERATION Water resistance Water does not get inside the transmitter except for the battery case when immersed in water up to 30 cm deep for 3 minutes. Power requirements Battery type: One AA type alkaline dry cell battery recommended, One manganese dry cell battery, One NiCd rechargeable battery, One NiMH battery Battery lifetime: ZS-910PA approximately 5 days (with an alkaline battery) Operator's Manual ZS-910PA 33 Environment Operating environment Operating Operating Operating Operating temperature: humidity: atmospheric pressure: voltage: 5 to 40°C, 41 to 104°F 30 to 85% (non-condensing) 70 to 106 kPa 0.9V to 1.6V Storage environment Storage temperature: Storage humidity: Storage atmospheric pressure: −20 to 65°C, −4 to 149°F 15 to 95% (non-condensing) 70 to 106 kPa Dimension and Weight Dimension: Weight: 54 W × 85 H × 22 D (mm) about 85 g (without battery) 34 Operator's Manual ZS-910PA Operator's Manual ZS-910PA 35 Standard Accessories Attach the channel number label to the monitor, too. No 36 Name strap Model --- Q’ty Supply code Y233 Operator's Manual ZS-910PA Options CAUTION Use only Nihon Kohden electrodes and electrode leads. Otherwise, the message indicating checking electrodes appears and monitoring may stop. Name Application Electrode lead 3 electrodes, snap type, lead length 80 cm 3 electrodes, clip type, lead length 80 cm 2 electrodes, clip type, lead length 80 cm 2 electrodes, snap type, lead length 80 cm Electrode lead tube Vitrode, General disposable electrode Model BR-913P Supply code K910A BR-903P K911 BR-902P K907A BR-912P K908A --Bs-150 C-150 D-90 F-150M G-600 J-150 Neonate Premature baby Operator's Manual ZS-910PA F-150S Q’ty 1 box (30 × 5 package) 1 box (30 × 5 package) 1 box (3 × 30 package) 1 box (3 × 50 package) 1 box (30 × 20 package) 1 box (30 × 5 package) 1 box (3 × 50 package) K120 G201 G204 G217 G210D G221 G250 G210C 37
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