Nihon Kohden ZM-930PA WMTS Transmitter User Manual Cover2 ZM920PA 930PA OM pmd
Nihon Kohden Corporation WMTS Transmitter Cover2 ZM920PA 930PA OM pmd
Contents
- 1. Users Manual
- 2. User Manual
Users Manual
TRANSMITTER ZM-920PA/930PA 0614-007205 Model: ZM-920PA/930PA Manual code no.: 0614-007205 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 ............................................................................... 3 Top Panel ...................................................................................... 3 Front Panel .................................................................................... 4 ZM-920PA ................................................................................ 4 ZM-930PA ................................................................................ 5 Important Safety Information .............................................................. 6 General ......................................................................................... 6 Battery ........................................................................................... 8 Transmitter Channel Management ............................................... 8 For Patients Using Implantable Pacemaker ................................. 9 Output Signal ................................................................................ 9 ECG Monitoring .......................................................................... 10 SpO2 Monitoring .......................................................................... 10 Maintenance ............................................................................... 13 Preparation ....................................................................................... 14 Installing (Replacing) Batteries .................................................. 14 Procedure .............................................................................. 15 WARNING and CAUTION for Battery Handling .......................... 15 Situations Requiring Battery Replacement ................................ 16 Attaching a Strap to the Transmitter ............................................ 16 Turning On/Off the Transmitter .................................................... 17 Check Items Before Turning On the Power ........................... 17 Turning On/Off the Power ...................................................... 17 Operator's Manual ZM-920PA/930PA Check Items After Turning On the Power ............................... 17 Check Items After the Power Off ............................................ 18 ECG Monitoring ................................................................................ 19 ECG Measurement Procedure ................................................... 20 Selecting Electrode Lead and Disposable Electrode ................ 21 Option .................................................................................... 21 Connecting the Electrode Lead to the Transmitter ..................... 22 Selecting the Electrode Position ................................................. 22 Six Electrodes ....................................................................... 23 When Using 4 to 6 DIN Type Leads to Monitor 6 Lead ECG 24 Three Electrodes ................................................................... 25 Connecting the Electrode Lead and Disposable Electrodes ..... 26 Preparing the Patient Skin .................................................... 26 Attaching Electrodes to the Patient ....................................... 26 Detection and Display of Measurement Condition .................... 27 Electrode Detachment .......................................................... 27 Respiration Monitoring ..................................................................... 28 Respiration Measurement Procedure ........................................ 29 Electrode Position for Respiration Monitoring ............................ 29 Electrode Position Examples ................................................ 29 SpO2 Monitoring ............................................................................... 31 Measurement Procedure ............................................................ 33 Selecting SpO2 Probe ................................................................. 33 Reusable Probes .................................................................. 34 Disposable Probes ................................................................ 35 Connecting SpO2 Probe to the Transmitter ................................. 36 Attaching the Probe to the Patient .............................................. 37 Starting Measurement ................................................................ 38 Turning SpO2 Data and Pulse Level Bar Graph Display On/Off . 39 Detecting and Displaying Measurement Condition ................... 39 External Light Noise Alarm ................................................... 39 Insufficient Light Alarm .......................................................... 40 Probe Malfunction Alarm ....................................................... 40 When Measurement Condition is Unstable .......................... 40 Alarm List .......................................................................................... 41 Troubleshooting ................................................................................ 43 ii Operator's Manual ZM-920PA/930PA Changing the Transmitter Channel .................................................. 45 Lifetime and Disposal ....................................................................... 46 Disposing of Used Batteries ....................................................... 46 Replacement ......................................................................... 46 Disposal ................................................................................ 46 Disposing of Disposable Electrodes .......................................... 46 Lifetime .................................................................................. 46 Disposal ................................................................................ 46 Disposing of the SpO2 Probe ...................................................... 47 Lifetime .................................................................................. 47 Disposal ................................................................................ 47 Cleaning, Disinfection and Sterilization ........................................... 48 Transmitter and Electrode Lead ................................................. 48 Cleaning ................................................................................ 48 Disinfection ............................................................................ 48 SpO2 Probe ................................................................................. 49 Replacing the Battery Case Cover ................................................... 50 Repair Parts Availability Policy ......................................................... 50 Specifications ................................................................................... 51 ECG measurement ................................................................ 51 Respiration measurement .................................................... 51 SpO2 measurement ............................................................... 51 Transmitter ............................................................................. 51 Safety standards ................................................................... 52 Water resistance ................................................................... 53 Power requirements .............................................................. 53 Environment .......................................................................... 53 Dimension and Weight .......................................................... 53 Standard Accessories ...................................................................... 54 Options ............................................................................................. 55 ECG/RESP ............................................................................ 55 SpO2 ...................................................................................... 56 Operator's Manual ZM-920PA/930PA 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 ZM-920PA/930PA (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 ZM-920PA/930PA 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 ZM-920PA/930PA 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 ZM-920PA/930PA 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 ZM-920PA/930PA If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden Corporation subsidiary or distributor for additional suggestions. vi Operator's Manual ZM-920PA/930PA 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 the 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. Operator's Manual ZM-920PA/930PA vii Explanations of the Symbols in this Manual and Instrument The following symbols found in this manual/instrument bear the respective descriptions as given. Symbol Description Power On Symbol Description Attention, consult operator’s manual Power Off Nurse call Defibrillation proof type BF applied part Replace battery Defibrillation proof type CF applied part Check electrode Direct current viii Operator's Manual ZM-920PA/930PA Introduction The ZM-920PA/930PA transmitter transmits ECG and other data from a patient to a Nihon Kohden monitor for continuous monitoring. Available parameters and functions vary between the models. Read the operator’s manual for the monitor before operation. Model Parameters ZM-920PA • ECG • Impedance respiration ZM-930PA • ECG • Impedance respiration • SpO2 Functions The following information is indicated by LED. • Check ECG electrodes • Replace batteries The following information is indicated on LCD. • SpO2 value • Pulse wave amplitude • Replace batteries The following information is indicated by LED. • Check ECG electrodes The transmitter channel can be changed by the QI-901PK Channel Writer. To change the channel number, refer to the channel writer manual. WARNING The following actions must be taken to properly receive the transmitter signal of the correct patient on the receiving instrument, otherwise, there may be signal loss or signals may mix causing a serious accident, such as monitoring a different patient. • Assign a channel administrator in the hospital and only he or she should manage channel assignments. • 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 the signal is properly received. Operator's Manual ZM-920PA/930PA • The channel administrator must replace the channel number label on the transmitter with the new one after changing the channel. CAUTION • Do not use the same channel for different patients, otherwise, two patients’ data will be lost due to mutual modulation interference, or the wrong 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 in the transmitter and there may be interference. NOTE • 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 ZM-920PA/930PA Panel Description Top Panel For attaching a strap ZM-930PA only SpO2 socket Connects to the SpO2 probe. Refer to the warnings below Refer to the symbol page Refer to the symbol page Refer to the warnings below ECG/RESP socket Connects to the electrode lead for measuring ECG and/or respiration by the impedance method. WARNING • Before performing defibrillation, check that the electrode leads and SpO2 probe attached to the patient are properly connected to the transmitter. Touching the metal parts of disconnected leads and probes may cause 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 and probes connected to the patient. Failure to follow this warning may result in serious electrical burn, shock or other injury. Operator's Manual ZM-920PA/930PA Front Panel ZM-920PA Power switch Turns transmitter power on or off. Replace batteries LED Lights when the batteries need replacement. RA LA LL Va Vb Check electrodes LED Lights when the electrode is detached from the patient. USAch 9002 608.025 MHz CALL key When this key is pressed, a "peep" sounds at the transmitter, and "CALL" message appears at the monitor. Depending on the settings on the monitor, an ECG waveform is recorded when this key is pressed. Channel lable Refer to the warning below. Battery case Contains two 1.5 V dry cell batteries (AA). WARNING Close the battery case cover during operation. If the transmitter is used with the battery case cover open, the patient may get an electrical shock when defibrillation is performed, and electrostatic discharge by the patient may intermittently interfere with the waveform or data. CAUTION Only use your finger to press the CALL key. Do not press the key with a sharp object, otherwise the key may be damaged. Operator's Manual ZM-920PA/930PA ZM-930PA For the descriptions except for the LCD, refer to the “ZM-920PA” section on the previous page. RA LA LL Va Vb USAch 9002 608.025 MHz LCD Battery replacement mark: Appears when the batteries are weak. Immediately replace the batteries when this appears. %SpO2: Displayed when the power is turned on. This indication is not displayed when SpO2 display is turned off. Pulse level bar graph: Displays pulse level in 7 steps. SpO2 data: Displays SpO2 data. When SpO2 is 41 to 100%, the value is displayed. (ex. ) When SpO2 is under 40%, “ ” is displayed. When the detected pulse is too small to measure, “ ” is displayed. Operator's Manual ZM-920PA/930PA Important Safety Information General WARNING • Never use this transmitter 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 transmitter in a high-pressure oxygen medical care tank. Failure to follow this warning may cause explosion or fire. • Never take this transmitter into an MRI test room. • Before performing defibrillation, check that the electrode leads and SpO2 probe attached to the patient are properly connected to the transmitter. Touching the metal parts of disconnected leads and probes may cause 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, the equipment connected to the patient, nor the metal parts of leads and probes connected to the patient. Failure to follow this warning may result in serious electrical burn, shock or other injury. • When performing defibrillation, discharge as far as possible from electrodes on the patient. If there is a possibility that the defibrillator paddle could touch electrodes, remove electrodes from the patient. If the defibrillator directly contacts the electrodes, the discharged energy may cause serious electrical burn to the patient. • When using this transmitter with an electrosurgery unit, its return plate and the electrodes for monitoring must be firmly attached to the patient. If the return plate is not attached correctly, it may burn the patient’s skin where the electrodes are attached. Refer to the instruction manual for the ESU. • Close the battery case cover during operation. If the transmitter is used with the battery case cover open, the patient may get an electrical shock when defibrillation is performed, and electrostatic Operator's Manual ZM-920PA/930PA discharge by the patient may intermittently interfere with the waveform or data. CAUTION • Use Nihon Kohden specified electrode leads and SpO2 probes to assure maximum performance from your instrument. • 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 cause injury to a person or damage surrounding instruments. • Attach a strap to the transmitter to prevent the transmitter from falling. • Turn off the power of cellular telephones, small wireless devices and other devices which produce strong electromagnetic interference around a patient. Radio waves from devices such as cellular telephones or small wireless devices may be mistaken as pulse waves and incorrect data may be displayed. • Do not use the same channel for different patients. This could produce a mutual modulation interference resulting in loss of data from both patients or the incorrect patient’s data can appear on the receiving monitor screen. • Do not use transmitters of adjacent channels in a hospital, otherwise, radio waves from one transmitter may affect the receiver of the adjacent channel’s transmitter and can cause interference. Operator's Manual ZM-920PA/930PA 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 flammable. • Never short-circuit the + and − terminals. This can produce overheating and with its flammable capabilities can produce a fire. • Make sure that the patient does not touch the batteries. CAUTION Battery replacement must be performed by medical staff. When replacing batteries in the transmitter currently used for a patient, disconnect electrode leads from the transmitter before replacing batteries. Do not touch the patient during replacement. Transmitter Channel Management WARNING The following actions must be taken to properly receive the transmitter signal of the correct patient on the receiving instrument, otherwise, there may be signal loss or signals may mix causing a serious accident, such as monitoring a different patient. • Assign a channel administrator in the hospital and only he or she should manage channel assignments. • 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 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 ZM-920PA/930PA For Patients Using 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 defibrillator, there may be time delay between the monitor and the other equipment and spike noise may interfere with the output signal and be mistaken as a trigger. Operator's Manual ZM-920PA/930PA ECG Monitoring CAUTION • Use Nihon Kohden specified consumables. With electrodes other than specified ones, the CHECK ELECTRODE message appears and monitoring may stop. • When the “ELECTRODE OFF” or “CHECK ELECTRODE” message is displayed on the receiving monitor, check electrodes and electrode leads. While “ELECTRODE OFF” or “CHECK ELECTRODE” message is being displayed, there is no ECG monitoring or alarms. SpO2 Monitoring WARNING • Measurement may be incorrect in the following cases. · When the oxyhemoglobin or methemoglobin (HbCO, Met Hb) increases abnormally. · When dye is injected in the blood. · When using an electrosurgical unit. · During CPR. · When measuring at a site where there are venous pulses. · When there is body movement. · When the pulse wave is small. • Check the circulation condition by observing the skin color of the measuring site and pulse waveform. Change the measuring site every 8 hours for disposable probes and every 4 hours for reusable probes. The skin temperature may increase at the attached site by 2 or 3°C (4 or 5°F) and cause a burn or pressure necrosis. When using the probe on the following patients, take extreme care and change the measurement site more frequently according to symptoms and degree. · A patient with a fever · A patient with peripheral circulation insufficiency · Neonate or low birth weight infant with delicate skin 10 Operator's Manual ZM-920PA/930PA • To avoid poor circulation, do not wrap the tape too tight. Check the blood circulation condition by observing the skin color and congestion at the skin peripheral to the probe attachment site. Even for short-term monitoring, there may be burn or pressure necrosis from poor blood circulation, especially on neonates or low birth weight infants whose skin is delicate. Accurate measurement cannot be performed on a site with poor peripheral circulation. • When not monitoring SpO2, disconnect the SpO2 probe cord from the transmitter. Otherwise, noise may interfere from the probe sensor and cause incorrect data to be displayed on the transmitter and receiving monitor. CAUTION • Do not pull or bend the probe cable or put caster feet on the probe cable. Do not immerse the probe cable in detergents or water. Failure to follow these cautions may cause cable discontinuity, short circuit, skin burn on the patient or incorrect measurement data. Replace any broken probe with a new one. • When the attachment site is wet with blood or when the patient has nail polish on, remove the dirt and nail polish before attaching the probe. The transmitted light may decrease due to the blood or nail polish and the measurement data may be incorrect. • If the skin gets irritated or redness appears on the skin by the probe, change the attachment site. • When the probe is attached to an appropriate site with sufficient circulation and an error message confirming the probe attachment repeatedly appears, the probe may be deteriorated. Replace it with a new one. • Do not use the probe over its stated lifetime. Otherwise the SpO2 measurement accuracy cannot be guaranteed. • Use the disposable probe only for one patient. Never reuse the disposable probe for another patient because it causes cross infection. • Do not use damaged or disassembled probe. Measured data may be incorrect. Operator's Manual ZM-920PA/930PA 11 • When measuring under strong light (surgical light, bilirubin light, sunlight, etc.), cover the probe with a blanket or cloth. Otherwise, noise may interfere. • When any of the following occurs, the probe may be broken. Replace it with a new one and check the probe. • The transmitter generates “pip” sound every 0.25 seconds. • SpO2 data is 85% and blinking. Disposable SpO2 Probes CAUTION • Replace the probe with a new one as specified in the probe manual. If the probe is deteriorated, correct SpO2 monitoring cannot be performed. • When using a disposable probe, be careful when removing the adhesive tape from neonatal skin. • When removing a disposable probe taped to the skin, do not pull from the cable of the probe because this can damage the probe’s cable connection. TL-260T Multi-site Y Probe CAUTION • Before use, be sure to attach the probe to the sponge attachment tape S or L. Do not use the probe without the sponge attachment tape attached. It causes incorrect measurement and may damage the attachment site on the skin. • When fixing the probe with the sponge attachment tape, confirm that the adhesive part of the tape is not on the skin. The adhesive may cause oversensitive symptoms on the skin such as redness or itch. If the adhesive touches the skin, remove it carefully and slowly because neonatal skin is very delicate. • Do not use a dirty sponge attachment tape. The measurement value may be incorrect. 12 Operator's Manual ZM-920PA/930PA • Do not pull from the cable when removing the probe from the sponge attachment tape because this can damaged the cable. Maintenance WARNING If detergents or dirty liquid spills into the transmitter, clean it and dry it completely before use. If the 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. If there is a problem with the transmitter after maintenance and inspection, contact your Nihon Kohden distributor. Reusable Probes CAUTION • Do not soak the probe in cleaning solution. It is not waterproof. • Do not use creosol soap, glutaraldehyde, sodium hypochlorite, or benzalkonium chloride, as these substances may damage the probe. Disposable Probes CAUTION • Do not soak the probe in cleaning solution. It is not waterproof. • Do not use any disinfecting alcohol. It can damage the probe. Operator's Manual ZM-920PA/930PA 13 Preparation Installing (Replacing) Batteries Use two AA type alkaline dry cell batteries, manganese dry cell batteries, NiCd rechargeable batteries or NiMH batteries. With new alkaline batteries, the transmitter can continuously measure ECG, respiration and SpO2 for approximately 3 days or ECG and respiration for approximately 4 days. Operation time depends on the thickness of SpO2 probe attachment site. NOTE The capacity of manganese, NiCd and NiMH batteries is less than that of alkaline batteries, therefore the lifetime of the battery 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) CAUTION Battery replacement must be performed by medical staff. When replacing batteries in the transmitter currently used for a patient, disconnect electrode leads from the transmitter before replacing the batteries. Do not touch the patient during replacement. If electrode leads are attached to the patient and the person replacing the batteries touches the patient, the patient leakage current over the amount allowed may occur. CAUTION • Replace both batteries at the same time. • Do not use different types of batteries together. 14 Operator's Manual ZM-920PA/930PA NOTE + and − Insert the batteries with the correct polarity (+ −). Procedure 1. Open the battery case cover. 2. Insert two dry cell batteries (LR6) into the battery case observing the correct polarity. 3. Close the cover and press it gently until it clicks. 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 flammable. • If the contents of the battery contacts the skin or clothes, wash immediately and thoroughly with running water. • Never short-circuit the + and − terminals. This can produce overheating and with its flammable capabilities can produce a fire. • Make sure that the patient does not touch the batteries. CAUTION When the transmitter is not in use, remove batteries or turn the power OFF. With the power ON, battery power is consumed even if measurement is not performed. The batteries may become unusable from overdischarge, and leakage from the battery may damage the transmitter. Operator's Manual ZM-920PA/930PA 15 NOTE • When using rechargeable NiCd batteries or NiMH batteries, shallow charging/discharging shortens battery capacity. For details, refer to the battery operator’s manual. • Remove the batteries from the transmitter before disposing of the transmitter. Situations Requiring Battery Replacement Replace the batteries when any of the following occurs. • The “ ” LED lights (ZM-920PA) or the “ ” mark is displayed on the LCD (ZM-930PA) on the transmitter. • The transmitter generates a constant alarm (continuous “peep” sound). • The monitor displays the battery replacement message on the screen. • When the power of the LCD transmitter is turned on, no message or icon is displayed. (Only the ZM-930PA). Attaching a Strap to the Transmitter To open the clip, firmly pull out the tab in direction of the arrow. NOTE • Attach a strap to the transmitter to prevent the transmitter from falling. • Do not attach the clip to hard objects such as thick cloths or zippers, or the clip may break. Attach a strap to the transmitter and fasten the clip to the patients’ clothes or bed sheets. If the transmitter falls off, the battery cover may be opened. If the patient touches the terminals of the batteries, patient leakage current over the allowable amount can occur. 16 Operator's Manual ZM-920PA/930PA Turning On/Off the Transmitter Check Items Before Turning On the Power To use the instrument in a safe and optimum condition, before turning on the transmitter power switch, check the following. Appearance • There is no damage or dirt on the outside of the transmitter. (Power switch, LED, LCD, CALL key, junction, battery case cover, battery case, etc.) • The transmitter is completely dry. • The electrode lead is not broken. • There is no damage or dirt on the SpO2 probe or on the disposable electrodes. Battery • The battery polarity is correct. • The battery case spring is firmly fixed and the battery is not loose. • The battery case cover is firmly closed. Channel Setting • The transmitter channel corresponds to those of the receiving monitor. • The same channel is not being used on a different transmitter in the surrounding area. Turning On/Off the Power ON To turn on the power, turn the power switch to the right. After a “peep” sound for about one second, the power is turned on. (There is no “peep” sound when the “ ” LED light or the “ ” are blinking on the LCD). OFF To turn off the power, turn the power switch to the left. Check Items After Turning On the Power After turning on the power, check the following items. Power On • The power switch is not damaged. • The transmitter generates a “peep” sound for about one second. Operator's Manual ZM-920PA/930PA 17 • • • • • All LEDs light and values are displayed on the LCD for about one second. The transmitter does not generate a continuous “pip” sound. The transmitter does not liberate excessive heat. The “ ” LED does not light or the “ ” mark is not displayed on the LCD. 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 “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. Check Items After the Power Off • ECG electrode leads and SpO2 probe 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. 18 Operator's Manual ZM-920PA/930PA ECG Monitoring When 6 leads are used on this transmitter, up to 8 lead (I, II, III, aVR, aVL, aVF, Va and Vb) of ECG waveforms can be displayed on the receiving monitor. The heart rate is also measured. When 3 leads are used, one channel ECG waveform of lead II can be displayed on the receiving monitor. Refer to the operator’s manual of the monitor for details. 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. * Minute ventilation is sensed in rate-adaptive pacemakers by a technology known as bioelectric impedance measurement (BIM). Many medical devices in addition to pacemakers use this technology. When one of these devices is used on a patient with an active, minute ventilation rate-adaptive pacemaker, the pacemaker may erroneously interpret the mixture of BIM signals created in the patient, resulting in an elevated pacing rate. For more information, see the FDA web site. http://www.fda.gov/cdrh/safety.html Operator's Manual ZM-920PA/930PA 19 WARNING When using the transmitter with an ESU, the ESU return plate and the electrodes for monitoring must be firmly attached to the patient. If the return plate is not attached correctly, it may burn the patient’s skin where the electrodes are attached. Refer to the instruction manual for the ESU. NOTE • This transmitter is not protected against noise generated from an electrosurgery unit. • If an electric blanket is used and incorrect heart rate is displayed on the monitor, turn off the pacing pulse detection on the monitor. ECG Measurement Procedure 1. Select the type of electrode lead and disposable electrode according to the purpose. 2. Connect the electrode lead to the ECG/RESP socket. 3. Connect disposable electrodes to the electrode lead and attach electrodes to the patient. After steps 1 to 3 are finished, ECG monitoring automatically starts. 20 Operator's Manual ZM-920PA/930PA Selecting Electrode Lead and Disposable Electrode CAUTION Use Nihon Kohden specified consumables. With electrodes other than specified ones, the CHECK ELECTRODE message appears and monitoring may stop. Option Electrode lead BR-916PA BR-906PA 6 electrodes, snap type BR-913PA 6 electrodes, clip type BR-903PA 3 electrodes, snap type 3 electrodes, clip type Operator's Manual ZM-920PA/930PA 21 Connecting the Electrode Lead to the Transmitter Connect the electrode lead to the ECG/RESP 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 cause injury to 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. 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 the “Electrode Position for Respiration Monitoring” section. 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. 22 Operator's Manual ZM-920PA/930PA Six Electrodes Electrode Position The 6-electrode method with lead II and lead V5 is effective for monitoring myocardial ischemia. You can improve monitoring accuracy considerably by adding lead V4 to this combination. Va and Vb can be at any position of the standard 12 leads V1 to V6, but V4 and V5 are most appropriate for myocardial ischemic monitoring. LA RA Va N (RL) Symbol Vb LL Lead Color (Clip Color) Electrode Position RA White (White) Right infraclavicular fossa LA Black (Black) Left infraclavicular fossa LL Red (Red) N (RL) Green (Green) Va Brown (Brown) (BR-906PA) Brown-blue (BR-916PA) Vb Brown (Brown) (BR-906PA) Brown-orange (BR-916PA) Operator's Manual ZM-920PA/930PA Lowest rib on the left anterior axillary line Right anterior axillary line at the same level as LL Fifth intercostal space on the left midclavicular line. (V4 position of standard 12 leads) Left anterior axillary line at the same level as Va. (V5 position of standard 12 leads) 23 Lead Position Standard limb leads Lead I RA Lead II LA Lead III RA LL N (RL) Monopolar limb leads aVR lead N (RL) aVL lead aVF lead RA LA RA LA N (RL) LA LL LL LL N (RL) LA LL LL N (RL) RA RA LA N (RL) Monopolar chest leads V1 to V6 leads to RA LA LL N (RL) When Using 4 to 6 DIN Type Leads to Monitor 6 Lead ECG When the BR-906PA/916PA electrode ON leads are not used, the transmitter is fixed to 3 lead ECG monitoring. To monitor 6 lead ECG using 4 to 6 DIN type leads, the transmitter must be fixed to 6 lead monitoring. To fix transmitter to the 6 lead ECG monitoring, turn off the transmitter CALL key power, press and hold the CALL key and turn on the transmitter power. 9002 RA LA LL Va Vb USAch 608.025 MHz When the transmitter power is turned off and on again, the monitoring mode returns to the original mode. 24 Operator's Manual ZM-920PA/930PA Three Electrodes By using the optional BR-913PA/903PA electrode lead, 3 lead ECG monitoring is available. Electrode Position • Lead MII, which is similar to standard lead II, used when ECG measurement has priority Electrode Position Symbol Lead Color Left infraclavicular fossa LA (N) Black RA (−) Right infraclavicular fossa White Below lowest rib on the LL (+) Red left anterior axillary line • Lead MI, which is similar to standard lead I Change LL and LA of the lead MII. • Lead MIII, which is similar to standard lead III Change RA and 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. Operator's Manual ZM-920PA/930PA 25 Connecting the Electrode Lead and Disposable Electrodes Preparing the Patient Skin Shave off excessive body hair. To reduce skin impedance, clean the electrode site with cream or with a cotton pad moistened with the electrode site with cream or with a cotton pad 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. 1. 26 Connect the electrode lead to the electrode. Operator's Manual ZM-920PA/930PA 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. Detection and Display of Measurement Condition Electrode Detachment The “ ” LED lights on the transmitter or the “CHECK ELECTRODE” message is displayed on the screen of the monitor in the following cases. • Electrode is detached from skin. • Electrode lead is disconnected from the electrode. • Polarization voltage between the electrode and skin is excessively high. In these cases, check the cause and if necessary, replace electrodes with new ones. CAUTION When the “ELECTRODE OFF” or “CHECK ELECTRODE” message is displayed on the receiving monitor, check electrodes and electrode leads and remove the cause. While “ELECTRODE OFF” or “CHECK ELECTRODE” message is being displayed, there is no ECG monitoring and no alarms. Operator's Manual ZM-920PA/930PA 27 Respiration Monitoring Respiration is monitored by measuring changes in impedance between the RA and LL ECG electrodes. This transmitter sends the changes in impedance to the monitor as a respiration waveform. The monitor displays the respiration waveform and calculates respiration rate. Refer to the operator’s manual of the monitor for details. 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. * Minute ventilation is sensed in rate-adaptive pacemakers by a technology known as bioelectric impedance measurement (BIM). Many medical devices in addition to pacemakers use this technology. When one of these devices is used on a patient with an active, minute ventilation rate-adaptive pacemaker, the pacemaker may erroneously interpret the mixture of BIM signals created in the patient, resulting in an elevated pacing rate. For more information, see the FDA web site. http://www.fda.gov/cdrh/safety.html 28 Operator's Manual ZM-920PA/930PA Respiration Measurement Procedure 1. Select the electrode lead and disposable electrodes. 2. Connect the electrode lead to the ECG/RESP socket. 3. Connect disposable electrodes to the electrode lead and attach electrodes to the patient. After steps 1 to 3 are finished, respiration monitoring automatically starts. Electrode Position for Respiration Monitoring Place the RA and LL electrodes so that the lungs are between the electrodes. 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. Electrode Position Examples NOTE The following examples are when monitoring with 3 electrodes. ECG cannot be monitored correctly when electrodes are attached as the following examples when monitoring with 6 electrodes. Position 1 In this position, respiration measurement is available; however, there is a difference in amplitude between different patients. RA LL Right infraclavicular fossa Fifth intercostal space on the left midclavicular line, V4 Operator's Manual ZM-920PA/930PA 29 Position 2 In this position, the waveform amplitude is usually large and the ECG lead is similar to Lead MII. This position can be generally recommended. RA LL Right infraclavicular fossa Fifth intercostal space on the left midaxillary line, V6 Position 3 In this position, the respiration waveform is optimum, but the ECG lead is unusual. RA LL Right midaxillary at the horizontal level of V4 Fifth intercostal space on the left midaxillary line, V6 Position 4 In this position, the respiration measurement is influenced by the impedance variation of the abdomen, so the cardiac pulse wave included in the respiration wave is reduced. Note that the waveform is inverted in phase compared with the chest movement (the waveform goes down during inspiration). It is difficult to measure the ECG at the same time. RA LL Lowest rib on the right anterior axillary line 30 Lowest rib on the left anterior axillary line Operator's Manual ZM-920PA/930PA SpO2 Monitoring The SpO2 monitoring is only available on the ZM-930PA transmitter. This transmitter sends SpO2 and pulse waveform to the monitor and displays SpO2 data and pulse level bar graph on the LCD. Refer to the operator’s manual of the monitor for details. WARNING • Measurement may be incorrect in the following cases. · When the oxyhemoglobin or methemoglobin (HbCO, Met Hb) increases abnormally. · When dye is injected in the blood. · When using an electrosurgical unit. · During CPR. · When measuring at a site where there are venous pulses. · When there is body movement. · When the pulse wave is small. • Check the circulation condition by observing the skin color of the measuring site and pulse waveform. Change the measuring site every 8 hours for disposable probes and every 4 hours for reusable probes. The skin temperature may increase at the attached site by 2 or 3°C (4 or 5°F) and cause a burn or pressure necrosis. When using the probe on the following patients, take extreme care and change the measurement site more frequently according to symptoms and degree. · A patient with a fever · A patient with peripheral circulation insufficiency · Neonate or low birth weight infant with delicate skin • To avoid poor circulation, do not wrap the tape too tight. Check the blood circulation condition by observing the skin color and congestion at the skin peripheral to the probe attachment site. Even for short-term monitoring, there may be burn or pressure necrosis from poor blood circulation, especially on neonates or Operator's Manual ZM-920PA/930PA 31 low birth weight infants whose skin is delicate. Accurate measurement cannot be performed on a site with poor peripheral circulation. • When not monitoring SpO2, disconnect the SpO2 probe cord from the transmitter. Otherwise, noise may interfere from the probe sensor and cause incorrect data to be displayed on the transmitter and receiving monitor. CAUTION • Do not pull or bend the probe cable or put caster feet on the probe cable. Do not immerse the probe cable in detergents or water. Failure to follow these cautions may cause cable discontinuity, short circuit, skin burn on the patient or incorrect measurement data. Replace any broken probe with a new one. • Turn off the power of cellular telephones, small wireless devices and other devices which produce strong electromagnetic interference around a patient. Radio waves from devices such as cellular telephones or small wireless devices may be mistaken as pulse waves and the displayed data may be incorrect. NOTE When monitoring SpO2, monitor ECG at the same time. The ECG electrode lead works as an antenna for transmitting data from the transmitter to the receiving monitor. If ECG is not measured, the telemetry signal may not be received. 32 Operator's Manual ZM-920PA/930PA Measurement Procedure 1. Select the SpO 2 probe. 2. Connect the SpO2 probe to the SpO2 socket. 3. Attach the SpO2 probe to the patient. After steps 1 to 3 are finished, SpO2 monitoring automatically starts. Selecting SpO2 Probe Select an appropriate probe for the patient. CAUTION Use Nihon Kohden specified SpO2 probe to assure maximum performance from your instrument. Operator's Manual ZM-920PA/930PA 33 Reusable Probes Model Finger Probe TL-201T Subject (Weight) Attachment Site Adults, children Finger (Weight more than 20 kg) Finger Probe TL-101T Adults, children Finger or toe (Weight more than 20 kg) Multi-site Probe TL-120T Adults, children, Finger or toe infants (Weight more than 3 kg) Foot Probe TL-121T Infants, neonates Instep and sole (Weight less than 3 kg) 34 Operator's Manual ZM-920PA/930PA Disposable Probes CAUTION Use the disposable probe only for one patient. Never reuse the disposable probe for another patient because it causes cross infection. Model TL-251T Subject (Weight) Attachment Site Adults Finger or toe (Weight more than 30 kg) TL-252T Children Finger or toe (Weight from 3 to 40 kg) TL-253T Neonates Instep and sole (Weight less than 3 kg) TL-260T Adults, children Finger or toe (Weight more than 3 kg) Neonates Instep and sole (Weight less than 3 kg) Operator's Manual ZM-920PA/930PA 35 Model TL-051S/052S Subject (Weight) Attachment Site Adults Finger (Weight more than 50 kg) Neonates Cable length Instep and sole TL-051S: 80 cm (Weight less than 3 TL-052S: 160 cm kg) TL-061S/062S Adults, children Finger (Weight from 15 to 50 kg) Children, infants Cable length TL-061S: 80 cm (Weight from 3 to TL-062S: 160 cm 15 kg) Toe Connecting SpO2 Probe to the Transmitter Connect the probe to the SpO2 socket on the transmitter. CAUTION • Do not shake or swing the transmitter holding the cables connected to the transmitter. Otherwise, the transmitter may come off and cause injury to a person or damage surrounding instruments. • Hold the connector when connecting/disconnecting the probe. If you disconnect the SpO2 probe holding the cable, it damages the cable. 36 Operator's Manual ZM-920PA/930PA Attaching the Probe to the Patient For details, refer to the operator’s manual of each probe. WARNING To avoid poor circulation, do not wrap the tape too tight. Check the blood circulation condition by observing the skin color and congestion at the skin peripheral to the probe attachment site. Even for short-term monitoring, there may be burn or pressure necrosis from poor blood circulation, especially on neonates or low birth weight infants whose skin is delicate. Accurate measurement cannot be performed on a site with poor peripheral circulation. CAUTION • When the attachment site is wet with blood or when the patient has nail polish on, remove the dirt and nail polish before attaching the probe. The transmitted light may decrease due to the blood or nail polish and the measurement data may be incorrect. • If the skin gets irritated by the tape or redness appears on the skin by the probe, change the attachment site. • When the probe is attached on an appropriate site with sufficient circulation and the error message confirming the probe attachment repeatedly appears, the probe may be deteriorated. Replace it with a new one. • Do not use the probe over its stated lifetime. Otherwise the SpO2 measurement accuracy cannot be guaranteed. • Do not use damaged or disassembled probe. • Replace the probe with a new one as specified in the probe manual. If the probe is deteriorated, correct SpO2 monitoring cannot be performed. • Do not attach the probe to the same limb that is used for NIBP measurement or an IBP catheter. • When attached, make sure that the photo emitter and the detector of the probe face each other. Otherwise, SpO2 cannot be measured properly. Operator's Manual ZM-920PA/930PA 37 • When using a disposable probe, be careful when removing the adhesive tape from neonatal skin. • When removing a disposable probe that is taped to the skin, do not pull the cable part of the probe because this can damage the probe’s cable connection. • Before using the TL-260T multi-site Y probe, be sure to attach the probe to the sponge attachment tape S or L. Do not use the probe without the sponge attachment tape attached. It causes incorrect measurement and may damage the attachment site on the skin. • When fixing the TL-260T multi-site Y probe with the sponge attachment tape, confirm that the adhesive part of the tape is not on the skin. The adhesive may cause oversensitive symptoms on the skin such as redness or itch. If the adhesive touches the skin, remove it carefully and slowly because neonatal skin is very delicate. • Do not use a dirty sponge attachment tape. The measurement value may be incorrect. • Do not pull the cable when removing the TL-260T multi-site Y probe from the sponge attachment tape. Otherwise the cable may get damaged. • Refer to the probe instruction manual for details. Starting Measurement When monitoring starts, SpO2 and pulse waveform are sent to the monitors and SpO2 data and pulse level bar graph are displayed on the transmitter LCD. You can turn off the display of SpO2 data and pulse level bar graph on the LCD. Refer to the “Turning SpO2 Data and Pulse Level Bar Graph Display On/Off” section. CAUTION When the probe is attached on an appropriate site with sufficient circulation and the error message confirming the probe attachment repeatedly appears, the probe may be deteriorated. Replace it with a new one. 38 Operator's Manual ZM-920PA/930PA Turning SpO2 Data and Pulse Level Bar Graph Display On/Off You can turn off the display of SpO2 data and pulse level bar graph on the LCD. SpO2 display off Press the CALL key for more than 3 seconds within 10 seconds after turning transmitter power on (after a “peep” sound). CALL key RA LA LL Va Vb “%SpO2” is not displayed. When SpO2 monitoring starts, SpO2 data and pulse level bar graph are not displayed on the LCD. USAch 9002 608.025 MHz To turn SpO2 display on, turn the transmitter power off and turn the power on again. Detecting and Displaying Measurement Condition External Light Noise Alarm CAUTION When measuring under strong light (surgical light, bilirubin light, sunlight, etc.), cover the probe with a blanket or cloth. Otherwise, noise may interfere. Strong external light (surgical light or inverter type fluorescent lamp, etc.), may affect SpO2 monitoring. When external light is too strong to correctly measure SpO2, the transmitter generates an alarm tone (“pip” sound every 0.5 seconds). Cover the probe attachment site with blanket or cloth. Operator's Manual ZM-920PA/930PA 39 Insufficient Light Alarm When sufficient light cannot be obtained from the photo emitter of the probe, the transmitter generates the following sound and indication. (4) (1) “peep” sound (every 1 second) (2) (2) pulse level bar graph is maximum (all bars are lit.) (3) SpO2 data is displayed as “ ” (4) %SpO2 is blinking. (3) In this case, change the attachment site to the appropriate site. Refer to the operator’s manual of the SpO2 probe. Probe Malfunction Alarm CAUTION When any of the following occurs, the probe may be broken. Replace it with a new one and check the probe. • The transmitter generates “pip” sound every 0.25 seconds. • SpO2 data is 85% and blinking. When Measurement Condition is Unstable SpO2 data blinks every 1 second when SpO2 signal stability decreases and the transmitter cannot detect correct pulse waveform because of patient body movement, poor attachment condition or poor circulation condition at the probe attachment site. CAUTION SpO2 data blinking every second indicates an unstable pulse waveform and displayed SpO2 value may be inaccurate. The displayed data may not reflect sudden SpO2 changes. 40 Operator's Manual ZM-920PA/930PA Alarm List (5) %SpO2 indication (1) Displayed as LED on ZM-920PA (4) pulse level bar graph (2) Sound Single “peep” sound for 4 s --- (1) Continuous “peep” sound All lights are off --- Intermittent “pip” sound every 0.5 s Display --- (2) RA LA LL Va Vb (3) SpO2 data Cause Countermeasure The CALL key is pressed. The sound lasts while the key is pressed. The battery voltage decreases and battery charge is almost zero. Battery is completely discharged. Electrode lead is disconnected from the electrode. Electrode lead is disconnected from the transmitter. Electrode lead discontinuity --- Electrode is not firmly attached to the skin. Polarization voltage is abnormally high. SpO2 measurement site is under fluorescent light, surgical light, sunlight, etc. Operator's Manual ZM-920PA/930PA Replace the batteries with new ones. Replace the batteries with new ones. To stop the sound, turn off the power. Firmly connect the electrode lead to the electrode. Firmly connect the electrode lead to the transmitter. Replace the electrode lead with a new one. Replace the electrode with a new one. Cover the measurement site with a blanket or cloth. 41 Sound Intermittent “peep” sound every 1 s Display (3) (4) all lit (5) blinking Cause Cannot receive sufficient light from the probe photo emitter. Intermittent “pip” sound every 0.25 s --- (3) 85%, blinking Broken probe (3) blinking Patient body movement Probe is not attached securely. 42 Countermeasure Attach probe to a site with 6 to 14 mm thickness where sufficient light can be received. Replace the probe with a new one. Remove the cause by checking the patient condition and changing the attachment site. Securely attach the probe. Operator's Manual ZM-920PA/930PA 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 LCD after turning the power on. (ZM-930PA only) 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. SpO2 display is turned off. The channel of the transmitter and monitor does not match. Electrode lead is not connected to the transmitter. Another transmitter of the same channel is used near by. Signals are mixing. The transmitter is damaged. Operator's Manual ZM-920PA/930PA Countermeasure Install the batteries correctly. Replace the batteries with new ones. Turn off the power, and turn on the power again. Set the correct channel on the monitor. Connect the electrode lead to the transmitter. ECG electrode lead works as an antenna for transmitting data to the receiving monitor. If ECG is not measured, the signal may not be received. 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. Contact your Nihon Kohden distributor. 43 Problem 3 electrode leads are properly attached to the patient but LEDs light. Heart rate of the patient who is using an electric blanket cannot be monitored on the receiving monitor. ECG baseline is thick. (Hum is overlapping) Respiration waveform measurement is unstable. SpO2 data is unstable and not reliable. Cause The transmitter is fixed to 6 lead monitoring. Countermeasure Turn off and on the transmitter power. Pacing pulse detection is set to ON on the monitor. Turn off the pacing pulse detection. The gel on the electrode is dried out. The gel on the electrode is coming off. Electric blanket is used. Replace the electrode with a new one. Hum filter is set to OFF on the monitor The gel on the electrode is dried out. The gel on the electrode is coming off. The probe size is not appropriate for the patient. Probe is attached to the same limb that is used for NIBP measurement. Probe attachment condition is poor. Probe is about to detach from the skin. External light gets in. Measurement site is dirty. Patient is wearing nail polish. 44 Cover the blanket with a shield cover. Set the filter to ON. Replace the electrode with a new one. Use the appropriate probe for the patient. Attach the probe to the opposite limb. Avoid a site where blood circulation condition changes greatly. Firmly attach the probe according to the procedure in the probe operator’s manual. Remove dirt and nail polish. Operator's Manual ZM-920PA/930PA Changing the Transmitter Channel The transmitter channel can be changed by the QI-901PK Channel Writer. To change the channel number, refer to the channel writer manual. WARNING The following actions must be taken to properly receive the transmitter signal of the correct patient on the receiving instrument. Otherwise, there may be signal loss or signals may mix causing a serious accident, such as monitoring a different patient. • Assign a channel administrator in the hospital and only he or she should manage channel assignments. • 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 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 ZM-920PA/930PA 45 Lifetime and Disposal Disposing of Used Batteries Replacement When the “ ” LED is lit or the “ ” is displayed on the LCD during operation, the batteries are running out. Replace the batteries with new ones. When using rechargeable batteries, recharge them. Disposal Before disposing of the 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. 46 Operator's Manual ZM-920PA/930PA Disposing of the SpO2 Probe Lifetime CAUTION • Do not use the probe over its stated lifetime. Otherwise the SpO2 measurement accuracy cannot be guaranteed. • When the probe is attached on an appropriate site with sufficient circulation and the error message confirming the probe attachment repeatedly appears, the probe may be deteriorated. Replace it with a new one. Reusable probe Do not use the probe for more than one year after opening the package. If the hours are recorded, you can use the probe for up to 6,000 hours. Warranty for reusable probe Nihon Kohden Corporation (NKC) shall warrant this probe against all defects in materials and workmanship for a period of 6 months after the package is opened. NKC or its authorized agents will repair or replace any probe which proves to be defective during the warranty period, provided the probe is used in accordance with the operator’s manual. Disposable probe Replace the probe with a new one as specified in the probes operator’s manual. If the probe is used beyond this time, it deteriorates and correct measurement cannot be performed. If the probe is dirty with blood or bodily fluids, replace it with a new one, regardless of the lifetime. Disposal Follow your local laws for disposing of medical waste. Operator's Manual ZM-920PA/930PA 47 Cleaning, Disinfection and Sterilization Transmitter and Electrode Lead WARNING If detergents or dirty liquid spills into the transmitter, clean it and dry it completely before use. If the 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 batteries from the transmitter. • 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. 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 non-abrasive cloth moistened with any of the disinfectants listed on the next page. Use the recommended concentration. 48 Operator's Manual ZM-920PA/930PA Disinfectant Glutaraldehyde solution Hydrochloric alkyl diaminoethylglycine Benzalkonium chloride Benzethonium chloride solution Chlorohexidine gluconate solution Concentration (%) 2.0 0.5 0.2 0.2 0.5 SpO2 Probe Refer to the probe manual. Operator's Manual ZM-920PA/930PA 49 Replacing the Battery Case Cover When the battery case cover is damaged, replace it with a new one. Battery case cover, code no. 6113-046365C. Other than the battery case cover, there are no serviceable parts for the transmitter. Repair Parts Availability Policy Nihon Kohden Corporation (NKC) shall stock repair parts (parts necessary to maintain the performance of the instrument) for a period of 6 years after NKC announces discontinuation of the instrument. In that period, NKC or its distributors will repair the instrument. This period may be shorter than 6 years if the necessary board or part is not available. For discontinuation announcements, contact your Nihon Kohden distributor or representative. 50 Operator's Manual ZM-920PA/930PA Specifications ECG measurement Channels: Input range: DC offset: Input impedance: Pacing pulse detection: Respiration measurement Measuring method: Impedance range: SpO2 measurement Measuring range: Measuring accuracy When the measuring accuracy of the SpO2 probe is not considered: ±5 mV or more ±500 mV or more 5 MΩ or more (5 Hz) ANSI/AAMI EC13 Based upon Pacemaker pulse rejection Capability Impedance method 0 to 2 kΩ 0 to 100%, in 1% steps ±1 digit (80% ≤ SpO2 ≤ 100%) ±2 digit (50% ≤ SpO2 ≤ 80%) Less than 50% is not specified. When the measuring accuracy of the SpO2 probe is considered: ±2 digit (80% ≤ SpO2 ≤ 100%) ±3 digit (70% ≤ SpO2 ≤ 80%) Less than 70% is not specified. Transmitter FCC regulation: Field strength limits: Undesired emission: Operator's Manual ZM-920PA/930PA FCC part 95 Subpart-H Wireless Medical Telemetry Service (WMTS) <200 mV/m (at 3 m) below 960 MHz: 200 µV/m (at 3 m) above 960 MHz: 500 µV/m (at 3 m) 51 Antenna: Transmission channel: Transmission frequency range: Channel spacing: Modulation scheme: Occupied bandwidth: Effective radiated power: Safety standards Safety standard: According to the type of protection against electrical shock: ECG electrode lead indicated on the transmitter 608.0250 to 613.9750 MHz 50 KHz (25 KHz when interleaved) FSK (Frequency Shift Keying) <20 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) INTERNALLY POWERED EQUIPMENT According to the degree of protection against electrical shock: ECG/impedance method respiration: DEFIBRILLATION-PROOF TYPE CF APPLIED PART SpO2: DEFIBRILLATION-PROOF TYPE BF 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 52 Operator's Manual ZM-920PA/930PA 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: Battery lifetime: ZM-930PA: ZM-920PA: two AA type alkaline dry cell batteries, manganese dry cell batteries, NiCd rechargeable batteries, NiMH batteries approximately 3 days (with alkaline batteries, measuring ECG, respiration and SpO2 of approximately 60 kg weight adult male patient at the pointing finger) approximately 4 days (with alkaline batteries, measuring ECG and respiration only) approximately 4 days Environment Operating environment Operating temperature: Operating humidity: Operating atmospheric pressure: Operating voltage: 5 to 40°C, 41 to 104°F 30 to 85% (non-condensing) 70 to 106 kPa 1.6 to 3.2 V Storage environment Storage temperature: Storage humidity: Storage atmospheric pressure: Dimension and Weight Dimension: Weight (without batteries): Operator's Manual ZM-920PA/930PA −20 to 65°C, −4 to 149°F 15 to 95% (non-condensing) 70 to 106 kPa 78 W × 122 H × 26 D (mm) ZM-930PA: about 180 g ZM-920PA: about 165 g 53 Standard Accessories Name Strap 54 Q’ty Supply code Y233 Operator's Manual ZM-920PA/930PA Options CAUTION Use only Nihon Kohden electrodes, electrode leads and SpO2 probes to assure maximum performance from your instrument. ECG/RESP Name Application Electrode lead 3 electrodes, clip type, lead length 80 cm 3 electrodes, snap type, lead length 80 cm 6 electrodes, clip type, lead length 80 cm 6 electrodes, snap type, lead length 80 cm Operator's Manual ZM-920PA/930PA Model Q’ty Supply code BR-903PA K911A BR-913PA K910B BR-906PA K912A BR-916PA K915A 55 SpO2 Name Cable length Finger probe Multi-site probe Foot probe SpO2 probe (disposable, for adult, BLUPRO) SpO2 probe (disposable, for child, BLUPRO) SpO2 probe (disposable, for neonate, BLUPRO) Multi-site Y probe (disposable, for adult, child, neonate, BLUPO) SpO2 probe (disposable, for adult, neonate) SpO2 probe (disposable, for child, infant) COTTONY tape Sponge attachment tape S for TL-260T Sponge attachment tape L for TL-260T Foam tape 56 1.6 Model/ Code No. TL-201T TL-101T TL-120T TL-121T Supply code P225F P224A P225C P225D TL-251T P201A TL-252T P201B TL-253T 0.8 1.6 0.8 1.6 Q’ty P201C TL-260T P205A TL-051S TL-052S TL-061S TL-062S 340703 P228A P228B P229A P229B P259 20 P260A --- --- 24 P260B 4 × 25 package P260 Operator's Manual ZM-920PA/930PA
Source Exif Data:
File Type : PDF File Type Extension : pdf MIME Type : application/pdf PDF Version : 1.3 Linearized : No Create Date : 2002:10:28 00:16:40Z Modify Date : 2002:10:29 17:40:04-05:00 Page Count : 69 Creation Date : 2002:10:28 00:16:40Z Mod Date : 2002:10:29 17:40:04-05:00 Producer : Acrobat Distiller 5.0 (Windows) Author : ro4894 Metadata Date : 2002:10:29 17:40:04-05:00 Creator : ro4894 Title : Cover2 ZM920PA-930PA OM.pmdEXIF Metadata provided by EXIF.tools