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.
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 ........................
Check Items Before Use ............................................................. 14 Appearance ........................................................................... 14 Battery ................................................................................... 14 Channel Setting ..................................................................... 14 Check Items After the Power On ................................................. 14 Power on .........................................................
Lifetime .................................................................................... 31 Disposal .................................................................................. 31 Cleaning, Disinfection and Sterilization ................................................ 32 Transmitter and Electrode Lead ..................................................... 32 Cleaning .................................................................................. 32 Disinfection ...............................
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.
(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.
. 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.
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.
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.
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.
Explanations of the Symbols in this Manual and Instrument The following symbols found in this manual/instrument bear the respective descriptions as given.
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.
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.
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.
Rear Panel Refer 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
• 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.
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.
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.
(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.
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.
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.
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.
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.
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.
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.
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.
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.
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 1 ±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 Medica
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 W
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.
Operator's Manual ZS-910PA 35
Standard Accessories Attach the channel number label to the monitor, too.
Options CAUTION Use only Nihon Kohden electrodes and electrode leads. Otherwise, the message indicating checking electrodes appears and monitoring may stop.
